Drug Shortage Compounding Patient Access Act of 2025

# Drug Shortage Compounding Patient Access Act of 2025 (HR 5316) - Summary **What the Bill Would Do:** This bill aims to address drug shortages by allowing pharmacies to compound (prepare) certain medications when the FDA-approved versions are unavailable. Compounding is when pharmacists mix ingredients to create custom medications, typically in their own pharmacies. The bill would expand when and how pharmacies can legally do this during drug shortage situations, potentially giving patients access to needed medications that aren't otherwise available through normal supply chains. **Who It Affects:** The bill would primarily impact patients who need medications that are experiencing shortages, pharmacies and pharmacists who would gain expanded authority to compound drugs, and pharmaceutical manufacturers.

It could also affect the FDA, which oversees drug safety and would need to implement any new regulations. **Current Status:** As of now, HR 5316 is in committee, meaning it has been introduced but has not yet been debated or voted on by the full House of Representatives. The bill was sponsored by Representative Diana Harshbarger (R-TN). Without additional action, the bill remains in early stages of the legislative process.