Bill > HR6509

This bill, known as the Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2025 (SAFE Drugs Act), proposes several key changes to regulate compounding pharmacies and outsourcing facilities. The legislation restricts compounding pharmacies from creating more than 20 drug product copies in a single month, defines what constitutes a "copy" of a commercially available drug product, and introduces new reporting requirements for pharmacies, facilities, and physicians who compound drugs for out-of-state patients. For large-scale outsourcing facilities (defined as those compounding more than 100 drug products in a calendar year), the bill mandates initial and biennial inspections by regulatory authorities. Additionally, the bill removes registration exemptions for outsourcing facilities and modifies the base establishment fee for such facilities, allowing the Secretary of Health and Human Services to determine an appropriate fee amount to fund safety activities related to compounded drugs. These provisions aim to enhance oversight, transparency, and safety in the production of compounded pharmaceutical products, addressing potential risks associated with large-scale drug compounding outside traditional manufacturing processes.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/6509/all-info