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Animal Experts Call on FDA to Enforce Laws Against Illegal Animal Drug Compounding

Companies mentioned in this article: Animal Health Institute

WASHINGTON, July 16, 2014 /PRNewswire-USNewswire/ -- Today, the Animal Health Institute, along with the experts in the field of animal health and veterinary medicine brought together consumers, media, veterinary experts, policymakers and industry stakeholders for a teleconference and two Congressional briefings calling for greater action by the U.S. Food and Drug Administration (FDA) on illegal animal drug compounding.

Recently more than a dozen horses were killed or severely injured after receiving illegally compounded drugs in Kentucky and Florida. These horses were prescribed illegal drug concoctions that contained unsafe levels of pyrimethamine, nearly 20 times the amount it was supposed to contain.

"Illegal animal drug compounding has been going on for more than a decade and there is a growing need - seen in these recent instances - for the FDA to do its job and enforce laws," said Dr. Scott Stanley, professor of veterinary medicine at University of California-Davis. "These animals suffered greatly and their deaths were extremely unpleasant. When you have a 1,000 pound horse convulsing, you also put human lives at risk as they are trying to comfort their beloved animals."

There are three levels at which drugs are compounded. The first involves customized manipulation of FDA-approved drugs as prescribed by a veterinarian for an individual patient, and is legal under federal law. The second, while illegal, is where the compounding is from bulk, active ingredients to meet a medical need under veterinarian prescription in circumstances where there are no FDA approved products or FDA approved therapeutic alternatives, and is allowed by FDA through enforcement discretion. Both of these types of compounding are supported by AHI and industry experts.

"The third type of compounded drugs - what we discussed today - is dangerous and illegal," said Dr. Richard Carnevale, Vice President for Regulatory, Scientific and International Affairs, AHI. "These are dangerous drugs crafted by pharmacies acting as manufacturers and often promoted to veterinarians as a way to increase profits. They are not looking to help Mrs. Jones's cat. They even offer disclaimers that they are not responsible for the safety or effectiveness of the preparations they compound."

Both events drew dozens of interested parties to learn about why this exists for animal drugs as well as what can be done to prevent future animal deaths.

"We want consumers to be aware that they may unknowingly be giving their pet or food animal a drug that was not approved by the FDA. And that should not - and cannot continue to happen," said Carnevale.

"These compounders are masquerading as pharmaceutical manufacturers, with the end result a lot of dead animals," said Peter Pitts, former FDA Commissioner and current co-founder of the Center for Medicine in the Public Interest. "FDA has stepped up and done its job with illegal drug compounding in regards to humans, but it is time for FDA to get in the game when dealing with animals."

Several prominent members of Congress - Reps. Harkin, Alexander, Upton and Waxman - recently called for a report from the U.S. Government Accountability Office on the FDA on the issue of illegal animal drug compounding.

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About The Animal Health Institute
The Animal Health Institute (AHI) represents companies that make medicines for pets and farm animals. AHI and its member companies launched the Healthy People. Healthy Animals. Healthy Planet. program to educate the public on the disease-prevention continuum. The initiative continues to unite stakeholders in the pet, agriculture, veterinary and public health communities with the goal of eliminating diseases at the nexus of animal and human health. For more information, please visit

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SOURCE Animal Health Institute