FDA: Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability Federal Register

Oct 7, 2021 - Notice from the Food and Drug Administration (FDA) seeking comment on revised draft guidance that, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State-licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. The draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient and the provision concerning compounded drug products that are essentially copies of a commercially available drug product. Comments are due by December 6, 2021.

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