In an attempt to tighten federal oversight of compounding pharmacies in the wake of the meningitis outbreak, the S.A.F.E. Compounded Drugs Act of 2012 (HR 6638) was introduced in Congress on December 5, 2012. The legislation, which is sponsored by Rosa DeLauro (D-CT) and Nita Lowery (D-NY), would require compounding pharmacies to register with FDA, which would enable the agency to set minimum production standards and impose new labeling conditions on compounded drugs.
The bill is the second of such proposed laws since the outbreak started in mid-September. The first bill, Verifying Authority and Legality in Drug Compounding Act of 2012 (HR 6584) was introduced by Ed Markey (D-MA) on November 2. Markey stated in a press release that the bill would give FDA new authority to oversee compounding pharmacies while preserving state regulatory authority for traditional small compounding pharmacies.
Neither the House nor Senate is expected to vote on either proposal this year because of the focus on deficit-reduction negotiations.
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