Drug Shortage Compounding Patient Access Act of 2025

What H.R. 5316 does, in plain terms

Drug Shortage Compounding Patient Access Act of 2025 This bill relaxes certain requirements for the compounding of drugs facing shortages. Currently, subject to certain requirements, compounded drugs (i.e., drugs altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. There are two general categories of compounding: (1) pharmacy compounding, wherein a licensed pharmacist or physician not registered with the FDA compounds in limited quantities for identified patients; and (2) bulk compounding, wherein an FDA-registered outsourcing facility compounds in bulk for use in medical facilities. The bill permits pharmacy compounding in limited quantities for an urgent medical need not involving a specific patient if, among other requirements, the drug appeared on the FDA’s drug shortage list within a specified period. The bill also formally waives limits on pharmacy compounding of drugs that are essentially copies of commercially available drugs if the drug appeared on the shortage list within a specified period. Separately, the bill extends the period during which an outsourcing facility may compound a drug that appeared on the shortage list to 180 days after the drug’s removal from the list. The bill also requires the FDA to publish annual updates on its evaluation of substances for inclusion on the list of bulk drug substances (i.e., active pharmaceutical ingredients) that may be used in bulk compounding of drugs not on the shortage list. Finally, manufacturers of certain drugs, including life-supporting and life-sustaining drugs, must report to the FDA certain surges in demand for such drugs.

Official summary by the Congressional Research Service, via Congress.gov.