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GUIDANCE DOCUMENT

CVM GFI #181 Blue Bird Medicated Feed Labels July 2019

Final
Docket Number:
FDA-2008-D-0165
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.


Submit Comments

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.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
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Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002