HR 6509 · 119th CongressIn Committeecongress.gov ↗

SAFE Drugs 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 changes the rules around compounded drugs, which are medications that are specially mixed or altered to meet a patient's specific needs. It updates the definition of when a compounded drug is considered a copy of a drug already available on the market and raises the limit on how many times per month a pharmacist or doctor can make such a copy from 4 to 20. The bill also requires doctors, pharmacies, and facilities that make compounded drugs for out-of-state patients more than 20 times a month to file yearly reports, and it adds regular inspections and reporting rules for large facilities that make compounded drugs in bulk.

Introduced

December 9, 2025

Policy Area

Health

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