Which of the following actions should be taken if a CSP is exposed at room temperature for longer than specified limits?

Prepare for the USP 797 Sterile Compounding Test with detailed questions and explanations. Study effectively with flashcards and multiple-choice questions. Get exam-ready now!

When a compounding sterile preparation (CSP) is exposed to room temperature for a duration that exceeds the specified limits, it is crucial to dispose of the CSP. This is because exceeding temperature limits can compromise the sterility, integrity, and efficacy of the preparation. The stability of compounded sterile preparations is closely linked to their storage conditions, and any deviation from recommended exposure times may create a risk of contamination or degradation of the active ingredients.

Disposing of the CSP is necessary to ensure patient safety, preventing the administration of potentially ineffective or harmful preparations. It's important to maintain strict adherence to established guidelines to ensure the quality and safety of sterile compounds.

In contrast, re-evaluating the preparation or conducting end-preparation testing would not mitigate the risks associated with a CSP that has already exceeded its safe exposure limits, nor would they guarantee patient safety in this scenario. Therefore, disposal is the only appropriate action in this situation to ensure compliance with regulations and protect patient health.

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