Hospitals facing a drug shortage would gain a new option for obtaining critical medications under this legislation, which amends the Federal Food, Drug, and Cosmetic Act's pharmacy compounding rules. Licensed pharmacists and physicians could compound certain drugs for urgent use in hospitals — not just for one named patient — as long as the drug appeared on the FDA's shortage list within the last 60 days, the prescriber certifies no other supply is available, and the compounder reports any adverse events to the FDA within 15 days. The bill also expands FDA drug-shortage reporting so manufacturers must notify the agency about demand surges, not just production interruptions, and requires the FDA to publish annual public updates on which bulk drug substances qualify for compounding. Patients in hospitals and other clinical settings, particularly those needing medications currently in short supply, would be the primary beneficiaries of faster access to compounded alternatives.
Average Household Impact
- Compounded drug access — Hospitals may obtain non-patient-specific compounded drugs during shortages
Transparency & Accountability
- Drug shortage reporting — Manufacturers must report demand surges, not just production interruptions
- Bulk drug substance list — FDA must publish annual public updates on compounding-eligible substances
Congressional Summary
Drug Shortage Compounding Patient Access Act of 2025This 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.
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2025-09-11
- Date Added
- 2026-07-07
- Source
- Congress.gov →
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