Animal biologicals are subject to both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the United States Department of Agriculture Animal Health Inspection Service (USDA-APHIS) Virus, Serum, Toxin Act (VSTA) (Public Law 430 of 1913, 73 Stat 832-833, 21 U.S.C. 151-158).
Under the regulations implementing the VSTA, 9 CFR part 101, animal biological products are defined in part as “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.” (9 CFR 101.2)
Under the FD&C Act (section 201 [21 U.S.C. § 321] (g)(1)), drugs are defined in part as 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 animals.
Although animal biological products are "drugs" within the meaning of the FD&C Act, animal drugs produced and distributed in full conformance with the VSTA and its implementing regulations are not subject to the animal drug approval requirements in section 512 of the FD&C Act. (See 21 CFR 510.4)
For more specific information regarding oversight of these types of products, please refer to the Memorandum of Understanding (MOU) between APHIS and FDA (APHIS Agreement #04-9100-0859-MU, FDA Serial #225-05-7000). Additional information about how USDA-APHIS regulates animal biologics can be found at the USDA-APHIS Veterinary Biologics webpage.
Additional questions, including jurisdictional inquiries, can be submitted to: AskCVM@fda.hhs.gov.