S. 3794 — SAFE Drugs Act of 2026

This section limits compounding of any drug product that is essentially a copy of a commercially available drug product to no more than 20 times in a single month. It defines an essentially copy as a product containing any active ingredient from a commercially available drug with no significant difference for the identified patient as determined by the prescribing practitioner, and defines commercially available drug product as one sold in the U.S. marketplace, manufactured in facilities complying with current good manufacturing practice, and not listed as discontinued.

This section requires pharmacies, facilities, and physicians that compound more than 20 times in a single month, for patients residing outside the state where compounding occurs, any drug product containing an active ingredient found in a commercially available drug product, to report to the Secretary beginning in calendar year 2025. Each report must identify the types of such drug products and the total number of times each type is compounded per month, with submissions due by the end of the calendar year in a form prescribed by the Secretary; the requirement does not apply to hospital pharmacies compounding for hospital patients.

This section requires large-scale outsourcing facilities—those compounding any drug product more than 100 times in a calendar year—to undergo an initial inspection before first compounding any drug product and reinspection at least biennially. It also eliminates the exemption from registration and reporting requirements under section 510(g)(1) for all outsourcing facilities. The changes take effect 6 months after enactment.

This section authorizes the Secretary to set the base amount of the annual establishment fee assessed on each outsourcing facility to fund activities ensuring the safety of compounded drug products, replacing the prior fixed amount of $15,000 (multiplied by the inflation adjustment factor and plus any small business adjustment factor). The reinspection fee remains $15,000 multiplied by the inflation adjustment factor.