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

In the context of compounding sterile preparations, low risk sterile preparations refer to those that are made with sterile ingredients and within controlled environments. According to USP <797>, which outlines the standards for compounding sterile preparations, the maximum beyond-use date (BUD) for low-risk sterile preparations is critically important for ensuring the safety and efficacy of these products.

For low-risk sterile preparations stored at room temperature, the BUD is set at 48 hours. This timeframe is designed to minimize the potential for microbial contamination and degradation of the compounded preparation, ensuring that patients receive products that are safe and effective. The 48-hour limit reflects best practices in pharmacy compounding and acknowledges that beyond this period, the risk of contamination or product instability increases.

Other durations, such as 24 hours or longer time frames like 72 hours or 1 week, are not appropriate for low-risk preparations at room temperature. Selecting a BUD that follows the guidelines established by USP <797> is vital for pharmacy practice, ensuring compliance with safety standards while protecting patient health.