More troubles for the compounding pharmacy that produced thousands of contaminated vials of a steroid injection blamed for the fungal meningitis outbreak that has spread to 12 states, sickened 205 patients and killed 15 more. Public health officials now say that the New England Compounding Center was operating in violation of its Massachusetts board of pharmacy license, producing thousands of vials of steroids at a time instead of in response to individual prescriptions.
"Our statutory and regulatory requirements stipulate that compounding can only be conducted upon receipt of a patient-specific prescription," says Madeleine Biondolillo, MD, director of the state division of health care quality. "NECC under Massachusetts board of pharmacy licensing regulations was licensed to deliver compounded products in response to individual patient-specific prescriptions. And it looks through the investigation as though they have violated that aspect of the state licensing regulation despite their assertion that they were operating under the regulations."
This isn't the first time New England Compounding has been implicated in below-standard compounding procedures. In 2006, the compounding pharmacy received a warning letter from the FDA regarding concerns about the scale of production and potential health risks, particularly with injectable sterile drugs.
NECC has ceased operations and recalled all of its products, including the steroid methylprednisolone acetate, which is believed to be the source of the fungal meningitis outbreak. NECC declined to comment on specific accusations, saying in a statement that its "intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations."
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