Published November 01, 2012
FRAMINGHAM, Mass. – A Massachusetts lawmaker says he'll introduce legislation to increase federal oversight of specialty pharmacies like the one linked to a deadly meningitis outbreak.
Democratic U.S. Rep. Ed Markey made the announcement Thursday outside the now-closed New England Compounding Center in Framingham.
A tainted steroid made by the center caused a fungal meningitis outbreak linked to 28 deaths across the country.
Compounding pharmacies custom-mix solutions that generally aren't commercially available. They aren't regulated by the U.S. Food and Drug Administration.
Under Markey's legislation, to be introduced Friday, such pharmacies would be FDA-regulated, if they produce larger quantities of a drug for general distribution. Officials say that's what the company appeared to be doing, though they were only permitted to produce patient-specific prescriptions.
The bill also requires pharmacies to label compounded drugs to show they haven't been FDA-tested.