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06-Sep-2019 12:35

, Pharmaceutical Compounding: Sterile Preparations, delineates the standards for compounding sterile preparations in all pharmacy settings.

As a standard established by the United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP 797 also outlines the required procedures for compounding sterile drug preparations.

The current chapter only explicitly calls for an investigation to be conducted in the event of a sterility test failure or the recovery of colony-forming units during environmental monitoring if the facility’s action level is exceeded.

The proposed chapter, however, identifies a number of specific scenarios that require that a designated person conduct investigations, implement corrective actions and document such activities, including: • Media fill failure • Personnel qualification failure • Facility certification failure • Out-of-specification results on laboratory tests • Quality-control check failures • Complaints that indicate a quality issue with CSPs • Adverse events The proposed chapter also places a larger emphasis on routine calibrations, certifications and qualifications of equipment and classified areas.

For example, the proposed chapter explicitly requires the certification or calibration of temperature and pressure monitoring devices, dry heat ovens, and incubators on an ongoing basis.

Additionally, the proposed chapter requires that calibrated chart recorders are used to monitor each cycle for sterilization and depyrogenation in autoclaves and dry heat ovens.

This is not an exhaustive list of changes in the proposed revision of USP chapter strongly recommend that compounding pharmacies review the revised chapter in order to determine how the potential changes could affect their practices.

If you have questions about any testing or compliance concerns, please contact us at 800.745.8916.

Topics to cover include: involves more complex “one to many/many to one” sterile compounding in an ISO 5 environment where multiple additives may be aggregated into an infusion device, batch compounding, and/or pooled admixtures that cover specific situations that arise during compounding.

The proposed chapter explicitly states that “terminal sterilization (e.g.

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