SAFE Drugs Act of 2025

Increased Oversight of Large-Scale Facilities: Large-scale outsourcing facilities, defined as those compounding a drug product more than 100 times in a single calendar year, will now be subject to an initial inspection before compounding any drug product and a reinspection at least every two years. This is found in Section 4(a).

Enhanced Tracking of Out-of-State Compounding: Pharmacies, facilities, or physicians must submit a report to the Secretary if they compound certain drug products more than 20 times in a single month for patients living outside the state where the compounding occurs. This ensures more data is provided regarding these transactions. This is found in Section 3(d)(1).

Regulating "Essentially a Copy" Drugs: The bill prevents compounding more than 20 times in a single month for drug products that are essentially a copy of a commercially available drug product without a significant difference for the patient. This is found in Section 2.

Increased Funding for Safety Activities: The base establishment fee is changed from a fixed $15,000 to a base amount deemed appropriate by the Secretary to fund activities for the safety of compounded drug products. This could result in different costs for the establishment. This is found in Section 5.

New Administrative Burdens: Pharmacies, facilities, or physicians must follow specific reporting requirements, including identifying drug types and monthly totals, and submitting them in a form and manner prescribed by the Secretary. This is found in Section 3(d).