How long can a frozen medium risk sterile product be stored according to its BUD?

For frozen medium risk sterile products, the established beyond-use date (BUD) is critical for ensuring patient safety and product efficacy. The correct duration for storing a frozen medium risk sterile product is 45 days. This time frame is set based on guidelines established by the United States Pharmacopeia (USP), which categorize sterile compounding risk levels.

Medium risk products pose a higher risk than low risk products due to the complexity of their preparation, typically involving multiple sterile ingredients or prolonged manipulation in non-sterile environments. Therefore, they require careful monitoring of storage times to prevent microbial contamination and maintain sterility. The 45-day BUD for frozen medium risk products reflects a balance between the need for patient safety and the practicalities of pharmacy practice, allowing sufficient time for use while minimizing risk.

Other options suggest either shorter or longer time frames that do not align with the established guidelines for medium risk sterile products. Thus, adhering to the 45-day guideline helps ensure compliance with best practices in sterile compounding.