PSM urges the House Energy & Commerce Committee to support the SAFE Drugs Act of 2025
On December 10, 2025, PSM sent a letter to the House Energy & Commerce Committee urging them to support the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act, which would help protect the American drug supply from unsafely compounded medication and restore transparency to a rapidly growing segment of the U.S. prescription drug supply chain.
The Safe Drugs Act would:
- codify the definition of “essentially a copy” to prevent illegal mass compounding of unapproved versions of FDA-approved drugs,
- require compounding pharmacies that ship more than 20 out of state prescriptions of a drug to report that activity to FDA. and
- require the FDA to inspect 503B outsourcing facilities before they begin compounding new products and to re-inspect them at least every two years.
Related:
- Read our February 2025 report on unsafe ingredients coming into the country, and updates from FDA import records
- Learn about outsourcing facilities and inspection delays