The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.''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.
Document
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Hospital and Health System Compounding Under the ...
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81 FR 22610
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“Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability,” thefederalregister.org (April 18, 2016), https://thefederalregister.org/documents/2016-08879/hospital-and-health-system-compounding-under-the-federal-food-drug-and-cosmetic-act-draft-guidance-for-industry-availabi.