Bill > S3794

This bill, known as the Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026 (SAFE Drugs Act of 2026), aims to strengthen regulations for compounding pharmacies and outsourcing facilities, which are entities that prepare customized medications for individual patients or provide large-scale sterile drug products. Key provisions include defining when a compounded drug is considered "essentially a copy of a commercially available drug product," which is a drug sold in the U.S. market that is not discontinued and is manufactured under specific quality standards, and limiting compounding pharmacies to making such copies no more than 20 times per month for any given drug. The bill also introduces a reporting requirement for pharmacies, facilities, or physicians who compound more than 20 times monthly for patients outside their state, requiring them to report the types and quantities of drugs compounded, with an exception for hospital pharmacies compounding for their own patients. Furthermore, large-scale outsourcing facilities, defined as those compounding more than 100 times annually, will be subject to mandatory inspections before their first compounding activity and at least every two years thereafter, and will no longer be exempt from certain registration requirements. Finally, the bill allows the Secretary of Health and Human Services to set an appropriate base establishment fee for these facilities to fund safety activities, replacing the previous fixed fee of $15,000.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3794/all-info