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USP Operational Considerations for Sterile Compounding during COVID-19 Pandemic

  • 04/13/2020 10:13 AM
    Message # 8896009
    Steve Glass (Administrator)

    Many of you are aware that several drugs required to care for ventilator patients have been in critically short supply. Pharmacies in areas with widespread COVID-19 infections are sometimes faced with difficult decisions to discard these medications or use them past the current maximum <797> beyond-use dates. In response, USP has posted a document with considerations from the Compounding Expert Committee with considerations for sterile compounding during the COVID-19 pandemic.

    The document includes a statement from USP supporting risk-based enforcement discretion related to compounding standards. It addresses the assignment of beyond-use dates, considerations for certification and recertification of engineering controls, and recommendations for cleaning and disinfecting a facility when someone is sick.

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