Florida health department suspends compounding pharmacyReprints
(Reuters) — The Florida Department of Health has temporarily suspended compounding operations at a pharmacy, the latest in a growing number of closings since a deadly meningitis outbreak caused by contaminated drugs in a Massachusetts facility.
The Florida pharmacy, based in Boca Raton and called Rejuvi Pharmaceuticals, prepares injectable drugs and medications. The Florida health department said in a statement that it violated "a number" of statutes and rules.
Rejuvi Pharmaceuticals' website says it makes "bio identical hormones" and compounded medications. No other information on its products was available and Rejuvi was not immediately available for a comment.
Compounding pharmacies mix large quantities of prescription drugs, typically for use by doctors and clinics.
Regulators are scrutinizing these pharmacies after thousands of vials of contaminated injectable steroids were shipped from a New England compounding facility, leading to 25 deaths so far from fungal meningitis. Hundreds more patients were sickened from the steroid shots, which were used to treat back and neck pain.
U.S. Representative Edward Markey, a Massachusetts Democrat, said in a report on Sunday that the U.S. Food and Drug Administration needs more authority to oversee and regulate these compounding facilities. It has fallen mostly to state agencies to regulate them.
Massachusetts regulators shut down a third pharmacy on Sunday, saying a surprise inspection raised concerns about sterility of the drugs.
The Florida health department said in an Oct. 26 statement that during a routine October inspection of Rejuvi it found that it had violated rules on "cleanliness of the prescription department, the dispensing of medications, the compounding of medications, and record keeping."
It said a review of previous inspections showed Rejuvi had previously been notified of these violations and failed to correct them.
Rejuvi can have a hearing before final action is taken and the suspension is in effect until final disciplinary action, until the suspension is lifted, or until the case is successfully appealed, the Florida health department statement said.
The company had been permitted to prepare injectable drugs and medications that are injected or delivered through a specially coated pill into the intestine.