Amends the Federal Food, Drug, and Cosmetic Act to regulate compounding pharmacies and outsourcing facilities.
The SAFE Drugs Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities. It defines "large-scale outsourcing facility" as any outsourcing facility that compounds more than 100 times in a single calendar year. The bill mandates inspections of large-scale outsourcing facilities, including an initial inspection before compounding any drug product and a reinspection at least biennially.
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