What is the beyond-use date (BUD) for high-risk compounded sterile preparations at room temperature?

The correct answer is that the beyond-use date (BUD) for high-risk compounded sterile preparations at room temperature is 24 hours.

High-risk compounded sterile preparations are those that are made under conditions that have a higher likelihood of contamination, such as when non-sterile ingredients are involved or when the preparation is made in an unclean environment. As stipulated by the United States Pharmacopeia (USP) Chapter <797>, which establishes standards for compounding sterile preparations, the shorter BUD is a precautionary measure to ensure patient safety.

This 24-hour BUD applies specifically to preparations stored at room temperature, reflecting the increased risk of microbial growth in these conditions. This guideline is critical as it emphasizes the need for caution in the handling of high-risk compounds to prevent potential harm to patients due to sterility issues.

In contrast, options like 3 days, 7 days, and 45 days are associated with low and medium-risk compounded preparations under controlled storage conditions, like refrigeration, and do not apply to high-risk preparations at room temperature.