Glossary of Terms Related to FDA’s Regulation of Animal Products
Adulteration: A violation of the Federal Food, Drug, and Cosmetic Act which includes products that are defective, unsafe, not shown to be safe, filthy, or produced under insanitary conditions. It also includes products which are manufactured under procedures and controls which do not comply with Current Good Manufacturing Practice regulations as well as new animal drug products which are not the subject of an NADA approval. Detailed definitions of adulteration are in the Act itself, and have been developed in regulations and by the courts.
Adverse Drug Experience: An adverse drug experience is any adverse event associated with the use of an animal drug, whether or not it is considered to be drug-related, and whether or not the drug was used according to approved labeling. It includes, but is not limited to, side effects, toxicities, sensitivity reactions, failure of the drug to produce its expected pharmacologic effect, product defects, or adverse events occurring in humans from exposure during manufacture, testing, handling or use of the animal drug.
Animal Feed: An article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal. It is not limited to a mixture intended to be the sole ration of the animal.
Biologics: see Veterinary Biologics
Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
Drug: The definition of a drug, in section 201(g) of the Act, includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Electronic Animal Identification Products: Implantable transponders which contain unique information for use in animal identification; A reader compatible with the transponder is used to make the final identification. These transponders are implanted into inedible portions of the animal (e.g., ear) and if the implant is rendered for animal feed, the Center is regulating the transponder as a food additive.
Extra-Label Use: Refers to the actual or intended use of an approved new animal drug in a manner that is not in accordance with the approved label directions.
Food Additive: Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, processing, preparing, treating, packaging, transporting, or holding food; and including source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures...to be safe under the conditions of its intended use... (see 21 U.S.C. 321 (s) for complete definition).
Labeling: All labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers or (2) accompanying such article.
Medicated Animal Feed: An article intended for use as food for animals, other than man, bearing, containing, or purporting to bear or contain any kind of animal drug/drug combination.
Misbranding: A drug or device shall be deemed to be misbranded (a) if its labeling is false or misleading in any particular; (b) if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; (c) If any word, statement, or other information required by or under authority of the Act to appear on the label is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use... The complete definition of misbranding can be found in the Act (21 U.S.C. 502).
New Animal Drug: Any drug intended for use for animals other than man which, among other things, is not generally recognized by qualified experts as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof.