USP 797 vs USP 800: Key Differences Explained
Feb 6, 2025
USP 797 and USP 800 are two essential standards in pharmaceutical practices, but they focus on different priorities:
USP 797: Focuses on sterile compounding to prevent contamination and ensure product safety.
USP 800: Focuses on handling hazardous drugs to protect healthcare workers and the environment.
Quick Comparison:
Aspect | USP 797 | USP 800 |
|---|---|---|
Primary Focus | Sterile compounding and contamination prevention | Hazardous drug handling and worker safety |
Scope | Sterile preparations only | Both sterile and non-sterile hazardous drugs |
Environment Type | Positive pressure rooms | Negative pressure rooms for hazardous drugs |
Training Requirements | Aseptic techniques, sterile compounding | Hazardous drug handling, safety procedures |
Documentation | Compounding logs, environmental monitoring | Exposure records, hazardous drug logs |
Facilities must comply with both standards, ensuring sterile medications and worker safety. USP 797 prioritizes product sterility, while USP 800 emphasizes protecting personnel from hazardous drug exposure.
Main Focus: USP 797 vs USP 800
USP 797: Rules for Sterile Compounding
USP 797 sets strict guidelines to prevent medication contamination during sterile compounding. These rules require controlled cleanroom environments, including ISO 5 primary engineering controls (PECs), ISO 7 buffer rooms, and ISO 8 ante-rooms. Positive pressure is essential in these spaces to keep contaminants out.
One critical aspect is the separation of hazardous and non-hazardous drug compounding areas. This ensures the safety of both the sterile products and the personnel working with them. USP 797 also specifies pressure differentials, measured in water columns, to regulate airflow and maintain a contamination-free environment.
USP 800: Rules for Hazardous Drugs
USP 800 shifts the focus to protecting healthcare workers from exposure to hazardous drugs. Unlike USP 797, this standard covers both sterile and non-sterile hazardous drug handling. It enforces stricter rules, including no exceptions for low-volume hazardous drug compounding in non-negative pressure rooms.
Key containment measures under USP 800 include:
Containment Primary Engineering Controls (C-PECs)
Containment Secondary Engineering Controls (C-SECs)
Specialized ventilation systems designed to safeguard workers.
Comparing Core Requirements
Here's a side-by-side look at the main differences between USP 797 and USP 800:
Aspect | USP 797 | USP 800 |
|---|---|---|
Primary Focus | Preventing contamination of sterile products | Protecting workers from hazardous drug exposure |
Environment Type | Positive pressure rooms | Negative pressure rooms for hazardous drugs |
Scope | Sterile compounding only | Both sterile and non-sterile hazardous drugs |
Engineering Controls | Standard PECs | C-PECs and C-SECs required |
Documentation | Compounding records, environmental monitoring | Hazardous drug handling logs, exposure records |
Training Requirements | Aseptic technique, sterile compounding | Hazardous drug handling, safety procedures |
Since November 1, 2023, facilities are required to comply with both standards.
"Facilities can meet both standards, which together ensure optimal safety for patients and workers".
USP 797 prioritizes product sterility, while USP 800 emphasizes worker safety when handling hazardous materials. Together, they create a comprehensive framework to address the risks involved in compounding, ensuring both patient and worker protection.
Understanding these distinctions is crucial for aligning facility design and equipment with the requirements of each standard.
Building and Equipment Standards
USP 797 Cleanroom Rules
USP 797 outlines the need for three distinct cleanroom areas to maintain sterile compounding standards:
Primary Engineering Controls (PECs): ISO 5 laminar flow hoods with external ventilation.
Buffer Rooms: Classified as ISO 7 with positive pressure to maintain sterility.
Ante-rooms: Serve as transitional spaces and must meet ISO 8 classification.
USP 800 Safety Area Rules
USP 800 focuses on handling hazardous drugs and sets specific containment requirements:
Containment Primary Engineering Controls (C-PECs): These must be externally vented to ensure safety.
Negative Pressure Rooms: Required for all areas where hazardous drugs are handled.
Pressure Monitoring: Continuous monitoring of negative pressure with pressure gauges is mandatory.
USP 800 strictly forbids handling hazardous drugs in positive pressure environments, no matter the volume.
Below is a comparison chart that highlights the distinct requirements for USP 797 and USP 800 compliance.
Building Requirements Chart
Requirement | USP 797 | USP 800 |
|---|---|---|
Primary Engineering Controls | ISO 5 laminar flow hoods | Externally vented C-PECs |
Room Pressure | Positive pressure (+) | Negative pressure (-) |
Buffer Room Classification | ISO 7 | ISO 7 with negative pressure |
Ante-room Classification | ISO 8 | ISO 7 for hazardous compounding |
Air Changes per Hour | Minimum 30 ACPH | Minimum 30 ACPH with external exhaust |
Storage Requirements | Temperature-controlled | Separate, negative pressure storage |
"The integration of USP 797 and USP 800 requirements demands careful facility planning to ensure both product sterility and personnel safety. Proper engineering controls and room pressurization are critical elements that cannot be compromised".
Facilities face a tough challenge in balancing these differing requirements. Designing spaces that meet USP 797's sterility standards while ensuring worker safety under USP 800 is no small task.
Staff Training and Safety Rules
USP 797 Staff Requirements
USP 797 training ensures sterile conditions are maintained and contamination is prevented during compounding. Staff need to show expertise in:
Environmental monitoring
Proper gowning and hand hygiene
Aseptic manipulation
Accurate documentation
Quality control practices
USP 800 Safety Training
USP 800 training focuses on advanced safety measures for handling hazardous drugs, including:
Proper use and disposal of PPE
Closed drug transfer systems
Protocols for hazardous drug spills
Handling hazardous waste
Emergency response plans
Training Requirements Chart
Training Component | USP 797 | USP 800 |
|---|---|---|
Initial Training | 40 hours minimum | 40 hours minimum + hazardous-specific training |
Competency Assessment | Annual | Every 6 months |
Documentation | Training records, protocols | Records, exposure monitoring, medical surveillance |
PPE Requirements | Basic sterile technique | Enhanced protection for hazardous drugs |
Emergency Procedures | Basic spill management | Detailed hazardous drug spill protocols |
Continuing Education | Annual updates | Bi-annual updates + immediate training for new risks |
"Though USP 797 and USP 800 have many similarities and may use similar engineering controls, their main focuses are different. USP 797 is fundamentally about preventing the contamination of medicines, while USP 800 is about protecting personnel and the environment from hazardous drugs."
Both standards require initial training before compounding begins. USP 797 demands annual competency assessments, while USP 800 requires evaluations every six months for hazardous drug handling. These timelines highlight their core goals: USP 797 focuses on product sterility, whereas USP 800 prioritizes worker safety.
These training and safety rules directly shape how daily compounding operations are managed.
USP 797 & 800 Update Highlights
Daily Work Changes
Daily workflows need to align with the specific requirements of USP 797 and USP 800 to ensure both medication sterility and the safety of workers.
Meeting USP 797 Standards
USP 797 focuses on maintaining sterile conditions during compounding. Pharmacies must follow a "clean-to-dirty" workflow to reduce contamination risks. This includes using ISO 5 primary engineering controls (PECs) and ISO 7 buffer areas for sterile preparations.
Here are some key adjustments:
Monitor environmental conditions daily, such as temperature, humidity, and pressure, along with ensuring equipment like PECs and HEPA filters are functioning properly.
Disinfect work surfaces regularly with approved cleaning agents.
Keep detailed records of all compounding activities and quality control measures.
Meeting USP 800 Standards
USP 800 introduces safety protocols for handling hazardous drugs. Facilities must integrate closed-system drug transfer devices (CSTDs) into their workflows to reduce exposure risks.
Daily tasks include:
Using dedicated tools, supplies, and personal protective equipment (PPE) for hazardous drug handling.
Following strict containment and disposal procedures for hazardous materials.
Regularly decontaminating surfaces that come into contact with hazardous drugs.
Work Changes Chart
Activity | USP 797 Requirements | USP 800 Requirements |
|---|---|---|
Work Area Setup and Flow | ISO-classified spaces with positive pressure, clean-to-dirty flow | Negative pressure rooms, separate hazardous drug workflow |
Cleaning and Decontamination | Standard cleaning agents, documented procedures | Specialized decontamination protocols, hazardous waste handling |
Equipment Usage | Dedicated equipment for sterile compounding | Additional CSTDs and containment devices required |
Documentation | Compounding logs, environmental monitoring | Exposure monitoring, spill reports |
Quality Control | Product testing, environmental sampling | Safety monitoring, exposure assessments |
Incorporating automation and refining processes can help pharmacies meet these daily requirements more efficiently. By implementing these adjustments, facilities can stay compliant with USP 797 and USP 800 while prioritizing safety and productivity.
Conclusion
Key Takeaways
Grasping the differences between USP 797 and USP 800 is essential for ensuring compliance in compounding practices. USP 797 emphasizes maintaining the sterility of preparations, while USP 800 zeroes in on protecting workers and the environment when handling hazardous drugs.
Here’s what implementing both standards involves:
Engineering Controls: USP 797 requires ISO-classified cleanrooms with positive pressure, whereas USP 800 mandates negative pressure rooms specifically for hazardous drug handling.
Documentation and Training: Both standards demand detailed record-keeping and focused training. For USP 797, the emphasis is on sterility, while USP 800 highlights exposure monitoring.
These differences underline the need to adapt operations to meet both sets of guidelines effectively.
The Future of USP Standards
The latest enforcement deadline took effect on November 1, 2023. Moving forward, USP standards may include stricter rules for environmental monitoring, more robust training requirements, and increased use of automated systems. These potential changes could make compliance more challenging, underscoring the need for facilities to stay ahead of updates.
Facilities should regularly review their protocols and keep an eye on regulatory developments. Successfully navigating both USP 797 and USP 800 requires a thoughtful balance between ensuring medication safety, protecting personnel, and maintaining operational efficiency.