Under HIGH RISK conditions, preparations stored at -20 C are held for how many days?

Under HIGH RISK conditions, preparations stored at -20 C are held for how many days?

• A. 14 days
• B. 60 days
• C. 45 days
• D. 90 days

Answer: (C)

Beyond-use dating for sterile preparations depends on both the risk level of the compounding and the storage temperature. For high-risk sterile preparations kept in a freezer at -20 C, the standard beyond-use date is 45 days. Freezing slows degradation and contamination, but a specific BUD is set to ensure continued sterility and potency, and 45 days is the established limit in this scenario. The other time frames correspond to different conditions (for example, higher risk at room temperature or different refrigerated/frozen settings), so they don’t apply to this exact high-risk, -20 C storage situation.

Beyond-use dating for sterile preparations depends on both the risk level of the compounding and the storage temperature. For high-risk sterile preparations kept in a freezer at -20 C, the standard beyond-use date is 45 days. Freezing slows degradation and contamination, but a specific BUD is set to ensure continued sterility and potency, and 45 days is the established limit in this scenario. The other time frames correspond to different conditions (for example, higher risk at room temperature or different refrigerated/frozen settings), so they don’t apply to this exact high-risk, -20 C storage situation.