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CVM GFI #181 Blue Bird Medicated Feed Labels July 2019

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

A new animal drug application (NADA) for a Type A medicated article is required to include, among other things, representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug (21 CFR 514.1 (b)(3)(v)(b)). FDA uses the term Blue Bird labels to refer to such representative labeling (November 19, 1999; 64 FR 63195 at 63197). Blue Bird labels are created by Type A medicated article sponsors and function as a guide to manufacturers of medicated animal feeds in the preparation of final printed feed labels. The purpose of this guidance is to provide NADA sponsors of Type A medicated articles with FDA’s current thinking on the recommended content and format of Blue Bird labels.

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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:

Dockets Management
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-2008-D-0165.


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