Bulk Mixers of Prescribed Drugs Get More Scrutiny
By MATTHEW PERRONE, AP Health Writer
WASHINGTON (AP) — 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 meningitis outbreak 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 bill gives the FDA authority to inspect large-volume compounders, but doesn’t require them to register with the federal agency.