United States Pharmaceutical

USP 800 Hazardous Drugs - Handling in Healthcare Settings

USP General Chapter 800 establishes standards for safe handling of hazardous drugs to protect healthcare workers, patients, and the environment. ATEK's environmental monitoring helps facilities maintain the negative pressure containment required for hazardous drug handling.

Authority: United States Pharmacopeia (USP)

Get Compliance Support View Requirements

Why Choose ATEK for USP 800 Compliance

Protect Your Staff

Continuous containment monitoring ensures HD areas maintain proper negative pressure.

Document Compliance

Automated logging provides evidence of proper containment conditions for inspections.

Immediate Alerts

Know instantly if containment is compromised so you can take immediate action.

Meet OSHA Requirements

Environmental documentation supports OSHA workplace safety compliance.

USP 800 Requirements

Key compliance requirements and how ATEK addresses each one.

Requirement	Description	ATEK Solution
800.5 Facilities and Engineering Controls	Facilities handling hazardous drugs must use containment secondary engineering controls (C-SECs) that maintain negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas. ISO Class 7 buffer rooms require minimum 30 air changes per hour (ACPH) for sterile HD compounding, while C-SCAs and nonsterile C-SECs require minimum 12 ACPH. All C-SECs must be externally vented.	Pressure Differential Monitoring Real-time monitoring of negative pressure in C-SEC areas with immediate alerts if containment is compromised.
800.6 Environmental Quality and Control	Environmental wipe sampling for HD surface residue should be performed routinely — initially as a benchmark and at least every 6 months — to verify the effectiveness of containment procedures.	Integrated Documentation Environmental monitoring data can be correlated with wipe sampling schedules for comprehensive contamination control.
800.7 Personal Protective Equipment	Appropriate PPE including chemotherapy gloves, gowns, and other protective equipment must be worn when handling hazardous drugs.	Environmental Context Environmental data provides context for PPE requirements and worker safety documentation.
800.15 Deactivating, Decontaminating, Cleaning, and Disinfecting	Written procedures must be established for deactivation, decontamination, cleaning, and for sterile compounding areas, disinfection.	Condition Verification Document environmental conditions before and after cleaning procedures in HD areas.
800.17 Documentation and Standard Operating Procedures	The entity must maintain SOPs for the safe handling of HDs for all situations in which these drugs are used throughout a facility.	Automated Documentation Complete audit trails of all environmental conditions with automated reporting for regulatory compliance.

Understanding USP 800

USP General Chapter 800 provides standards for safe handling of hazardous drugs throughout healthcare settings. The chapter focuses on protecting healthcare workers from occupational exposure to hazardous drugs through required engineering controls, administrative controls, and personal protective equipment.

Scope of USP 800

The chapter applies to all healthcare personnel who handle hazardous drugs and all facilities where HDs are:

Received and stored
Compounded (sterile and non-sterile)
Dispensed
Administered
Disposed

Containment Requirements

USP 800 requires specific engineering controls for HD handling:

C-SEC (Containment Secondary Engineering Control) — the room containing the C-PEC:

Negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas
Externally vented (C-PEC exhaust passes through HEPA filtration)
Minimum 30 ACPH for ISO Class 7 buffer rooms (sterile HD compounding), or 12 ACPH for C-SCAs and nonsterile HD compounding

C-SCA (Containment Segregated Compounding Area) — an unclassified C-SEC option:

Minimum 12 air changes per hour (ACPH)
Negative pressure between 0.01 and 0.03 inches of water column
Externally vented; limits beyond-use dating per USP 797

How ATEK Supports USP 800 Compliance

ATEK’s monitoring platform helps facilities maintain and document the containment requirements essential for hazardous drug safety.

Continuous Pressure Monitoring

Our differential pressure sensors provide:

Real-time visibility of containment status
Immediate alerts if negative pressure is lost
Historical trending to identify patterns
Documentation for regulatory inspections

Multi-Room Monitoring

Monitor your entire HD handling operation:

C-SEC areas
HD storage rooms
Ante-rooms and buffer areas
Relative pressures between all spaces

Worker Safety Documentation

Environmental monitoring data supports:

OSHA compliance documentation
Incident investigation
Exposure assessment
Safety program validation

USP 800 FAQs

What is USP 800?

USP 800 is a chapter in the United States Pharmacopeia that establishes requirements for safe handling of hazardous drugs (HDs) in healthcare settings. It covers receipt, storage, compounding, dispensing, administration, and disposal of hazardous drugs.

What makes a drug hazardous under USP 800?

The NIOSH List of Antineoplastic and Other Hazardous Drugs defines which drugs are considered hazardous. These include drugs that exhibit carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, or genotoxicity, as well as new drugs that mimic existing hazardous drugs in structure or toxicity.

What environmental controls are required by USP 800?

USP 800 requires containment secondary engineering controls (C-SECs) — the rooms where hazardous drug compounding occurs — to maintain negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas, with HEPA filtration and a minimum of 12 ACPH (or 30 ACPH for ISO Class 7 buffer rooms used for sterile HD compounding).

How does ATEK help with USP 800 compliance?

ATEK monitors differential pressure in hazardous drug handling areas to ensure negative pressure containment is maintained. Our system provides continuous monitoring with immediate alerts if pressure differentials are compromised.

Why is negative pressure important for hazardous drugs?

Negative pressure ensures that air flows into the HD handling area rather than out, preventing hazardous drug particles from escaping into surrounding spaces and exposing healthcare workers and patients.

How is USP 800 different from USP 797?

USP 797 covers sterile compounding in general, while USP 800 specifically addresses hazardous drug handling. USP 800 requires additional containment controls, including negative pressure environments, that go beyond USP 797 requirements.

Need Help with USP 800 Compliance?

Our team of compliance experts can help you implement monitoring solutions that meet USP 800 requirements. Contact us for a consultation or demo.

Customized compliance assessment for your facility

Validation documentation packages (IQ/OQ/PQ)

Expert support for audits and inspections

Speak with a Compliance Expert

Our team is available to discuss your specific USP 800 compliance requirements.

compliance@atek.io

Get in Touch

Related Regulations

United States

USP 797

USP General Chapter 797 establishes standards for compounding sterile preparations to help ensure patient safety. ATEK's environmental monitoring solutions help pharmacies maintain the controlled conditions required for sterile compounding.

Ready to Simplify USP 800 Compliance?

Join organizations that trust ATEK to maintain compliance with continuous environmental monitoring.

Schedule a Demo Call 1-855-982-2835