CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1341Introduced by Assembly Member BermanFebruary 16, 2023 An act to amend Section 4052.01 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1341, as introduced, Berman. Pharmacists: opioid antagonists: emergency regulations.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: NO Bill TextThe people of the State of California do enact as follows: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. 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).
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 1341Introduced by Assembly Member BermanFebruary 16, 2023 An act to amend Section 4052.01 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 1341, as introduced, Berman. Pharmacists: opioid antagonists: emergency regulations.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: NO
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.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 1341, as introduced, Berman. Pharmacists: opioid antagonists: emergency regulations.
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.
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 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. 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 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. 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).
SECTION 1. Section 4052.01 of the Business and Professions Code is amended to read:
### SECTION 1.
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. 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).
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. 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).
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. 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).
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. 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).