California 2021-2022 Regular Session

California Assembly Bill AB2055 Compare Versions

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1-Amended IN Assembly April 21, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2055Introduced by Assembly Member LowFebruary 14, 2022 An act to amend Section 208 of, and to amend, repeal, and add Section 209 of, the Business and Professions Code, and to amend, repeal, and add Sections 11164.1, 11165, 11165.1, 11165.2, and 11165.5 of, and to add Section 11164.8 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGESTAB 2055, as amended, Low. Controlled substances: CURES database.Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.SEC. 2. Section 209 of the Business and Professions Code is amended to read:209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
1+CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2055Introduced by Assembly Member LowFebruary 14, 2022 An act to amend Section 208 of, and to amend, repeal, and add Section 209 of, the Business and Professions Code, and to amend, repeal, and add Sections 11164.1, 11165, 11165.1, 11165.2, and 11165.5 of, and to add Section 11164.8 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGESTAB 2055, as introduced, Low. Controlled substances: CURES database.Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.SEC. 2. Section 209 of the Business and Professions Code is amended to read:209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
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3- Amended IN Assembly April 21, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2055Introduced by Assembly Member LowFebruary 14, 2022 An act to amend Section 208 of, and to amend, repeal, and add Section 209 of, the Business and Professions Code, and to amend, repeal, and add Sections 11164.1, 11165, 11165.1, 11165.2, and 11165.5 of, and to add Section 11164.8 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGESTAB 2055, as amended, Low. Controlled substances: CURES database.Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
3+ CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2055Introduced by Assembly Member LowFebruary 14, 2022 An act to amend Section 208 of, and to amend, repeal, and add Section 209 of, the Business and Professions Code, and to amend, repeal, and add Sections 11164.1, 11165, 11165.1, 11165.2, and 11165.5 of, and to add Section 11164.8 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGESTAB 2055, as introduced, Low. Controlled substances: CURES database.Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
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5- Amended IN Assembly April 21, 2022
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7-Amended IN Assembly April 21, 2022
6+
7+
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99 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION
1010
1111 Assembly Bill
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1313 No. 2055
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1515 Introduced by Assembly Member LowFebruary 14, 2022
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1717 Introduced by Assembly Member Low
1818 February 14, 2022
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2020 An act to amend Section 208 of, and to amend, repeal, and add Section 209 of, the Business and Professions Code, and to amend, repeal, and add Sections 11164.1, 11165, 11165.1, 11165.2, and 11165.5 of, and to add Section 11164.8 to, the Health and Safety Code, relating to controlled substances.
2121
2222 LEGISLATIVE COUNSEL'S DIGEST
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2424 ## LEGISLATIVE COUNSEL'S DIGEST
2525
26-AB 2055, as amended, Low. Controlled substances: CURES database.
26+AB 2055, as introduced, Low. Controlled substances: CURES database.
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28-Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.
28+Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor.
2929
3030 Existing law classifies certain controlled substances into Schedules I to V, inclusive. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) database for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the department for inclusion in the database and requires a health care practitioner to consult the CURES database to review a patients controlled substance history before prescribing Schedule II, III, or IV controlled substances to the patient for the first time and at least once every 4 months thereafter if the controlled substance remains part of the treatment plan, except as specified.
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32-This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.
32+This bill, as of April 1, 2023, would transfer the responsibility for administration of the CURES database from the Department of Justice to a department specified by the Governor.
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3434 ## Digest Key
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3636 ## Bill Text
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38-The people of the State of California do enact as follows:SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.SEC. 2. Section 209 of the Business and Professions Code is amended to read:209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
38+The people of the State of California do enact as follows:SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.SEC. 2. Section 209 of the Business and Professions Code is amended to read:209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
3939
4040 The people of the State of California do enact as follows:
4141
4242 ## The people of the State of California do enact as follows:
4343
44-SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
44+SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
4545
4646 SECTION 1. Section 208 of the Business and Professions Code, as amended by Section 6 of Chapter 630 of the Statutes of 2021, is amended to read:
4747
4848 ### SECTION 1.
4949
50-208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
50+208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
5151
52-208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
52+208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
5353
54-208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
54+208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.(2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.(3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.(4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.(5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).(e) This section shall become operative on April 1, 2023.
5555
5656
5757
5858 208. (a) Beginning April 1, 2023, a Controlled Substance Utilization Review and Evaluation System (CURES) fee of nine dollars ($9) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensees license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than nine dollars ($9) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.
5959
6060 (b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.
6161
6262 (2) Licensees issued a license that has been placed in a retired or inactive status pursuant to a statute or regulation are exempt from the CURES fee requirement in subdivision (a). This exemption shall not apply to licensees whose license has been placed in a retired or inactive status if the licensee is at any time authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances.
6363
6464 (3) Wholesalers, third-party logistics providers, nonresident wholesalers, and nonresident third-party logistics providers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.
6565
6666 (4) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.
6767
6868 (5) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.
6969
70-(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).
70+(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).
7171
72-(d) The Department of Consumer Affairs shall contract with the department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code California State Board of Pharmacy on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).
72+(d) The Department of Consumer Affairs shall contract with the Department of Justice department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the California State Board of Optometry, and the Podiatric Medical Board of California to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).
7373
7474 (e) This section shall become operative on April 1, 2023.
7575
7676 SEC. 2. Section 209 of the Business and Professions Code is amended to read:209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
7777
7878 SEC. 2. Section 209 of the Business and Professions Code is amended to read:
7979
8080 ### SEC. 2.
8181
8282 209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
8383
8484 209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
8585
8686 209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
8787
8888
8989
9090 209. The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:
9191
9292 (a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.
9393
9494 (b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.
9595
9696 (c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.
9797
9898 (d) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
9999
100-SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
100+SEC. 3. Section 209 is added to the Business and Professions Code, to read:209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
101101
102102 SEC. 3. Section 209 is added to the Business and Professions Code, to read:
103103
104104 ### SEC. 3.
105105
106-209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
106+209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
107107
108-209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
108+209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
109109
110-209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
110+209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.(b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.(c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.(d) This section shall become operative on April 1, 2023.
111111
112112
113113
114-209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, California State Board of Pharmacy, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:
114+209. The department specified by the Governor pursuant to Section 11164.8 of the Health and Safety Code, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:
115115
116116 (a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall be made to implement a streamlined application and approval process that a licensed health care practitioner or pharmacist can complete at the time that they are applying for licensure or renewing their license.
117117
118118 (b) Identify necessary procedures to enable licensed health care practitioners and pharmacists with access to the CURES PDMP to delegate their authority to access reports from the CURES PDMP.
119119
120120 (c) Develop a procedure to enable health care practitioners who do not have a federal Drug Enforcement Administration (DEA) number to opt out of applying for access to the CURES PDMP.
121121
122122 (d) This section shall become operative on April 1, 2023.
123123
124-SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
124+SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
125125
126126 SEC. 4. Section 11164.1 of the Health and Safety Code is amended to read:
127127
128128 ### SEC. 4.
129129
130-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
130+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
131131
132-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
132+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
133133
134-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
134+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c)This section shall become operative on January 1, 2021.(c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
135135
136136
137137
138138 11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.
139139
140140 (2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.
141141
142142 (b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.
143143
144+(c)This section shall become operative on January 1, 2021.
145+
146+
147+
144148 (c) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
145149
146-SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
150+SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
147151
148152 SEC. 5. Section 11164.1 is added to the Health and Safety Code, to read:
149153
150154 ### SEC. 5.
151155
152-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
156+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
153157
154-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
158+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
155159
156-11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
160+11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.(c) This section shall become operative on April 1, 2023.
157161
158162
159163
160164 11164.1. (a) (1) Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.
161165
162-(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy in the manner prescribed by subdivision (d) of Section 11165.
166+(2) A prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the department specified by the Governor pursuant to Section 11164.8 in the manner prescribed by subdivision (d) of Section 11165.
163167
164168 (b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.
165169
166170 (c) This section shall become operative on April 1, 2023.
167171
168-SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
172+SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
169173
170174 SEC. 6. Section 11164.8 is added to the Health and Safety Code, to read:
171175
172176 ### SEC. 6.
173177
174-11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
178+11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
175179
176-11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
180+11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
177181
178-11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
182+11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).(d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.(e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.(2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.(3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
179183
180184
181185
182-11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor. the California State Board of Pharmacy.
186+11164.8. (a) Beginning April 1, 2023, full responsibility for the maintenance and operation of CURES shall be transferred from the Department of Justice to a department specified by the Governor.
183187
184-(b) The specified department board may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.
188+(b) The specified department may adopt emergency regulations to reorganize, clarify, or make consistent regulations, including regulations adopted by the Department of Justice before or in place as of April 1, 2023.
185189
186-(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a). board.
190+(c) All agreements, memoranda of understanding, and contracts in support of the CURES database that are in effect as of April 1, 2023, shall be transferred to the department specified in subdivision (a).
187191
188192 (d) This section does not restrict, eliminate, or substantially modify the authority of the Department of Justice to engage in any investigation or enforcement activity, either independently or on behalf of a board or state agency.
189193
190194 (e) (1) On or before February 1, 2023, the Department of Justice shall submit a report to the appropriate policy and fiscal committees of the Legislature on the status of the transfer prescribed by this section.
191195
192196 (2) The requirement for submitting a report imposed under this subdivision is inoperative on January 1, 2026, pursuant to Section 10231.5 of the Government Code.
193197
194198 (3) A report to be submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.
195199
196-(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department board until the board has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
200+(f) Until January 1, 2024, the Department of Justice shall provide staff support to the department specified in subdivision (a) until that department has hired its own staff. The Department of Justice shall be reimbursed by the State Department of Consumer Affairs from the CURES Fund for these services.
197201
198202 SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
199203
200204 SEC. 7. Section 11165 of the Health and Safety Code, as amended by Section 5 of Chapter 618 of the Statutes of 2021, is amended to read:
201205
202206 ### SEC. 7.
203207
204208 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
205209
206210 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
207211
208212 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
209213
210214
211215
212216 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
213217
214218 (b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
215219
216220 (c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.
217221
218222 (2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.
219223
220224 (B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.
221225
222226 (3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:
223227
224228 (A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.
225229
226230 (B) The purposes for which a health care practitioner may access information in CURES.
227231
228232 (C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.
229233
230234 (D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.
231235
232236 (4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.
233237
234238 (d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:
235239
236240 (1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.
237241
238242 (2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.
239243
240244 (3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.
241245
242246 (4) National Drug Code (NDC) number of the controlled substance dispensed.
243247
244248 (5) Quantity of the controlled substance dispensed.
245249
246250 (6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.
247251
248252 (7) Number of refills ordered.
249253
250254 (8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.
251255
252256 (9) Prescribing date of the prescription.
253257
254258 (10) Date of dispensing of the prescription.
255259
256260 (11) The serial number for the corresponding prescription form, if applicable.
257261
258262 (e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
259263
260264 (f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
261265
262266 (g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
263267
264268 (h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.
265269
266270 (2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.
267271
268272 (3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.
269273
270274 (4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.
271275
272276 (5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).
273277
274278 (i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
275279
276280 (j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.
277281
278282 (k) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
279283
280-SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
284+SEC. 8. Section 11165 is added to the Health and Safety Code, to read:11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
281285
282286 SEC. 8. Section 11165 is added to the Health and Safety Code, to read:
283287
284288 ### SEC. 8.
285289
286-11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
290+11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
287291
288-11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
292+11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
289293
290-11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
294+11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.(B) The purposes for which a health care practitioner may access information in CURES.(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:(1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.(2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.(4) National Drug Code (NDC) number of the controlled substance dispensed.(5) Quantity of the controlled substance dispensed.(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.(7) Number of refills ordered.(8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.(9) Prescribing date of the prescription.(10) Date of dispensing of the prescription.(11) The serial number for the corresponding prescription form, if applicable.(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.(k) This section shall become operative on April 1, 2023.
291295
292296
293297
294-11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
298+11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the department specified by the Governor pursuant to Section 11164.8 shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
295299
296-(b) The department board may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department board shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
300+(b) The department may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
297301
298302 (c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.
299303
300-(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, board, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, board, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department board shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.
304+(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.
301305
302306 (B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.
303307
304-(3) The department board shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department board initiates a new rulemaking process to make changes or additions to these regulations, the department board shall consult with all stakeholders identified by the department board during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:
308+(3) The department shall, no later than April 1, 2024, revisit existing regulations previously adopted by the Department of Justice regarding the access and use of the information within CURES. If the department initiates a new rulemaking process to make changes or additions to these regulations, the department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:
305309
306310 (A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.
307311
308312 (B) The purposes for which a health care practitioner may access information in CURES.
309313
310314 (C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.
311315
312316 (D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.
313317
314318 (4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patients CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patients medical record in compliance with subdivision (d) of Section 11165.1.
315319
316-(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department board or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department: board:
320+(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patients representative, in a format specified by the department:
317321
318322 (1) Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the ultimate user.
319323
320324 (2) The prescribers category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.
321325
322326 (3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.
323327
324328 (4) National Drug Code (NDC) number of the controlled substance dispensed.
325329
326330 (5) Quantity of the controlled substance dispensed.
327331
328-(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, board, if available.
332+(6) The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.
329333
330334 (7) Number of refills ordered.
331335
332336 (8) Whether the drug was dispensed as a refill of a prescription or as a first-time request.
333337
334338 (9) Prescribing date of the prescription.
335339
336340 (10) Date of dispensing of the prescription.
337341
338342 (11) The serial number for the corresponding prescription form, if applicable.
339343
340-(e) The department board may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
344+(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
341345
342-(f) The department board shall, prior to upgrading CURES, consult with prescribers licensed by the board or one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, board, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
346+(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
343347
344-(g) The department board may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
348+(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
345349
346-(h) (1) The department board may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.
350+(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.
347351
348-(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department board pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department board for interstate data sharing of prescription drug monitoring program information.
352+(2) Data obtained from CURES may be provided to authorized users of another states prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.
349353
350-(3) An agreement entered into by the department board for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.
354+(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.
351355
352356 (4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another states prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that states prescription drug monitoring program.
353357
354-(5) The department board shall not enter into an agreement pursuant to this subdivision until the department board has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).
358+(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).
355359
356-(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department board as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
360+(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
357361
358-(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department board or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department board or contracted prescription data processing vendor shall be extended until normal operations have resumed.
362+(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.
359363
360364 (k) This section shall become operative on April 1, 2023.
361365
362-SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
366+SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
363367
364368 SEC. 9. Section 11165.1 of the Health and Safety Code, as amended by Section 20 of Chapter 77 of the Statutes of 2021, is amended to read:
365369
366370 ### SEC. 9.
367371
368-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
372+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
369373
370-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
374+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
371375
372-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
376+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the Department of Justice.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.(2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
373377
374378
375379
376380 11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).
377381
378382 (ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.
379383
380384 (iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.
381385
382386 (iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.
383387
384-(B) The department may deny an application or suspend a subscriber for reasons that include, but are not limited to, the following:
388+(B) The department may deny an application or suspend a subscriber, subscriber for reasons that include, but are not limited to, the following:
385389
386390 (i) Materially falsifying an application to access information contained in the CURES database.
387391
388392 (ii) Failing to maintain effective controls for access to the patient activity report.
389393
390394 (iii) Having their federal DEA registration suspended or revoked.
391395
392396 (iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.
393397
394398 (v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.
395399
396400 (C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.
397401
398402 (D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.
399403
400404 (E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:
401405
402406 (i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.
403407
404408 (ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:
405409
406410 (I) The date of the query.
407411
408412 (II) The time of the query.
409413
410414 (III) The first and last name of the patient queried.
411415
412416 (IV) The date of birth of the patient queried.
413417
414418 (V) The identification of the CURES user for whom the system is making the query.
415419
416420 (iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.
417421
418422 (iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.
419423
420424 (F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.
421425
422426 (G) The department shall not access patient-identifiable information in an entitys health information technology system.
423427
424428 (H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.
425429
426430 (I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).
427431
428432 (2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.
429433
430434 (b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.
431435
432436 (c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.
433437
434438 (d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.
435439
436440 (e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.
437441
438442 (f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.
439443
440444 (g) For purposes of this section, the following terms have the following meanings:
441445
442446 (1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.
443447
444448 (2) Department means the Department of Justice.
445449
446450 (3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.
447451
448452 (4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.
449453
450454 (h) (1) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.
451455
452456 (2) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
453457
454-SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
458+SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
455459
456460 SEC. 10. Section 11165.1 is added to the Health and Safety Code, to read:
457461
458462 ### SEC. 10.
459463
460-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
464+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
461465
462-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
466+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
463467
464-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department board shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2)Department means the department specified by the Governor pursuant to Section 11164.8.(2) Board means the California State Board of Pharmacy.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
468+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:(i) Materially falsifying an application to access information contained in the CURES database.(ii) Failing to maintain effective controls for access to the patient activity report.(iii) Having their federal DEA registration suspended or revoked.(iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.(v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:(I) The date of the query.(II) The time of the query.(III) The first and last name of the patient queried.(IV) The date of birth of the patient queried.(V) The identification of the CURES user for whom the system is making the query.(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.(G) The department shall not access patient-identifiable information in an entitys health information technology system.(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.(e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.(g) For purposes of this section, the following terms have the following meanings:(1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.(2) Department means the department specified by the Governor pursuant to Section 11164.8.(3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.(4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.(h) This section shall become operative on April 1, 2023.
465469
466470
467471
468-11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).
472+11165.1. (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioners care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP or CURES database).
469473
470-(ii) A pharmacist shall, upon licensure, submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. board. Upon approval, the department board shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.
474+(ii) A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacists care based on data contained in the CURES PDMP.
471475
472-(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department board to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. board. Upon approval, the department board shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.
476+(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.
473477
474-(iv) The department board shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).
478+(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii).
475479
476-(B) The department board may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:
480+(B) The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:
477481
478482 (i) Materially falsifying an application to access information contained in the CURES database.
479483
480484 (ii) Failing to maintain effective controls for access to the patient activity report.
481485
482486 (iii) Having their federal DEA registration suspended or revoked.
483487
484488 (iv) Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.
485489
486490 (v) Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.
487491
488-(C) An authorized subscriber shall notify the department board within 30 days of a change to the subscriber account.
492+(C) An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.
489493
490-(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments boards online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.
494+(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the departments online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.
491495
492496 (E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:
493497
494498 (i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.
495499
496500 (ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query, the health information technology system submits the following data regarding the query to CURES:
497501
498502 (I) The date of the query.
499503
500504 (II) The time of the query.
501505
502506 (III) The first and last name of the patient queried.
503507
504508 (IV) The date of birth of the patient queried.
505509
506510 (V) The identification of the CURES user for whom the system is making the query.
507511
508512 (iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.
509513
510-(iv) The entity has entered into a memorandum of understanding with the department board that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.
514+(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.
511515
512-(F) The department board shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.
516+(F) The department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.
513517
514-(G) The department board shall not access patient-identifiable information in an entitys health information technology system.
518+(G) The department shall not access patient-identifiable information in an entitys health information technology system.
515519
516520 (H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.
517521
518-(I) The department board may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).
522+(I) The department may prohibit integration or terminate a health information technology systems ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).
519523
520524 (2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.
521525
522-(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department. board.
526+(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.
523527
524-(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department board may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.
528+(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in the CURES database to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.
525529
526-(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department board pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.
530+(d) The history of controlled substances dispensed to an individual based on data contained in the CURES database that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.
527531
528532 (e) Information concerning a patients controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.
529533
530534 (f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.
531535
532536 (g) For purposes of this section, the following terms have the following meanings:
533537
534538 (1) Automated basis means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.
535539
536540 (2) Department means the department specified by the Governor pursuant to Section 11164.8.
537541
538-
539-
540-(2) Board means the California State Board of Pharmacy.
541-
542542 (3) Entity means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.
543543
544544 (4) Health information technology system means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.
545545
546546 (h) This section shall become operative on April 1, 2023.
547547
548-SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
548+SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
549549
550550 SEC. 11. Section 11165.2 of the Health and Safety Code is amended to read:
551551
552552 ### SEC. 11.
553553
554-11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
554+11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
555555
556-11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
556+11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
557557
558-11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
558+11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.(c) The system shall contain the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
559559
560560
561561
562562 11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.
563563
564564 (b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.
565565
566566 (c) The system shall contain the following provisions:
567567
568568 (1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.
569569
570570 (2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.
571571
572572 (3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.
573573
574-(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
574+(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that that, if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
575575
576-(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.
576+(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement abatement, which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.
577577
578578 (6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:
579579
580580 (A) A citation may be issued without the assessment of an administrative fine.
581581
582582 (B) Assessment of administrative fines may be limited to only particular violations of law or department regulations.
583583
584-(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.
584+(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.
585585
586586 (e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.
587587
588588 (f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.
589589
590-(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.
590+(g) Nothing in this section shall be deemed to This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.
591591
592592 (h) This section shall become inoperative on April 1, 2023, and, as of January 1, 2024, is repealed.
593593
594-SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
594+SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
595595
596596 SEC. 12. Section 11165.2 is added to the Health and Safety Code, to read:
597597
598598 ### SEC. 12.
599599
600-11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
600+11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
601601
602-11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
602+11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
603603
604-11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
604+11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.(c) The system shall contain all of the following provisions:(1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.(2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.(4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.(A) A citation may be issued without the assessment of an administrative fine.(B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.(d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.(h) This section shall become operative on April 1, 2023.
605605
606606
607607
608-11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.
608+11165.2. (a) The department specified by the Governor pursuant to Section 11164.8 may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.
609609
610-(b) The department board may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department board if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.
610+(b) The department may establish, by regulation, a system for citation of a CURES Prescription Drug Monitoring Program subscriber. A citation may contain an order of abatement or an order to pay an administrative fine assessed by the department if the subscriber is in violation of this chapter or any regulation adopted pursuant to this chapter.
611611
612612 (c) The system shall contain all of the following provisions:
613613
614614 (1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation determined to have been violated.
615615
616616 (2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.
617617
618-(3) The administrative fine assessed by the department board shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.
618+(3) The administrative fine assessed by the department shall not exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to factors such as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.
619619
620620 (4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
621621
622-(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department board regarding the citation. At the conclusion of the informal conference, the department board may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.
622+(5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement, which could include permanent suspension from the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive the right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of the subsequent citation.
623623
624-(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. board. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.
624+(6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or to comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account shall be terminated.
625625
626626 (A) A citation may be issued without the assessment of an administrative fine.
627627
628628 (B) Assessment of administrative fines may be limited to only particular violations of statute or regulations.
629629
630630 (d) Notwithstanding any other law, if a fine is paid to satisfy an assessment based on a violation, payment of the fine shall be a satisfactory resolution of the matter for purposes of public disclosure.
631631
632632 (e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.
633633
634634 (f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.
635635
636-(g) This section does not prevent the department board from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.
636+(g) This section does not prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.
637637
638638 (h) This section shall become operative on April 1, 2023.
639639
640-SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
640+SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
641641
642642 SEC. 13. Section 11165.5 of the Health and Safety Code is amended to read:
643643
644644 ### SEC. 13.
645645
646-11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
646+11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
647647
648-11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
648+11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
649649
650-11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
650+11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
651651
652652
653653
654654 11165.5. (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.
655655
656656 (b) For purposes of this section, the following definitions apply:
657657
658-(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.
658+(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code. 11057.
659659
660660 (2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
661661
662662 (3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.
663663
664664 (4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.
665665
666666 (c) This section shall become inoperative on April 1. 2023, and, as of January 1, 2024, is repealed.
667667
668-SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
668+SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
669669
670670 SEC. 14. Section 11165.5 is added to the Health and Safety Code, to read:
671671
672672 ### SEC. 14.
673673
674-11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
674+11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
675675
676-11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
676+11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
677677
678-11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
678+11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.(b) For purposes of this section, the following definitions apply:(1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.(2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).(3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.(4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.(c) This section shall become operative on April 1, 2023.
679679
680680
681681
682-11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 California State Board of Pharmacy may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department board shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.
682+11165.5. (a) The department specified by the Governor pursuant to Section 11164.8 may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.
683683
684684 (b) For purposes of this section, the following definitions apply:
685685
686686 (1) Controlled substance means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057.
687687
688688 (2) Health care service plan means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
689689
690690 (3) Insurer means an admitted insurer writing health insurance, as defined in Section 106 of the Insurance Code, and an admitted insurer writing workers compensation insurance, as defined in Section 109 of the Insurance Code.
691691
692692 (4) Qualified manufacturer means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.
693693
694694 (c) This section shall become operative on April 1, 2023.