What is the BUD for low risk compounded sterile products in the refrigerator?

The beyond-use date (BUD) for low-risk compounded sterile products stored in the refrigerator is established as 14 days. This timeframe is based on guidelines set forth by the United States Pharmacopeia (USP), which categorizes compounded sterile preparations according to the level of risk involved in the compounding process.

Low-risk compounded sterile products are those that are prepared with minimal manipulation and under sterile conditions. When stored under refrigeration, the 14-day BUD allows for the stability and sterility of the product while minimizing the risk of contamination. This ensures that patients receive safe and effective compounded medications while also providing a reasonable window for use before degradation or potential contamination occurs.

In evaluating the other options, it is important to note that choosing a BUD longer than 14 days, such as 30 days or 45 days, could lead to increased risk for patients due to potential degradation or contamination of the compounded product. Conversely, a BUD of 9 days does not align with established guidelines for low-risk compounds, as it is shorter than the accepted timeframe. Thus, the 14-day period reflects a consensus in the clinical and regulatory community aimed at promoting patient safety during the use of compounded sterile products.