Who Regulates Veterinary Drugs?

The U.S. Food and Drug Administration (FDA) is responsible for regulating a plethora of consumer products, including drugs, tobacco products, human vaccines, and cosmetics. In addition to this, the FDA also regulates animal drugs, animal food (both livestock and pet food), and animal medical devices.

The FDA also regulates oral and injectable flea and tick medications. “Spot on” treatments, which are applied directly to a dog or cat’s skin, are regulated by the Environmental Protection Agency because they are classified as pesticides.

The Center for Veterinary Medicine (CVM) is the animal and veterinary arm of the FDA. In other words, the people working at the CVM are the ones actively regulating animal drugs, animal food, and animal medical devices at the FDA.

Broadly, the CVM’s mission is to “protect human and animal health.” Through the drug approval process, the CVM makes sure that new animal drugs are safe for the animals, the people around the animals, and the people administering the drug. The CVM also works to make sure that drugs for niche uses get to market to increase treatment availability to all animals.

In addition to drug regulation, the CVM monitors the pet food market and conducts research on animal food safety. One thing the CVM does not regulate is the actual practice of veterinary medicine. In essence, the FDA approves drug with labeling to describe the indications and dosage regimen that they have evaluated but cannot explicitly tell a veterinarian how or when to use the drug.

The U.S. Department of Agriculture (USDA) has oversight of regulating the agricultural industry. Though the FDA regulates human vaccines, the USDA regulates veterinary vaccines, in part, because the first animal vaccines were for livestock. The USDA has retained oversight of veterinary biologics (e.g., vaccines), which now includes vaccines for companion animals such as cats and dogs.