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Massachusetts curbs compounding pharmacies after 2012 meningitis outbreak

by Reuters
Thursday, 10 July 2014 17:54 GMT

BOSTON, July 10 (Reuters) - Massachusetts Governor Deval Patrick signed a law Thursday to rein in compounding pharmacies, after tainted drugs produced by a local company sparked a meningitis outbreak in 2012 that killed 64 people across the United States.

The new law gives greater power to the state board that regulates such pharmacies - which mix but do not manufacture drugs and are subject to lighter standards of oversight than drug manufacturers - and sets stricter licensing standards.

"Every patient deserves to know that the medication they are taking is safe," Patrick, a Democrat, said after signing the bill into law.

Under the Massachusetts legislation, the state's Board of Registration in Pharmacy will be required to participate in national reporting systems on pharmacies. It will be authorized to conduct unannounced inspections of pharmacies that hold the companies accountable to the newly raised standards.

In October 2012, regulators shut down the New England Compounding Center, a Framingham, Massachusetts-based company identified as the source of the tainted steroids that triggered the worst outbreak of fungal meningitis in U.S. history.

In response to the episode, U.S. President Barack Obama signed a law last year allowing, but not requiring, large compounding pharmacies to register with the U.S. Food and Drug Administration and adhere to federal regulations and standards.

The new law also directs the state's Department of Public Health to develop a website that allows members of the public to search for data on compounding pharmacies, and increases the pharmacies' obligation to provide more information about their products to consumers. (Reporting by Scott Malone; Editing by Bernadette Baum)

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