FDA provides comprehensive resources on extra-label drug use


Veterinarians contemplating extra-label or off-label drug use in animals sometimes encounter gray areas or tough-to-answer questions.

To help veterinarians remain confident that they are staying within the rules, the FDA has published a comprehensive guide titled "The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians."

According to the FDA, the resource will help veterinarians to accurately define extra-label use, gain insight into the legalities surrounding extra-label use, and learn how to meet the FDA requirements that govern extra-label drug use on animals.

The article includes links to several additional resources and focuses on five key points from the Animal Medicinal Drug Use Clarification Act (AMDUCA), which veterinarians must observe in order to prescribe approved human and animal drugs for extra-label uses in animals. According to the FDA, these key points are:

  • 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

In addition to the above points covered in the FDA article, the agency also recommends that veterinarians who work with food animals become familiar with the 2012 guidance document titled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals."  

More information

Read the full article on the FDA website for a comprehensive overview of extra-label drug use rules.


This article was provided by the American Animal Hospital Association.


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