The SAFE Drugs Act of 2025 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 "compounding" and "commercially available drug product" and modifies the registration and reporting requirements for pharmacies, facilities, and physicians. It also introduces inspections for large-scale outsourcing facilities and modifies the base establishment fee. The amendments apply six months after the enactment of this Act.
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- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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