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Clearance Procedures for New Animal Drugs and Feed Additives

Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Maryland 20857

ABSTRACT

Food and Drug Administration's Bureau of Veterinary Medicine has a mandate under the Food, Drug, and Cosmetic Act to assure that animal drugs and feed additives are both safe and effective. We are responsible for evaluating newly proposed animal drugs for these two criteria before they can be introduced on to the marketplace. Our operating laws and regulations in this preclearance function are clearcut, yet also very complex.

Important Definitions

Before the requirements of the Act can be interpreted or understood, certain terms such as "drug", "new animal drug", and "feed additive" need to be defined. The Food, Drug, and Cosmetic Act defines "drug" as "(A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals, and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C); but does not include devices or their components, parts or accessories".