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FDA chief will testify at first meningitis hearing

Associated Press Modified: November 5, 2012 at 5:03 pm •  Published: November 5, 2012
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In recent weeks, inspectors from the FDA and Massachusetts department of health have reported unsterile conditions at the Framingham, Mass. pharmacy's facilities. The most recent inspection from the FDA uncovered green and yellow residues, water droplets and standing water in or around production rooms that were supposed to be sterile.

House and Senate lawmakers have called for hearings to examine how the outbreak could have been prevented.

Compounding pharmacies have long operated in a legal gray area between state and federal laws. All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards. However, the FDA has attempted to exercise its authority in cases where major problems have arisen. In several instances, federal courts have ruled that the agency overstepped its bounds.

FDA officials said last month that new laws may be needed to clarify the federal government's role in overseeing compounding pharmacies.