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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

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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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:

Dockets Management
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-1309.

 
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