An animal drug (also veterinary drug) refers to a

drug A drug is any chemical substance other than a nutrient or an essential dietary ingredient, which, when administered to a living organism, produces a biological effect. Consumption of drugs can be via insufflation (medicine), inhalation, drug i ...

intended for use in the diagnosis, cure, mitigation, treatment, or prevention of

disease A disease is a particular abnormal condition that adversely affects the structure or function (biology), function of all or part of an organism and is not immediately due to any external injury. Diseases are often known to be medical condi ...

in animals.

Regulation

United States

The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) has the broad mandate under the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety ...

(21 U.S.C. 321 et seq.) to assure the safety and effectiveness of animal drugs and their use in all animals, including

farm animal Livestock are the Domestication, domesticated animals that are raised in an Agriculture, agricultural setting to provide labour and produce diversified products for consumption such as meat, Egg as food, eggs, milk, fur, leather, and wool. The t ...

s. The division of the FDA responsible for this is the

Center for Veterinary Medicine The Center for Veterinary Medicine (CVM) is a branch of the U.S. Food and Drug Administration (FDA) that regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals. These include animals from whi ...

(CVM). The equivalents of the

Investigational New Drug The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical industry, pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug inte ...

and

New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

are known as the Investigational New Animal Drug and

New Animal Drug Application A New Animal Drug Application is an American legal terminology, defined in 21 CFR ¶514, after the definition in ¶510 of the term New Animal Drug. It is utilized by the FDA. A new animal drug is defined, in part, as any drug intended for use in a ...

, respectively. The FDA enumerates veterinary drug approvals in the FDA Green Book. Drugs approved by the FDA for use in veterinary medicine are structurally similar to drugs approved for use in humans, owing to highly conserved physiology across species, and half of drugs approved for animals are separately approved for use in human

ref> Before CVM formally approves an animal drug, the sponsor or manufacturer of the drug must document in scientific testing that the drug has been found "safe and effective". The testing data also must demonstrate that a methodology is available to detect and measure any residue left in edible

animal product An animal product is any material derived from the body of a non-human animal or their excretions. Examples are meat, fat, blood, milk, eggs, honey, and lesser known products, such as isinglass, rennet, and cochineal. The word animals inc ...

s. Farmers and

veterinarian A veterinarian (vet) or veterinary surgeon is a medical professional who practices veterinary medicine. They manage a wide range of health conditions and injuries in non-human animals. Along with this, veterinarians also play a role in animal r ...

s using drugs on farm animals must adhere to guidelines about how much time must elapse before a treated animal can be slaughtered, and any other use constraints or warnings stated on the drug label. Animal

biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...

(e.g., vaccines and tests) are regulated by the

Animal and Plant Health Inspection Service The Animal and Plant Health Inspection Service (APHIS) is an agency of the United States Department of Agriculture (USDA) based in Riverdale Park, Maryland, Riverdale, Maryland responsible for protecting animal health, animal welfare, and plant h ...

References

External links

Approved Animal Drugs
at

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

website
Animal drugs
at

DailyMed DailyMed is a website operated by the United States National Library of Medicine, U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general publ ...

website {{Authority control Veterinary drugs

Regulation

United States

See also

References

External links