- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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-1267.