SAFE Drugs Act of 2026

The SAFE Drugs Act of 2026 restricts pharmacies, facilities, and physicians from compounding more than 20 times in a single month for out-of-state patients any drug that is essentially a copy of a commercially available product (e.g., containing the same active ingredient without a significant patient-specific difference). It requires these providers to submit annual reports to the federal government detailing the types of drugs compounded and the frequency for such out-of-state compounding, with reports due by year-end. The bill also mandates initial and biennial inspections for large-scale compounding facilities (those compounding over 100 times yearly) and adjusts the base fee for compounding registration to be set by the Secretary. Hospital pharmacies are exempt from the reporting requirement.