Docket Number:
FDA-2016-D-1309
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C
Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound
regularly or in inordinate amounts any drug products that are essentially copies of a commercially
available drug product, among other conditions. This guidance sets forth FDA’s policies regarding
this provision of section 503A, including the terms commercially available, essentially a copy of a
commercially available drug product, and regularly or in inordinate amounts.
 

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All written comments should be identified with this document's docket number: FDA-2016-D-1309.