Vaccines are regulated by the Center for Veterinary Biologics (CVB) in the Animal and Plant Health Inspection Service (APHIS), a branch of the United States Department of Agriculture (USDA).
To manufacture and sell veterinary biologics, animal health companies must have both an establishment license and a product license, both of which are granted by the CVB. These licenses are given to manufacturers that have appropriate, inspected facilities, as well as qualified persons to run them. Before a product license is approved, the CVB requires all products to undergo an approval process to ensure compliance with the four characteristics outlined in the Virus-Serum-Toxin Act of 1913: purity, potency, safety and efficacy.
- Efficacy means that the product has the ability to produce the desired effect. In this case, efficacy means that the biologic has to be effective in preventing, treating or diagnosing a disease in animals.
- Safety means that the biologic needs to relatively mild or infrequent side effects. Even after approval, firms maintain post-marketing surveillance for any side-effects that were not discovered before release. These side effects are usually have a very low occurrence in the population, or are caused when the product interacts with other drugs or vaccines.
- Potency means that the biologic needs to work before it expires. Because some veterinary biologics can degrade over time, regulations require each dose of the product to contain enough of the active ingredient to work properly – even on the day it expires.
- Purity means the assurance that the product does not contain anything that might adversely affect potency, safety or efficacy. Veterinary biologics are tested for purity at each step of the manufacturing process, and are then tested again before release.
Products developed by AHI’s member companies have been tested extensively in both laboratory and clinical trials and are shown to be safe and effective. AHI also provides the CVB with dozens of tests and trials to prove the existence and prevalence of these four characteristics.