Marlborough Pharmacy Among 32 To Fail Surprise Inspection
A Marlborough compounding pharmacy is one of 11 that have been completely or partially shut down due to violations found during unannounced inspections by the state.
According to a press release issued by the state's Department of Public Health (DPH), surprise inspections were done at 40 sterile compounding pharmacies across Massachusetts as part of actions instituted by Gov. Deval Patrick last fall with the intention of strengthening oversight of the industry. The changes followed a fungal meningitis outbreak linked to Framingham's New England Compounding Center that was responsible for 45 deaths and nearly 700 illnesses across 20 states, according to the federal Centers for Disease Control and Prevention. NECC was subsequently shut down and later filed for bankruptcy protection.
Each of the 11 pharmacies must submit a written plan of correction to the state's Board of Pharmacy, then implement the corrective measures, perform any necessary renovations and pass another inspection before returning to operational. Eight of the 11 pharmacies have submitted corrective plans, including West River Pharmacy in Marlborough, the DPH said.
According to the DPH, West River was ordered to stop all sterile compounding and quarantine all of its prepared sterile compounds Dec. 20. Compounding centers make specialized medications for individual patients that aren't available from major manufacturers. Sterile compounding deals with medications that can be injected and therefore must be made in a sterile environment.
The pharmacy was found to be non-compliant with required standards on facility design and control. It submitted a plan of correction last month.
According to the pharmacy's website, it provides services throughout New England and New York. The company declined to comment on the violation.
Another 21 pharmacies were cited for minor deficiencies that the DPH said have since been corrected or are being addressed.
"While these results are troubling, this process has led to significant corrective measures and increased compliance among sterile compounders in Massachusetts," DPH interim Commissioner Dr. Lauren Smith said. "These findings underscore the need for additional budget resources and legislation the governor has proposed to further strengthen our monitoring of this industry."
Included in Patrick's initiatives to improve compounding oversight are regulations that require sterile compounding pharmacies to report volume and distribution to the state for the first time.
A $1-million investment in the governor's fiscal 2014 budget will allow the pharmacy board to hire additional inspectors to continue unannounced pharmacy inspections and create more than 30 full-time positions across DPH.
Last month, Patrick filed legislation that would require a special license for sterile compounding, among other changes.
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