Drug Shortage Compounding Patient Access Act of 2025

HR 5316 allows pharmacists and physicians to compound drugs for urgent hospital use during shortages when commercially available alternatives are unavailable. It requires the drug to have appeared on the FDA’s shortage list within 60 days, prescriber certification of failed attempts to obtain alternatives, and specific labeling stating the drug is not FDA-approved. Hospitals must track patient administration records within 7 days and report adverse events to the FDA within 15 days. The bill also expands drug shortage reporting to include sudden demand spikes, not just manufacturing interruptions.