Mode Action and Intended Use
Veterinary regulations: many, if not the majority, of veterinary products are regulated. As a rule of thumb, the regulatory purview (FDA vs USDA) is based on the product’s mechanism of action (chemical reaction on or within the body, metabolism, immune modulation, topical insecticidal, etc.) and intended use. Determining which US agency regulates veterinary products can be very different from regulations as they apply to human pharmaceuticals, biologics and devices. Human healthcare companies seeking to enter veterinary medicine should be aware of differences in veterinary product regulations concerning veterinary biologics, devices, pharmaceuticals, diagnostics, and even pet supplements. Prior to starting development of a veterinary product or technology, it is important to understand which veterinary regulations apply to a product or service, and if any veterinary clinical trials are required before sale and distribution. The regulatory purview can affect study requirements, labeling, manufacturing, and distribution of the end use product. The following generally describes the various veterinary regulatory agencies and the veterinary products they regulate.
Veterinary Regulations : General Overview
Veterinary Regulatory Oversight: For most products, there are three primary US regulatory agencies which regulate veterinary products including the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM), United States Department of Agriculture Center for Veterinary Biologics (USDA-CVB) and the Environmental Protection Agency (EPA). In addition, the Association of American Feed Control Officials (AAFCO) may regulate the sale and distribution of animal feeds and animal drug remedies.
Veterinary Approval Process: Certain veterinary products such as veterinary vaccines, veterinary drugs, ectoparasitics (flea and tick products) and several veterinary diagnostic products have a formal veterinary approval process in order to be legally sold and distributed into the veterinary market.
Exceptions: There are some products where no such formal veterinary approval process exists, such as nutritional supplements, IV fluids or large volume parenterals, biomarker diagnostics, animal cosmetic products and medical devices (animal medical devices). Although there may be no formal approval process, these products may be subject to certain labeling and manufacturing requirements, and those products that are misbranded or mislabeled may be subject to regulatory enforcement.
Overview of Veterinary Regulations by Product Category
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. In addition, the Dietary Supplement Health and Education Act (DSHEA), does not necessarily apply to animals. More information can be found at this link: Pet Supplement Product Regulations
Veterinary vaccines 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.
Veterinary diagnostics that are point-of-care pathogen diagnostics are regulated as veterinary biologics by the United States Department of Agriculture. These products must meet sensitivity and specificity requirements, in additional to other criteria, to be eligible for sale and distribution. Although point-of-care pathogen diagnostics are regulated by the United States Department of Agriculture-Center for Veterinary Biologics, reference laboratory assays may not require a formal USDA approval. In addition, biomarker assays, hormone assays, CBCs, chemistry panels, and other reference diagnostics services are not currently under the jurisdiction of the USDA.
Cell and tissue-based products are a more recent development. These products can be regulated by either the FDA-CVM or FDA-CVB, depending on their primary mechanism of action. Should the primary mode of action be immune modulation in nature, then it is likely the veterinary cell based therapy will be considered a veterinary biologic and fall under the purview of the USDA-CVB. All other veterinary cell-based therapies will likely be regulated by the FDA-CVM as a drug.
Veterinary ectoparasitics are those products which are used for the control of fleas, ticks, and other ectoparasites. If applied topically or on the premise, 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.