Drug Shortage Compounding Patient Access Act of 2025
Key claim: HR5316 would relax FDA compounding requirements during drug shortages by permitting pharmacy compounding for urgent needs without a specific patient, waiving copy-drug limits, extending outsourcing facility compounding windows to 180 days post-shortage, and requiring manufacturers of life-sustaining drugs to report demand surges.
Abstract
(HR5316 · 119th Congress) 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. Latest action (2025-09-11): Referred to the House Committee on Energy and Commerce.
Why this matters
Drug shortages routinely force patients off commercial supply and onto compounded alternatives, but current FDA rules constrain when pharmacies and outsourcing facilities can compound. HR5316 would broaden those pathways during shortages and impose new manufacturer reporting for life-sustaining drugs, directly affecting what patients can access and how quickly providers can substitute. The bill is at introduction stage, so no immediate change in what is covered or paid.