Enrolled September 05, 2024 Passed IN Senate August 27, 2024 Passed IN Assembly August 31, 2024 Amended IN Senate August 21, 2024 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 3063Introduced by Assembly Member McKinnor(Coauthor: Assembly Member Bains)February 16, 2024An act to amend, repeal, and add Section 4126.8 of the Business and Professions Code, relating to healing arts, and declaring the urgency thereof, to take effect immediately.LEGISLATIVE COUNSEL'S DIGESTAB 3063, McKinnor. Pharmacies: compounding.Existing law, the Pharmacy Law, requires the California State Board of Pharmacy to license and regulate the practice of pharmacy by pharmacists and pharmacy corporations in this state. Existing law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. Existing law requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes the board to adopt regulations to impose additional standards for compounding drug preparations.This bill would, for purposes of those provisions, specify that the addition of a flavoring agent to a conventionally manufactured product is not considered compounding if certain conditions are met, including that the flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia. The bill would require the addition of the flavoring agent to be documented in the prescription record, as specified. The bill would make those provisions operative until January 1, 2030.This bill would declare that it is to take effect immediately as an urgency statute.Digest Key Vote: 2/3 Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4126.8 of the Business and Professions Code is amended to read:4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.SEC. 2. Section 4126.8 is added to the Business and Professions Code, to read:4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:In order to address the immediate public health threat to patients, especially young patients that do not take their medicine as prescribed, it is necessary for this act to take effect immediately.
Enrolled September 05, 2024 Passed IN Senate August 27, 2024 Passed IN Assembly August 31, 2024 Amended IN Senate August 21, 2024 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 3063Introduced by Assembly Member McKinnor(Coauthor: Assembly Member Bains)February 16, 2024An act to amend, repeal, and add Section 4126.8 of the Business and Professions Code, relating to healing arts, and declaring the urgency thereof, to take effect immediately.LEGISLATIVE COUNSEL'S DIGESTAB 3063, McKinnor. Pharmacies: compounding.Existing law, the Pharmacy Law, requires the California State Board of Pharmacy to license and regulate the practice of pharmacy by pharmacists and pharmacy corporations in this state. Existing law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. Existing law requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes the board to adopt regulations to impose additional standards for compounding drug preparations.This bill would, for purposes of those provisions, specify that the addition of a flavoring agent to a conventionally manufactured product is not considered compounding if certain conditions are met, including that the flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia. The bill would require the addition of the flavoring agent to be documented in the prescription record, as specified. The bill would make those provisions operative until January 1, 2030.This bill would declare that it is to take effect immediately as an urgency statute.Digest Key Vote: 2/3 Appropriation: NO Fiscal Committee: YES Local Program: NO
Enrolled September 05, 2024 Passed IN Senate August 27, 2024 Passed IN Assembly August 31, 2024 Amended IN Senate August 21, 2024
Enrolled September 05, 2024
Passed IN Senate August 27, 2024
Passed IN Assembly August 31, 2024
Amended IN Senate August 21, 2024
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Assembly Bill
No. 3063
Introduced by Assembly Member McKinnor(Coauthor: Assembly Member Bains)February 16, 2024
Introduced by Assembly Member McKinnor(Coauthor: Assembly Member Bains)
February 16, 2024
An act to amend, repeal, and add Section 4126.8 of the Business and Professions Code, relating to healing arts, and declaring the urgency thereof, to take effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 3063, McKinnor. Pharmacies: compounding.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy to license and regulate the practice of pharmacy by pharmacists and pharmacy corporations in this state. Existing law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. Existing law requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes the board to adopt regulations to impose additional standards for compounding drug preparations.This bill would, for purposes of those provisions, specify that the addition of a flavoring agent to a conventionally manufactured product is not considered compounding if certain conditions are met, including that the flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia. The bill would require the addition of the flavoring agent to be documented in the prescription record, as specified. The bill would make those provisions operative until January 1, 2030.This bill would declare that it is to take effect immediately as an urgency statute.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy to license and regulate the practice of pharmacy by pharmacists and pharmacy corporations in this state. Existing law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. Existing law requires the compounding of drug preparations by a pharmacy for furnishing, distribution, or use to be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. Existing law authorizes the board to adopt regulations to impose additional standards for compounding drug preparations.
This bill would, for purposes of those provisions, specify that the addition of a flavoring agent to a conventionally manufactured product is not considered compounding if certain conditions are met, including that the flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia. The bill would require the addition of the flavoring agent to be documented in the prescription record, as specified. The bill would make those provisions operative until January 1, 2030.
This bill would declare that it is to take effect immediately as an urgency statute.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 4126.8 of the Business and Professions Code is amended to read:4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.SEC. 2. Section 4126.8 is added to the Business and Professions Code, to read:4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:In order to address the immediate public health threat to patients, especially young patients that do not take their medicine as prescribed, it is necessary for this act to take effect immediately.
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 4126.8 of the Business and Professions Code is amended to read:4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
SECTION 1. Section 4126.8 of the Business and Professions Code is amended to read:
### SECTION 1.
4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:(A) The date on which the flavoring agent was added.(B) The prescription number and name of the medication.(C) The name, lot number, expiry date, and quantity used of each flavor component.(D) The initials of the person who prepared the product.(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
4126.8. (a) The compounding of drug preparations by a pharmacy for distribution, furnishing, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.
(b) (1) For purposes of subdivision (a), the addition of a flavoring agent to a conventionally manufactured product shall not be considered compounding if the following conditions are met:
(A) The flavoring agent is inert, nonallergenic, and produces no effect other than the instillation or modification of flavor.
(B) The flavoring agent does not alter a medications concentration beyond the level of variance accepted by the United States Pharmacopeia.
(2) The addition of a flavoring agent to a conventionally manufactured product shall be documented in the prescription record. The documentation shall include all of the following:
(A) The date on which the flavoring agent was added.
(B) The prescription number and name of the medication.
(C) The name, lot number, expiry date, and quantity used of each flavor component.
(D) The initials of the person who prepared the product.
(c) This section shall remain in effect only until January 1, 2030, and as of that date is repealed.
SEC. 2. Section 4126.8 is added to the Business and Professions Code, to read:4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.
SEC. 2. Section 4126.8 is added to the Business and Professions Code, to read:
### SEC. 2.
4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.
4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.
4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.(b) This section shall become operative on January 1, 2030.
4126.8. (a) The compounding of drug preparations by a pharmacy for furnishing, distribution, or use in this state shall be consistent with standards established in the pharmacy compounding chapters of the current version of the United States Pharmacopeia-National Formulary, including relevant testing and quality assurance. The board may adopt regulations to impose additional standards for compounding drug preparations.
(b) This section shall become operative on January 1, 2030.
SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:In order to address the immediate public health threat to patients, especially young patients that do not take their medicine as prescribed, it is necessary for this act to take effect immediately.
SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:In order to address the immediate public health threat to patients, especially young patients that do not take their medicine as prescribed, it is necessary for this act to take effect immediately.
SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:
### SEC. 3.
In order to address the immediate public health threat to patients, especially young patients that do not take their medicine as prescribed, it is necessary for this act to take effect immediately.