Friday, October 26, 2012

Florida Issues Suspension Order Against Compounding Pharmacy

 

 

# 6667

 

In the midst of the investigation into the devastating multistate meningitis outbreak linked to products from the New England Compounding Center, it is of little surprise that officials around the country are taking a hard look at compounding pharmacies operating in their jurisdictions. 

 

Today, the State of Florida DOH issued an emergency suspension order (ESO) against a compounding pharmacy located in Boca Raton, Fl. citing conditions that posed `an immediate serious danger to public health’

 

That said, the target of this suspension has a right to a hearing before any final decree is rendered, as is explained below (from the press release).

 

The subject is entitled to a hearing before final action is taken by a regulatory board or by DOH. However, the ESO will remain in effect until final disciplinary action is taken, the suspension is lifted, or the case is successfully appealed. 

 

Excepts from the announcement follow:

 

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TALLAHASSEE- The Florida Department of Health (DOH) today issued an Emergency Suspension Order (ESO) of Rejuvi Pharmaceuticals, Inc., a compounding pharmacy located in Boca Raton. The ESO immediately suspends Rejuvi from operating as a community compounding pharmacy in the state of Florida.


"The Florida Department will take swift action to ensure the safety of medications compounded in our state," said State Surgeon General and Secretary of Health Dr. John Armstrong. "We continue to collaborate with the Food and Drug Administration, Centers for Disease Control and Prevention, and Florida's health professional and health care associations to promote safe compounding practices in Florida."


Earlier this month, DOH conducted a routine inspection of Rejuvi, and the inspection revealed that the pharmacy was in violation of a number of statutes and rules relating to the cleanliness of the prescription department, the dispensing of medications, the compounding of medications, and record keeping. A review of previous inspections revealed that Rejuvi had previously been notified of these violations and failed to correct them.

 

 
Prior to the ESO being issued, Rejuvi was permitted to engage in the sterile preparation, or compounding, of injectable (parenteral) drugs and medications entered through injection or through a specially coated pill into the intestine (enteral). 

 

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