FDA Accuses Franck’s Pharmacy of Illegal Compounding

In a highly publicized pharmacy error case from last year that our Washington D.C. Pharmacy Error Attorneys covered in a blog, 21 Venezuelan polo team horses tragically died after being given a drug mixed by Frank’s Pharmacy Compounding Lab, aimed to replicate Biodyl, a vitamin and mineral supplement that is often used to treat muscle fatigue in horses. The drug concoction was allegedly too strong, causing a medication error that lead to the death of the horses at the International Polo Club of Palm Beach in Florida.

This week, Franck’s Pharmacy voluntarily suspended all veterinary compounding in the lab, after reportedly being threatened with an injunction by the U.S. Food and Drug Administration (FDA). Last month, the FDA filed a complaint that Franck’s was going around the law by producing and selling misbranded and adulterated drugs and pharmacy compounds that were too similar to drugs that are FDA-approved.

According to the FDA, compounded drugs are not reviewed by the FDA for effectiveness and safety. Drug compounding has been criticized for lack of oversight—especially when both human and animal patients could be exposed to unapproved medication, that could result personal injury or even in this case death. In an FDA Compliance Policy Guide from 2003, the agency stated concerns about the risks posed by pharmacists and veterinarians who manufacture, distribute, and mass-markets animal drugs that are unapproved.

The FDA has reportedly had a strong interest in this case, as the deaths of these horses were caused by pharmacy error—from the same pharmacy that produces drugs for humans.

In Maryland and the Washington D.C.-area, contact Lebowitz and Mzhen, LLC today.

Franck’s Pharmacy Voluntarily Stops Veterinary Compounding to Address FDA Concerns, Veterinary News, May 19, 2010
Florida Pharmacy Accused of Illegal Compounding, May 19, 2010

Related Web Resources:

U.S. Food and Drug Administration: Medication Error Reports

National Coordinating Council for Medication Error Reporting and Prevention, (NCCMERP)

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