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GADA Points to Safety of FDA Approved Generics in Wake of Wellington Polo Horse Deaths from Compounded Drugs
Date:5/6/2009

WASHINGTON, May 6 /PRNewswire/ -- The Generic Animal Drug Alliance (GADA), an independent professional trade organization representing generic animal health industry interests, says that the recent tragic deaths of 21 horses in Wellington, Florida illustrates the potential safety issues surrounding compounded drugs and reinforces the need for, and value of, Food and Drug Administration (FDA) approved animal generic drugs.

The polo horse deaths were reportedly caused by improperly compounded drugs. Compounded drugs are customized medications prepared by a pharmacist under prescription by a veterinarian. Considered a last resort, compounded drugs should be used only when no FDA-approved animal or human drug is available to treat the animal. Unlike generic drugs, compounded drugs are not FDA-approved and do not follow current good manufacturing practice (cGMP) requirements.

GADA has been working to help veterinarians understand the difference between compounded drugs and generic drugs. Generic drugs, widely used and trusted by veterinarians, are FDA-approved bio-equivalent versions of branded medicines, manufactured under strict regulatory guidelines. Generic drugs, as with other FDA-approved drugs, undergo rigorous testing to meet quality standards. Stephanie Batliner, GADA Chairperson, says that veterinarians face a variety of prescribing options and must be aware of the safety issues. "While generic drugs meet safety standards ensured by FDA-approval, compounded drugs have inherent risks associated with uncontrolled, extemporaneous preparation," says Batliner. GADA provides further information on their website, as well as a link to the brochure "Veterinary Compounding" co-authored by the American Veterinary Medical Association (AVMA), the Animal Health Institute (AHI), and the American Veterinary Distributors Association (AVDA), www.gadaonline.org.


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SOURCE The Generic Animal Drug Alliance
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