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119-hr-6509119th CongressWALLET

SAFE Drugs Act of 2025

Sponsored By: Representative Yakym, Rudy [R-IN-2]

Introduced

Summary

This bill would strengthen oversight of drug compounding. It limits routine production of drugs that copy commercially available products and adds new reporting, inspection, and fee rules to improve safety.

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  • Families and patients: Would limit compounding of an "essentially copy" drug to no more than 20 times in a single month, potentially reducing high-volume production of copied products. Hospital-based pharmacy compounding for hospital patients is excluded.
  • Pharmacies, physicians, and facilities: Would require any pharmacy, facility, or physician that compounds such a product more than 20 times in a month for patients who live outside the compounding state to submit an annual report listing each product type and the monthly counts.
  • Outsourcing facilities and regulators: Would define a large-scale outsourcing facility as one that compounds more than 100 times in a year, require an initial inspection before first compounding and a biennial reinspection, remove an outsourcing exemption in the statute, and let the Health Secretary replace the fixed $15,000 base establishment fee with an amount the Secretary deems appropriate to fund safety activities.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 0 benefits, 0 costs, 3 mixed.

Inspections and rules for outsourcing facilities

If enacted, beginning six months after enactment outsourcing facilities that compound more than 100 times in a calendar year would be labeled "large-scale." Those large-scale facilities would need an inspection before they compound any drug for the first time. If enacted, such facilities would also face reinspection at least once every two years. If enacted, the bill would also remove a statutory exemption so outsourcing facilities are no longer exempt from the registration/reporting rule referenced in 21 U.S.C. 360(g)(1), starting six months after enactment.

Limits and reports for compounders

If enacted, the bill would ban compounding a drug that is basically a copy of a commercial drug more than 20 times in one month. A product is a copy if it uses an active ingredient in a commercial product and lacks a patient-specific change the prescriber says makes a real difference. If enacted, starting in 2025 and each year after, pharmacies, facilities, or doctors that make such a drug more than 20 times in one month for patients who live in another State would have to file an annual report. Reports would be due by the end of the calendar year and must follow forms the Secretary prescribes. On-premises hospital pharmacies compounding for hospital patients would be excluded from the reporting rule.

Secretary-set establishment fee for compounding

If enacted, the bill would replace the fixed $15,000 base establishment fee with a base amount the HHS Secretary sets. This change would take effect upon enactment. If the Secretary raises the base amount, compounding facilities could pay more. If the Secretary lowers it, fees could fall.

Sponsors & CoSponsors

Sponsor

Yakym, Rudy [R-IN-2]

IN • R

Cosponsors

  • Rep. Carson, André [D-IN-7]

    IN • D

    Sponsored 12/9/2025

  • Rep. McGuire, John J. [R-VA-5]

    VA • R

    Sponsored 1/30/2026

  • Rep. Vindman, Eugene Simon [D-VA-7]

    VA • D

    Sponsored 1/30/2026

  • Rep. Moran, Nathaniel [R-TX-1]

    TX • R

    Sponsored 2/11/2026

  • Rep. Ross, Deborah K. [D-NC-2]

    NC • D

    Sponsored 2/11/2026

  • Rep. Miller, Carol D. [R-WV-1]

    WV • R

    Sponsored 3/3/2026

  • Rep. Tenney, Claudia [R-NY-24]

    NY • R

    Sponsored 3/3/2026

  • Rep. McDowell, Addison P. [R-NC-6]

    NC • R

    Sponsored 3/5/2026

  • Rep. Bean, Aaron [R-FL-4]

    FL • R

    Sponsored 3/17/2026

  • Rep. Kelly, Mike [R-PA-16]

    PA • R

    Sponsored 3/18/2026

  • Rep. Baird, James R. [R-IN-4]

    IN • R

    Sponsored 4/13/2026

  • Rep. Houchin, Erin [R-IN-9]

    IN • R

    Sponsored 4/15/2026

  • Rep. Fong, Vince [R-CA-20]

    CA • R

    Sponsored 5/12/2026

  • Rep. Shreve, Jefferson [R-IN-6]

    IN • R

    Sponsored 5/12/2026

  • Rep. Messmer, Mark B. [R-IN-8]

    IN • R

    Sponsored 5/20/2026

  • Rep. Edwards, Chuck [R-NC-11]

    NC • R

    Sponsored 6/2/2026

  • Rep. Mrvan, Frank J. [D-IN-1]

    IN • D

    Sponsored 7/9/2026

  • Rep. Stutzman, Marlin A. [R-IN-3]

    IN • R

    Sponsored 7/13/2026

  • Rep. Davis, Donald G. [D-NC-1]

    NC • D

    Sponsored 7/21/2026

  • Rep. Van Orden, Derrick [R-WI-3]

    WI • R

    Sponsored 9/16/2026

Roll Call Votes

No roll call votes available for this bill.

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