- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance sets forth the FDA's policy regarding repackaging by State-licensed pha1macies, Federal facilities, and facilities that register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act). This guidance describes the conditions under which FDA does not intend to take action for violations of sections 505, 502(f)(l ), 582, and where specified, section 501(a)(2)(B) of the Act, when a State licensed pharmacy, a Federal facility, or an outsourcing facility repackages human prescription drug products.
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-2014-D-1524.