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Drug compounding safety legislation passes House

WASHINGTON Drug compounding pharmacies like the one involved in a 2012 multistate meningitis outbreakmay soon be facing more regulation following the House passage of a new safety bill.

On Saturday, the House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.

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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 including bacteria and mold on multiple surfaces located in the clean room at the New England Compounding Center (NECC), which has since been shut down.

Compounding pharmacies mix customized solutions, creams and other medications in formulas specified by a doctor's prescription. Over the last two decades though, larger compounding operations have emerged that produce medications in bulk with prescriptions, shipping products across state lines.

The 2012 outbreak of meningitis and other fungal infections was eventually linked to steroidal injections given as pain treatments produced by the NECC.

The House's 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 introduced similar legislation in April.

"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."

Last Nov., FDA chief Dr. Margaret Hamburg told House lawmakers at a hearing that the problems uncovered at the New England Compounding Centers in inspections were "very serious," but that the agency was obligated to defer to Massachusetts authorities, who had more direct oversight over pharmacies.

"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," she said at the time to lawmakers in asking them to give her agency more authority.

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