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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