CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 3063Introduced by Assembly Member McKinnorFebruary 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, as introduced, 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, notwithstanding those provisions, specify that compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. The bill would require a pharmacy to retain documentation that a flavoring agent was added to a prescription and to make that documentation available to the board or its agent upon request. 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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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.
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 3063Introduced by Assembly Member McKinnorFebruary 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, as introduced, 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, notwithstanding those provisions, specify that compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. The bill would require a pharmacy to retain documentation that a flavoring agent was added to a prescription and to make that documentation available to the board or its agent upon request. 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
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Assembly Bill
No. 3063
Introduced by Assembly Member McKinnorFebruary 16, 2024
Introduced by Assembly Member McKinnor
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, as introduced, 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, notwithstanding those provisions, specify that compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. The bill would require a pharmacy to retain documentation that a flavoring agent was added to a prescription and to make that documentation available to the board or its agent upon request. 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, notwithstanding those provisions, specify that compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. The bill would require a pharmacy to retain documentation that a flavoring agent was added to a prescription and to make that documentation available to the board or its agent upon request. 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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.(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 furnishing, 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) Notwithstanding subdivision (a), compounding does not include reconstitution of a drug pursuant to a manufacturers directions, the sole act of tablet splitting or crushing, capsule opening, or the addition of a flavoring agent to enhance palatability. A pharmacy shall retain documentation that a flavoring agent was added to a prescription and that documentation shall be made available to the board, or an agent of the board, upon request.
(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.