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Massachusetts Cracks Down On Unregulated Compounding Pharmacies Linked To Deadly Meningitis Outbreak

By Tara Culp-Ressler on October 29, 2012 at 5:30 pm

"Massachusetts Cracks Down On Unregulated Compounding Pharmacies Linked To Deadly Meningitis Outbreak"

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Contaminated steroid injections that led to meningitis infections

Now that the current deadly meningitis outbreak — which has infected an estimated 337 Americans across 18 different states, and caused 25 deaths so far — has put a spotlight on compounding pharmacies that currently fall outside the jurisdiction of the Food and Drug Administration’s safety regulations, state officials are beginning to crack down on the pharmacies that produce compounded drugs.

In Massachusetts, where tainted steroid shots produced at the New England Compounding Center (NECC) first exposed thousands of Americans to a rare strain of fungal meningitis, local officials are taking a more serious look at compounding pharmacies that remix and repackage drugs for widespread sale. As the New York Times reports, Massachusetts Gov. Deval Patrick (D) is working to address the public health risks posed by compounding pharmacies in the absence of FDA regulatory oversight, and recently shut down the third compounding pharmacy in his state that did not meet inspection standards:

Gov. Deval Patrick last week directed the state’s Board of Registration in Pharmacy to immediately start unannounced inspections of compounding pharmacies that prepare sterile, injectable medications. There are 25 such pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state rules governing them were insufficient. Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.

At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies. The goal is to inspect all of them by Jan. 1, she added.

Smith told Reuters that the statewide inspections are part of “a series of aggressive and necessary actions to protect public safety and enhance oversight of this industry” after the contaminated steroid shots from the NECC brought on the national meningitis epidemic.

Although public health advocates have called for strengthened FDA regulatory power over compounded drugs for decades — warning that since compounding pharmacies are not currently subject to the FDA’s health and safety guidelines, they are able to distribute products like the tainted steroids that pose serious public health risks — the pharmaceutical industry has lobbied to prevent the agency from having any additional oversight in that area. Some members of Congress have already called for a criminal investigation into the meningitis outbreak.

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