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USP <800> Hazardous Drugs Handling
A practical white paper on reducing hazardous drug exposure risk, implementing containment strategies, and building audit-ready execution systems across the HD lifecycle
Last updated: January 2026
By: SOSCleanroom
Last updated: January 2026
By: SOSCleanroom
Hazardous drug handling basics for pharmacies, hospitals, clinics, and new technicians
USP <800> overview NIOSH HD list Containment strategy C-PEC / C-SEC / C-SCA PPE Deactivation & decontamination Spill & waste Customer checklist
USP <800> is a USP–NF General Chapter that describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection. Handling includes (but is not limited to) receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.
Important note on sources: USP standards are copyrighted. This SOSCleanroom white paper is an educational, operational interpretation written in plain language. It does not reproduce USP–NF text verbatim and is not a substitute for the official USP–NF chapter. Always consult the official USP–NF text and your jurisdiction’s adoption/enforcement requirements for definitive requirements.
In one sentence: USP <800> reduces the risk of HD exposure by requiring a documented containment strategy, appropriate engineering controls, standardized work practices, PPE, routine surface decontamination, and defensible documentation across the full HD lifecycle.
1) Executive summary
USP <800> should be implemented as an enterprise exposure-control system. Strong programs align seven operational elements: (1) hazard identification (NIOSH-based HD list approach), (2) a documented containment strategy, (3) appropriate engineering controls, (4) standardized work practices and PPE, (5) routine deactivation/decontamination/cleaning (and disinfection where applicable), (6) spill response and waste handling discipline, and (7) audit-ready documentation and staff competency.
What “good” looks like
- HDs are handled in clearly defined zones with the right tools at point-of-use.
- Containment is planned (not improvised): engineering + workflow + PPE.
- Surface contamination is reduced with consistent decontamination routines and logs.
- Spills and waste are managed with rehearsed response steps and documented outcomes.
What causes most compliance failures
- Uncontrolled receiving/unpacking or storage (HD residue spreads to clean areas).
- Inconsistent PPE use (glove changes, double-gloving discipline, doffing habits).
- No clear “who owns what” (gaps in logs, training, and incident follow-up).
- Cleaning is treated as “janitorial,” not exposure control (wrong tools, weak technique, no verification).
2) Who is impacted & what is a hazardous drug
USP <800> impacts any entity that handles hazardous drugs—across receipt, storage, compounding, dispensing, administration, and disposal—whether the product is sterile or nonsterile. For classification, USP <800> references the most current NIOSH list as the basis for identifying hazardous drugs within the chapter’s scope.
Operational takeaway: Document your HD inventory decision logic and keep it current. A strong program clearly labels which products are treated as HDs, where they may be stored, where they may be manipulated, and what PPE/engineering controls apply.
3) USP <797> vs USP <800>: what’s different (plain-language)
| Topic | USP <797> (Sterile compounding) | USP <800> (Hazardous drugs) |
|---|---|---|
| Main risk controlled | Nonsterility and contamination of CSPs | Exposure of staff/patients/environment to HD residue and aerosols |
| Where it applies | Sterile preparation activities and supporting controlled environments | Across the entire HD lifecycle: receive → store → compound → dispense → administer → dispose |
| Facilities language | ISO spaces, PECs, sterile workflow discipline | Containment strategy with engineering controls (C-PEC, C-SEC, C-SCA as applicable) |
| Cleaning intent | Reduce microbial and particulate contamination | Reduce HD residue and surface contamination (exposure control), plus disinfection where applicable |
Practical interpretation: USP <797> is about producing a sterile preparation safely. USP <800> is about keeping people and spaces safe from hazardous drug exposure—often in addition to sterile requirements when the drug is both hazardous and sterile.
4) Core compliance pillars
Practical rule: Exposure control is won by reducing opportunities for HD residue to spread. Standardize zones, tools, PPE, and cleaning technique—and prove it with logs.
A) Hazard identification and inventory governance
- Maintain an HD list approach aligned to NIOSH classification referenced by USP <800>.
- Define which dosage forms/tasks trigger full containment versus reduced controls (documented policy).
- Ensure staff can identify HDs quickly (labeling and storage rules).
B) Containment strategy and engineering controls
- Define where HDs are received/unpacked, stored, and manipulated (zones and traffic control).
- Use appropriate containment engineering controls for HD manipulation/compounding (C-PEC in a C-SEC/C-SCA as applicable).
- Maintain certification/maintenance evidence and assess impacts after repairs or changes.
C) Standardized work practices and PPE discipline
- Define task-based PPE and ensure consistent donning/doffing behavior.
- Reduce open handling steps and unnecessary transfers (workflow engineering).
- Train to one method, validate competency, and document retraining triggers.
D) Deactivation, decontamination, cleaning, and (where applicable) disinfection
- Standardize tools and technique so surface residue is reduced consistently across shifts.
- Specify application methods, contact/dwell times, and change-out rules in SOPs.
- Log completion and investigate misses or deviations as exposure-control events.
E) Spill response and hazardous waste handling
- Maintain spill response readiness: location, ownership, training, and documentation.
- Control waste pathways so HD residue does not contaminate general trash streams or clean areas.
- Document incidents and corrective actions (CAPA) to prevent repeats.
5) Charts and program maps
How to use these charts: Share with stakeholders and new staff. They map exposure pathways to controls and clarify what documentation should exist to defend performance.
Chart 1 — HD lifecycle map: where exposure risk concentrates and what to prove
| Lifecycle step | Where exposure happens | Controls (examples) | Evidence to maintain |
|---|---|---|---|
| Receipt / unpacking | Damaged packages, outer residue transfer to clean spaces | Defined unpacking area • PPE • segregation rules | Receiving SOP • incident logs • training records |
| Storage | Leaking containers, shelf contamination, cross-contact | Segregation • labeled zones • secondary containment as appropriate | Inventory rules • cleaning logs • spill readiness checks |
| Compounding / manipulation | Aerosols, droplets, touch points on surfaces and devices | Containment engineering controls • standardized technique • decontamination steps | Training/competency • cleaning records • maintenance/certification records |
| Administration | Line disconnections, drips, contaminated work surfaces | Task PPE • standardized handling • surface cleaning routines | Unit procedures • incident logs • training evidence |
| Spills / waste | High-consequence residue spread and exposure events | Spill SOP • ready supplies • documented response • controlled waste pathway | Spill reports • corrective actions • waste handling records |
6) SOSCleanroom execution tools that support USP <800> programs
USP <800> success is driven by consistent execution: standardized cleaning technique, controlled tools that minimize shedding and spread, and repeatable supply staging that prevents improvisation. SOSCleanroom supports critical environments with cleanroom-grade consumables and practical guidance that helps teams stay consistent and audit-ready.
Non-endorsement clarity: USP does not endorse specific brands or products. The examples below map “program needs → execution tools” that customers commonly standardize within their SOPs and validation expectations.
| Program need | Execution tools (examples) | SOSCleanroom starting points |
|---|---|---|
| Surface decontamination discipline (point-of-use) | Low-lint wipes • controlled packaging formats • standardized wipe patterns | Cleanroom wipers Cleanroom swabs |
| Large-area cleaning routines (rooms, floors, staging areas) | Mops/handles/refills • consistent coverage and change-out rules | Cleanroom mops Mops & refills |
| Controlled chemical application (as defined by your SOPs) | Compatible solutions • consistent application tools • documented contact times | Cleaning solutions |
| PPE and barrier consumables (task-based selection) | Gloves and barrier supplies aligned to the specific task and risk | Cleanroom gloves |
| Zone discipline (where appropriate) | Entryway/transition consumables as part of a broader contamination control plan | Facilities & accessories |
Implementation tip: Standardize “HD handling kits” by task (receiving/unpacking, compounding/manipulation, administration support, spill response). When tools are consistent, technique is more consistent—and exposure risk drops.
7) USP <800> customer checklist
Use this checklist for a rapid internal self-assessment. Align each item to the currently applicable USP–NF official text and your jurisdiction’s enforcement posture. This checklist is designed to be operationally useful without quoting USP text.
How to use: Print this section and store it in your compliance binder. During audits, initial each line after verifying the supporting record exists and is complete.
A) Governance and HD inventory control
B) Receipt and unpacking controls
C) Storage and segregation
D) Compounding/manipulation controls (where applicable)
E) Administration and transport controls (where applicable)
F) Spill response and hazardous waste
G) Training, competency, and documentation
Audit stress test question: If an inspector asked you to prove how HD exposure is controlled for last Tuesday, could you produce your logs, training records, and incident history in under 15 minutes?
8) Official USP references
Use the official USP resources below as your source of truth for requirements, official dates, and the current chapter text pathway.
- USP General Chapter <800> portal: https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
- USP–NF DOI pathway for <800>: https://doi.usp.org/USPNF/USPNF_M7808_07_01.html
- USP–NF RB notice (historical context on official status): https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-800-rb-notice-20190531.pdf
- USP–NF RB notice (NIOSH list clarification context): https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-800-rb-notice-20200626.pdf
- USP FAQ — Identifying “official text” in USP–NF: https://www.usp.org/frequently-asked-questions/identifying-official-text
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Briefed and approved by the SOSCleanroom (SOS) staff.
Briefed and approved by the SOSCleanroom (SOS) staff.
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Last reviewed: January 10, 2026 Customer-first, audit-ready guidance Cleanroom consumables + education
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