USP 797 is a set of guidelines established by the United States Pharmacopeia (USP) to ensure that compounded sterile preparations (CSPs) are handled and prepared in a safe manner. Compliance with these standards is critical for hospitals, laboratories, and pharmacies to prevent contamination and patient harm. This article provides an overview of these regulations and tips on how to stay compliant. 

What Is USP 797? 

The guidelines cover various areas, including facility design, air quality, cleaning and disinfection, personnel training, and quality control measures. Compliance with these guidelines helps to reduce the risk of infection and ensure that sterile medications and compounds are prepared and handled in a clean and safe environment. 

Facility design is a crucial component of USP 797 compliance. The guidelines outline the requirements for cleanroom design, including construction materials, air filtration systems, and environmental monitoring equipment. Facilities must also have appropriate cleaning and disinfection procedures in place to maintain the sterility of the environment. 

Personnel training is another critical aspect of compliance. All personnel involved in the preparation and handling of sterile compounds must receive appropriate training in aseptic technique, gowning and gloving procedures, and environmental monitoring. Facilities must also have a quality control program in place to ensure the ongoing effectiveness of their procedures and processes.

How to Stay Compliant 

To stay compliant with USP 797, medical facilities must regularly review and update their procedures and processes to align with the latest guidelines. They must also maintain appropriate documentation to demonstrate compliance and undergo regular audits to identify areas for improvement.

Environmental monitoring is a key area of focus for compliance. Facilities must regularly test the air quality, surface contamination, and personnel gowning and gloving procedures to ensure that the environment remains clean and sterile. They must also have appropriate procedures in place for handling and disposing of hazardous materials and for responding to environmental contamination events. 

Personnel training and education are also crucial. All personnel involved in the preparation and handling of sterile compounds must receive ongoing training and education to remain up to date on the latest best practices and guidelines. Facilities must also have a system in place for identifying and addressing any gaps in personnel knowledge or skills. 

Midwest Medical Systems in Dayton, OH, can provide assistance with USP 797 compliance. This family-owned business has been providing medical facilities with quality laboratory casework products for over 30 years. Their knowledgeable team can work with you to customize a solution to help you stay compliant and improve your facility's overall efficiency. Contact them at (800) 762-7722 or visit their website for more information.