SAFE Drugs Act of 2025
What does the SAFE Drugs Act of 2025 do?
HR 6509 is a House bill sponsored by Rep. Rudy Yakym (R-IN). Pharmacies and doctors can mix custom versions of drugs (compounding) without FDA approval, so long as they stay inside limits on copying drugs already sold commercially. This bill turns the copying limit into a fixed number - 20 times in a single month - adds a report for compounding above that same count for out-of-State patients, and requires a first-time inspection plus a reinspection at least every two years for outsourcing facilities that compound more than 100 times a year. Replaces the Secretary-defined "regularly or in inordinate amounts" ceiling on compounding copies of commercially available drugs with a fixed limit of 20 times in a single month, and adds inspection, registration, reporting, and fee changes for outsourcing facilities.
Did HR 6509 pass? Where it stands
As of August 27, 2026, HR 6509 has reached the In Committee stage.
Status: In Committee
Outlook: Long shot
Key provisions
- Limits on Compounding Drug Copies
- Copies of commercial drugs capped at 20 times a month
- Replaces the Secretary-defined "regularly or in inordinate amounts" standard
- Copy test: shared active ingredient, no patient-specific difference
- Out-of-State Compounding Reports
- Report required above 20 out-of-State compounds in a month
- Applies from calendar year 2025 on; due by year end
- Hospital pharmacies compounding for hospital patients are excluded
- Outsourcing Facility Oversight
- Large-scale means more than 100 compounds in a calendar year
- Inspection before first compounding, then at least every two years
- Outsourcing facilities lose the pharmacy registration exemption
Last updated August 27, 2026