What is the purpose of USP <797> in sterile compounding, and what core practices does it emphasize?

• A. To prevent contamination and ensure sterility; emphasizes aseptic technique, cleanroom controls, garbing, and quality testing.
• B. To regulate pharmacy billing and reimbursements.
• C. To standardize dosing regimens for all drugs.
• D. To eliminate all handling of hazardous drugs.

Answer: (A)

USP <797> is about preventing contamination and ensuring sterility in sterile compounding. It sets the standard for how sterile preparations should be prepared, handled, and stored so that patients receive products that are truly free from harmful microbes.

To achieve this, it emphasizes practices that control every step of the process. Aseptic technique is foundational—every action performed during compounding must maintain a sterile environment and product. Proper garbing and hand hygiene reduce the chance of introducing organisms from the personnel. Cleanroom controls, including appropriate room classifications, validated cleaning and disinfection, and proper environmental monitoring, ensure the space itself remains clean enough to support sterile work. The workflow and equipment are designed to minimize contamination risk, with clear procedures for material handling, labeling, and movement within the compounding area.

Quality testing and verification are also central. This includes methods like media fills to simulate sterile technique, fingertip and surface sampling to verify aseptic practices, and sterility and particulate testing of finished products as part of ongoing quality assurance. Together, these elements create a system that regularly checks and maintains sterility throughout the compounding process.

Other options don’t fit because they address areas outside the purpose of USP <797>. Billing and reimbursement are unrelated to compounding sterility standards, standardizing dosing regimens isn’t the role of these guidelines, and eliminating all handling of hazardous drugs is not the objective—hazardous-drug handling is covered by USP <800> with its own specific requirements.