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Mass. Pharmacists: NECC May Have ‘Disregarded’ Rules And Regulations

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BOSTON (CBS/AP) – Two groups representing pharmacists across Massachusetts tried to distance themselves Wednesday from the specialty pharmacy in Framingham at the center of a deadly nationwide meningitis outbreak.

In a joint statement, the Massachusetts Pharmacists Association and the Massachusetts Independent Pharmacists Association said it appears that “rules and regulations may have been disregarded” by the New England Compounding Center (NECC).

Contaminated steroid shots distributed by NECC have infected 247 people with fungal meningitis in 15 states, according to the Centers for Disease Control and Prevention. Nineteen people have died.

Gov. Deval Patrick said last week that NECC might have misled regulators and done work beyond the scope of its state license. Federal and state investigators have said they have found fungus in more than 50 vials from the company, but they have not said whether they have pinpointed the source of the contamination.

“As pharmacists we are disheartened by the practices of NECC and greatly concerned that a compounding pharmacy was able to distribute contaminated injectable products in such an excessive quantity despite a history of inspections by both the Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy,” the pharmacists association said Wednesday.

“Although the facts are still emerging, the actions of NECC appear to more closely resemble the manufacturing of medications rather than addressing the needs of an individual pursuant to a prescription.”

Two members of Congress have asked the U.S. Department of Justice to investigate whether NECC outbreak violated any federal laws or regulations.

Rep. Edward Markey, D-Massachusetts, wrote in a letter to the Department of Justice that the list of products recalled by the Framingham company appears to include controlled substances that fall under the jurisdiction of the Drug Enforcement Agency.

The DEA requires pharmacies that sell or compound controlled substances to be registered with the agency, which NECC was not, Markey wrote. He added that the rules only allow pharmacies to sell controlled substances directly to patients with specific prescriptions unless the pharmacies register with the DEA as manufacturers or suppliers.

“This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances,” said Markey.

In a recent letter to U.S. Attorney General Eric Holder, Sen. Richard Blumenthal, a Connecticut Democrat, also called for a criminal investigation of the company, its officers and employees, pointing to reports that NECC may have “flagrantly and blatantly violated” state and federal laws.

NECC, in a statement, did not directly respond to the legislators but said it was cooperating with ongoing probes by other agencies.

Federal agents carried boxes of documents and evidence out of NECC’s Framingham offices early Wednesday morning.

Criminal investigators from the Food and Drug Administration were also at the Framingham company on Tuesday. FDA spokesman Steven Immergut said the investigators were there as part of a broad investigation by several state and federal agencies into the outbreak.

Company attorney Paul Cirel said it was “difficult to understand the purpose” of the FDA search. He said the company has made clear it would provide, and has provided, anything requested by investigators.

“We’ve been clear that warrants weren’t needed; asking would have produced the same result,” he said. “Nevertheless, we continue to offer our cooperation.”

Boston U.S. Attorney Carmen Ortiz confirmed that her office is part of the investigation.

(TM and © Copyright 2012 CBS Radio Inc. and its relevant subsidiaries. CBS RADIO and EYE Logo TM and Copyright 2012 CBS Broadcasting Inc. Used under license. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.)

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