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HR6509119th CongressWALLET

SAFE Drugs Act of 2025

Sponsored By: Representative Yakym

Introduced

Summary

Tightens compounding rules and boosts oversight of large outsourcing facilities. This bill would limit high-volume compounding of drugs that are essentially copies of commercial products, set reporting for out-of-state compounding, and expand inspections and fee authority for regulators.

Show full summary
  • Patients: May see fewer compounded versions of commercially available drugs because the bill targets products that are "essentially copies" of market drugs and limits high-volume compounding.
  • Pharmacies, facilities, and physicians: Would have to report any compounded drug that contains an active ingredient found in a commercial product when it is compounded more than 20 times in a single month for patients living outside the compounding state. Reports must list each product type and the monthly totals and be submitted by year end in a form the Secretary prescribes.
  • Large-scale outsourcing facilities: Would face a required inspection before their first compounding and inspections at least every two years. "Large-scale" is defined as compounding more than 100 times in a calendar year, and a current exemption in one inspection provision would not apply to certain outsourcing facilities.
  • Hospital pharmacies: Hospital-based compounding activities are excluded from the new out-of-state reporting requirement.
  • FDA and the Secretary: Would be given authority to set the base establishment fee instead of the fixed $15,000 figure to fund safety activities. The new inspection and related requirements would apply beginning six months after enactment.

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Bill Overview

Analyzed Economic Effects

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

New base fee for drug establishments

If enacted, the bill would let the Secretary set the base establishment fee used to fund safety activities for compounded drugs instead of a fixed $15,000 amount. Drug establishments and outsourcing facilities that pay that fee could see the amount change. This change would take effect upon enactment.

New limits and reports for compounders

If enacted, the bill would bar compounding a drug that is "essentially a copy" more than 20 times in one month. A drug is a copy if it has any active ingredient in a sold commercial product and the prescriber finds no significant difference for the patient. Starting in 2025, pharmacies, facilities, or physicians that in any month compound such products for out-of-state patients more than 20 times would file one annual report listing each product type and monthly counts. Reports are due by the end of the calendar year and do not apply to pharmacy compounding for hospital patients on hospital premises.

Tighter oversight for outsourcing facilities

If enacted, the bill would define a "large-scale" outsourcing facility as one that compounds more than 100 times in a year. Those facilities would need an inspection before they first compound and a reinspection at least every two years. The bill would also remove a registration exemption so outsourcing facilities must register and report under the standard registration rules. These changes would begin six months after enactment.

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Sponsors & CoSponsors

Sponsor

Yakym

IN • R

Cosponsors

  • Rep. Carson, Andre [D-IN-7]

    IN • D

    Sponsored 12/9/2025

  • McGuire

    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

  • Miller (WV)

    WV • R

    Sponsored 3/3/2026

  • Tenney

    NY • R

    Sponsored 3/3/2026

  • McDowell

    NC • R

    Sponsored 3/5/2026

  • Bean (FL)

    FL • R

    Sponsored 3/17/2026

  • Kelly (PA)

    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

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
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