HB1361: HB1361 Pharmacies; compounding of certain active pharmaceutical ingredients; provisions

Some Georgia pharmacies compound (mix custom versions of) drugs using active ingredients similar to popular weight-loss and diabetes medications, such as GLP-1 and GIP receptor agonists. This bill adds a new section to Georgia's pharmacy law (O.C.G.A. Title 26, Chapter 4) that makes it illegal to sell, transfer, or distribute these compounded drugs unless the pharmacy verifies the active ingredient meets specific purity and sourcing standards, confirms it comes from an FDA-registered manufacturing facility, and documents quality testing both before and after compounding. The bill also requires manufacturers and wholesalers who sell these ingredients in Georgia to give pharmacies written proof of quality and sourcing. Records must be kept for at least two years and handed over to the State Board of Pharmacy within one business day of a request. The Board can inspect compounders and suppliers, and violations carry a $1,000 fine per dose plus loss of the pharmacy or business license. The Board may also write additional rules to carry out the law.

• Bans selling, transferring, or distributing compounded GLP-1 or GIP receptor agonist weight-loss and diabetes drugs unless the compounder meets specific ingredient, testing, and sourcing standards.
• Requires manufacturers and wholesalers selling these active pharmaceutical ingredients in Georgia to provide written proof of quality, purity, and sourcing to purchasers.
• Requires compounders to test both the raw ingredient and the finished drug for impurities and to document the results before release.
• Requires records on ingredient sourcing and testing to be kept for at least two years and produced to the State Board of Pharmacy within one business day of a request.
• Gives the State Board of Pharmacy authority to inspect compounders, suppliers, and wholesalers, and makes refusing an inspection a violation.
• Sets a penalty of $1,000 per dose of an illegally compounded drug and allows revocation of the pharmacy's or business's license.

Georgia pharmacies and pharmacists who compound weight-loss or diabetes drugs, manufacturers and wholesalers who supply the active ingredients used in compounding, and the State Board of Pharmacy, which gains new inspection and enforcement duties.

Patients using compounded versions of drugs like semaglutide or tirzepatide would be affected if pharmacies cannot meet the new sourcing and testing rules, potentially limiting availability of cheaper compounded alternatives. Pharmacies and suppliers face new paperwork, testing costs, and the risk of steep fines or losing their license.

• New Code section 26-4-91(a) defines 'active pharmaceutical ingredient,' 'human drug establishment,' and 'pharmaceutical grade product' for purposes of the new rules.
• Subsection (b) bars sale of compounded GLP-1/GIP-based obesity or weight management drugs unless the compounder verifies the ingredient's compendial standards, FDA approval history, pharmaceutical grade status, certificate of analysis, and quality testing.
• Subsection (b)(7) requires proof that the ingredient was made in an FDA-registered facility that has passed an FDA human drug establishment inspection and is not under an FDA import alert.
• Subsection (c) requires manufacturers and wholesalers to give purchasers written documentation of the ingredient's grade, certificate of analysis, and testing and sourcing history.
• Subsection (d) sets a two-year record retention requirement and a one-business-day deadline to furnish records to the Board of Pharmacy upon request.
• Subsection (e) authorizes the Board of Pharmacy or its agents to inspect compounders and ingredient suppliers, and makes refusing an inspection a violation.
• Subsection (f) sets penalties: a $1,000 fine per dose of an illegally compounded drug and revocation of the pharmacy or business license.
• Subsection (g) authorizes the Board of Pharmacy to adopt rules and regulations to implement the section.

1. 2026-02-20House Second Readers (House)
2. 2026-02-19House First Readers (House)
3. 2026-02-18House Hopper (House)

• Trey Kelley (R, HD-016)Primary sponsor
• Lee Hawkins (R, HD-027)
• Katie Dempsey (R, HD-013)

• pharmacy regulation
• drug compounding
• weight-loss drugs
• GLP-1 medications
• pharmaceutical safety