Compliance · United States Pharmacopeia
USP General Chapter <800>: hazardous drugs, handling in healthcare settings
Indoor: hazardous drug compounding (USA)
USP General Chapter <800>, Hazardous Drugs — Handling in Healthcare Settings, protects workers who prepare and handle hazardous drugs such as chemotherapy agents. Sterile hazardous drugs are compounded in a containment secondary engineering control (C-SEC): an externally vented room with at least 12 air changes per hour that must hold negative pressure of 0.01 to 0.03 inches of water column (about 2.5 to 7.5 Pa) relative to all adjacent areas at all times. Relative humidity is held at 60 % or below, as in USP <797>.
Limit values
USP 800 Limit Values
Every value United States Pharmacopeia publishes for the 2 parameters below, with its averaging period, as the standard states it.
Who it applies to
Who Must Comply
Every healthcare setting that receives, stores, compounds, dispenses, or administers hazardous drugs: hospital and retail pharmacies, infusion centers, oncology clinics, and veterinary practices, as enforced by state boards of pharmacy.
Monitoring
How Monitoring Demonstrates Compliance
The negative pressure range is the requirement most often monitored continuously, because a room that drifts positive pushes hazardous drug residue outward. A continuous differential pressure record with alarms, together with temperature and humidity, documents that the containment held between the periodic certifications.
Recommended
best match-
Industrial monitor for indoor and outdoor sites. Built-in sensors cover the essentials, and hot-swappable gas sensor cartridges and a differential-pressure option add more.
Built-inRelative HumidityGas 1
Free: one more gas sensor cartridge
Gas 2
Free: one more gas sensor cartridge
MultiSense
Free: a MultiSense, stock or built to order
Expansion
Aethair Diff. Pressure
Differential PressureA gauge sensor reads 0–10 kPa, with the higher-pressure side connected to its port.
Also measures 12 more
Dew PointHeat IndexIlluminance / LightParticle Count (by size)PM1PM10PM2.5Total PM / Mass Conc.Barometric PressureEquivalent Continuous Level (Leq)Sound Pressure Level (SPL)Air Temperature
Who measures each parameter
| Parameter | Aethair PRO |  Aethair IAQ |  External |
|---|---|---|---|
| Differential Pressure | Diff. Pressure cartridge | — | — |
| Relative Humidity | Built in | Built in | 12 instruments via Thiamis |
Devices
Devices That Cover USP 800
How much of this standard one Aethair monitor covers, followed by the third-party instruments in the sensor catalog that measure its parameters. Each connects to Environet through a Thiamis gateway, which adds whatever the monitor leaves out.
Aethair monitors
Aethair PRO Built in + Aethair Diff. PressureCovers bothAethair IAQ Built-in sensors1 of 2: Relative HumidityCovers part of it (combine on one Thiamis)
Solutions
Solutions Judged Against USP 800
Healthcare Air Monitoring
Clinical air quality, pressurization, and patient safety
Article Library
Articles on USP 800
Hospital Air Quality Monitoring: Standards by Space
Hospital air quality standards from ASHRAE 170 and The Joint Commission explained, plus what to measure in operating rooms, isolation rooms, and labs.
ASHRAE 170 Requirements and Which Edition Applies to You
ASHRAE 170 requirements explained: what the standard sets, which edition your facility is held to, what changed in 2025, and how each value gets verified.
Questions
USP 800 FAQ
What pressure does USP 800 require for a hazardous drug room?
Negative pressure of 0.01 to 0.03 inches of water column (about 2.5 to 7.5 Pa) relative to all adjacent areas, at all times.
How many air changes does USP 800 require?
At least 12 air changes per hour in the containment room, which must be externally vented.
How does USP 800 relate to USP 797?
USP 797 sets the standards for sterile compounding in general; USP 800 adds the containment requirements for hazardous drugs, including negative pressure.
Monitor Against USP 800
Schedule a callBuild a Configuration All standards
A 30-minute call: you tell us about your application, then we demo the solution for it.