Bill > HB1361

This bill establishes new regulations for pharmacies compounding certain active pharmaceutical ingredients, specifically those used for obesity or weight management, which are often referred to as GLP-1 receptor agonists. It defines "active pharmaceutical ingredient" as a substance intended to be incorporated into a drug product to provide a therapeutic effect, and "pharmaceutical grade product" as a drug manufactured under strict quality standards and approved by the federal Food and Drug Administration (FDA) for human use. The bill prohibits the sale, transfer, or distribution of compounded drugs using these specific ingredients unless the compounder adheres to a comprehensive set of requirements, including using ingredients that meet FDA standards or are listed by the FDA, verifying their quality through certificates of analysis and rigorous testing for identity, content, and impurities, and ensuring the ingredient's manufacturer is registered with and inspected by the FDA. Furthermore, manufacturers and wholesalers must provide purchasers with documentation proving the ingredient's pharmaceutical grade, analysis, and sourcing. Pharmacies must maintain records for at least two years and provide them to the State Board of Pharmacy within one business day of a request, and the Board is authorized to inspect compounding facilities and their suppliers. Violations can result in a $1,000 fine per illegally compounded drug dose and license revocation, and the Board is empowered to create further rules to implement these provisions.

Health and Social Services

https://www.legis.ga.gov/legislation/73339