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Questions raised about meningitis pharmacy

NECC licensed only to dispense and mix medications for individual patients

BOSTON | October 11, 2012

Massachusetts officials said an executive of a sister company of the pharmacy linked to the meningitis outbreak recused herself as a state regulator.

Sophia Pasedis, vice president of regulatory affairs and compliance at Ameridose, which shares the same owner as that of the New England Compounding Center in Framingham, Mass., was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in June 2004 and reappointed in 2008, The Boston Globe reported.

The New England Compounding Center is at the center of the fungal meningitis outbreak that has killed 12 and sickened 137 in 10 states. The compounding pharmacy in Framingham, Mass., produced about 13,000 doses of the injectable steroid methylprednisolone acetate used to treat back pain.

The investigation into the exact cause of the outbreak is ongoing locally and nationally. The Centers for Disease Control and Prevention in Atlanta said its preliminary analyses showed all infected patients received an injection of preservative-free methylprednisolone acetate, a steroid prepared by the New England Compounding Center.

"The compounding center voluntarily surrendered its license at the request of the state of Massachusetts and at the direction of public health officials, announced a recall of all products that were distributed from its facility in Framingham," Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health said in a statement.

"Massachusetts regulations stipulate that licensed compounding pharmacies are only permitted to prepare and dispense medications pursuant to a prescription from a registered practitioner for an individual patient. If a compounding pharmacy manufactures without a patient-specific prescription, it would be a violation of the terms of its licensure with the Board of Pharmacy."

State health officials have said the New England Compounding Center was licensed only to dispense and mix medications for individual patients. This raises questions about how and why it produced and shipped thousands of vials of the drugs to facilities nationwide, the Globe said.

The U.S. Food and Drug Administration and the Massachusetts Board of Pharmacy conducted joint inquiries for more than a decade at the New England Compounding Center, Biondolillo said.

Compounding pharmacies are regulated primarily by state agencies as pharmacies, not drug manufacturers, therefore they are not regulated as strictly as drug manufacturers, which are regulated by the U.S. Food and Drug Administration.

"Compounding pharmacies currently fall into a regulatory black hole," Rep. Ed Markey, D-Mass., said in a letter to Margaret Hamburg, the FDA commissioner.

Markey said he would introduce legislation to strengthen the oversight of compounding pharmacies.

"These compounding pharmacies are operating as factories, mass producing and packaging specialized new drugs in large quantities and then sending them over state lines," Markey said. "These compounding pharmacies are compounding risk -producing complex drugs in bulk and then distributing them across the country. Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer."

Andrew Paven, a spokesman for Ameridose and New ­England Compounding Center, said Ameridose is a separate entity from New England Compounding Center, with distinct operational management.

"We have separate production facilities, separate processes and operate at separate locations in different cities," Paven said in a statement. ­Although the two companies share "common ownership," they "operate under separate registrations and different licensure."

Both companies are owned by Barry Cadden and Gregory Conigliaro, the Globe said.

© 2012 United Press International, Inc. All Rights Reserved

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