Skip to main content

Agora
Sign in

House bill · H.R. 6509 (119th Congress)

SAFE Drugs Act of 2025

U.S. House of Representatives

Latest action Mar 3, 2026

Sponsor: Rudy Yakym III (U.S. Representative, IN-2, Republican)

Follow

Following needs an Agora account. You will sign in first, then come back to this page.

From Congress.gov and official rosters. This record was last updated Jul 30, 2026. About our data

Summary

Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 or the SAFE Drugs Act of 2025 This bill provides for increased oversight of drug compounding and imposes statutory limits on compounded drugs that are essentially copies of commercially available drugs. Currently, subject to certain requirements, compounded drugs (i.e., drugs that are mixed or altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. Additional limits apply to the compounding of drugs that are essentially copies of commercially available drug products. Under the bill, a compounded drug is essentially a copy of a commercially available drug product if (1) the compounded drug contains any active ingredient found in a commercially available drug product, and (2) there is no change made for an individual patient that results in a significant difference between the compounded drug and the commercially available drug. (The FDA’s current definition of the term also addresses dosage strength and route of administration.) The bill increases the frequency at which a licensed pharmacist or physician may compound a drug that is essentially a copy of a commercially available drug to 20 times per month. Current FDA policy allows four such prescriptions per month. The bill also imposes annual reporting requirements on physicians, facilities, and pharmacies (except hospital-based pharmacies) that compound certain drug products for out-of-state patients more than 20 times per month. Further, the bill subjects certain large-scale outsourcing facilities (i.e., FDA-registered facilities that compound in bulk) to regular inspection and reporting requirements.

Summary from the Congressional Research Service. How we handle summaries

Where it stands

Assigned to a committee for review.

  1. Introduced
  2. In committee
  3. Up for a vote
  4. Passed one chamber
  5. Passed
  6. Enacted

Committee

House Committee on Energy and Commerce · U.S. House of Representatives

Your position on this bill

Choose the position closest to yours. You'll sign in or create an account to save it.

Sign in or create an account to give your position

Cosponsors

19

Cosponsors listed on Congress.gov, shown A to Z.

  • Republican14
  • Democratic5

This bill has cosponsors from more than one party.

Shown in neutral colors by design; Agora is non-partisan.

Show the full list (19 names)

Related bills

As identified by Congress.gov.

Full history

  1. Mar 3, 2026

    Introduced

    Introduced in U.S. House

    U.S. House

  2. Dec 9, 2025

    Introduced

    Introduced in House

    U.S. House of Representatives

  3. Dec 9, 2025

    In committee

    Referred to the House Committee on Energy and Commerce.

    U.S. House

  4. Dec 9, 2025

    Referred to committee

    Referred to the House Committee on Energy and Commerce.

    U.S. House of Representatives

Read the record