Understanding USP 800
USP General Chapter <800> establishes requirements for the safe handling of hazardous drugs in compounding pharmacies, hospital pharmacies, healthcare facilities, and medical centers. Building on the standards defined in USP <797>, USP 800 introduces additional safeguards designed to protect pharmacists, healthcare workers, and patients from exposure to chemotherapy drugs and other hazardous medications.
Compliance with USP 800 extends beyond the physical handling of hazardous drugs. The standard also addresses facility design, ventilation systems, airflow management, containment strategies, and engineering controls required to maintain a safe environment. Healthcare facilities must implement proper environmental monitoring and airflow control solutions to help ensure regulatory compliance, worker safety, and effective contamination prevention.
Major Difference between USP 797 and USP 800?
One of the most significant differences between USP <797> and USP <800> affecting facility compliance is the use of a Segregated Compounding Area (SCA). Under USP <797>, only low-risk, nonhazardous and radiopharmaceutical Compounded Sterile Preparations (CSPs) with a beyond-use date (BUD) of 12 hours or less may be prepared in an unclassified SCA.
USP <800> expands these requirements by permitting the preparation of low- and medium-risk hazardous drug CSPs within an unclassified Containment Segregated Compounding Area (C-SCA). To ensure worker safety and minimize exposure to hazardous drugs, the C-SCA must meet specific facility and ventilation requirements. These include fixed walls, external exhaust ventilation, a minimum of 12 air changes per hour (ACPH), and a negative pressure differential of 0.01 to 0.03 inches of water column relative to adjacent spaces.
Because USP <800> places greater emphasis on airflow management, pressure control, and environmental monitoring, healthcare facilities must implement reliable monitoring solutions to maintain compliance, protect personnel, and support safe hazardous drug compounding operations.
Monitoring Negative Pressure for USP 800 Compliance
Establishing the required negative pressure in a USP <800> containment area is only part of the compliance challenge. Maintaining that pressure consistently and documenting performance over time can be just as critical. That’s where the Rooster™ Pressure100, provides valuable support. The Rooster™ Pressure100 continuously monitors room differential pressure and immediately activates visual and audible alarms when pressure conditions fall outside user-defined thresholds. This real-time monitoring helps healthcare facilities maintain compliance with USP <800> requirements while protecting personnel from potential exposure to hazardous drugs.
In addition to differential pressure and pressure mode monitoring, the Pressure100 measures and displays temperature and relative humidity, providing comprehensive environmental monitoring for pharmacies, cleanrooms, and healthcare facilities.
To improve visibility and response times, the Pressure100 provides clear alarm notifications for both single and multiple events. An easily accessible INFO button gives users instant access to critical system information, including calibration dates, alarm thresholds, and operating status. The monitor also uses color-changing screen backgrounds to indicate pressure increases, decreases, and normal operating conditions, while a flashing LED highlights critical safety alarms requiring immediate attention.
For enhanced security and regulatory compliance, password protection allows authorized users to customize operational settings while preventing unauthorized changes to critical safety parameters established by facility administrators.
More Information on USP 800 Compliance:
United States Pharmacopeia – USP 800
About Degree Controls, Inc. – DegreeC
DegreeC engineers and manufactures airflow solutions delivering both instrumentation-class airflow sensors and sensors embedded in the world’s most demanding products. Our airflow monitoring solutions for laboratories, buildings, and industrial safety applications bring air precisely where it’s needed.