February 15, 2014

 

 FDA offers resource on extralabel drug use

​Posted Jan. 29, 2014

 

The Food and Drug Administration recently released “The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians.”
 
The FDA article notes that federal law did not permit extralabel drug use in animals before Congress passed the Animal Medicinal Drug Use Clarification Act in 1994. The AMDUCA provisions amended the Food, Drug, and Cosmetic Act to allow veterinarians to prescribe human and animal drugs for extralabel uses in animals under certain conditions.

The article covers the following topics: the requirement for a valid veterinarian-client-patient relationship, general conditions for extralabel drug use, conditions for extralabel drug use in food animals, compounding, drugs prohibited from extralabel uses in animals, and how the FDA’s recommendations for judicious use of antimicrobials in food animals affect extralabel drug use.

The resource is available here.