HR 5316 · 119th CongressIn Committeecongress.gov ↗

Drug Shortage Compounding Patient Access Act of 2025

Road to The Floor

How it works

Introduced

In Committee

On The Floor

Passed a Chamber

Passed Congress

To President

Became Law

What this bill does

AI plain-language summary

This bill makes it easier for pharmacists and compounding facilities to prepare certain drugs when there are shortages. Right now, pharmacists who mix or alter drugs for patients usually have to do it for a specific patient, but this bill would let them also make limited amounts for urgent medical needs even without a specific patient, as long as the drug was recently on the FDA's shortage list. It also gives FDA-registered compounding facilities more time — up to 180 days after a drug is removed from the shortage list — to keep making that drug. Additionally, the bill requires drug manufacturers to report sudden increases in demand for certain important drugs, including ones that are life-supporting or life-sustaining.

Introduced

September 11, 2025

Policy Area

Health

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