Thursday, May 23, 2013

Meningitis: Compounding bill emerges from Senate

http://www.tennessean.com/article/20130522/NEWS07/305220152/Meningitis-Compounding-bill-emerges-from-Senate


Meningitis: Compounding bill emerges from Senate


A proposed law to set clear oversight authority over compounding pharmacies that make medicine on a large scale is on its way to a vote before the full Senate.

The legislation, which is intended to prevent another fungal meningitis outbreak, emerged from the Senate Health, Education, Labor and Pensions Committee on a voice vote Wednesday morning without any amendments. Infections linked to contaminated medicine made by New England Compounding Center last year have sickened 741 people across the nation with 55 deaths.

Under the proposed legislation, compounding manufacturers must register with the U.S. Food and Drug Administration and comply with good manufacturing processes. Traditional compounding pharmacies that mix smaller batches of drugs would remain under the purview of state regulators.


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