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GUIDANCE DOCUMENT

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry June 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-3517
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance sets forth the Food and Drug Administration’s (FDA or Agency) interim regulatory
policy concerning compounding using bulk drug substances under section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act or Act). Section 503A of the FD&C Act includes certain
restrictions on the bulk drug substances that can be used in compounding and directs FDA to develop
a list of bulk drug substances that can be used in compounding under that section. FDA is
developing this list of bulk drug substances (the 503A bulks list), and this guidance describes
FDA’s interim regulatory policy for licensed pharmacists in State-licensed pharmacies and Federal
facilities and for licensed physicians that compound human drug products using bulk drug substances
while the list is being developed.
 

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All written comments should be identified with this document's docket number: FDA-2015-D-3517.

 
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