Glossary of Terms Related to FDAs

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 eects, toxicities, sensitivity
reactions, failure of the drug to produce its expected pharmacologic eect, 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 aect 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 aect 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 aecting 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 eective for use under the condition
prescribed, recommended, or suggested in the labeling thereof.

Veterinary Biologics: Vaccines, bacterins, diagnostics, etc, which are used to prevent, treat, or
diagnose animal diseases. These products generally work through some immunological method or
process.

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