AB 782: 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.