Definitions

 Animal Drug, Generic A term for a drug that is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient and must contain the same active ingredients as the original formulation.
 Animal Drug, Not Marketed A term used to refer to a product that is considered no longer manufactured or marketed. The drug may be viable, but the manufacturer has chosen to no longer manufacture the product, has gone out of business, or has sold its interest in the product. A drug that is no longer marketed does not necessarily mean it has been “withdrawn”.
 Animal Drug, Safe A drug is considered “safe” where study results show that the product is safe under the explicit conditions of use in the proposed labeling. “Safe" is a relative term; it means that the benefits of the drug appear to outweigh the risks.
 Animal Drug, Withdrawn Drug Withdrawals are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
 Chicken, Broiler, Fryer and  Roaster Chickens being raised for meat purposes only.
 Chicken, Replacement Chickens being raised for the purpose of egg production.
 Doseage Form The form the drug is available (eg. Tablets, Injection, Premix, etc.).
 Drug Something that treats a disease or changes the structure or function of the body.
 Drug Classification This is a five character alpha-numeric code used by the Veterans Administration [VA] in the USA to classify drug products by their primary clinical role. In the FARAD database ingredients and products are classified as to their significant class and can have more than one code assigned.
 Drug Sponsor The entity responsible for collecting all the information about a new animal drug and submitting this information to the CVM for review.
 Dry Dairy Cow aka Dry Cows have previously produced milk for human consumption and will again in the future after completion of the “dry period” between lactations.
 Free-Choice Medicated  Feed Medicated feed that is placed in feeding or grazing areas and is not intended to be consumed fully at a single feeding or to constitute the entire diet of the animal.
 Food Animal An animal that produces food for human consumption [meat, offal, milk and eggs].
 Heifer A young cow (beef or dairy), before it's had it's first calf.
 Freedom of Information  Summary A public document describing the safety and effectiveness information that supports the CVM's decision to approve the new animal drug.
 Non-lactating Dairy Cattle Includes replacement dairy heifers, replacement dairy bulls, and dairy calves. These classes of dairy cattle have not yet, or would never produce, milk for human consumption. The term non-lactating dairy cattle does not include dry dairy cows.
 Safe Animal Drug For a drug to be considered "safe" it must include safety to the animal as well as to food products made from the treated animal, if the drug is for use in food-producing animals.
 Target Animal Safety The Sponsor must prove that a drug is safe to a specific animal species, when it it used according to the label, by indentifing any harmful side affects and establishing a margin of safety for the drug.
 Tolerance The level of chemical residues allowed to be in or on food products made from treated animals, using the ADI [acceptable daily intake].
 Veterinary Feed Directive (commonly called a VFD order) is a written statement issued by a licensed veterinarian in the context of professional practice that orders the use of a VFD drug in or on an animal feed. This statement authorizes the client to obtain and use the VFD drug in or on animal feed to treat the client’s animals only in accordance with the directions for use approved or indexed by the FDA.

Last Updated 1/27/14