Veterinarians sometimes have the medical need and legal ability to use drugs in extra- or off-label applications. They need however, to understand the acceptable conditions for doing so and other regulations tied to the practice, particularly in food animals. To help practitioners negotiate those regulations, the FDA’s Center for Veterinary Medicine has developed an article titled “The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians,” along with links to additional resources.

In 1994, Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow veterinarians to prescribe approved human and animal drugs for extra-label uses in animals under specified conditions. Key provisions of the act, each covered in detail in the FDA/CVM, include:

  • Valid Veterinarian-Client-Patient Relationship
  • General Conditions for Extra-Label Drug Use
  • Conditions for Extra-Label Drug Use in Food-Producing Animals
  • Compounding
  • Drugs Prohibited from Extra-Label Uses in Animals

The article also provides details on how FDA’s judicious use recommendations affect extra-label drug use in food-producing animals.

The full article and additional resources are available on the FDA/CVM website.