What should be done if a compounded sterile preparation fails sterility testing?

If a compounded sterile preparation fails sterility testing, the appropriate action is to quarantine and dispose of it according to established protocols. This approach ensures that any potentially non-sterile medications do not pose a risk to patients. The failure of sterility testing indicates that the preparation may harbor pathogens, which could lead to serious, potentially life-threatening infections if administered to patients.

Proper disposal protocols are in place to protect patient safety and uphold the standards of sterile compounding practices. Quarantining the preparation prevents its use until the situation is resolved. This action is not only a matter of adhering to safety guidelines but also a legal and ethical responsibility of the compounding pharmacy to ensure patient safety and maintain the integrity of the healthcare system.

Other potential actions, such as ignoring the results or conducting further testing before making a decision, could expose patients to unacceptable risks. Additionally, repacking the preparation for retesting does not address the root issue of sterility and could lead to further complications and safety concerns. Therefore, the most responsible and correct action is to follow protocols for quarantine and disposal.