Contact: DOH Communications
DEPARTMENT OF HEALTH TAKES ACTION AGAINST FLORIDA PHARMACY
~DOH issues Emergency Suspension of Rejuvi Pharmaceuticals, Inc. permit~
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).
One role of compounding pharmacies is to make medicinal drugs prescribed by physicians for specific patients that cannot be filled by commercially available drugs. To do this, pharmacists combine or process ingredients utilizing various tools. Laws also permit compounding of drugs for office use. For full details of compounding pharmacy regulation in Florida, please click here.
Emergency suspension or restriction orders are not considered final agency action but are imposed when the subject’s actions pose an immediate serious danger to public health, as specified by section 456.074, Florida Statutes. 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.
The Florida Department of Health’s Division of Medical Quality Assurance (MQA) is committed
to ensuring that all of Florida’s licensed health care practitioners place the health and safety of
patients first and foremost.
To view the most recent ESOs, EROs, Final Orders and Administrative Complaints, please visit
http://newsroom.doh.state.fl.us/2012/02/21/most-recent-esoserosadministrative-complaints/. For other information on Medical Quality Assurance, including information about enforcement terms or definitions, boards and councils, or the heath care practitioner licensing process itself, visit http://newsroom.doh.state.fl.us/category/healthcare-licensing/.
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