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.

Questions?