H.R. 5316 · Where this bill is now
In committee
Introduced in the House, sent to the Committee on Energy and Commerce, Sep 11, 2025
What this bill does
In plain words · AI-written from the official summaryEases rules for making shortage-hit drugs
When drugs become hard to find, pharmacies and compounding facilities (which are specialized manufacturers) face strict rules about how much they can make and what they're allowed to create. This bill loosens those rules for drugs on the FDA's shortage list, letting pharmacies make copies of commercial drugs and prepare doses for urgent needs even when there's no specific patient yet identified. It also gives compounding facilities longer to keep making these drugs after they've been removed from the shortage list.
How it affects you
If you need a medication that's in short supply, this bill could make it easier for your pharmacy or hospital to get a compounded version made for you. Patients who rely on life-supporting or life-sustaining drugs may benefit from manufacturers having to report sudden spikes in demand, which could help the FDA better track and respond to shortages.
Read the official 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 AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionH. R. 5316
A BILL
Drug Shortage Compounding Patient Access Act of 2025
Sponsor: Rep. Diana Harshbarger (R-TN-1) · Introduced Sep 11, 2025 · Health · 1 version of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Sep 11, 2025: “Referred to the House Committee on Energy and Commerce.”