September 28, 2013 10:18:31 PM
WASHINGTON -- The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.
The measure, approved on a voice vote, comes almost a year after a meningitis outbreak that killed 64 people and sickened hundreds more was traced to a compounding company in Framingham, Mass. Inspectors later found unsanitary conditions at the New England Compounding Center, which has since closed.
The measure, aimed at improving how drugs are tracked from production until they are purchased at a drug store, would clarify what sponsors said was confusion over the Food and Drug Administration's authority over compounded drugs. It would also require the agency to coordinate its oversight of compounded-drug safety with states.
Compounders could voluntarily register as outsourcing facilities, which would bring them under FDA authority. Registering will let the agency identify who these companies are and what they produce, and allow the FDA to receive reports about any problems.
Companies that remain traditional pharmacies would continue to be overseen mostly by state pharmacy boards.
The Senate is working on similar legislation.
"We are near the resolution of last year's deadly outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee and an author of the legislation.
That panel's top Democrat, Rep. Henry Waxman of California, said, "There is no question that this bill represents a step forward."
Rep. Rosa DeLauro, D-Conn., criticized the legislation, saying its voluntary registration for compounding companies "is not strong enough to ensure the public safety."
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