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GUIDANCE DOCUMENT

Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry December 2016

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

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

 
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