Pharmacy Law Practice Exam 2025 – Complete Study Resource

According to USP Chapter 797, which outlines the standards for sterile compounding in pharmacy practice, it requires facilities to have a minimum of 46 standard operating procedures (SOPs) in place. These SOPs are crucial for ensuring the safety and quality of compounded sterile products. They provide detailed guidelines on various aspects of the compounding process, such as hand hygiene, equipment cleaning and maintenance, gowning and gloving procedures, and training protocols. The establishment of these SOPs helps ensure compliance with regulations, promotes consistency in practices, and minimizes the risk of contamination and associated complications. Therefore, the requirement of a minimum of 46 SOPs reflects the complexity and stringent standards necessary for safe sterile compounding practices.