FDA CVM GFI #181 Blue Bird Medicated Feed Labels

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Blue Bird Medicated Feed Labels Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION 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)). The Center for Veterinary Medicine (the Center or CVM) 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 1

medicated 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 the Center’s current thinking on the recommended content and format of Blue Bird labels. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. BACKGROUND Type A medicated articles are intended solely for use in the manufacture of another Type A medicated article or in the manufacture of Type B or Type C medicated feed (21 CFR 558.3(b)(2)). Type B medicated feed is intended solely for the manufacture of other medicated feeds (Type B or Type C) and therefore it cannot be fed as is without being further diluted to Type C medicated feed. Type B medicated feed contains a substantial quantity of nutrients including vitamins and/or other nutritional ingredients in an amount not less than 25% of the weight. Type B medicated feed is manufactured by diluting a Type A medicated article or another Type B medicated feed (21 CFR 558.3(b)(3)). Type C medicated feed is intended as the complete feed for the animal or may be fed 'top dressed' (added on top of usual ration) or offered 'free choice' in conjunction with other animal feed. It is manufactured by diluting a Type A medicated article, a Type B medicated feed, or another Type C medicated feed (21 CFR 558.3(b)(4)).

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Final printed feed labels are also known as product or brand labels. 3

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