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Massachusetts cites violations at 32 compounding pharmacies

Source: Thomson Reuters Foundation - Tue, 5 Feb 2013 19:53 GMT
Author: Reuters
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Feb 5 (Reuters) - Massachusetts health regulators have ordered 11 compounding pharmacies to partially or completely halt operations and cited another 21 for minor violations, after unannounced inspections of 40 pharmacies across the state.

The wave of inspections follow a deadly U.S. meningitis outbreak stemming from a tainted steroid that was made by the New England Compounding Center in Framingham, Massachusetts. The 2012 outbreak led to 45 deaths, according to the U.S. Centers for Disease Control and Prevention.

The Massachusetts Department of Public Health (DPH) said pharmacies that were ordered to cease operations must submit a written plan of corrective action to the state's Board of Pharmacy. They must then implement the measures and pass re-inspection before being allowed to operate.

The DPH said eight of the 11 pharmacies have submitted corrective plans.

"While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts," said DPH interim Commissioner Dr. Lauren Smith.

Last Friday, Republicans in the House of Representatives set a deadline for the U.S. Food and Drug Administration to produce documents related to the meningitis outbreak, saying the FDA has produced few documents and that those it has "raise new and troubling questions" about its oversight of NECC. (Reporting By Toni Clarke; Editing by Steve Orlofsky)

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