Tuesday, February 5, 2013

Just 4 of 40 Massachusetts compounding pharmacies passed surprise health inspections



The state ordered 11 compounding pharmacies to shut down all or part of their operations and cited another 21 for more minor violations, health officials said Tuesday in announcing the results of surprise inspections conducted in recent months. Only four of 40 compounding pharmacies in the state were fully compliant with regulations.
The Department of Public Health began the surprise inspections in the fall, after injectable steroids produced at a Framingham pharmacy were linked to a national outbreak of fungal meningitis and other infections. The tainted drugs have sickened nearly 700 people and been blamed for 45 deaths.
“While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts,” Dr. Lauren Smith, the department’s interim commissioner said in a press release of the inspections.
Compounding pharmacies are supposed to prepare doses and formulations of drugs for individual patients that are not available from drug manufacturers, and sterile compounders make injectable and intravenous medications that must meet the highest standards of purity. But state officials have said New England Compounding Center, the pharmacy that made the contaminated steroids, was mass-producing drugs and making what were supposed to be sterile injections in unsanitary facilities.
New England Compounding shut down in October, and two sister companies with common owners remain closed under temporary orders. With the previously announced closure of Waltham-based Infusion, that leaves just four compounding pharmacies that were found to be operating properly.
“These investigations are in most cases still ongoing,” Madeleine Biondolillo, director of the health department’s Bureau of Health Care Safety and Quality, told the state pharmacy board Tuesday morning. “There were some pharmacies that were willing to correct the problems and others that chose not to.”

Source found here

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