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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 Biologicals: Animal biological products are products regulated by USDA under the Virus, Serum, Toxin Act (21 U.S.C. 151-158) and are defined in part as “viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response.” (9 CFR part 101)

Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTP): Animal cells, tissues, and cell- and tissue-based products (ACTPs) mean those articles subject to regulation under the FD&C Act that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion, or transfer into an animal recipient.

Animal Drug Compounding: The process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals.

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.

Conditional Approval: “Conditional approval” allows the sponsor to make a drug available before collecting all necessary effectiveness data, but after proving the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness. The drug sponsor can keep the product on the market for up to five years, through annual renewals, while collecting the remaining required effectiveness data. While originally intended only for applications for products for minor uses and minor species, this option was expanded in 2018 to also include certain major uses in major species in order to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs where demonstration of effectiveness would require a complex or particularly difficult study or studies.  

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).

Indexing: The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) is a list of new animal drugs intended for use in minor species that have had their safety and effectiveness affirmed through an alternative FDA review process involving an expert panel from outside the FDA. The Index is limited to non-food producing minor species and non-food early life stages of food producing minor species, and provides a faster and less expensive process to obtain legal marketing status for eligible products.

Intentional Genomic Alteration (IGA): IGAs in animals are changes to an animal's genomic DNA produced using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions. The IGA can be introduced into the animal’s genome using recombinant DNA, genome editing, or other technologies.

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.

Veterinary Feed Directive Drugs: A drug intended for use in or on animal feed that is limited to use under the professional supervision of a licensed veterinarian.


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