Posts Tagged ‘“New England Compounding Center”’

State officials have announced they will seek permanent surrender of New England Compounding Center’s (NECC) pharmacy license in the wake of a fungal meningitis outbreak which has infected more than 300 people and left 23 dead.

At a Tuesday press conference, state officials announced they will seek the pharmacy’s license and permanent license revocation for NECC’s three pharmacists. Recent state inspections of the closed-down Framingham facility found dirty and defective equipment and showed the company had failed to follow its own safety tests and properly sterilize tools.

Governor Deval Patrick said a federal criminal investigation has been launched, while Madeleine Biondolillo, director of the state Bureau of Health Care Safety and Quality, said the company had been violating its state compounding license. The facility was licensed to produce medicine with a patient-specific prescription in hand, not manufacture large shipments.

As of this week, 304 people had contracted fungal meningitis or joint infections linked to the injectable steroid produced by NECC, reported The Boston Globe. Testing has found the fungus matches a type found in unopened vials of the steroid shipped from NECC, though they are still investigating how the fungus got into the vials. The injectable steroid is methylprednisolone acetate.

The 23 deaths linked to the defective steroid come from seven states. No one has been reported ill in Massachusetts. But federal officials say as many as 14,000 people may have been exposed to the contaminated drug between May 21 and Sept. 26, when it was recalled. The company went onto recall all its drugs.

The Food and Drug Administration released a list this week of more than 3,000 NECC customers who received products other than the injectable steroid blamed for the meningitis outbreak. They included 215 Massachusetts doctors, health centers and hospitals. The shipments fell within the time frame of when the defective steroids were produced at the facility.

Ameridose, a Westborough pharmacy with the same owners as NECC, has also been closed down since Oct. 10 in an agreement with state officials. It is scheduled to remain closed until Nov. 5 for state inspections.

Related:

• CDC: 10 more people have fungal infections linked to Framingham pharmacy, The Boston Globe.
• New England Compounding did not follow sterility procedures, investigators find; state orders regular inspections of similar pharmacies, The Boston Globe.
• Corrected list of New England Compounding customers includes 215 in Massachusetts, The Boston Globe.

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