Andover Townsman, Andover, MA

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October 23, 2012

Records detail issues at firm linked to meningitis

(Continued)

The committee said NECC’s actions “call into question whether the NECC was operating as a traditional compounding pharmacy or on a commercial scale as a drug manufacturer.”

Compounding pharmacies, regulated primarily by states, specialize in customizing doses for patients who have allergies to ingredients in FDA-approved drugs or who might need smaller dosages than what’s available commercially. But some pharmacies have pushed into full-scale manufacturing.

Committee members say they want to know “how long NECC has been operating in this manner and why, six years after the FDA’s warning letter and 10 years after an inspection relating to methylprednisolone acetate produced and distributed by the NECC, the company was able to continue to do so.”

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