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What is the BUD for high-risk CSPs stored at Refrigerator temperature?

a) 24 hours
b) 48 hours
c) 72 hours
d) 7 days

User Affaz
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1 Answer

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Final answer:

c) 72 hours. The Beyond Use Date (BUD) for high-risk compounded sterile preparations (CSPs) stored at refrigerator temperature is 72 hours, according to USP Chapter 797 guidelines.

Step-by-step explanation:

The question refers to the Beyond Use Date (BUD) for high-risk compounded sterile preparations (CSPs) stored at refrigerator temperature. High-risk CSPs are a category of compounded medications that carry a higher risk of contamination due to the conditions under which they are made. The BUD is the date after which a compounded preparation should not be used; it is determined by the risk level of the CSP, the type of compounding environment, and storage conditions.

In this context, the BUD for high-risk CSPs stored at refrigerator temperatures (typically between 2°C and 8°C) is not provided among the answer options a) 24 hours, b) 48 hours, c) 72 hours, or d) 7 days. However, according to USP Chapter 797, which provides guidelines for the compounding of sterile preparations, a high-risk CSP in the absence of specific stability information will have a BUD of 24 hours at controlled room temperature, 3 days or 72 hours in the refrigerator, and 45 days if frozen at -20°C or colder after being compounded.

Without additional stability information, the correct answer for the BUD of high-risk CSPs stored in the refrigerator is c) 72 hours.

User Jonshot
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