Bill would let pharmacists pre-mix shortage drugs before a patient is named
In committeeH.R. 5316Latest action
Sponsor: Diana Harshbarger · Representative · TN
AIDecoded by AI · checked against the recordRead the official text
Official title: Drug Shortage Compounding Patient Access Act of 2025
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
The plain-language version comes first. 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
What does this do?
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.
Who does it affect?
Affects hospitals, pharmacists, physicians who compound medications, drug manufacturers, and the FDA.
Why does it matter?
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. Check it against the official text before you act on it.
Read the official bill on Congress.govMake the call
Where does it stand?
- IntroducedSep 11, 2025
- House committeeYou are here · Sep 11, 2025
- House vote
- Senate
- The president's desk
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.