California 2017-2018 Regular Session

California Senate Bill SB528 Compare Versions

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1-Amended IN Assembly June 12, 2017 Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 528Introduced by Senator StoneFebruary 16, 2017 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 528, as amended, Stone. Pharmacy: automated drug delivery systems.(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law The Pharmacy Law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the delivery of drugs from the system. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated drug delivery system within the covered entity and developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
1+Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 528Introduced by Senator StoneFebruary 16, 2017 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 528, as amended, Stone. Pharmacy: automated drug dispensing delivery systems.(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivering delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the dispensing delivery of drugs from the system. The pharmacy would also be responsible for, among other things, developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
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3- Amended IN Assembly June 12, 2017 Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 528Introduced by Senator StoneFebruary 16, 2017 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 528, as amended, Stone. Pharmacy: automated drug delivery systems.(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law The Pharmacy Law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the delivery of drugs from the system. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated drug delivery system within the covered entity and developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
3+ Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Senate Bill No. 528Introduced by Senator StoneFebruary 16, 2017 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTSB 528, as amended, Stone. Pharmacy: automated drug dispensing delivery systems.(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivering delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the dispensing delivery of drugs from the system. The pharmacy would also be responsible for, among other things, developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
44
5- Amended IN Assembly June 12, 2017 Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017
5+ Amended IN Senate April 20, 2017 Amended IN Senate March 28, 2017
66
7-Amended IN Assembly June 12, 2017
87 Amended IN Senate April 20, 2017
98 Amended IN Senate March 28, 2017
109
1110 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION
1211
1312 Senate Bill No. 528
1413
1514 Introduced by Senator StoneFebruary 16, 2017
1615
1716 Introduced by Senator Stone
1817 February 16, 2017
1918
2019 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts.
2120
2221 LEGISLATIVE COUNSEL'S DIGEST
2322
2423 ## LEGISLATIVE COUNSEL'S DIGEST
2524
26-SB 528, as amended, Stone. Pharmacy: automated drug delivery systems.
25+SB 528, as amended, Stone. Pharmacy: automated drug dispensing delivery systems.
2726
28-(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law The Pharmacy Law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the delivery of drugs from the system. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated drug delivery system within the covered entity and developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
27+(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivering delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the dispensing delivery of drugs from the system. The pharmacy would also be responsible for, among other things, developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.(2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
2928
30-(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law The Pharmacy Law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.
29+(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system. Existing law authorizes a licensed clinic to make use of an automated drug delivery system, operated under the supervision of a pharmacist, but under the clinics license and under which the clinic is responsible for the safety and security of the drugs in the system.
3130
32-This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.
31+This bill would provide an alternative program to authorize a pharmacy to provide pharmacy services to covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined.
3332
34-This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the delivery of drugs from the system. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated drug delivery system within the covered entity and developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.
33+This bill would provide that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivering delivery system would be the responsibility of the pharmacy, and would increase the level of the pharmacists involvement in the dispensing delivery of drugs from the system. The pharmacy would also be responsible for, among other things, developing and implementing written policies and procedures to ensure the safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, purity, and potency of the stored drugs. The bill would require that the drugs removed from the system for a patient be labeled in accordance with existing law and that records of each transaction be maintained by the pharmacy for 3 years. The bill would require the pharmacy to review the operation and maintenance of the automated delivery system and the drugs contained therein on a monthly basis. The bill would require that the pharmacy provide for patient consultations via a 2-way audio and visual link, as specified.
3534
3635 (2) Because this bill would expand the law regarding the use of automated drug delivery systems, the violation of which is a crime, it would impose a state-mandated local program.
3736
3837 The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
3938
4039 This bill would provide that no reimbursement is required by this act for a specified reason.
4140
4241 ## Digest Key
4342
4443 ## Bill Text
4544
46-The people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
45+The people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
4746
4847 The people of the State of California do enact as follows:
4948
5049 ## The people of the State of California do enact as follows:
5150
52-SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
51+SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
5352
5453 SECTION 1. Section 4119.11 is added to the Business and Professions Code, immediately following Section 4119.1, to read:
5554
5655 ### SECTION 1.
5756
58-4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
57+4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
5958
60-4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
59+4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
6160
62-4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350). (1)(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients. (2)(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.(3)(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.(4)(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.(5)(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.(6)(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j)After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient. (k)(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l)(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m)(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
61+4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. (3)(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.(4)(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.(5)(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.(6)(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.(7)(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.(c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.(e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.(2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.(f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.(i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
6362
6463
6564
66-4119.11. (a) A pharmacy may provide pharmacy services to an entity a clinic, as defined in Sections 1200 and 1200.1 of the Health and Safety Code, that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug delivery system, located on the premises of the covered entity, which need not be the same location as the pharmacy, if all of the following conditions are met:
65+4119.11. (a) A pharmacy may provide pharmacy services to an entity that qualifies as a covered entity under Section 340B of the federal Public Health Service Act to purchase and dispense or arrange for the dispensing of drugs purchased at reduced costs under the 340B Drug Pricing Program to its outpatients, through the use of an automated drug dispensing delivery system, located on the premises of the entity, which need not be the same location as the pharmacy, if all of the following conditions are met:
6766
68-(1) The pharmacy obtains a license from the board to operate the automated drug delivery system within the covered entity. As part of the application, the pharmacy shall provide the address of the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be two hundred dollars ($200) and may be increased to three hundred fifty dollars ($350).
67+(1) The automated drug dispensing delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the entity shall be under contract with that entity to facilitate its 340B drug program through the use of the automated drug dispensing delivery system to dispense 340B drugs to its eligible outpatients.
6968
70-(1)
69+(2)Drugs shall be released to the patient from the automated drug dispensing system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.
7170
7271
73-
74-(2) The automated drug delivery system shall be stocked with drugs purchased under the federal 340B Drug Pricing Program, and the pharmacy providing the pharmacy services to the covered entity shall be under contract with that covered entity to facilitate its 340B drug program through the use of the automated drug delivery system to dispense 340B drugs purchased under the federal 340B drug pricing program to its eligible outpatients.
75-
76-(2)
77-
78-
79-
80-(3) Drugs stored in an automated drug delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, covered entity and drugs dispensed from the automated drug delivery system shall be considered to have been dispensed by that pharmacy.
8172
8273 (3)
8374
8475
8576
86-(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug delivery system separate from other pharmacy records.
77+(2) Drugs stored in an automated drug dispensing delivery system shall be part of the inventory of the pharmacy providing pharmacy services to the health center, and drugs dispensed from the automated drug dispensing delivery system shall be considered to have been dispensed by that pharmacy.
8778
8879 (4)
8980
9081
9182
92-(5) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug delivery system.
83+(3) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated drug dispensing delivery system separate from other pharmacy records.
9384
9485 (5)
9586
9687
9788
98-(6) The pharmacy shall provide training regarding the operation and use of the automated drug delivery system to both pharmacy and covered entity personnel using the system.
89+(4) The pharmacy shall own and shall be solely responsible for the security, operation, and maintenance of the automated drug dispensing delivery system.
9990
10091 (6)
10192
10293
10394
104-(7) The operation of the automated drug delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug delivery system and may supervise the system electronically.
95+(5) The pharmacy shall provide training regarding the operation and use of the automated drug dispensing delivery system to both pharmacy and entity personnel using the system.
10596
106-(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated drug delivery system at the address of a clinic licensed under Section 4180.
97+(7)
10798
108-(b) For purposes of this section, an automated drug delivery system has the same meaning as in subdivision (a) of Section 4105.5.
99+
100+
101+(6) The operation of the automated drug dispensing delivery system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the health center. The pharmacist need not be physically present at the site of the automated drug dispensing delivery system and may supervise the system electronically.
102+
103+(b) For purposes of this section, an automated drug dispensing delivery system has the same meaning as in subdivision(h) (a) of Section 4186. 4105.5.
109104
110105 (c) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.
111106
112107 (d) Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.
113108
114109 (e) (1) The pharmacy shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of stored drugs. Policies and procedures shall define access to the automated drug delivery system and limits to access to equipment and drugs.
115110
116111 (2) All policies and procedures shall be maintained at the pharmacy operating the automated drug delivery system and the location where the automated drug delivery system is being used.
117112
118113 (f) Drugs removed from the automated drug delivery system for a patient shall be labeled pursuant to Section 4076.
119114
120-(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions. Drugs shall be released from the system only upon completion of that review.
115+(g) A pharmacist shall review and approve all orders prior to a drug being removed from the automated drug delivery system for a patient. The pharmacist shall review the prescribers order and the patients profile for potential contraindications and adverse drug reactions.
121116
122-(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. The record shall be maintained for a minimum of 180 days.
117+(h) Access to the automated drug delivery system shall be controlled and tracked using an identification or password system or biosensor.
123118
124119 (i) The automated drug delivery system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.
125120
126121 (j) After the pharmacist reviews the prescribers order, access by licensed personnel to the automated drug delivery system shall be limited only to drugs ordered by the prescriber and reviewed by the pharmacist and that are specific to the patient.
127122
128-
129-
130-(k)
131-
132-
133-
134-(j) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:
123+(k) The stocking of an automated drug delivery system shall be performed by a pharmacist. If the automated drug delivery system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopoeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:
135124
136125 (1) The task of placing drugs into the removable pockets, cards, drawers, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.
137126
138127 (2) The removable pockets, cards, drawers, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.
139128
140-(3) The facility pharmacy, in conjunction with the clinic, has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.
129+(3) The facility has developed policies and procedures to ensure that the removable pockets, cards, drawers, or unit of use or single dose containers are properly placed into the automated drug delivery system.
141130
142-(l)
131+(l) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.
143132
144-
145-
146-(k) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.
147-
148-(m)
149-
150-
151-
152-(l) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
133+(m) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
153134
154135 SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
155136
156137 SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
157138
158139 SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
159140
160141 ### SEC. 2.