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GUIDANCE DOCUMENT

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

Final

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

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.
 


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.