Florida Suspends Compounding Pharmacy
In an emergency order, the Florida Department of Health suspended the license of a Boca Raton compounding pharmacy, Rejuvi Pharmaceuticals Inc.
DOH said Rejuvi prepares injectable drugs -- the same type of delivery system implicated in the ongoing nationwide outbreak of fungal meningitis from contaminated steroid injections. The DOH release did not mention the outbreak, linked to New England Compounding Center in Massachusetts, and there is no apparent connection.
Rejuvi's attorney, Julie Gallagher of Akerman Senterfitt, sent a quick note this morning to Health News Florida advising, "Don't go bonkers with this story. It is nothing like the MA situation." Senterfitt said she would offer more details later.
At its web site, Rejuvi says it specializes in "biologically identical hormone replacement therapy" and other "alternative" treatments.
DOH's release said it found the problems at Rejuvi earlier this month during a "routine inspection." DOH said similar problems had been found in past inspections and that Rejuvi had failed to correct them.
State corporate records list only one name for Rejuvi Pharmaceuticals: Ryan Hogan, president and CEO. DOH records show a licensed pharmacy technician by that name at the same address as Rejuvi; he has a clear license with no pending complaints publicly recorded.
An attempt to reach Hogan at the pharmacy's phone number was unsuccessful.
The DOH release did not make clear why the agency's inspection was considered routine if previous visits had found problems. (Health News Florida sent that and other questions to DOH and will update this article when more information is made available).
The release quoted Florida Surgeon General John Armstrong as saying, "The Florida Department will take swift action to ensure the safety of medications compounded in our state."
State law allows pharmacies to make prescription drugs outside the purview of the Food and Drug Administration if they are prepared specifically for a particular patient.
In the case of the New England operation, Massachusetts officials discovered it had exceeded what the law allows and engaged in actual manufacturing of injectable steroids. DOH did not say anything about the extent of operations of Rejuvi, and there has been no suggestion that it is linked to any outbreaks.
Rejuvi, like others under emergency suspension or restriction orders, is entitled to a hearing before final action is taken on its license.
The company's web site says it is "the foremost expert in the compounding industry with a state of the art facility that caters to today's physician. With over 60 years combined experience, our Pharmacists are trained to meet the demands of all your compounding needs. Rejuvi can compound your specified medications in all forms including: injectable, capsules, sublingual, creams, and topical gels. We use only the highest quality active ingredients in every order prepared to meet your exact specifications."
The fungal meningitis outbreak linked to tainted steroid shots from NECC has spread to 17 states and more than 300 cases, according to the Centers for Disease Control web site. On Wednesday, as Health News Florida reported, Armstrong said Florida's case count had reached 22, with three deaths. All the patients had been treated at pain clinics in Ocala and Pensacola.
--Health News Florida, journalism for a healthy state, is a service of WUSF Public Media. Question? Comment? Contact Carol Gentry at 813-974-8629 or on cell at 727-410-3266, or by e-mail at Carol.Gentry@HealthNewsFlorida.org.