*Blue Bird labels are now located on Animal Drugs @ FDA.
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.
- 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.
- The representative labeling proposed for use in Type B and Type C medicated feeds containing the new animal drug.
Searching for Blue Bird Labels
Blue Bird labels are now located on Animal Drugs @ FDA. There are different ways to search the database for Blue Bird labels. It is recommended users use the Advanced Search function which allows for searching by application number, sponsor name, proprietary name, ingredient, application status, dosage form, route of administration, indication, and/or species. Once a list of search results displays, click on an Application# to view more information about the approved new animal drug. If there is a Blue Bird label associated with the new animal drug, it will be listed in the Supporting Documents and can be viewed as a PDF. For more detailed instructions on searching for Blue Bird labels on Animal Drugs @ FDA, see the user guide below.