Newspaper article St Louis Post-Dispatch (MO)

Compounding Pharmacies May Get More Scrutiny; Move Comes after Fatal Meningitis Outbreak Last Year Was Traced to Massachusetts Firm

Newspaper article St Louis Post-Dispatch (MO)

Compounding Pharmacies May Get More Scrutiny; Move Comes after Fatal Meningitis Outbreak Last Year Was Traced to Massachusetts Firm

Article excerpt

WASHINGTON * Congress is taking 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 steroid pain injections killed at least 64 people and sickened hundreds more.

The Senate approved the bill Monday by voice vote, sending it to President Barack Obama for his signature. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September.

Last year's meningitis outbreak was eventually traced to a now- closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states. More than 750 people were sickened.

Jurisdiction over such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or other health professional are typically regulated by state boards, but the Food and Drug Administration regulates manufacturers of medicines. The compromise bill gives the FDA authority to inspect and close down large-volume compounders, but it doesn't require the pharmacies to register with the FDA, as manufacturers of prescription drugs must do.

The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA's authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors' prescriptions.

Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. …

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