What is the BUD for medium risk sterile products when stored in the refrigerator?

The beyond-use date (BUD) for medium risk sterile products stored in the refrigerator is indeed 9 days. Medium risk sterile compounding refers to scenarios where multiple sterile products are used to create a compounded medication, which often involves more complex preparation and a greater potential for microbial contamination compared to low-risk scenarios.

According to the guidelines set by the United States Pharmacopeia (USP), specifically USP Chapter <797>, medium risk sterile preparations have specific storage requirements. When these products are compounded and then stored under refrigeration, they should not be used beyond the 9-day mark to ensure patient safety and product integrity. After this time frame, the likelihood of microbial growth increases significantly, which poses a risk to patients who are dependent on these sterile products for their treatment.

This standard helps pharmacies maintain a high level of quality and safety in sterile compounding practices, ensuring that compounded medications are safe for patient administration within the specified BUD.