Overview of US Veterinary Regulations
Veterinary Regulations in the US: Determining which US agency regulates veterinary products can be very different from the regulations for human pharmaceuticals, biologics and devices. Veterinary products in the United States, such as vaccines, drugs, ectoparasitics and certain diagnostics require formal approval processes to be legally marketed. However, other veterinary products, such as supplements, IV fluids, biomarkers, and medical devices may not require a formal approval process, but may be subject to certain labeling and manufacturing requirements.
Prior to starting development, it is important to understand which veterinary regulations apply as this can affect study requirements, labeling, manufacturing, and distribution of the end use product. In most cases, the regulatory purview is based on the product’s mechanism of action (chemical reaction within the body, metabolism, immune modulation, topical insecticidal, etc.). The following generally describes the various veterinary regulatory agencies and the veterinary products they regulate.
01 FDA-Center for Veterinary Medicine
drugs, devices, food, medicated feeds, and supplements
Definition of Veterinary Drug
The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
Definition of Veterinary Device
The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, 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 its primary 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 its primary intended purposes.
Approval Process: Veterinary Drugs and Veterinary Devices
Veterinary drugs (pharmaceuticals) are regulated by the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM). Veterinary pharmaceuticals must satisfy the veterinary regulatory requirements of a New Animal Drug Application (NADA), or abbreviated NADA (ANADA) before being eligible for marketing, distribution or sale. Minor Use Veterinary Drugs: certain products may qualify to be developed under the Minor Use Minor Species (MUMS) category. Similar to orphan drug status for human pharmaceuticals, these products are intended for minor use indications or for species that qualify as a minor species. In addition, these products may enjoy a conditional license in advance of satisfying a full veterinary drug approval, permitting their sale and distribution under limited conditions.
Veterinary nutritional products and supplements, including veterinary nutraceuticals, are regulated by the FDA-CVM. Veterinary nutraceuticals are regulated by discretion, and should be manufactured and labeled according to FDA-CVM policies.
Veterinary Medical Devices (Animal Devices, Animal Medical Devices): despite the fact there is no formal approval process (510k or PMA) for veterinary medical devices, they still are subject to FDA and FDA-CVM regulations. Veterinary medical devices should conform to the appropriate labeling and intended use and conform to the definition of a medical device. More information can be found at “How FDA Regulates Animal Devices“.
- Veterinary pharmaceuticals
- Veterinary medical devices
- Veterinary feeds (foods)
- Veterinary nutraceuticals
- Oral flea and tick products
02 USDA - Center for Veterinary Biologics
vaccines, diagnostic kits, immune modulators & stimulants, bacterins, and toxoids
Definition of Veterinary Biologics (9 CFR 101.2)
The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all 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. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.
Veterinary vaccines and veterinary biologics are regulated by the United States Department of Agriculture – Center for Veterinary Biologics (USDA-CVB). These products must undergo testing to ensure safety, efficacy, potency and purity before being eligible for sale and distribution within the United States.
In the United States, veterinary diagnostic kits which are used to diagnose pathogens or a patient’s immune status are regulated as biologics by the United States Department of Agriculture – Animal and Plant Health Inspection Service (USDA-APHIS). Approval for these veterinary diagnostic kits are managed by the USDA’s Center for Veterinary Biologics (USDA-CVB). Examples of veterinary diagnostics are point-of-care diagnostics such as those to test for feline leukemia virus, canine parvovirus, canine heartworm, and other viruses, bacteria, parasites and veterinary pathogens. Other products which may be considered a veterinary diagnostic kit, and thus regulated by the USDA-CVB, are tests for failure of passive transfer which measures a component of immune status.
- Veterinary vaccines
- Toxoids and bacterins
- Immune stimulants
- Immune modulators
- Diagnostic kits
03 Environmental Protection Agency
ectoparasitics, pesticides, premise control pesticides, and insecticides
Veterinary ectoparasitics are those products which are used for the control of fleas, ticks, and other ectoparasites. These products are under the purview of the Environmental Protection Agency (EPA) and must undergo testing and approval before being eligible for marketing, sale and distribution. Veterinary ectoparasitics, often referred to as flea and tick products, represent one of the largest market segments in animal health. In addition to fleas and ticks, the veterinary ectoparasitic market also consists of products to repel and/or kill mosquitos. Fleas and ticks are not only unsightly on your pet or in the environment, but also represent vectors which can transmit veterinary and human diseases.
Veterinary ectoparasitics can come in a variety of forms including sprays, spot-ons, collars, shampoos, foggers, and premise control products. Veterinary ectoparasitics which are used topically on your pet, or are for premise control (sprays for bedding, etc.). There are a variety of chemicals which have been used to control fleas, ticks and/or mosquitos including pyrethrins, pyrethroids, permethrins, organophosphates, and insect growth regulators. Many of these chemicals can be found in topical flea and tick sprays, flea and tick shampoos, flea and tick collars, and flea and tick spot-ons. The terms biopesticide, pesticide, ectoparasitic, and/or ectoparasiticide are often used to refer to these products which can be generally classified as veterinary ectoparasitics.
- Topical flea and tick products
- Tick and flea collars