If using an automated compounding device, how long must reports be kept?

The correct answer is three years because USP 797 requires that records related to sterile compounding be maintained in order to provide accountability and traceability throughout the compounding process. This includes reports generated by automated compounding devices, which serve as important documentation of the compounding activities performed. Keeping these reports for a duration of three years ensures compliance with regulatory standards and allows for effective quality assurance measures to be implemented in case of any discrepancies or investigations. Maintaining records for this period also facilitates adherence to best practices in sterile compounding, supporting patient safety and proper medication administration.

While different options may suggest varying timeframes for retaining such records, the three-year period aligns with established guidelines to preserve essential documentation without being excessively burdensome to the facility.