USP 800 PPE Requirements for Compounding
Apr 30, 2025
Handling hazardous drugs safely starts with the right PPE. USP Chapter <800> sets strict guidelines to protect healthcare workers, patients, and environments during compounding. Here's what you need to know:
Key PPE Requirements:
Use chemotherapy-rated gloves (ASTM D6978 compliant).
Wear protective gowns, eye protection, and shoe covers based on risk.
Facility and Storage:
Separate clean and contaminated areas for PPE.
Maintain proper temperature (59–86°F) and humidity (30–60%).
Training and Protocols:
Train staff on proper PPE use, donning, and disposal.
Conduct regular risk assessments and inspections.
Environmental Controls:
Use negative pressure rooms for hazardous drugs.
Ensure 30 air changes per hour in sterile compounding areas.
These steps ensure compliance with USP <800> and reduce exposure risks. Keep reading for detailed protocols and implementation tips.
Cardinal Health USP 800 Ask the Expert – Personal Protective ...
Required PPE Under USP 800
When compounding hazardous drugs, USP 800 requires the use of chemotherapy-rated gloves that comply with ASTM D6978 standards. These gloves are specifically designed to safeguard personnel from exposure to hazardous drugs. Beyond gloves, additional protective garments and equipment are also necessary to ensure safety. Let’s break down these requirements.
Implementing PPE Protocols
Establishing clear PPE protocols is crucial for protecting staff and ensuring compliance with USP 800 standards. By building on proper PPE selection, well-defined procedures help maintain safety during compounding tasks.
PPE Risk Assessment
Start with a detailed risk assessment to guide your PPE protocols. Consider factors like the type of formulation, exposure duration, handling frequency, physical state, and potential splash risks. Document these risks and match them with appropriate PPE choices. For instance, the type of gloves used should align with the specific formulation being handled.
Staff PPE Training
A comprehensive training program is essential to ensure staff understand and follow PPE protocols. Key elements include:
Initial orientation for new employees
Annual refreshers to reinforce knowledge
Hands-on demonstrations for proper donning and removal of PPE
Training documentation to track completion
Competency checks to confirm understanding
Training should highlight critical safety practices, such as inspecting gloves for tears, safely removing contaminated PPE, and disposing of it correctly. Regular assessments help ensure staff stay compliant and confident in their skills.
PPE Standard Operating Procedures
Create detailed, task-specific guidelines for PPE use. Specify requirements like glove types, garment details, face and eye protection, and shoe covers. Conduct daily visual checks, monthly audits, and quarterly reviews of disposal practices to maintain standards.
Key procedures to include:
Steps for handling PPE breaches during compounding
Response protocols for spills or exposures
Decontamination procedures to follow immediately
Incident reporting processes
Regularly review and update these protocols to keep them effective and in line with USP 800 standards. Keep thorough records of all implementations and revisions for inspection purposes.
Facility Design for PPE Use
A well-thought-out facility design plays a crucial role in maintaining PPE quality and ensuring staff safety during hazardous drug compounding while adhering to USP 800 guidelines.
PPE Storage and Change Areas
Set up dedicated storage areas for PPE outside hazardous drug zones. These spaces should have strict temperature controls ranging from 59–86°F (15–30°C) to keep equipment in good condition.
Key storage features include:
Clean, designated spaces with non-porous, easy-to-clean surfaces
Labeled storage cabinets placed at least 3 feet away from hazardous drug unpacking areas
Separate compartments to keep clean and contaminated equipment apart
Temperature monitoring systems with automated alerts for quick response
The anteroom should clearly define clean (donning) and contaminated (doffing) zones to reduce cross-contamination risks.
"Cushing Terrell's 2021 pharmacy redesigns incorporated separate 'clean' and 'dirty' anteroom zones with color-coded PPE storage cabinets, reducing cross-contamination incidents by 42% in follow-up inspections."
Beyond proper storage, facility controls are essential for maintaining a safe compounding environment.
Facility Controls
Environmental controls are key to ensuring PPE remains effective and contamination risks are minimized. Here are the main requirements:
Control Type | Requirement | Purpose |
|---|---|---|
Temperature | 68–77°F (20–25°C) | Prevent PPE degradation and ensure user comfort |
Humidity | 30–60% | Minimize fogging on eye protection |
Air Changes | 30 ACH (sterile), 12 ACH (non-sterile) | Maintain cleanliness in the workspace |
Pressure | -0.01 to -0.03 inches water column | Contain hazardous drug particles |
Combining these controls with proper storage ensures a contamination-free environment. Hazardous drug areas should maintain negative pressure, while clean zones should have positive pressure to safeguard PPE and prevent contamination.
Modern facilities often utilize advanced systems such as:
Real-time pressure differential monitoring with Magnehelic gauges and audible alarms
Independent HVAC zones capable of maintaining ±1°F accuracy
HEPA filtration with 99.97% efficiency for particles as small as 0.3μm
"Phoenix Controls' 2023 HVAC retrofit for USP 800 compliance at Mayo Clinic maintained -0.02 inches water column pressure in HD storage areas while achieving 35 air changes per hour in sterile compounding rooms."
Hands-free intercoms in anterooms can help maintain PPE integrity while allowing communication. UV-C light cabinets are another option to sanitize PPE effectively, supporting compliance with USP 800 standards.
Routine monitoring tasks include:
Daily pressure differential checks
Quarterly HVAC filter inspections
Annual system recertification
Immediate reporting of any control deviations
Conclusion
PPE Requirements Overview
To manage hazardous drug handling effectively, use the right equipment, establish clear protocols, adapt facilities as needed, and maintain systematic monitoring alongside regular staff training.
Compliance Action Steps
Here’s a streamlined approach to ensure compliance:
Assessment and Documentation
Conduct thorough risk assessments for hazardous drug procedures. Keep detailed records of PPE protocols and staff training to ensure accountability.
Training Implementation
Develop and deliver training programs focusing on proper PPE use, care, and disposal. Include hands-on practice and regular competency evaluations to reinforce skills.
Facility Optimization
Create and maintain designated PPE areas that align with USP <800> standards to ensure safety and compliance.
503Pharma offers verified resources and educational tools to support compounding pharmacies in implementing best practices and staying aligned with USP <800> guidelines. Explore these materials through 503Pharma to establish effective PPE protocols.
FAQs
What training is needed to ensure staff properly use PPE according to USP 800 guidelines?
To ensure compliance with USP 800, staff handling hazardous drugs must undergo comprehensive training on proper personal protective equipment (PPE) use. Training should include how to select, don, and remove PPE correctly to minimize exposure risks, as well as understanding when specific PPE is required based on the compounding activity.
Regular refresher courses and competency assessments are recommended to keep staff informed about updates to USP 800 standards and reinforce safe practices. Documenting all training sessions is essential to demonstrate compliance during inspections.
What steps can facilities take to ensure proper environmental controls for PPE storage and safe handling of hazardous drugs?
Facilities can ensure compliance with USP 800 guidelines by implementing robust environmental controls for PPE storage and hazardous drug handling. Key steps include:
Designated storage areas: Ensure PPE is stored in a clean, dry, and easily accessible location, separate from areas where hazardous drugs are handled.
Ventilation systems: Maintain proper ventilation, such as negative pressure rooms, to minimize exposure to hazardous drug particles or vapors.
Regular inspections: Conduct routine checks of storage areas and environmental controls to ensure they meet USP 800 standards.
By adhering to these practices, facilities can create a safer environment for staff and patients while maintaining compliance with regulatory requirements.
What happens if a compounding pharmacy doesn't follow USP 800 PPE guidelines for handling hazardous drugs?
Failing to comply with USP 800 PPE guidelines can lead to serious consequences for compounding pharmacies. Non-compliance may result in increased risk of exposure to hazardous drugs for staff, which can cause short-term health issues like skin irritation or long-term effects such as reproductive harm or cancer. Additionally, it could lead to regulatory penalties, fines, or even suspension of pharmacy operations.
Adhering to these guidelines is essential not only for protecting healthcare workers but also for maintaining patient safety and ensuring compliance with industry standards.