# 119-hr-6509: SAFE Drugs Act of 2025

119-hr-6509, SAFE Drugs Act of 2025, is a 119th Congress bill sponsored by Rep. Yakym, Rudy [R-IN-2] (R-IN); status introduced; PRIA reads it as touching household money (as of 2026-09-21).

- Canonical: https://policyrisk.com/legislation/119-hr-6509
- As of: 2026-09-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-6509
- Congress: 119
- Title: SAFE Drugs Act of 2025
- Status: introduced
- Introduced: 2025-12-09
- Sponsor: Rep. Yakym, Rudy [R-IN-2] (R-IN)
- Cosponsors: 20
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-21

## 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. - 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.

## Cosponsors (20)

- Rep. Carson, André [D-IN-7] (D-IN), 2025-12-09T00:00:00.000Z
- Rep. McGuire, John J. [R-VA-5] (R-VA), 2026-01-30T00:00:00.000Z
- Rep. Vindman, Eugene Simon [D-VA-7] (D-VA), 2026-01-30T00:00:00.000Z
- Rep. Moran, Nathaniel [R-TX-1] (R-TX), 2026-02-11T00:00:00.000Z
- Rep. Ross, Deborah K. [D-NC-2] (D-NC), 2026-02-11T00:00:00.000Z
- Rep. Miller, Carol D. [R-WV-1] (R-WV), 2026-03-03T00:00:00.000Z
- Rep. Tenney, Claudia [R-NY-24] (R-NY), 2026-03-03T00:00:00.000Z
- Rep. McDowell, Addison P. [R-NC-6] (R-NC), 2026-03-05T00:00:00.000Z
- Rep. Bean, Aaron [R-FL-4] (R-FL), 2026-03-17T00:00:00.000Z
- Rep. Kelly, Mike [R-PA-16] (R-PA), 2026-03-18T00:00:00.000Z
- Rep. Baird, James R. [R-IN-4] (R-IN), 2026-04-13T00:00:00.000Z
- Rep. Houchin, Erin [R-IN-9] (R-IN), 2026-04-15T00:00:00.000Z
- Rep. Fong, Vince [R-CA-20] (R-CA), 2026-05-12T00:00:00.000Z
- Rep. Shreve, Jefferson [R-IN-6] (R-IN), 2026-05-12T00:00:00.000Z
- Rep. Messmer, Mark B. [R-IN-8] (R-IN), 2026-05-20T00:00:00.000Z
- Rep. Edwards, Chuck [R-NC-11] (R-NC), 2026-06-02T00:00:00.000Z
- Rep. Mrvan, Frank J. [D-IN-1] (D-IN), 2026-07-09T00:00:00.000Z
- Rep. Stutzman, Marlin A. [R-IN-3] (R-IN), 2026-07-13T00:00:00.000Z
- Rep. Davis, Donald G. [D-NC-1] (D-NC), 2026-07-21T00:00:00.000Z
- Rep. Van Orden, Derrick [R-WI-3] (R-WI), 2026-09-16T00:00:00.000Z

## Provisions PRIA read

- Inspections and rules for outsourcing facilities: mixed, low. 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…
- Limits and reports for compounders: mixed, low. 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, s…
- Secretary-set establishment fee for compounding: mixed, low. 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.

## Related bills

- 119-hr-909: Crime Victims Fund Stabilization Act of 2025
- 119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act
- 119-hr-1502: North Platte Canteen Congressional Gold Medal Act
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025

## Sources
- [119-hr-6509 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/6509)

## Related
- [119-hr-909: Crime Victims Fund Stabilization Act of 2025](https://policyrisk.com/legislation/119-hr-909)
- [119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act](https://policyrisk.com/legislation/119-hr-4382)
- [119-hr-1502: North Platte Canteen Congressional Gold Medal Act](https://policyrisk.com/legislation/119-hr-1502)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-6509 (as of 2026-09-21).