SAFE Drugs Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to strengthen oversight of drug compounding by pharmacies and facilities. It redefines what constitutes "essentially a copy of a commercially available drug product" and prohibits pharmacies from compounding such drugs more than 20 times per month. Furthermore, it establishes a new reporting requirement for pharmacies, facilities, or physicians that compound certain drug products more than 20 times monthly for out-of-state patients, detailing the types and quantities of drugs compounded. For outsourcing facilities , the legislation introduces more rigorous oversight, particularly for those designated as "large-scale." These facilities, defined as compounding any drug product more than 100 times annually, will face mandatory pre-compounding inspections and biennial reinspections. The bill also removes the general registration exemption for all outsourcing facilities and replaces the fixed $15,000 base establishment fee with an amount the Secretary deems appropriate to fund activities ensuring the safety of compounded drug products.