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H.R. 5316119th CongressIn committeeLatest action Sep 11, 2025Decoded by AI · checked against the record
Official title: Drug Shortage Compounding Patient Access Act of 2025
Introduced:
Read the official bill on Congress.govThe plain-language version leads. The official text is always the reference.
HR 5316 would let compounders pre-make small batches of FDA shortage-list drugs for urgent hospital use.
35-second read · 4 questions answered below
HR 5316 lets pharmacists or physicians compound small batches of FDA shortage-list drugs for hospitals or clinics before a specific patient is named, provided the prescriber first tried and failed to get the drug from an approved outsourcing facility, the product is labeled properly, and follow-up records and adverse reactions are reported to the FDA. It also updates FDA shortage definitions to include demand surges and adds reporting requirements for outsourcing facilities and manufacturers.
Affects hospitals, pharmacists, physicians who compound medications, drug manufacturers, and the FDA.
The change could ease hospital access to backup supplies of critical drugs during shortages, while adding new reporting and transparency obligations for the FDA and manufacturers.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: a House committee is reviewing it. If the Senate changes it, it goes back to the House before reaching the President.
Latest action: — Referred to the House Committee on Energy and Commerce.