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March 11, 2013

Compounding Pharmacists Respond To CBS Report

By Emily Micucci

The International Academy of Compounding Pharmacists (IACP) on Sunday released a statement calling recent reports by CBS News on the meningitis outbreak tied to Framingham-based New England Compounding Center (NECC) "important," and "deeply troubling."

"These news accounts are consistent with our long-held belief that NECC acted illegally and outside of its license as a pharmacy," the statement said.

CBS reported on the CBS Evening News on March 7 and 8, and on 60 Minutes on March 10, that NECC had increased production of injectable drugs to the point where it was operating as a manufacturer, not a compounding pharmacy, which makes drugs by prescription.

CBS reported that manufacturers are subject to federal oversight, but compounding pharmacies are not, leading to undetected problems with sterility at NECC. The IACP disputed that in its statement.

"Both the state board and the (Federal Drug Administration) in fact possessed the authority to close NECC, and both had been notified of issues and potential problems with that company before this series of tragic events occurred. Massachusetts and the FDA inspected NECC repeatedly as far back as 2004 over concerns about their sterile compounding practices.

"IACP has worked and will continue to work with state and federal policy makers to do what is necessary to see that nothing like this ever happens again while assuring that physicians, pharmacists and patients can still work together so that patients can have access to customized medicines that are not available from manufacturers."

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