What is the beyond-use date (BUD) for low risk sterile product at room temperature?

The beyond-use date (BUD) for low-risk sterile products when stored at room temperature is 48 hours. This guideline is derived from the United States Pharmacopeia (USP) standards, which categorize sterile compounding practices into risk levels. Low-risk sterile compounding refers to situations where the preparation involves minimal manipulation of sterile products, maintaining a sterile environment.

In this context, the BUD is critical for ensuring patient safety, as it helps to mitigate the risk of microbial contamination. After 48 hours at room temperature, the risk of contamination increases, which could compromise the integrity of the sterile preparation and pose risk to patients.

Other choices do not align with the established regulations for low-risk sterile products. For example, a BUD of 24 hours would be appropriate for certain other conditions, particularly when products are compounded in less controlled environments or under different risk categories. A longer BUD of 72 hours or even one week may apply to specific conditions but typically does not apply for low-risk preparations stored at room temperature according to current regulations.