Compounding pharmacies fill important medical niche

By Carolyn Y. Johnson

| Globe Staff November 03, 2012

Among the many surprises that have emerged since a Framingham pharmacy was implicated in a national fungal meningitis outbreak is this one: Hundreds of US hospitals, includ­ing most of those in Massachusetts, bought medications from the lightly regulated New England Compounding Center.
Unlike major drug manufacturers, the specialty pharmacy was not regularly inspected or monitored by the Food and Drug Administration, yet prestigious hospitals from Massachusetts General to Yale-New Haven were among its customers, according to a list posted online by the FDA.
Hospitals and pharmacists say companies such as New England Compounding play a critical role in supplying scarce drugs, specialized medications, and individually packaged doses. But over the years, some companies have grown so large that they quietly crossed a line, acting more like drug manufacturers than pharmacies that prepare drugs for individual ­patients.
“We do think we need to clarify some of the regulations and who is doing the regulation,” said Dr. Elizabeth Mort, interim senior vice president of quality and safety at Massachusetts General Hospital. “We want to be part of that conversation, because we’re at the ­delivery end. We want to make sure we have continuous, ­uninterrupted, high-quality drugs delivered to our patients.”

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