What is the required BUD for Low Risk CSPs compounded in a segregated compounding area (SCA) at room temperature?

The correct answer reflects the guidelines set by the United States Pharmacopeia (USP) for the BUD of low-risk compounded sterile preparations (CSPs) when prepared in a segregated compounding area (SCA) at room temperature. According to the standards, low-risk CSPs that are compounded in an SCA must be used or disposed of within a shorter timeframe due to the lower level of environmental controls compared to a cleanroom setting.

For low-risk CSPs compounded in an SCA, the maximum BUD at room temperature is set at 12 hours. This ensures that the integrity of the compounded preparation is maintained for patient safety, as the sterility and efficacy can diminish over time if not properly stored or used promptly.

It is important to note that options indicating longer BUDs are not applicable in this scenario, as these regulations are designed to mitigate risks associated with microbial contamination in preparations that are not stored under the stringent conditions of a sterile compounding environment.