H.R. 5316 · 119th Congress
Drug Shortage Compounding Patient Access Act of 2025
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Not yet voted on. This bill is still a proposal: it hasn't reached a floor vote, and its text can change in committee or on the floor before any vote.
R
HarshbargerSponsor3 cosponsors · 3 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill relaxes certain requirements for the compounding of drugs facing shortages.
What it does: CRS summary · Introduced in House · Sep 11, 2025
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Drug Shortage Compounding Patient Access Act of 2025
Latest action (Sep 11, 2025): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Sep 11, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.