HB 1361: Pharmacies; compounding of certain active pharmaceutical ingredients; provisions

Compounded versions of popular weight-loss and diabetes drugs, built from active pharmaceutical ingredients rather than the brand-name product, are not currently subject to Georgia-specific sourcing and testing rules. This bill adds a new section to Georgia's pharmacy law (O.C.G.A. § 26-4-91) that makes it illegal to sell, transfer, or distribute compounded GLP-1 or GIP receptor agonist drugs used for obesity or weight management unless the compounder verifies the ingredient's purity, obtains a certificate of analysis, tests for impurities, and confirms the ingredient came from an FDA-registered and FDA-inspected manufacturing facility. The bill also requires manufacturers and wholesalers who sell these ingredients in Georgia to give purchasers written proof of quality and sourcing. Anyone compounding or distributing these drugs must keep related records for at least two years and turn them over to the State Board of Pharmacy within one business day of a request. The Board gains inspection authority, and violators face a $1,000 fine per illegal dose plus loss of their 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 drugs unless the compounder meets specific ingredient purity, testing, and sourcing standards.
• Requires manufacturers and wholesalers selling these active pharmaceutical ingredients in Georgia to give buyers written proof of grade, purity testing, and sourcing.
• Requires compounders and distributors to keep acquisition and testing records for at least two years after the drug's expiration date.
• 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 illegally compounded dose sold plus revocation of the pharmacy or business license.
• Authorizes the Board of Pharmacy to issue further rules to implement the law.

Compounding pharmacies, drug manufacturers, and wholesalers that supply active pharmaceutical ingredients in Georgia, along with the State Board of Pharmacy, which gains new inspection and enforcement duties. Patients who use compounded weight-loss or diabetes drugs are also affected by the added quality controls.

Compounded versions of drugs like semaglutide have become common and cheaper alternatives to brand-name weight-loss medications, but their ingredient quality has varied. This bill would force compounders and suppliers to document purity and sourcing, giving patients more assurance while exposing violators to steep fines and license loss.

• New O.C.G.A. § 26-4-91(a) defines 'active pharmaceutical ingredient,' 'human drug establishment,' and 'pharmaceutical grade product.'
• Subsection (b) bans sale of compounded GLP-1/GIP obesity drugs unless the compounder meets eight specific conditions, including using FDA-recognized ingredient standards and verified certificates of analysis.
• Subsection (c) requires manufacturers and wholesalers to give purchasers written proof of ingredient grade, testing, and sourcing.
• Subsection (d) requires records to be kept for at least two years and furnished to the Board within one business day of a request.
• Subsection (e) authorizes the Board of Pharmacy or its agents to inspect compounders, suppliers, and wholesalers, making refusal a violation.
• Subsection (f) sets penalties of $1,000 per illegal dose and revocation of the pharmacy or business license.
• Subsection (g) authorizes the Board to adopt implementing rules and regulations.

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
• weight-loss drugs
• drug compounding
• GLP-1 medications
• consumer safety