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H.R. 5316 119th Congress House

Drug Shortage Compounding Patient Access Act of 2025

Official title: To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes.

Introduced: September 11, 2025 Introduced by: Diana Harshbarger Republican · Tennessee See on congress.gov
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 Everywhere this bill has been 2 steps
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In committee
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Passed House
Passed Senate
To President
Became law
Sep 11, 2025
Referred to the House Committee on Energy and Commerce.
Sep 11, 2025
Introduced in House
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What's happening now September 11, 2025

Referred to the House Committee on Energy and Commerce.

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 23

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

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 Cosponsors 3
All 3 Republican 3
R
Harris, Andy
Maryland · Oct 24, 2025
 R
Owens, Burgess
Utah · Sep 17, 2025
 R
Carter, Earl L. "Buddy"
Georgia · Sep 11, 2025
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5316: Drug Shortage Compounding Patient Access Act of 2025. 119th Congress. Open America. https://openamerica.io/bill/119-HR-5316/
MLA
"H.R. 5316: Drug Shortage Compounding Patient Access Act of 2025." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-5316/.
Bluebook (legal)
H.R. 5316, 119th Cong. (2026), https://openamerica.io/bill/119-HR-5316/.
Markdown link
[H.R. 5316: Drug Shortage Compounding Patient Access Act of 2025](https://openamerica.io/bill/119-HR-5316/)
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