Bulk mixers of prescribed drugs get more scrutiny

November 18, 2013 by Matthew Perrone

Congress has taken a half step toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds of others.

The Senate approved the bill Monday by voice vote, sending it to President Barack Obama for his signature. The House passed the bill in September.

Last year's was traced to a now-closed pharmacy in Framingham, Mass., where inspectors found mold and other unsterile conditions.

Jurisdiction over large-volume compounders has been murky. Pharmacies are typically regulated by state boards, but the Food and Drug Administration regulates drug manufacturers. The gives the FDA authority to inspect large-volume compounders, but doesn't require them to register with the federal agency.

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