California 2019 2019-2020 Regular Session

California Assembly Bill AB973 Chaptered / Bill

Filed 08/30/2019

                    Assembly Bill No. 973 CHAPTER 184 An act to add Section 4126.8 to the Business and Professions Code, relating to healing arts.  [ Approved by  Governor  August 30, 2019.  Filed with  Secretary of State  August 30, 2019. ] LEGISLATIVE COUNSEL'S DIGESTAB 973, Irwin. Pharmacies: compounding.Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. A violation of that law is a crime.This bill would require 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. The bill, by imposing a new requirement on pharmacies, the violation of which would be a crime, would impose a state-mandated local program. The bill would authorize the board to adopt regulations to impose additional standards for compounding drug preparations.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.Digest Key Vote: MAJORITY  Appropriation: NO  Fiscal Committee: YES  Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4126.8 is added to the Business and Professions Code, to read:4126.8. 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.SEC. 2. 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.

 Assembly Bill No. 973 CHAPTER 184 An act to add Section 4126.8 to the Business and Professions Code, relating to healing arts.  [ Approved by  Governor  August 30, 2019.  Filed with  Secretary of State  August 30, 2019. ] LEGISLATIVE COUNSEL'S DIGESTAB 973, Irwin. Pharmacies: compounding.Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. A violation of that law is a crime.This bill would require 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. The bill, by imposing a new requirement on pharmacies, the violation of which would be a crime, would impose a state-mandated local program. The bill would authorize the board to adopt regulations to impose additional standards for compounding drug preparations.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.Digest Key Vote: MAJORITY  Appropriation: NO  Fiscal Committee: YES  Local Program: YES 

 Assembly Bill No. 973 CHAPTER 184

 Assembly Bill No. 973

 CHAPTER 184

 An act to add Section 4126.8 to the Business and Professions Code, relating to healing arts. 

 [ Approved by  Governor  August 30, 2019.  Filed with  Secretary of State  August 30, 2019. ] 

LEGISLATIVE COUNSEL'S DIGEST

## LEGISLATIVE COUNSEL'S DIGEST

AB 973, Irwin. Pharmacies: compounding.

Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. A violation of that law is a crime.This bill would require 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. The bill, by imposing a new requirement on pharmacies, the violation of which would be a crime, would impose a state-mandated local program. The bill would authorize the board to adopt regulations to impose additional standards for compounding drug preparations.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.

Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy by pharmacists and pharmacy corporations in this state. That law prohibits a pharmacy from compounding sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board. A violation of that law is a crime.

This bill would require 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. The bill, by imposing a new requirement on pharmacies, the violation of which would be a crime, would impose a state-mandated local program. The bill would authorize the board to adopt regulations to impose additional standards for compounding drug preparations.

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.

## Digest Key

## Bill Text

The people of the State of California do enact as follows:SECTION 1. Section 4126.8 is added to the Business and Professions Code, to read:4126.8. 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.SEC. 2. 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.

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 is added to the Business and Professions Code, to read:4126.8. 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.

SECTION 1. Section 4126.8 is added to the Business and Professions Code, to read:

### SECTION 1.

4126.8. 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.

4126.8. 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.

4126.8. 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.



4126.8. 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.

SEC. 2. 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. 2. 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. 2. 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. 2.