USP 800 Compliance

The deadline for USP 800 compliance has come and gone. Don’t worry, we’re here to help!

USP 797 compliance

What is USP 800 Compliance? Need Help?

The focus of USP 800 is the mandates for handling hazardous drugs in compounding pharmacies, medical centers, and hospital pharmacies. The intent is to add protection for workers and pharmacists but the regulations go beyond the physical handling and include facility design.

But, the UPS 800 Deadline of December 1, 2019 has come and passed, and many pharmacies are under pressure because they STILL are NOT in compliance. To make matters worse, it’s not immediately clear what is required. Understanding and planning for these changes while going about daily business is a big challenge. We get it and we’re here to help.

Here are some of the ways that we can help:

  • 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

USP 800 Negative Pressure Requirement

Establishing negative pressure is one thing, but some facilities struggle with managing it. Managing it in terms of monitoring it and performing data logging. This is where our product Rooster™ Pressure100, comes in. The Rooster™ Pressure100 monitors, pressure at the room level and signals with an alarm if pressure falls outside the set threshold. This helps bring your facility into compliance. In addition to air pressure and pressure mode, the Pressure100 monitors and displays temperature and relative humidity.

Consult with an Airflow Sensor Specialist

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USP 800 regulations call for maintaining negative air pressure in segregated compounding areas within pharmacies and laboratories that compound hazardous drugs.
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