Another compounding group shuts amid outbreak
As the meningitis outbreak spreads, so does the fallout from it. A second company in Massachusetts is suspending operations, The Boston Globe reports, while officials investigate. Meanwhile, calls for tougher oversight of pharmaceutical compounding are, predictably, intensifying.
Ameridose--a compounding group that shares ownership with the outbreak's apparent epicenter, New England Compounding--"proactively and voluntarily" agreed to stop manufacturing and compounding, said Dr. Madeleine Biondolillo, director of Massachusetts' Bureau of Healthcare Safety. At the same time, its distribution partner, Alanaus Pharmaceuticals, will stop shipping all of Ameridose's products.
Though New England Compounding has now recalled all its products, none of Ameridose's products are affected, and state officials haven't asked the company to conduct a recall.
News of the outbreak has taken center stage, highlighting the patchwork of state regulations that govern the compounding pharmacy business. Lawmakers are calling for federal oversight. But as Massachusetts Gov. Deval Patrick pointed out yesterday, a lack of rules may not be the problem: New England Compounding is suspected of violating its state license by selling drugs in bulk, rather than prescription by prescription.
The state has now asked all its compounding pharmacies to sign affidavits promising that they're operating within the bounds of their licenses. "There is a gray area where some organizations may have operated contra to the licensing regulations," said Biondolillo, who emphasized that the investigation is ongoing.