Wednesday, May 23, 2012
Breaking News: Franck's Ceases Sterile Compounding Service
Franck's Pharmacy announced Wednesday it will stop producing sterile compounds at its Ocala lab and also confirmed the layoffs of several employees.
The decisions come after the Centers for Disease Control and Prevention warned doctors to avoid sterile products made by the pharmacy. The warning, issued on May 3, came after two ophthalmic products made by Franck's were suspected in causing at least 33 cases of fungal eye infections.
The cases were spread over California, Colorado, Illinois, Indiana, Louisiana, Nevada and New York, and in many cases the patients suffered partial to severe vision loss and required additional eye surgery, according to the CDC report.
The products involved are injected directly into the eye.
Tests on sealed bottles and syringes of the preparations conducted by the CDC confirmed the presence of several bacterial and fungal contaminants.
Initially, Franck's said it would continue to compound sterile products after identifying and fixing the cause of the contamination. The cause was not disclosed.
On Wednesday, Franck's business manager, Stephen Floyd, announced the change in direction via email.
"Franck's has made the difficult but necessary decision to cease production of sterile compound products and is turning our focus to the non-sterile side of the business. This change necessitated a reduction in force," the email stated.
The company did not say how many people were laid off or how many people it employs. In 2007 the company said it had more than 75 employees. It was not clear what portion of Franck's business came from sterile compounding."We greatly value and appreciate our employees and are providing support to them to help bridge the gap during their transition," according to the email.
Specifics of the support were not disclosed.
Franck's will continue to compound non-sterile human and veterinary medicine. The retail pharmacy, home infusion pharmacy and wellness store will continue normal operation.
It is the second time the company has faced claims of improper compounding. In 2009, Franck's veterinary division improperly mixed a nutritional supplement for 21 polo horses that contained far more selenium than required. The horses all died.
That incident prompted the Food and Drug Administration to try to stop Franck's from compounding veterinary medicine and supplements. Franck's eventually prevailed in U.S. District Court.
The FDA as well as the Florida Department of Health are investigating the latest case.
Compound pharmacies make medications and other medical preparations from scratch. They cannot make commercially available medications and can only make medications when they are ordered by a doctor.
These pharmacies fine tune drugs to a patient's need, whether it be for a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.