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CPG Sec 615.115 Extralabel Use of Medicated Feeds for Minor Species December 2016

Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Office of Regulatory Affairs

This revised Compliance Policy Guide (CPG) is an update to the Compliance Policy Guide published in April 2001. The revised CPG represents the Agency’s current thinking on extralabel use of new animal drugs approved for use in or on animal feed (medicated feeds) (as defined in 21 CFR Sec. 558.3(b)(8)) for minor species (as defined in 21 CFR 516.3(b). Minor species are defined by exclusion as animals other than cattle, horses, swine, chickens, turkeys, dogs and cats. The CPG is intended to provide guidance to the field concerning the Agency’s exercise of enforcement discretion with regard to the extralabel use of over-the-counter (OTC) and veterinary feed directive (VFD) medicated feeds in minor species. It does not confer any rights for or on any person and does not operate to bind FDA or the public.

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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


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