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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.