Sunday, October 28, 2012

U.S. regulator needs new authority over compounding pharmacies: report



WASHINGTON (Reuters) - The U.S. Food and Drug Administration's power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.

The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner "the authority we need to help prevent tragedies like this from happening again."
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