Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act." This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.