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New England Compounding Center Indictment

Joe Cabaleiro

    International Journal of Pharmaceutical Compounding
    |December 22, 2015
    PubMed

    Insights

    This review examines lapses in United States Pharmacopeia (USP) standards and pharmacy law compliance, highlighted by the New England Compounding Center indictment. It serves as a guide for compounding pharmacies to assess and improve their practices.

    Area of Science:

    • Pharmaceutical Compounding
    • Pharmacy Law and Regulation
    • Infection Control

    Background:

    • The New England Compounding Center indictment stemmed from a fungal meningitis outbreak.
    • The outbreak was linked to contaminated compounded methylprednisolone for epidural injections.
    • This highlights critical failures in sterile compounding practices.

    Purpose of the Study:

    • To review lapses in United States Pharmacopeia (USP) standards and pharmacy law compliance.
    • To analyze the specific failures leading to the New England Compounding Center indictment.
    • To provide a gap analysis tool for compounding facilities.

    Main Methods:

    • Review of the New England Compounding Center indictment details.
    • Analysis of alleged violations of USP standards and pharmacy law.
    • Comparative assessment framework for compounding compliance.

    Main Results:

    • Identified significant deviations from USP <797> and <71> standards.
    • Highlighted failures in aseptic technique, environmental monitoring, and personnel training.
    • Demonstrated a direct link between non-compliance and patient harm.

    Conclusions:

    • Compounding pharmacies must rigorously adhere to USP standards and pharmacy law.
    • Implementing robust quality management systems is essential for patient safety.
    • Continuous evaluation and improvement of compounding practices are necessary to prevent future outbreaks.

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