Bill would tighten FDA rules on compounded drug copies and inspections
In committeeH.R. 6509Latest action
Sponsor: Rudy Yakym III · Representative · IN
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Official title: SAFE Drugs Act of 2025
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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The SAFE Drugs Act of 2025 caps near-copy compounded drugs at 20 monthly and adds FDA reporting and inspections.
45-second read · 4 questions answered below
What does this do?
The bill narrows the definition of an illegal "copy" of a commercial drug and limits pharmacies to 20 near-copies per month for a patient unless a documented medical difference exists. It adds annual FDA reporting for compounders exceeding that limit for out-of-state patients, mandates inspections for large outsourcing facilities before and every two years after making a new drug, removes a registration exemption, and lets the FDA set its own base registration fee instead of a fixed amount.
Who does it affect?
Affects compounding pharmacies, large-scale drug outsourcing facilities, and prescribing physicians; hospital pharmacies treating their own patients are exempt from the new reporting rule.
Why does it matter?
The changes give the FDA more oversight and data on large-scale production of drugs resembling existing commercial medications, which could affect how available certain customized medications are to patients.
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Where does it stand?
- IntroducedDec 9, 2025
- House committeeYou are here · Dec 9, 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.