File number:
FDA-2016-D-0271
Issued by:

Guidance issuance office

Center for Drug Evaluation and Research

Pharmacies located in a hospital, or stand-alone pharmacies that are part of a healthcare system, frequently provide compound drug products for administration within the hospital or healthcare system. Some of these compounders seek to prepare drugs under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 353a) and others have registered with the Food and Drug Administration (FDA, agency or us) as an outsourcing facility and are subject to Section 503B of the FD&C Act (21 USC 353b).

This revised draft guideline describes how the FDA intends to apply certain provisions of Section 503A of the FD&C Act to human pharmaceuticals that are compounded by state-licensed pharmacies that do not outsource facilities. for distribution within a hospital or healthcare system. First, the revised version of the draft guidance addresses the requirement that preparation must be based on receipt of a valid prescription for an identified individual patient (Section 503A (a) of the FD&C Act). Second, it deals with the provision for compound pharmaceuticals that are essentially copies of a commercially available pharmaceutical product (Section 503A (b) (1) (D) of the FD&C Act). These guidelines do not apply to human pharmaceuticals compounded by outsourcing facilities under Section 503B of the FD&C Act, compounded pharmaceuticals that are not distributed for use in a hospital or healthcare system. , or compound pharmaceuticals for use in animals.


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All written comments should be identified with the file number for that document: FDA-2016-D-0271.