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FDA Product Classifications by Species

Blue Bird labels requirements by species as per FDA regulation.

?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 Code of Federal Regulations (CFR) 514.1 (b)(3)(v)(b)). The Center for Veterinary Medicine (CVM) uses the term Blue Bird labels to refer to such representative labeling (November 19, 1999; 64 Federal Register (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 sponsor of a Type A medicated article must submit, as part of its NADA, two labeling components.

1. The specimens of labeling to be used for such new animal drug which must include adequate directions for the manufacture and use of finished feeds for all conditions for which the new animal drug is intended, recommended, or suggested in any of the labeling, including advertising, sponsored by the applicant.

2. The representative labeling proposed for use in Type B and Type C medicated feeds containing the new animal drug.

Copies of these Blue Bird labels for Type B and Type C medicated feeds have not been readily available. CVM believes that having Blue Bird labels readily available could help to ensure greater public safety by outlining the proper use levels, indications for use, cautions and warnings approved in the new animal drug application process. Making correct label information easier to obtain should increase the probability that feeds are manufactured and used safely. The absence of having Blue Bird labels readily available to those who need them has been identified as a gap in the Animal Feed Safety System (AFSS). CVM is filling this gap by supplying blue bird labels on its website. This listing is not a comprehensive listing of labels; as new or revised labels are approved, they will be posted and made available to the public.

Disclaimer: The labels presented here are the last approved submitted labels by NADA sponsors.  Some of these labels may use an older format in its presentation.  For example, some of the older labels may not include appropriate guarantees for a particular species of animal; as NADAs are updated and new labels are approved, these labels missing appropriate guarantees or other missing data will be replaced with newer formatting.

For more information by species:

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