By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
July 31, 2012, marked the end of an era for Franck’s Pharmacy in Ocala, Florida, as the retail location closed its doors for good. According to an Ocala Star-Banner article, in July 2012, Franck’s Compounding Lab, which was one of the largest compounding labs in the country, was bought by Wells Pharmacy Network. The deal included Franck’s Lifestyles, which sells supplements and wellness products, but did not include the retail pharmacy location.
Closed Pharmacy Comes After a U.S. Food and Drug Administration (FDA) Finding of Fungal Growth in Pharmacy’s Clean Room.
In May of 2012, Franck’s Pharmacy Inc., issued a recall for its compounded prescriptions. The prescriptions impacted by this recall included all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012.
The recall was apparently prompted by an action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy recalled its sterile compounds to prevent any possible risk of infection.
Eye Infection Outbreak Linked to Franck’s Pharmacy Products.
Franck’s Pharmacy ceased sterile compounding in its Ocala lab after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used.
Franck’s Trouble in the Past.
According to the Ocala Star-Banner, the eye preparation case was the second time Franck’s faced claims of improper compounding. In 2009, Franck’s veterinary division allegedly improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.
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Medina, Carlos. “Franck’s Pharmacy Closes its Doors.” Ocala Star-Banner. (July 31, 2012). From: http://www.ocala.com/article/20120731/ARTICLES/120739961?p=3&tc=pg
Ulbricht, Christopher. “Wells Pharmacy Network Expands to Ocala, Florida.” Franck’s. (July 5, 2012.) From: http://www.francks.com/
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
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