Markey's Post-Outbreak Bill May Fall Short Of Desired Overhaul
Law360, New York (November 2, 2012, 8:59 PM EDT) -- Rep. Edward Markey, D-Mass., introduced legislation this week that aims to strengthen the U.S. Food and Drug Administration's oversight of compounding pharmacies, but attorneys say the bill grants the agency authority it already has and maintains the same federal-state regulatory split that critics have linked to the recent meningitis outbreak.
The bill, known as the Verifying Authority and Legality in Drug Compounding Act, would preserve state pharmacy boards' oversight of compounders that manufacture drugs that are not commercially available, based on prescriptions for individual patients. If a compounder manufactures drugs outside of that context — by making them in bulk, for...
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