SAFE Drugs Act of 2025
Sponsored By: Representative Yakym, Rudy [R-IN-2]
Introduced
Summary
Tightening oversight of compounding pharmacies and outsourcing facilities. This bill would amend the Federal Food, Drug, and Cosmetic Act to limit copycat compounding, require new reporting for cross‑state compounding, expand inspections of large outsourcing facilities, and let the Secretary set a new base fee to fund safety work.
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- Families and patients: Pharmacies, facilities, or physicians that compound a drug containing an active ingredient found in a commercially available product for patients outside the compounding state would have to report each product type and monthly counts if they exceed 20 times in a month. Reports must be submitted by year end and exclude hospital-on-premises compounding.
- Compounding pharmacies and outsourcing facilities: The bill would tighten the definition of an “essentially copy” product and cap certain compounding at 20 times monthly. It would define a large-scale outsourcing facility as one compounding more than 100 times a year and require an inspection before first compounding and reinspections at least biennially.
- Regulators and fees: The fixed $15,000 base establishment fee would be removed and replaced with a Secretary-determined base amount to fund oversight activities. Certain changes would take effect six months after enactment.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
New limits and reports for compounding
If enacted, the bill would bar a pharmacy, facility, or prescriber from compounding a drug that is "essentially a copy" of a sold drug more than 20 times in one month. It would define "essentially a copy" as any compounded product that uses an active ingredient found in a commercially available product and that has no patient-specific change producing a significant difference as determined by the prescriber. The bill would also require annual reports starting for calendar year 2025 from any pharmacy, facility, or physician that in a single month compounds more than 20 times for patients who live outside the State where the compounding occurs, when the product contains an active ingredient found in a commercially available product. Reports must list each drug type and monthly counts and be filed by the end of the calendar year in the form the Secretary prescribes. The reporting rule would not apply to a pharmacy compounding for hospital patients on hospital premises.
Higher fees and inspections for compounding
If enacted, the bill would let the FDA Secretary set the base establishment fee for compounding-related registrants instead of a fixed $15,000 base fee. The bill would also define a "large-scale outsourcing facility" as any outsourcing facility that compounds more than 100 times in a calendar year. Beginning six months after enactment, such large facilities would need an FDA inspection before their first compounding and at least biennial reinspections. The bill would also remove a statutory exemption so outsourcing facilities are not excluded under the cited exemption provision.
Sponsors & CoSponsors
Sponsor
Yakym, Rudy [R-IN-2]
IN • R
Cosponsors
Carson
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
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
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
Rep. Fong, Vince [R-CA-20]
CA • R
Sponsored 5/12/2026
Rep. Shreve, Jefferson [R-IN-6]
IN • R
Sponsored 5/12/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov