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HB 1361

Pharmacies; compounding of certain active pharmaceutical ingredients; provisions

2025-2026 Regular Session Introduced by Katie Dempsey and 2 co-sponsors

Georgia bill allows pharmacies to compound scarce active pharmaceutical ingredients under specified conditions, addressing drug shortages while raising federal regulatory and quality control concerns.

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Bill Summary · HB 1361

Legislative bill overview

HB 1361 would authorize Georgia pharmacies to compound certain active pharmaceutical ingredients (APIs) that are currently in shortage or unavailable through normal pharmaceutical supply chains. The bill establishes regulatory provisions governing which ingredients can be compounded, quality standards, and pharmacy licensing requirements for this expanded practice.

Why is this important

Drug shortages significantly impact patient care, forcing healthcare providers to delay treatments, use less effective alternatives, or ration medications. This bill could provide a state-level mechanism to address supply disruptions, particularly for critical medications, while potentially reducing costs for patients and healthcare systems. However, it also expands pharmacy authority into territory traditionally reserved for pharmaceutical manufacturers.

Potential points of contention

  • Federal regulatory overlap: The FDA regulates pharmaceutical compounding under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act; state-level authorization could create compliance conflicts or legal ambiguity about which standards apply
  • Quality and safety standards: Without sufficient oversight mechanisms, compounded medications could pose quality control risks if standards are less rigorous than those required of licensed manufacturers
  • Market impact: Competitors (pharmaceutical manufacturers, wholesale distributors) may argue this undermines normal market channels and could disincentivize production of profitable medications if pharmacies can legally compound alternatives

Compiled from official sources — confirm details with the bill’s official record.

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