Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is the BUD for high risk sterile compounds mixed within a clean room according to USP 797?

1. 3 days refrigerated

2. 24 hours at room temperature

3. 14 days refrigerated

4. 30 hours at room temperature

The correct answer is: 24 hours at room temperature

The beyond-use date (BUD) for high-risk sterile compounded preparations mixed within a clean room is specifically defined in the United States Pharmacopeia (USP) Chapter 797. High-risk sterile compounding involves more complex procedures that elevate the risk of contamination and spoilage. According to USP 797, the BUD for high-risk sterile compounds is 24 hours when stored at room temperature. This time frame is critical because it reflects the increased vulnerability of these compounds to contamination and degradation, necessitating stricter handling and storage requirements to protect patient safety. While other durations provided in the options refer to different categories of sterile compounding or storage conditions, none align with the established guideline for high-risk sterile compounds. Therefore, recognizing that 24 hours at room temperature is the BUD set forth ensures adherence to safety and quality standards in pharmaceutical practice.