Following on the heels of the state of Massachusetts, where officials announced on Sunday that they had shuttered a third compounding pharmacy for alleged health and safety violations, Florida officials announced on Monday that they have closed down their first compounding pharmacy. According to a report by Reuters, Rejuvi Pharmaceuticals, which is based in Boca Raton, violated “a number” of health regulations.
The news follows a crackdown on the operations of compounding pharmacies across the United States in the wake of the meningitis outbreak caused by tainted injectables that had been compounded by the New England Compounding Center in Massachusetts. The tainted injectables, which contained a particular variety of fungus, have now been linked to more than 354 cases of infection and 25 deaths, according to reports by NBC News and other media outlets.
Here is some of the key information regarding the crackdown on compounding pharmacies that continues around the U.S.
* The FDA released an official statement on Oct. 26 regarding the agency’s investigation into the New England Compounding Center (NECC). Among the FDA’s findings were several instances where company officials noted the presence of mold and bacteria in the center’s “clean room,” a situation that remained unaddressed for much of the year. The FDA also noted that the NECC violated regulations pertaining to the dispensing of prescription drugs.
* The FDA announced in its statement that the NECC had been issued a Form 483, which is an official document stating that agency inspectors “believe that they observed conditions or practices” which could point to major health violations.
* The agency did caution in its press release that a Form 483 is not a “final FDA determination,” and that its investigation into the meningitis outbreak is ongoing. NECC has been stripped of its license and has shut its doors.
* Massachusetts health officials, who had noted violations by NECC prior to the meningitis outbreak, have cracked down on other compounding pharmacies in the state. The Massachusetts branch of Infusion Resource is the latest compounding pharmacy to be shut down after surprise inspections turned up possible violations, according to a New York Times report on Sunday.
* Massachusetts Gov. Deval Patrick had ordered state health officials to begin conducting unannounced inspections of compounding pharmacies in the state that deal specifically with injectable medications last week, after preliminary reports indicated that state regulations governing such facilities were “insufficient,” as quoted by the New York Times.
* According to Monday’s report by NBC News, Rejuvi Pharmaceuticals in Florida was shut down by state health officials for multiple violations, which included concerns regarding the “cleanliness of the prescription department” and “the compounding of medications,” among other violations.
* Rejuvi had reportedly been cited for the same issues before, and the most recent inspection concluded that the problems had not been addressed after they were brought to the company’s attention.
Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.
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Florida and Massachusetts Shut Down More Compounding Pharmacies
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Florida and Massachusetts Shut Down More Compounding Pharmacies
