SAFE Drugs Act of 2025

HR 6509, the SAFE Drugs Act of 2025, limits how often pharmacies and healthcare providers can create custom drug formulations that copy standard medications. It restricts compounding any drug essentially identical to a commercially available product to no more than 20 times per month for individual patients. The bill also requires pharmacies compounding such drugs for out-of-state patients more than 20 times monthly to report details to the FDA, while exempting hospital pharmacies. These changes aim to improve safety oversight of non-standard drug compounding by setting clear limits and reporting rules.