Massachusetts cites violations at 32 compounding pharmacies

Tue Feb 5, 2013 2:59pm EST

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(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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Comments (1)
ahmiles wrote:
We hear the loud cry from so many who feel the Government is hurting the business community by imposing unnecessary regulations. This is a mythical argument when so many people fail to exercise due diligence as operators… who are only focused on profit margins…
These bad apples are why so many people are injured or die …. And YET we fail to lock them up.. we permit these crooks to wiggle out of accountability .
If our Government were not there we would be like a third world Nation Subject to the Greedy hack.. who tries to distort the need of good Government enforcement….
The idea they would float the notion that tort reform is a good idea is without merit…. And leads to a more risky behavior by these CEOs
They seem to feel they are above the law….

We need enforcement tools to avoid more dead people not less… it is a real mistake to permit anyone who allows lowers standards to continue to walk free.

Feb 05, 2013 4:04pm EST  --  Report as abuse
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