Pharmacy Law: compounded medications: consumer protection.

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy within the Department of Consumer Affairs to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies. Under existing law, it is unlawful for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription unless they are licensed, as specified. A violation of that law is a crime. Existing law also 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 advertisements for prescription drugs, if the advertisement conforms with certain requirements, including not containing a false, fraudulent, misleading, or deceptive statement. This bill would make it unlawful for a person or entity to engage in the sale, transfer, or distribution of a compounded drug using a drug substance that is a glucose-dependent insulinotropic polypeptide receptor or glucagon-like-peptide-1 receptor agonist used for obesity or weight management or a drug substance that is a component of a similar drug approved by the federal Food and Drug Administration for obesity or weight management unless the compounder of the drug takes specified actions. These acts would include ensuring that the bulk drug substance, as defined, is a pharmaceutical grade product and is accompanied by a valid certificate of analysis. The bill would also make it unlawful for a manufacturer or wholesaler to sell, transfer, or distribute a bulk drug substance for use in compounding without providing to the purchaser written verification that the bulk drug substance meets specified conditions, including being pharmaceutical grade. The bill would make a violation of these provisions punishable by a fine of $1,000 per dose of the illegally compounded drug sold, transferred, or distributed and license revocation. The bill would require any person or entity engaging in the sale, transfer, or distribution of compounded drugs to maintain all records related to the acquisition, examination, and testing of the bulk drug substance for not less than 2 years after the expiration date of the last lot of drug containing the bulk drug substance and, upon request, to furnish that information to the board. The bill would authorize the board or its duly authorized agent to inspect any person or entity that engages in compounding drugs, as prescribed. The bill would also make it unlawful for any person to advertise or otherwise promote compounded medications unless the advertisement is truthful and not misleading, including not containing an unsubstantiated claim with respect to the product. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. 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.