Amended IN Assembly March 16, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1341Introduced by Assembly Member BermanFebruary 16, 2023An act to amend Section 4052.01 of the Business and Professions Code, relating to healing arts. An act to amend and repeal Section 1206.7 of, and to add and repeal Section 4052.04 of, the Business and Professions Code, and to amend and repeal Section 101161 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTAB 1341, as amended, Berman. Pharmacists: opioid antagonists: emergency regulations. Public health: COVID-19: testing and dispensing sites: oral therapeutics.Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.This bill would repeal these provisions as of July 1, 2028.Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber. This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill 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.The Pharmacy Law establishes the California State Board of Pharmacy (board) to license and regulate pharmacists. Existing law authorizes a pharmacist to furnish an opioid antagonist approved by the federal Food and Drug Administration (FDA), in accordance with standardized procedures or protocols developed and approved by the board and the Medical Board of California, in consultation with other entities, as specified. Existing law authorizes the board to adopt emergency regulations, exempt from review by the Office of Administrative Law, to establish the standardized procedures or protocols. Existing law makes the emergency regulations effective until the earlier of either 180 days following their effective date, or the effective date of regulations adopted by both the board and the Medical Board of California, in consultation with other entities, as specified.This bill would recast the provision regarding the authority of the board to adopt emergency regulations to specify that the board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the FDA.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOYES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 1206.7 of the Business and Professions Code is amended to read:1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.SEC. 2. Section 4052.04 is added to the Business and Professions Code, to read:4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.SEC. 3. Section 101161 of the Health and Safety Code is amended to read:101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.SEC. 4. 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.SECTION 1.Section 4052.01 of the Business and Professions Code is amended to read:4052.01.(a)Notwithstanding any other provision of law, a pharmacist may furnish a federal Food and Drug Administration-approved opioid antagonist in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. In developing those standardized procedures or protocols, the board and the Medical Board of California shall include the following:(1)Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to, opioid overdose prevention, recognition, and response, safe administration of opioid antagonists, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.(2)Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of drug treatment programs.(3)Procedures for the notification of the patients primary care provider with patient consent of any drugs or devices furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent.(b)A pharmacist furnishing an opioid antagonist pursuant to this section shall not permit the person to whom the drug is furnished to waive the consultation required by the board and the Medical Board of California.(c)Prior to performing a procedure authorized under this section, a pharmacist shall complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of opioid antagonists.(d)The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees. This section does not expand the authority of a pharmacist to prescribe any prescription medication.(e)The board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the federal Food and Drug Administration. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to subdivision (a).
Amended IN Assembly March 16, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1341Introduced by Assembly Member BermanFebruary 16, 2023An act to amend Section 4052.01 of the Business and Professions Code, relating to healing arts. An act to amend and repeal Section 1206.7 of, and to add and repeal Section 4052.04 of, the Business and Professions Code, and to amend and repeal Section 101161 of the Health and Safety Code, relating to public health.LEGISLATIVE COUNSEL'S DIGESTAB 1341, as amended, Berman. Pharmacists: opioid antagonists: emergency regulations. Public health: COVID-19: testing and dispensing sites: oral therapeutics.Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.This bill would repeal these provisions as of July 1, 2028.Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber. This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill 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.The Pharmacy Law establishes the California State Board of Pharmacy (board) to license and regulate pharmacists. Existing law authorizes a pharmacist to furnish an opioid antagonist approved by the federal Food and Drug Administration (FDA), in accordance with standardized procedures or protocols developed and approved by the board and the Medical Board of California, in consultation with other entities, as specified. Existing law authorizes the board to adopt emergency regulations, exempt from review by the Office of Administrative Law, to establish the standardized procedures or protocols. Existing law makes the emergency regulations effective until the earlier of either 180 days following their effective date, or the effective date of regulations adopted by both the board and the Medical Board of California, in consultation with other entities, as specified.This bill would recast the provision regarding the authority of the board to adopt emergency regulations to specify that the board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the FDA.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOYES
Amended IN Assembly March 16, 2023
Amended IN Assembly March 16, 2023
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Assembly Bill
No. 1341
Introduced by Assembly Member BermanFebruary 16, 2023
Introduced by Assembly Member Berman
February 16, 2023
An act to amend Section 4052.01 of the Business and Professions Code, relating to healing arts. An act to amend and repeal Section 1206.7 of, and to add and repeal Section 4052.04 of, the Business and Professions Code, and to amend and repeal Section 101161 of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 1341, as amended, Berman. Pharmacists: opioid antagonists: emergency regulations. Public health: COVID-19: testing and dispensing sites: oral therapeutics.
Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.This bill would repeal these provisions as of July 1, 2028.Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber. This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill 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.The Pharmacy Law establishes the California State Board of Pharmacy (board) to license and regulate pharmacists. Existing law authorizes a pharmacist to furnish an opioid antagonist approved by the federal Food and Drug Administration (FDA), in accordance with standardized procedures or protocols developed and approved by the board and the Medical Board of California, in consultation with other entities, as specified. Existing law authorizes the board to adopt emergency regulations, exempt from review by the Office of Administrative Law, to establish the standardized procedures or protocols. Existing law makes the emergency regulations effective until the earlier of either 180 days following their effective date, or the effective date of regulations adopted by both the board and the Medical Board of California, in consultation with other entities, as specified.This bill would recast the provision regarding the authority of the board to adopt emergency regulations to specify that the board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the FDA.
Existing law authorizes a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under specified federal regulations for high complexity testing.
This bill would repeal these provisions as of July 1, 2028.
Existing law, the Pharmacy Law, establishes the California State Board of Pharmacy to license and regulate pharmacists. A violation of these requirements is a crime. Existing law authorizes a pharmacist, among other things, to administer drugs and biological products that have been ordered by a prescriber.
This bill, until January 1, 2025, would authorize a pharmacist to furnish COVID-19 oral therapeutics, as defined, following a positive test for SARS-CoV-2, the virus that causes COVID-19, as specified. Among other things, the bill would require a pharmacist to document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to these provisions, as well as information regarding any testing services provided, in the record system maintained by the pharmacy and to maintain those records for 3 years. Because a violation of these requirements would be a crime, the bill 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.
The Pharmacy Law establishes the California State Board of Pharmacy (board) to license and regulate pharmacists. Existing law authorizes a pharmacist to furnish an opioid antagonist approved by the federal Food and Drug Administration (FDA), in accordance with standardized procedures or protocols developed and approved by the board and the Medical Board of California, in consultation with other entities, as specified. Existing law authorizes the board to adopt emergency regulations, exempt from review by the Office of Administrative Law, to establish the standardized procedures or protocols. Existing law makes the emergency regulations effective until the earlier of either 180 days following their effective date, or the effective date of regulations adopted by both the board and the Medical Board of California, in consultation with other entities, as specified.
This bill would recast the provision regarding the authority of the board to adopt emergency regulations to specify that the board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the FDA.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 1206.7 of the Business and Professions Code is amended to read:1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.SEC. 2. Section 4052.04 is added to the Business and Professions Code, to read:4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.SEC. 3. Section 101161 of the Health and Safety Code is amended to read:101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.SEC. 4. 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.SECTION 1.Section 4052.01 of the Business and Professions Code is amended to read:4052.01.(a)Notwithstanding any other provision of law, a pharmacist may furnish a federal Food and Drug Administration-approved opioid antagonist in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. In developing those standardized procedures or protocols, the board and the Medical Board of California shall include the following:(1)Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to, opioid overdose prevention, recognition, and response, safe administration of opioid antagonists, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.(2)Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of drug treatment programs.(3)Procedures for the notification of the patients primary care provider with patient consent of any drugs or devices furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent.(b)A pharmacist furnishing an opioid antagonist pursuant to this section shall not permit the person to whom the drug is furnished to waive the consultation required by the board and the Medical Board of California.(c)Prior to performing a procedure authorized under this section, a pharmacist shall complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of opioid antagonists.(d)The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees. This section does not expand the authority of a pharmacist to prescribe any prescription medication.(e)The board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the federal Food and Drug Administration. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to subdivision (a).
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 1206.7 of the Business and Professions Code is amended to read:1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
SECTION 1. Section 1206.7 of the Business and Professions Code is amended to read:
### SECTION 1.
1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
1206.7. (a) Notwithstanding Section 1206.5, a person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in a clinical laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.
(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
SEC. 2. Section 4052.04 is added to the Business and Professions Code, to read:4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.
SEC. 2. Section 4052.04 is added to the Business and Professions Code, to read:
### SEC. 2.
4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.
4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.
4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.
4052.04. (a) In addition to the authority provided in Section 4052, a pharmacist may furnish COVID-19 oral therapeutics following a positive test for SARS-CoV-2, the virus that causes COVID-19.
(b) Prior to furnishing COVID-19 oral therapeutics pursuant to subdivision (a), a pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the federal Center for Disease Control, National Institutes of Health, Infectious Diseases Society of America, or other clinically recognized recommendations in providing these patient care services.
(c) A pharmacist who furnishes COVID-19 oral therapeutics shall notify the patients primary care provider, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs furnished and advise the patient to consult a physician of the patients choice.
(d) A pharmacist shall document, to the extent possible, the kind and amounts of COVID-19 oral therapeutics furnished pursuant to subdivision (a), as well as information regarding any testing services provided, in the patients record in the record system maintained by the pharmacy. The records shall be maintained for three years and shall be available for inspection by all properly authorized personnel of the board.
(e) For purposes of this section, COVID-19 oral therapeutics means drugs that are approved or authorized by the United States Food and Drug Administration for the treatment of COVID-19 and administered orally.
(f) This section shall remain in effect only until January 1, 2025, and as of that date is repealed.
SEC. 3. Section 101161 of the Health and Safety Code is amended to read:101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
SEC. 3. Section 101161 of the Health and Safety Code is amended to read:
### SEC. 3.
101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
101161. (a) A person may perform an analysis of samples to test for SARS-CoV-2, the virus that causes COVID-19, in any city or county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing.
(b) This section shall remain in effect only until July 1, 2028, and as of that date is repealed.
SEC. 4. 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.
SEC. 4. 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.
SEC. 4. 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.
### SEC. 4.
(a)Notwithstanding any other provision of law, a pharmacist may furnish a federal Food and Drug Administration-approved opioid antagonist in accordance with standardized procedures or protocols developed and approved by both the board and the Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. In developing those standardized procedures or protocols, the board and the Medical Board of California shall include the following:
(1)Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to, opioid overdose prevention, recognition, and response, safe administration of opioid antagonists, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.
(2)Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of drug treatment programs.
(3)Procedures for the notification of the patients primary care provider with patient consent of any drugs or devices furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent.
(b)A pharmacist furnishing an opioid antagonist pursuant to this section shall not permit the person to whom the drug is furnished to waive the consultation required by the board and the Medical Board of California.
(c)Prior to performing a procedure authorized under this section, a pharmacist shall complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of opioid antagonists.
(d)The board and the Medical Board of California are each authorized to ensure compliance with this section. Each board is specifically charged with enforcing this section with respect to its respective licensees. This section does not expand the authority of a pharmacist to prescribe any prescription medication.
(e)The board may adopt emergency regulations to establish the standardized procedures or protocols, and adopt emergency regulations that amend existing regulations, to address any opioid antagonist that receives approval by the federal Food and Drug Administration. The adoption of regulations pursuant to this subdivision shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations authorized by this subdivision are exempt from review by the Office of Administrative Law. The emergency regulations authorized by this subdivision shall be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted pursuant to subdivision (a).