Amended IN Senate August 21, 2023 Amended IN Senate June 27, 2023 Amended IN Senate June 19, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 782Introduced by Assembly Member McKinnor(Coauthors: Assembly Members Irwin and Lackey)February 13, 2023An act to amend Section 4126.8 of the Business and Professions Code, relating to healing arts.LEGISLATIVE COUNSEL'S DIGESTAB 782, as amended, 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 wold 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.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 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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
Amended IN Senate August 21, 2023 Amended IN Senate June 27, 2023 Amended IN Senate June 19, 2023 CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Assembly Bill No. 782Introduced by Assembly Member McKinnor(Coauthors: Assembly Members Irwin and Lackey)February 13, 2023An act to amend Section 4126.8 of the Business and Professions Code, relating to healing arts.LEGISLATIVE COUNSEL'S DIGESTAB 782, as amended, 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 wold 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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
Amended IN Senate August 21, 2023 Amended IN Senate June 27, 2023 Amended IN Senate June 19, 2023
Amended IN Senate August 21, 2023
Amended IN Senate June 27, 2023
Amended IN Senate June 19, 2023
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Assembly Bill
No. 782
Introduced by Assembly Member McKinnor(Coauthors: Assembly Members Irwin and Lackey)February 13, 2023
Introduced by Assembly Member McKinnor(Coauthors: Assembly Members Irwin and Lackey)
February 13, 2023
An act to amend Section 4126.8 of the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 782, as amended, 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 wold 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.
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 wold 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.
## 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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
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) 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 California State Board of Pharmacy, or an agent of the board, upon request.
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) 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 California State Board of Pharmacy, or an agent of the board, upon request.