By Carol Gentry
10/26/12 © Health News Florida
A Florida Department of Health report that became public on Friday ordered the suspension of a Boca Raton compounding pharmacy because it “constitutes an immediate, serious danger” to the public.
Conditions at Rejuvi Pharmaceuticals Inc. were so “deplorable” when a state inspector arrived on Oct. 12 that nothing short of an immediate shut-down would suffice, the DOH report said.
Other than timing, there is no apparent connection between the DOH action in Florida and an ongoing outbreak of illness attributed to a compounding pharmacy in Massachusetts.
The discoveries included rodent feces, dead bugs, and a sink full of dirty water, the report said. A film of powder covered surfaces in the drug- compounding area, where containers of drugs were open, it said.
Information on patients and prescriptions was missing from the pharmacy, and drug labels were missing crucial information on the dose, lot number, and prescribing physician, the report said. That would make it impossible to track down drugs if a lot was found to be contaminated, the report said.
DOH noted that the compounding pharmacy has been cited in past inspections for some of the same problems, but this time they were more severe. The inspector “has never been as horrified by the conditions of a pharmacy department as he was by the conditions of Rejuvi,” the report said.
Julie Gallagher of Akerman Senterfitt, attorney for Rejuvi, said DOH would normally have given the pharmacy 10 days or two weeks to resolve its problems and come back for re-inspection. That did not occur this time, and Gallagher says it’s a matter of timing.
The inspection occurred just as the headlines were full of news about a nationwide outbreak of fungal meningitis attributed to contaminated drugs made by a compounding pharmacy in Massachusetts, the New England Compounding Center.
“All the compounding pharmacies are under a microscope right now, and DOH wants to be more safe than sorry,” Gallagher said. “I don’t want to minimize the DOH effort to protect the public. But for the Massachusetts case, this might not have risen to the level of an ESO (emergency suspension order).”
Gallagher had been about to contact DOH about a re-inspection for Rejuvi when the order came out, surprising her. “We’re hopeful and confident that DOH will be fair, and that we’ll be able to clear the problems and lift the ESO,” she said. “Right now we’re focused on showing DOH there is no immediate danger.”
Unlike the New England pharmacy, there is no allegation in the Florida suspension report that the one in Boca made anyone sick. Some lots of injectable steroid drugs from the New England pharmacy contaminated by a fungus have made more than 300 people sick and killed 23.
More than 1,000 Floridians were exposed to drugs from the contaminated lots, state health officials said, but most have not become ill. As of Wednesday, the case count in Florida was 22, with three deaths.
Rejuvi does not compound steroids, Gallagher said. But it does make injectable drugs; the DOH report cited in particular HCG, human chorionic gonadotropin. HCG has a legitimate use in treatment for infertility, but it is often used by body builders to bulk up muscle mass – a use that is not considered safe. Some clinics also have drawn attention for promoting HCG for weight loss.
Physicians can be disciplined if they are found to have prescribed HCG for inappropriate purposes.
At its web site, Rejuvi says it specializes in "biologically identical hormone replacement therapy" and other "alternative" treatments.
State corporate records list Ryan Hogan as president and CEO of Rejuvi. He is a licensed pharmacy technician, DOH records show. He has a clear license with no pending complaints publicly recorded. An attempt to reach Hogan at the pharmacy's phone number was unsuccessful.
Compounding pharmacies have recently come under scrutiny. They are allowed to make prescription drugs outside the purview of the Food and Drug Administration if they are prepared specifically for a particular patient with a physician’s prescription. They are not allowed to manufacture drugs in quantity; states are supposed to regulate them.
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. The drugs were distributed throughout the country to hospitals and clinics.
Like other DOH licenses under emergency suspension or restriction orders, Rejuvi is entitled to a hearing before final action is taken on its license. Sometimes courts lift emergency orders pending a hearing.
--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.