Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is the BUD for low risk sterile compounds not mixed in a clean room but under an ISO 5 hood according to USP 797?

1. 24 hours

2. 12 hours

3. 30 hours

4. 48 hours

The correct answer is: 12 hours

The beyond-use date (BUD) for low-risk sterile compounding that occurs under an ISO 5 hood but outside of a clean room is typically 12 hours. This time frame is based on the risk level of the compounded preparation and the conditions under which it is made. Low-risk compounded sterile preparations (CSPs) are those that involve simple manipulations, such as transferring a solid dosage form into a sterile container or diluting a sterile product with a sterile diluent. When these preparations are made under an ISO 5 hood, they are considered to have an increased risk of contamination compared to those made in a more controlled environment, such as a clean room. Therefore, USP 797 establishes the BUD for these low-risk preparations as 12 hours when not stored under refrigeration and made in this manner. In the context of the other choices, a BUD of 24 hours, 30 hours, or 48 hours would represent different levels of sterility assurance and risk management that do not apply to low-risk sterile compounding done outside a clean room setting. Those longer BUDs are typically associated with higher-risk environments, additional sterility assurance, or refrigeration conditions that further extend the allowable time for the preparation's stability