Under LOW RISK conditions, refrigerated storage without sterility testing is allowed for how many days?

Under LOW RISK conditions, refrigerated storage without sterility testing is allowed for how many days?

• A. 7 days
• B. 21 days
• C. 14 days
• D. 28 days

Answer: (C)

Sterile compounding BUD depends on both the risk level and storage conditions. For a low-risk CSP kept refrigerated and not subjected to sterility testing, the allowed storage time is 14 days. Refrigeration slows degradation and microbial growth, but without sterility verification you can’t extend the period beyond two weeks with confidence. If sterility testing were performed, or different risk conditions applied, the BUD could be extended under the applicable guidelines, but the standard for this scenario is 14 days.

Sterile compounding BUD depends on both the risk level and storage conditions. For a low-risk CSP kept refrigerated and not subjected to sterility testing, the allowed storage time is 14 days. Refrigeration slows degradation and microbial growth, but without sterility verification you can’t extend the period beyond two weeks with confidence. If sterility testing were performed, or different risk conditions applied, the BUD could be extended under the applicable guidelines, but the standard for this scenario is 14 days.