federal_register: 2016-31607

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2016-31607 Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. 2016-12-29 2016 12 https://www.federalregister.gov/documents/2016/12/29/2016-31607/prescription-requirement-under-section-503a-of-the-federal-food-drug-and-cosmetic-act-guidance-for https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31607.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance sets forth FDA's...

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