The Mass. Board of Pharmacy (MBP) has completed more than a dozen unannounced inspections of sterile compounders en route to an across-the-board evaluation of all 25 of those that have been identified in the state.
The inspections are part of a state crack down on compounders that ensued in the wake of the fungal meningitis outbreak caused by the Mass.-based New England Compounding Center. Both NECC and its affiliate Ameridose have been shut down and all products compounded at the two companies recalled. NECC filed for Chapter 11 bankruptcy in late December.
The new regulations require sterile compounding pharmacies in Massachusetts to report, for the first time, volume and distribution figures to the state. That data will be monitored to detect a pharmacy that is acting more like a drug manufacturer, which requires inspection and licensing from FDA. They are also required to attest that they are meeting all state laws and regulations.
[Editor’s Note: See the IPQ “Special Report” November 2012 for an in-depth analysis of the far-reaching implications of the pharmacy compounding quality control breakdown that stretch across the regulatory, political, legislative and health policy arenas.]The broader inspection initiative was announced by the Mass. Department of Health at the beginning of November along with a series of emergency regulations to bring greater scrutiny to the compounding industry (IPQ “The News in Depth” Nov. 27, 2012).
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