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Withdrawal of Compounding Guidance Endangers Animal Health

WASHINGTON – November 7, 2017 – Today’s action by the Food and Drug Administration to withdraw Draft Guidance for Industry #230 on compounded animal drugs from bulk substances endangers animal health by failing to curb illegal activity.

Under federal law, compounding of animal drugs from bulk drug substances is illegal, as stated in the draft guidance issued in 2015 and by three federal appeals courts.  AHI recognizes that there are unmet medical needs where no approved product is available. Therefore, a limited amount of this kind of compounding is necessary to meet those needs when the life of the animal is threatened.   The guidance was FDA’s attempt to clearly define the instances where enforcement discretion would be used to permit this needed compounding.

“Withdrawal of the guidance document does not change the law,” said Alex Mathews, President and CEO of the Animal Health Institute.  “Until FDA better defines and clarifies this issue, veterinarians and their patients are at risk.”

The guidance was an effort to curtail widespread illegal activity in which compounding pharmacies act like manufacturers by illegally making large quantities of compounded drugs from bulk substances and marketing them to veterinarians as less expensive or more convenient alternatives to approved products.  Veterinarians and animal owners should remember that compounded products have not been evaluated for safety, efficacy and proper manufacturing practices by FDA and, there is no assurance that the pharmacy will take any liability for adverse reactions.   These compounded formulations have often been found to contain too much or too little of an active ingredient and often have shelf-lives that fall short of what is advertised on the label.  The well-publicized deaths of 21 polo ponies in Florida in 2009 and additional death and injury to horses in Kentucky and Florida in 2014 were attributed to compounded products.

“We continue to support legal compounding that is done for an individual patient under the prescription of a veterinarian using an approved product,” said Mathews.  “But the continuing and unrestrained compounding of drugs from bulk drug substances imperils animal health by placing animals at risk from unsafe or ineffective treatment.  We urge FDA to move quickly to draw a clear line between compounding activity it will permit to meet medical needs and illegal activity, and to aggressively enforce against illegal activity.

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Animal Health Institute

The Animal Health Institute (AHI) represents companies that make medicine for animals.  Our members develop and produce the medicines that help our pets live longer, healthier lives and contribute to safe food by keeping food animals healthy. Since our inception in 1941, AHI has helped create an environment that fosters robust research and development of innovative and needed veterinary medicines. AHI member companies further the discovery, development and approval of medicines that promote animal health in a research-driven industry.

For More information:

Ron Phillips

202.637.2440

rphillips@ahi.org

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