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  4. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B 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 Approved Drug Products Under Section 503B 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-1267
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

For a drug product compounded by an outsourcing facility to qualify for the exemptions under
section 503B of the Federal Food,  Drug, and Cosmetic  Act (FD&C Act), it  must  not  be
“essentially a copy of one  or more  approved drug products,”  and must meet the other  conditions
in section 503B. This guidance sets forth  FDA’s policies  concerning  the essentially a copy
provision  of  section 503B.
 

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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-1267.

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