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November 13, 2013

Senate votes to advance specialty pharmacy bill

WASHINGTON, D.C. — The Senate voted Tuesday to advance a bill designed to tighten government oversight of pharmacies that custom-mix prescription drugs, in the wake of last year’s deadly meningitis outbreak tied to contaminated pain injections.

The bill cleared a parliamentary hurdle on a 97-1 vote, indicating its overwhelming support in the Senate. The legislation, passed by the House in September, also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies. Final passage sending it to President Barack Obama for his signature could come as early as Wednesday.

The lone vote against the measure came from Sen. David Vitter. The Louisiana Republican is championing a measure to make lawmakers disclose which of their aides are enrolling in the president’s new health care program as part of an ongoing effort to discredit “Obamacare.”

The compounding pharmacy bill is intended to prevent a repeat of last year’s fungal meningitis outbreak that killed 64 people and sickened more than 750 others across the U.S. The sickness was traced to a now-closed pharmacy in Massachusetts, the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions.

Compounded medicines have been tied to contamination problems for years. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the federal Food and Drug Administration regulates manufacturers of medicines.

The bill attempts to sort out that legal gray area, which allowed the NECC and other large pharmacies to skirt both state and federal regulations.

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