What does USP <797> cover?

What does USP <797> cover?

• A. Pharmaceutical compounding—nonsterile preparations.
• B. Pharmacovigilance reporting standards.
• C. Pharmaceutical compounding—sterile preparations.
• D. Medication history documentation.

Answer: (C)

Sterile compounding standards aim to protect patients by controlling the environment, personnel practices, and the preparation process. USP <797> covers how sterile preparations should be created, stored, and handled—from the design and operation of cleanrooms and appropriate equipment to garbing, aseptic technique, and validated procedures to prevent contamination and pyrogens. It also addresses risk categories for sterile preparations, beyond-use dating, quality assurance, cleaning and environmental monitoring, and thorough documentation. Areas outside its scope include pharmacovigilance, medication history documentation, and nonsterile compounding; nonsterile compounding is covered by USP <795>.

Sterile compounding standards aim to protect patients by controlling the environment, personnel practices, and the preparation process. USP <797> covers how sterile preparations should be created, stored, and handled—from the design and operation of cleanrooms and appropriate equipment to garbing, aseptic technique, and validated procedures to prevent contamination and pyrogens. It also addresses risk categories for sterile preparations, beyond-use dating, quality assurance, cleaning and environmental monitoring, and thorough documentation. Areas outside its scope include pharmacovigilance, medication history documentation, and nonsterile compounding; nonsterile compounding is covered by USP <795>.