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24-10-2012 | Article

Unsanitary conditions found at Mass compounding pharmacy

Abstract

Report

medwireNews: Medications were prepared under unsanitary conditions at the Massachusetts compounding pharmacy implicated in the nationwide fungal meningitis outbreak, Massachusetts health officials say.

Drugs prepared at the New England Compounding Center (NECC) in Framingham, Massachusetts, were not produced under minimum requirements to ensure sterility, and at least 11 lots of medication were shipped before results from the company's own safety tests were complete, according to Madeleine Biondolillo, director of the Commonwealth of Massachusetts Bureau of Health Care Safety and Quality.

"While NECC's records show the sterility tests found no contamination, the adequacy of NECC's sterility testing methods are currently under examination," state health inspectors wrote in a report of the preliminary findings from their investigation.

The report notes that visible black particulate matter could be seen in several sealed vials of recalled methylprednisolone acetate prepared at NECC, and that powder hoods used to protect pharmacists from inhaling particulates during drug preparation in the pharmacy's allegedly sterile compounding were not thoroughly cleaned, and had visible residual powder.

"This contamination may subsequently lead to contamination of compounded medications," the inspectors suggested.

Investigators also noted fluid from a leaking boiler in the utility room adjacent to the compounding room, and tacky mats (used to trap dirt from shoes of employees entering a clean room) that violated federal sterility standards for sterile preparation in compounding pharmacies (USP 797).

The inspectors found that NECC had acted as a de facto drug maker, routinely shipping large quantities of medications without prescriptions from individual patients, as required by state law.

"With this violation, NECC was operating beyond the scope of its compounding license, instead operating as a manufacturer," Biondolillo said at a briefing, at which it was also announced that the state had permanently revoked NECC's pharmacy license.

The Food and Drug Administration has reported that all products prepared at NECC should be "retained, secured, and withheld from use."

As of October 24, the Centers for Disease Control and Prevention (CDC) is reporting 312 cases of fungal infections and 24 deaths in 17 states.

By Neil Osterweil, medwireNews reporter