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After meningitis deaths, Alexander seeks clarity in FDA regulations

April 26th, 2013 9:26 pm by Michael Collins

After meningitis deaths, Alexander seeks clarity in FDA regulations

WASHINGTON — A deadly meningitis outbreak that killed 32 people, including 13 in Tennessee, and sickened more than 460 others last year has led to a push in Congress to regulate large compounding pharmacies that mass-produce drugs and ship them across the country.
U.S. Sens. Lamar Alexander, R-Tenn., and Tom Harkin, D-Iowa, said Friday they and other lawmakers are drafting a bill that would give the Food and Drug Administration the authority to regulate compounding manufacturers that make sterile products without a prescription and sell them across state lines.
“Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again,” said Alexander, the top Republican on the Senate Health, Education, Labor and Pensions Committee.

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