Florida Department of Health Obtains Relinquishment of New England Compounding Pharmacy Permit
Contact: DOH Communications
(850) 245-4111
FLORIDA DEPARTMENT OF HEALTH OBTAINS RELINQUISHMENT OF NEW ENGLAND COMPOUNDING PHARMACY PERMIT
~Disciplinary relinquishment of NECC permit obtained~
TALLAHASSEE- The Florida Department of Health today obtained a relinquishment of the New England Compounding Center’s (NECC) permit to operate as a pharmacy in the state of Florida. The Relinquishment is considered disciplinary action against NECC’s permit and the company will cease to operate as a pharmacy in our state immediately. The NECC may never reapply for a pharmacy permit in the state of Florida.
On Sept. 25, 2012, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recalled three lots of NECC methylprednisolone acetate used for epidural back injections. The contaminated injections were linked to cases of fungal meningitis in Tennessee. Throughout this ongoing investigation, CDC has also questioned the sterility of all NECC injectable products and issued a precautionary voluntary recall of all NECC products on Oct. 6. The FDA has since urged health care providers to contact their patients who were exposed to NECC products and inform them to closely monitor their health and seek immediate medical attention if they begin to experience any of the outlined symptoms, including fever, swelling, increasing pain, redness, warmth at injection site; vision changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).
As of today, the number of cases of fungal meningitis nationwide is 257 across 16 states. Thus far, 20 deaths have been associated with this outbreak of fungal infections due to contaminated NECC products. Florida has confirmed 17 cases, including three deaths.
All contaminated lots of NECC steroid injections in Florida have been returned in accordance with FDA recall procedures. The Florida Department of Health continues to work with the Department of Business and Professional Regulation, health related professional associations, and affected clinics to ensure that all patients who received NECC products are properly notified.
DOH will continue to update our websites at http://newsroom.doh.state.fl.us/ or http://www.myfloridalicense.com/dbpr/. We have set up a toll-free hotline at 1-866-523-7339 for those who may have additional questions.
The Department works to protect, promote and improve the health of all people in Florida through integrated state, county and community efforts.
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