Docket Number:
FDA-2016-D-0269
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance sets forth the 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 (FD&C Act or Act).

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-0269.