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Affiliate of US meningitis-linked firm extends shutdown

By Toni Clarke

BOSTON (Reuters) - Ameridose LLC, sister company to the pharmacy at the heart of a meningitis outbreak in the United States, agreed on Friday to extend its closure by two weeks while state and federal investigators continue to examine its facilities.

The company will remain closed until November 19, according to an agreement between Ameridose and Massachusetts regulators, a copy of which was obtained by Reuters.

Ameridose has the same owners as the New England Compounding Center (NECC), which distributed a tainted steroid used for back pain that has killed 28 people in the meningitis outbreak. On Thursday, the U.S. Centers for Disease Control and Prevention said the toll was revised down from 29 deaths.

Separately, Massachusetts regulators said they had approved emergency regulations to strengthen the oversight of so-called compounding pharmacies such as NECC.

Two days ago, Ameridose issued a voluntary recall of all its products following a U.S. Food and Drug Administration directive to improve its sterility testing process.

Westborough, Massachusetts-based Ameridose closed on October 10. It said on Wednesday that it had not received any reports of adverse reactions to the drugs it is recalling. NECC's injectable steroids turned out to be contaminated with fungus and as of Thursday, were blamed for 377 cases of fungal meningitis.

The FDA has said it is in contact with other manufacturers about filling the supply gap left by the shutdown of Ameridose, which makes and ships sterile injectable drugs.

In a blog post on Friday, FDA Commissioner Dr. Margaret Hamburg said the agency has identified a number of Ameridose products, including drugs used during surgery and to treat conditions that include congestive heart failure, that were on the current drug shortages list before the recall.

"We also know that the supply of other drugs may be affected by the Ameridose recall," she said. "FDA is doing everything we can to minimize the impact this recall may have on current drug shortages, and to prevent other shortages from occurring."

James DeVita, president of the Massachusetts Board of Registration in Pharmacy, said that new regulations adopted by the body would help "fill the grey area" between state and federal oversight for compounding pharmacies.

The changes include giving the state board, for the first time, the ability to track the volume and distribution of compounded products.

"This action will assist the Board in determining whether compounding pharmacies are operating in a traditional and necessary role rather than in a manner analogous to that of a manufacturing facility," DeVita said.

(Additional reporting by Ros Krasny; Editing by Gerald E. McCormick, Grant McCool, Steve Orlofsky and Lisa Shumaker)

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