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GUIDANCE DOCUMENT

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Guidance for Industry January 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-1524
Issued by:
Guidance Issuing Office
Center 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.
 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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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-2014-D-1524.

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