This SOP establishes the requirements for release checks and testing of compounded sterile preparations (CSPs)—including visual inspection for particulates, incompatibilities, and container integrity; verification of labeling and compounding records; sterility testing per USP <71>; endotoxin testing per USP <85>; documentation of pH, potency, and other quality checks; and investigation of out-of-specification results—to ensure product safety, quality, and compliance with USP <797>.