What is USP 797 and How to Stay Compliant with USP 797. Need Help?
What is USP 797 Compliance. We Can Help!
USP 797 was implemented on January 1, 2004 after being published in the United States Pharmacopeia and National Formulary (USP-NF).
So, what is USP 797? In short, it is a standard for compounding sterile preparations by which pharmacies and laboratories are mandated to comply. The standard was established by United States Pharmacopeia Convention (USP), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply. As such, it outlines the requirements and procedures for ALL Pharmacies Compounding Sterile Drug Preparations (CSPs) including the pharmacies in retail settings, hospitals ambulatory care centers, long-term care facilities, radio/nuclear pharmacies, chemo therapy units, hospital nursing stations, and operating rooms. We Are Here to Help.
Here are some of the ways that we can help with USP 797 Compliance:
- Solutions for Monitoring and Data Logging of Air Pressure – ensuring negative pressure in the C-SCA (containment segregated compounding area)
- Full-time Tracking of Air Velocities within Biosafety Cabinets (BSC), Chemical Fume Hoods, and Exhaust Systems – ensuring that air movement never falls below user-defined thresholds
- Provide Alarm Capability – by retrofitting biosafety cabinets and fume hoods with a fast, reliable, and affordable way to monitor airflow safety and achieve OSHA or NSF-49/ANSI compliance
How to Maintain USP 797 Compliance
USP 797 is designed to protect patients and pharmacists and in order to do this, it requires compliance with three mandates: staff training and ongoing guidance, determination of categories, and development and implementation of policies and procedures deemed appropriate to meet the regulations. It is recommended that the facility (pharmacy or lab) develop a task management system to ensure that each requirement is addressed as outlined in policy and procedure.