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Guidance Issuing OfficeCenter for Drug Evaluation and Research
Pharmacies located within a hospital, or standalone pharmacies that are part of a health system, frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders seek to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) and others have registered with the Food and Drug Administration (FDA, the Agency, or we) as outsourcing facilities and are subject to section 503B of the FD&C Act (21 U.S.C. 353b).
This revised draft guidance describes how FDA intends to apply certain provisions of section 503A of the FD&C Act to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient (section 503A(a) of the FD&C Act). Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D) of the FD&C Act). This guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-0271.