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FDA Wanted To Close Mass. Pharmacy In 2002



A Congressional reports offers the most detailed account yet of the numerous regulatory complaints against the pharmacy, which nearly date back to its founding in 1998.

More than a decade ago, federal health inspectors wanted to shut down the pharmacy linked to a recent deadly meningitis outbreak until it cleaned up its operations, according to congressional investigators, reports MSBC.com.

Nearly 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and at least 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. That has put the Framingham, Mass., pharmacy at the center of congressional scrutiny and calls for greater regulation of compounding pharmacies, which make individualized medications for patients and have long operated in a legal gray area between state and federal laws.

The House Energy and Commerce Committee released a detailed history of NECC’s regulatory troubles on Monday, ahead of a meeting Wednesday meeting to examine how the outbreak could have been prevented. The 25-page report summarizes and quotes from FDA and state inspection reports and internal memos, though the committee declined to release the original documents.

The report shows that after numerous complaints over years, Food and Drug Administration officials in 2002 suggested that the compounding pharmacy be “prohibited from manufacturing” until it improved its operations. But FDA regulators deferred to their counterparts in Massachusetts, who ultimately reached an agreement with the pharmacy to settle concerns about the quality of its prescription injections.

 

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