Massachusetts Authorities Take Action on Compounding Pharmacies
Partial or complete cease and desist orders were issued to 11 pharmacies for a range of violations. DPH also cited another 21 pharmacies for minor deficiencies that have since been corrected or are being addressed.
The Massachusetts Department of Public Health announced Feb. 5 that, as a result of its unannounced inspections of 40 compounding pharmacies triggered by the New England Compounding Center-linked outbreak, partial or complete cease and desist orders were issued to 11 pharmacies for a range of violations. DPH also cited another 21 pharmacies for minor deficiencies that have since been corrected or are being addressed, according to the agency's announcement.
Injectable steroids produced by NECC were linked to fungal meningitis cases in more than a dozen states. As a result, the department undertook the inspections as part of a state plan to enhance state oversight of the compounding pharmacy industry. The inspections began last fall.
"While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts," said DPH Interim Commissioner Dr. Lauren Smith. "These findings underscore the need for additional budget resources and legislation the governor has proposed to further strengthen our monitoring of this industry."
The Board of Pharmacy also has issued new regulations that require sterile compounding pharmacies in Massachusetts to report volume and distribution to the state for the first time, and $1 million in Gov. Deval Patrick's FY14 budget will enable the board to hire additional inspectors to continue the unannounced inspections.
Eight of the 11 pharmacies receiving cease and desist orders have submitted corrective plans, according to the announcement.