SAFE Drugs Act of 2026

The "Safeguarding Americans from Fraudulent and Experimental Drugs Act of 2026" aims to enhance the regulation of drug compounding to improve patient safety. It amends the Federal Food, Drug, and Cosmetic Act by placing new restrictions on compounding pharmacies. Specifically, the bill limits pharmacies to compounding a drug product that is "essentially a copy of a commercially available drug product" no more than 20 times in a single month. It also introduces a new reporting requirement for pharmacies, facilities, or physicians that compound such drug products more than 20 times monthly for out-of-state patients, requiring them to identify the drug types and compounding frequency to the Secretary. Furthermore, the legislation increases oversight for outsourcing facilities , particularly those deemed "large-scale" for compounding over 100 times annually. These facilities will now require an inspection prior to their first compounding activity and subsequent biennial reinspections. The bill also removes the general registration exemption for all outsourcing facilities and allows the Secretary to determine an appropriate base establishment fee to fund activities ensuring the safety of compounded drug products.