What steps should be taken if a compounded sterile preparation is found to have a defect?

The correct approach when a compounded sterile preparation is found to have a defect is to report the defect, isolate the affected product, and conduct an investigation. This is essential for several reasons. First, isolating the affected product prevents any risk of further use that could compromise patient safety or lead to potential health risks. By reporting the defect, the compounding pharmacy can initiate a more thorough investigation into the root cause, which is vital for preventing future occurrences. This systematic approach aligns with best practices in quality assurance and patient safety, ensuring that any issues are addressed appropriately and efficiently.

Additionally, addressing defects proactively through isolation and investigation contributes to overall organizational learning and improvement. Compounding facilities are responsible for maintaining rigorous quality standards and must take every defect seriously to uphold the integrity of their preparations and safeguard patients' health.