Hazardous Drug Handling (USP 800)
Hazardous Drug Handling (USP 800) template for daily checks of the BSC/CACI, PPE, wipe sampling, and hazardous waste segregation. Use it to catch contamination, missing controls, and disposal gaps before they become exposure events.
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Overview
This Hazardous Drug Handling (USP 800) inspection template is built for the daily controls that keep hazardous drug work areas contained and traceable. It walks through the primary engineering control, PPE readiness and use, surface wipe sampling and decontamination follow-up, and hazardous waste segregation and disposal. The structure matches how a reviewer would actually move through the space, starting with the BSC or CACI and ending with waste staging and removal.
Use this template when hazardous drugs are prepared, transferred, cleaned up, or staged in a pharmacy, oncology clinic, or hospital compounding area. It is especially useful for shift-start checks, post-cleaning verification, and routine compliance audits where you need to confirm that controls are present, current, and being used correctly. The template is also a good fit after a spill, a wipe-sampling result, a certification renewal, or a process change that could affect containment.
Do not use it as a substitute for your full hazardous drug program, SOPs, or training records. It is not a general inventory form and it is not meant for non-hazardous medication handling. If your site does not compound or handle hazardous drugs, this template is not the right fit. The value is in catching specific deficiencies early: expired certification, blocked airflow, missing chemo-rated gloves, incomplete wipe-sampling documentation, or waste containers that are mislabeled or left open.
Standards & compliance context
- This template supports USP 800 hazardous drug handling expectations by documenting engineering controls, PPE, environmental monitoring, and waste segregation.
- It also aligns with OSHA general industry requirements for hazard communication, PPE, and exposure control programs where hazardous drugs are handled.
- Facilities can use it alongside ANSI/ASSP and internal EHS procedures to show that controls are being checked in a repeatable way.
- If your site follows state pharmacy board rules, accreditation standards, or hospital policy, add those references to the corrective action or sign-off fields.
- Waste handling and staging should be reviewed against the facility’s hazardous waste procedures and applicable environmental requirements, including local authority expectations.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Primary Engineering Control (BSC/CACI)
This section matters because the cabinet is the main containment barrier, and any certification, airflow, or cleanliness issue can compromise the entire work area.
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BSC/CACI is present, clean, and designated for hazardous drug use
Confirm the primary engineering control is the correct device for hazardous drug work and is visibly clean, organized, and dedicated to the task.
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Certification status is current and posted
Verify the BSC/CACI certification label or record is current per facility policy and available for review.
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Airflow / operational check completed before use
Confirm required daily operational checks are completed and the device is functioning as expected before hazardous drug handling begins.
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Work surface and interior are free of visible contamination
Inspect the work area for visible residue, spills, damaged liners, or other contamination that could indicate a deficiency in containment or cleaning.
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Required supplies are staged without obstructing airflow
Verify only necessary supplies are present and positioned to avoid blocking airflow or compromising containment.
PPE Availability and Use
This section matters because hazardous drug exposure often happens when the right gloves, gown, or face protection are missing or worn incorrectly.
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Chemo-rated gloves are available and in use
Confirm appropriate chemotherapy-rated gloves are available at point of use and worn during hazardous drug handling.
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Disposable gown or protective apparel is available and worn correctly
Verify the required gown or protective apparel is worn, fastened, and provides adequate coverage per facility procedure.
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Eye and face protection is available when splash risk exists
Confirm eye/face protection is available and used when task conditions create a splash or aerosol exposure risk.
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PPE is donned and doffed in the correct sequence
Observe or verify the required sequence for putting on and removing PPE to reduce contamination risk.
Surface Wipe Sampling and Decontamination
This section matters because wipe results show whether contamination is being controlled and whether cleaning actions are actually working.
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Required surface wipe sampling is scheduled and documented
Confirm the facility’s surface wipe sampling plan is current and the latest sampling event is documented per policy.
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Sampling locations reflect high-risk touch points and work surfaces
Verify sample locations include representative high-risk areas such as work surfaces, pass-throughs, and other contamination-prone points.
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Out-of-limit or positive findings have documented corrective action
Confirm any failed wipe sampling results have a documented response, including investigation, cleaning, and follow-up testing as required.
Hazardous Waste Segregation and Disposal
This section matters because waste handling is a common failure point where hazardous and non-hazardous streams get mixed or left unsecured.
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Hazardous drug waste is segregated from non-hazardous waste
Confirm hazardous drug waste is not mixed with regular trash, sharps, or non-hazardous pharmaceutical waste.
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Waste containers are labeled, closed, and in good condition
Verify containers are properly labeled, not overfilled, and maintained to prevent leakage or exposure.
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Waste staging area is secure and compliant with facility procedure
Confirm hazardous waste is staged in the designated area with access controls and housekeeping conditions that prevent contamination or mix-ups.
How to use this template
- 1. Set up the template with your room name, date, shift, inspector, and the hazardous drug area or equipment being reviewed.
- 2. Verify the primary engineering control first by confirming the BSC or CACI is designated for hazardous drug use, certified, clean, and free of airflow obstructions.
- 3. Check PPE availability and use by confirming chemo-rated gloves, protective apparel, and eye or face protection are present and worn according to the task risk.
- 4. Review wipe sampling records and decontamination notes to confirm sampling is scheduled, locations are appropriate, and any positive result has a documented corrective action.
- 5. Walk the waste area last and confirm hazardous waste is segregated, labeled, closed, and staged securely for disposal under facility procedure.
Best practices
- Inspect the BSC or CACI before hazardous drug work starts, not after compounding has already begun.
- Treat certification status as a required control point and escalate any expired or missing certification immediately.
- Verify that supplies are staged without blocking airflow or crowding the work zone inside the primary engineering control.
- Confirm that chemo-rated gloves and protective apparel match the task and are replaced when contaminated, torn, or past facility limits.
- Document wipe-sampling locations that reflect actual touch points, such as work surfaces, handles, and transfer areas, rather than generic room spots.
- Record corrective actions the same day a deficiency is found so positive findings do not remain open without ownership.
- Keep hazardous waste containers closed when not actively in use and separate them from non-hazardous waste at the point of generation.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What does this Hazardous Drug Handling (USP 800) template cover?
This template covers the daily verification points most facilities need for hazardous drug handling: the primary engineering control, PPE availability and use, surface wipe sampling, and hazardous waste segregation. It is designed for pharmacy compounding, preparation, and handling areas where exposure control matters. The checklist focuses on observable conditions and documented follow-up, not general policy review.
How often should this inspection be used?
Use it daily when hazardous drugs are being prepared, handled, or staged, and also after any event that could affect containment or contamination control. Some facilities pair it with a shift-start check and a separate periodic environmental monitoring review. If your workflow is intermittent, use it on each day of hazardous drug activity rather than on a calendar-only basis.
Who should complete this audit?
A trained pharmacist, pharmacy technician, supervisor, or safety lead can complete it, provided they understand hazardous drug handling procedures and the facility’s escalation path. The reviewer should be familiar with the BSC/CACI setup, PPE requirements, and waste handling rules. If your site has a designated competent person or environmental health and safety role, that person should review unresolved deficiencies.
How does this relate to USP 800 and other regulations?
The template is aligned to USP 800 expectations for hazardous drug handling and supports the kind of documentation facilities use alongside OSHA general industry requirements, PPE programs, and hazardous communication controls. It also helps reinforce facility procedures for containment, housekeeping, and waste segregation. If your site operates under additional pharmacy, state board, or accreditation requirements, you can add those fields without changing the core walk-through.
What are the most common mistakes this template helps catch?
Common misses include using a BSC or CACI that is not current on certification, staging supplies in a way that disrupts airflow, wearing the wrong glove or gown type, and skipping documented action after a positive wipe result. Facilities also overlook unlabeled waste containers or mixing hazardous and non-hazardous waste streams. This template makes those issues visible before they become a compliance or exposure problem.
Can this template be customized for our pharmacy or hospital workflow?
Yes. You can add drug-specific handling notes, room identifiers, shift sign-off fields, corrective action owners, or links to your SOPs and SDS library. Many teams also add a section for compounding batch references, cleaning logs, or certification due dates. Keep the core inspection order intact so the walk-through still matches how the work area is actually used.
How does surface wipe sampling fit into the checklist?
The template includes wipe sampling as a documented control point, not just a lab task. That means you can record whether sampling is scheduled, whether the locations reflect high-touch and high-risk areas, and whether any positive or out-of-limit result has a corrective action. If your facility uses a third-party lab, you can link the result record or attach the report.
What should happen when a deficiency is found?
Each deficiency should be assigned, dated, and tracked to closure with a clear corrective action, such as cleaning, re-certification, PPE replacement, or waste re-labeling. If the issue affects containment or exposure control, the area should be paused or escalated according to your SOP. The goal is not just to record the problem but to show that the hazard was controlled.
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