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Capitol Health Call
July 10, 2013

Bill Calls for Tighter Regulation of Drug Compounders

JAMA. 2013;310(2):133. doi:10.1001/jama.2013.8470

The Senate’s Health, Education, Labor, and Pension Committee approved on May 22 the Pharmaceutical Compounding Quality and Accountability Act (S959), which, if signed into law, would give the Food and Drug Administration (FDA) oversight of large compounding companies that are currently regulated at the state level. To demonstrate the need for such legislation, the committee released a bipartisan staff report showing that since last fall’s outbreak of fungal meningitis infection, caused by contaminated drugs produced by the Massachusetts-based New England Compounding Center, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions (http://tinyurl.com/nxog9uq).