GAO Calls on FDA to Better Monitor, Regulate Compounded Veterinary Drugs

January 13, 2016 12:24 PM

By: John Maday, editor, Bovine Veterinarian 

In a new report, the Government Accounting Agency (GAO) outlines the current lack of information on the use of animal-drug compounding, and calls on the FDA to modify its policies regarding compounded drugs.

Drug compounding for animals involves combining, mixing, or altering ingredients to create drugs tailored to the medical needs of individual animals. The report’s authors note that while states have primarily exercised responsibility for oversight of drug compounding, FDA is responsible for ensuring their safety and effectiveness. FDA regulations generally allow for drug compounding for animals from approved animal or human drugs but not from bulk active pharmaceutical ingredient.

The report acknowledges that compounded drugs offer benefits by providing treatment options when no suitable FDA-approved drugs are available. It notes though, that mistakes in compounding drugs for animals can result in injuries to or deaths of animals.

The report examines:

  • The benefits and risks of drug compounding for animals.
  • The extent of drug compounding for animals.
  • FDA's approach to regulating these drugs.

In preparing the report, GAO reviewed federal regulations and guidance, FDA documents, 18 studies assessing drugs compounded for animals and interviewed federal and state regulatory officials and stakeholders in the animal health industry.


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