AB 3063: 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.