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  4. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
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GUIDANCE DOCUMENT

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry January 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
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.

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