PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · 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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Harshbarger, Diana [R-TN-1] · R–TN
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jul 6, 2026. Consult Congress.gov for the current record.
AI Conversation Starters
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Analyze H.R.5316 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.5316 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine H.R.5316 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine H.R.5316 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.