SAFE Drugs Act of 2026 regulates compounding pharmacies and outsourcing facilities by requiring inspections and reporting.

The SAFE Drugs Act of 2026 amends the Federal Food, Drug, and Cosmetic Act to enhance oversight of compounding pharmacies and outsourcing facilities. It mandates inspections for large-scale outsourcing facilities, defined as those compounding more than 100 times annually. These facilities must undergo an initial inspection before compounding and a reinspection every two years. The Act also requires pharmacies, facilities, or physicians compounding more than 20 times monthly for out-of-state patients to report to the Secretary of Health and Human Services.

SAFE Drugs Act of 2026 regulates compounding pharmacies and outsourcing facilities by requiring inspections and reporting.

The SAFE Drugs Act of 2026 amends the Federal Food, Drug, and Cosmetic Act to enhance oversight of compounding pharmacies and outsourcing facilities. It mandates inspections for large-scale outsourcing facilities, defined as those compounding more than 100 times annually. These facilities must undergo an initial inspection before compounding and a reinspection every two years. The Act also requires pharmacies, facilities, or physicians compounding more than 20 times monthly for out-of-state patients to report to the Secretary of Health and Human Services.