What is the Beyond Use Dating for Low Risk preparations at room temperature?

In the context of sterile compounding, Beyond Use Dating (BUD) is a critical concept that defines the period in which a compounded preparation can be used safely before it should be discarded. For low-risk preparations, the BUD is determined based on various factors, including the category of the preparation and the storage conditions.

For low-risk sterile preparations that are stored at room temperature, the Beyond Use Dating is appropriately set at 48 hours. This timeframe is grounded in standards established by the United States Pharmacopeia (USP), which delineates guidelines for compounded sterile preparations. The 48-hour BUD allows for sufficient time to ensure the sterility and stability of the preparation under the specified storage conditions.

Choosing a BUD longer than 48 hours, such as 72 hours, would not adhere to the established guidelines for low-risk preparations at room temperature, potentially compromising the safety and efficacy of the compounded product. Thus, the 48-hour period is both evidence-based and aligned with safe pharmaceutical practices.