What is the BUD for high risk CSP when stored at room temperature?

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The beyond-use date (BUD) for high-risk compounded sterile preparations (CSPs) stored at room temperature is set at 24 hours. High-risk CSPs are those that involve the preparation of sterile products that may have a higher potential for contamination due to the complexity of the compounding process or the use of non-sterile ingredients.

The shorter BUD is designed to ensure patient safety, as high-risk CSPs are more susceptible to microbial growth if not stored properly. According to the United States Pharmacopeia (USP) guidelines, which dictate standards for compounding practices, the 24-hour limit is crucial for maintaining the integrity and safety of these preparations when they are not refrigerated.

In contrast, other time frames such as 48 hours, 30 hours, or 14 days typically apply to lower-risk CSPs or to those stored under refrigeration. The regulations focus on minimizing the risk of infection and ensuring that the medications remain effective and safe for patient use. Thus, the BUD for high-risk CSPs at room temperature is clearly defined as 24 hours, making it critical for healthcare professionals to adhere to these guidelines to protect patient health.

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