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SOSCleanroom Education Center

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

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.

2) 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

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.

3) USP <800> customer checklist

Disclaimer

These checklists are provided by SOSCleanroom for general educational use and operational planning only. They are recommendations and do not constitute legal, regulatory, clinical, or safety advice, and should not be treated as a statement of fact about your specific facility. SOSCleanroom does not certify compliance through this document. You are responsible for developing, approving, and maintaining your own SOPs, training, documentation, and validation based on the official USP–NF text, your state/federal requirements, and your organization’s risk assessment. Always consult qualified professionals and the applicable authorities having jurisdiction (AHJ).

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.

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USP <800> Customer Checklist (PDF)

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A) Governance and HD inventory control

HD list approach documented (NIOSH-referenced logic) and reviewed on a defined cadence. Task-based PPE/work practice rules defined; staff can explain them.

B) Receipt and unpacking controls

Receiving/unpacking area defined; outer packaging does not enter clean/critical areas. Damage/spill response pathway documented and staff trained to execute it.

C) Spill response and hazardous waste basics

Spill response supplies are accessible; staff can demonstrate response steps. Waste streams are controlled and labeled; disposal practices are documented.

4) 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 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.

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Last reviewed: January 10, 2026 Customer-first, audit-ready guidance Cleanroom consumables + education

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