In what situations should a compounding facility undergo a thorough re-evaluation?

A thorough re-evaluation of a compounding facility is crucial following significant alterations to procedures or after an adverse event. This process ensures that any changes made to the compounding practices are safe, effective, and compliant with established standards. When procedures are altered, it may affect sterility, accuracy, or the overall quality of compounded products. Similarly, after an adverse event, such as a contamination issue or patient harm, a comprehensive evaluation is necessary to identify the root causes, implement corrective actions, and prevent future occurrences. Such evaluations help in not only maintaining compliance with USP 797 requirements but also in safeguarding patient health.

While changes in marketing strategies, managerial staffing, or routine inspections may warrant adjustments or reviews, they do not inherently necessitate a full re-evaluation of the compounding processes and safety measures in the same critical way as the significant procedural changes or adverse events would.