This SOP establishes the requirements for assigning beyond-use dates (BUDs) to sterile compounded preparations—including Category 1, 2, and 3 CSP distinctions; aseptic processing vs. terminal sterilization; stability and sterility considerations; storage condition limits; sterility, stability, particulate, and container-closure testing for Category 3 CSPs; and documentation in MFRs and CRs—to ensure product integrity, patient safety, and compliance with USP <797>.