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The Boston Globe


FDA looks at rules for compounders

SILVER SPRING, Md. — US Food and Drug Administration officials met in an open forum with state health representatives Wednesday to come up with a framework for new federal laws that would tighten oversight of compounding pharmacies such as the Massachusetts company blamed for the national fungal meningitis outbreak.

The FDA regulates drug manufacturers but not compounders, which typically custom make medicines for individual patients, such as those who cannot take standard versions of drugs. Regulators say New England Compounding Center in Framingham produced medications in bulk and distributed drugs nationwide, much like a manufacturer, in ­violation of its state license.

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