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The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians

January 8, 2014 — 

Are you aware that failing to administer the second dose of an antimicrobial labelled as a two-dose treatment constitutes an extra-label use and may be illegal? As a practicing veterinarian, you’ve likely prescribed a drug for an extra-label use. What does that mean? What gives you the legal ability to do so? What conditions must be met? By explaining FDA’s requirements for extra-label drug use in animals, this article answers these questions and more. Every food animal veterinarian should read this article. It is posted in its entirety on the AASV web site.

To prescribe drugs in an extra-label manner, you need to follow FDA’s extra-label drug use requirements, as stated in the FD&C Act and FDA regulations. You should also educate your clients, particularly food animal producers, on these requirements and on FDA’s recommendations for the judicious use of antimicrobial drugs.

Before Congress passed the Animal Medicinal Drug Use Clarification Act (AMDUCA) in 1994, federal law did not permit extra-label drug use in animals. The AMDUCA provisions amended the FD&C Act to allow veterinarians to prescribe approved human and animal drugs for extra-label uses in animals under specified conditions. The key points are:

This article examines each point separately and describes how FDA’s judicious use recommendations affect extra-label drug use in food-producing animals.