Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

According to USP 797 guidelines, what is the beyond-use date (BUD) for low risk sterile compounds mixed within a clean room?

1. 48 hours at room temperature

2. 12 hours under ISO 5 hood

3. 30 hours at room temperature

4. 24 hours at room temperature

The correct answer is: 48 hours at room temperature

The correct answer states that the beyond-use date (BUD) for low-risk sterile compounds mixed within a clean room is 48 hours at room temperature. This aligns with the United States Pharmacopeia (USP) 797 guidelines, which categorize low-risk sterile compounding as processes that involve simple procedures, such as transferring a sterile vial to a sterile syringe. According to these guidelines, low-risk preparations made in a cleanroom environment are given a BUD of 48 hours when stored at room temperature. This timeframe is established to minimize the risk of contamination and ensure that the compounded sterile products remain safe and effective for patient use. The 48-hour period provides a reasonable balance between ensuring product sterility and the operational needs of pharmacies. In contrast, the other options exceed the recommended BUD for low-risk sterile compounds. Given the methods of preparation and storage conditions described in those choices, they do not adhere to the safety and sterility protocols outlined by USP 797, which is why they do not represent the correct BUD for low-risk sterile compounding.