USP 797 is an important publication issued by the United States Pharmacopeia. Widely agreed to improve the safety of the compounding environment and the products produced in that environment, USP 797 is mandated by some state boards of pharmacy and recommended by others. Sterile compounding environments designed, built, and operated in compliance with USP 797 are considered by most pharmaceutical professionals as state-of-the-art.
USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. The intent of the chapter is “to prevent patient harm and fatality from microbial contamination (non-sterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations.”
Three broad areas contribute to meeting the objectives of USP 797:
- Contamination Control
- Address particulate sources (people, products, processes)
- Create a “clean” environment where aseptic compounding will take place
- Training and Documentation
- Compounding personnel are skilled, educated, and trained
- Operator testing for proficiency
- Written policies and procedures
- Document training
- Compounded Sterile Products (CSP) Checks and Tests
- Reduce occurrence of contamination
- Verify process produced correct CSPs
- Use the same process each time
- If error happens, detect and take action
Issued by U.S. Pharmacopoeia (USP), the regulation governs any pharmacy that prepares “compounded sterile preparations” (CSPs).
Originally published in 2004 with updates in 2008 and one anticipated in 2017.