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When a pharmacy acts like a manufacturer of drugs and undertakes to compound sterile drugs, which drugs will later be injected or infused into patients' bodies, who should be ultimately responsible for maintaining the sterility of the compounding facility? One would think that the answer would be the compounding pharmacy. The Massachusetts compounding pharmacy linked to the nationwide meningitis outbreak that has been blamed for 39 deaths and hundreds of illnesses is blaming its cleaning contractor.

According to the Boston Globe, lawyers for New England Compounding Center sent a letter to UniFirst Corp. demaniding that it take legal responsibility for mounting claims against the pharmacy. UniFirst is a cleaning contractor that provided once-a-month services to NECC's cleanroom facilities. UniFirst disclosed in a filing with the Securities and Exchange Commission that it received the letter last week. It takes the position that its cleaning services were limited and that it was not responsible for the contaminated drugs. A UniFirst spokesman called NECC's claims "unfounded and without merit." Imagine that; an unfounded, fivolous claim by a manufacturer!

Just as this finger pointing is coming to light, Massachusetts' Governonr, Duval Patrick, proposed new laws for his state that would strengthen significantly state control over compounding pharmacies. The legislation would establish strict licensing requirements for compounding sterile drugs; let the state assess fines against pharmacies that violate its rules; protect whistle-blowers who work in the pharmacies; and reorganize the state pharmacy board to include more members who are independent of the industry and fewer who are a part of the industry.

Governor Patrick said the new rule will help alert the state when a pharmacy like NECC is acting like a manufacturer and should obtain a license from the federal Food and Drug Administration. Federal investigators found multiple sterility violations at NECC, which has since filed for bankruptcy protection. In addition, Massachusetts has shut down four more compounding pharmacies where problems were found.

This approach places responsibility where it belongs. The buck stops with the compounding pharmacy when it comes to the sterility of the cleanroom where sterile drugs are made. Blaming low-paid cleaning staff who come once-a-month seems like a major cop out.

3 Comments

  1. Gravatar for Christian Hartman
    Christian Hartman

    The Commission on Compounding made several recommendations that were not included in the proposed legislation. Full report enclosed: http://mhalink.informz.net/mhalink/data/images/13-01-04advisorypharmacycorrectattach.pdf

  2. Gravatar for chaz

    It's good to see that people are still checking on companies to make sure that they only do jobs legislated to them but should still take responsibility if in charge of the project.

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