Hazardous Drugs — Handling in Healthcare Settings
Requirements for handling hazardous drugs across receipt, storage, compounding, transport, administration and disposal, to protect personnel, patients and the environment. Official 1 December 2019, and applicable to any entity handling drugs on the NIOSH hazardous-drug list.
What this does not cover
stated in the document's own scope- Governs the protective handling of hazardous drugs, not the pharmaceutical quality of a compounded preparation, which is set by <795> and <797>.
- Depends on the NIOSH hazardous-drug list to define scope; a drug not on that list is outside its containment requirements unless locally designated.
- Applies to handling in healthcare settings, not to the industrial manufacture of the drug, which is governed by cGMP.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
USP General Chapter <800>, Hazardous Drugs — Handling in Healthcare Settings, sets standards for handling hazardous drugs to protect personnel, patients, and the environment. It applies across the whole handling chain — receipt, storage, compounding, dispensing, transport, administration, and disposal — for any entity that handles drugs on the NIOSH hazardous-drug list. It covers facility and engineering controls such as containment ventilation and negative-pressure rooms, personal protective equipment, a written hazard-communication and assessment-of-risk program, deactivation and decontamination, spill control, and medical surveillance of exposed staff. The chapter became official on 1 December 2019.
Scope & applicability
All healthcare and compounding settings handling hazardous drugs — not only those that compound them. The chapter reaches receipt and storage, so a site that merely stocks a hazardous drug is in scope.
Legal basis & how it acquires force
Chapter <800> is a USP–NF general chapter, but unlike the enumeration chapters its enforceability rests on external adoption: State Boards of Pharmacy and other regulators may adopt it into law, and workplace-safety authorities apply overlapping occupational-exposure duties. It is built on the NIOSH List of Hazardous Drugs, which defines the substances in scope. So <800> operates at the intersection of pharmacy-practice regulation and occupational health and safety, and its force in a given jurisdiction depends on state and workplace-safety adoption.
Document structure
| Part | Covers |
|---|---|
| List of hazardous drugs and risk assessment | Using the NIOSH list and performing an assessment of risk to scope controls |
| Facilities and engineering controls | Containment ventilation, negative-pressure storage and compounding rooms, and segregation |
| Personal protective equipment | Gowns, gloves, respiratory protection, and their selection by activity |
| Handling across the chain | Receipt, storage, compounding, transport, administration, and disposal controls |
| Deactivation, decontamination, and spills | Cleaning of hazardous-drug residue and spill-control procedures |
| Personnel and documentation | Training, medical surveillance, and the hazard-communication program |
Key requirements
- Designated person responsible for the hazardous-drug programme
- List of hazardous drugs handled, based on the current NIOSH list
- Containment engineering controls appropriate to the activity
- Documented assessment of risk where full containment is not applied
- Personnel training, PPE and documented competency
- Surface-wipe sampling with defined response actions
Implementation tips
- Keep the hazardous-drug list current against NIOSH updates — the list is the trigger for everything else
- Run surface-wipe sampling on a schedule with a written response plan; ad-hoc sampling without action criteria is worse than none
- Coordinate with EHS and OSHA obligations rather than treating <800> as purely a pharmacy chapter
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Chapter <800> complements the compounding chapters <795> and <797>: where a hazardous drug is compounded, its containment requirements apply in addition to the relevant compounding standard. Its scientific basis is the NIOSH List of Hazardous Drugs, and it aligns in intent with occupational-exposure frameworks administered by workplace-safety authorities, extending compounding-era containment thinking to every point at which a hazardous drug is handled.
USP <800>: frequently asked questions
Quick answers to common questions about USP <800>.
What does USP <800> cover?
The safe handling of hazardous drugs across receipt, storage, compounding, transport, administration, and disposal — through facility and engineering controls, PPE, hazard communication, decontamination, spill control, and medical surveillance — to protect personnel, patients, and the environment.
When did USP <800> become official?
It became official on 1 December 2019 and applies to any entity that handles drugs appearing on the NIOSH List of Hazardous Drugs.
How does <800> relate to <795> and <797>?
It adds hazardous-drug containment on top of the compounding standards. A hazardous drug compounded nonsterile is subject to <795> and <800>; compounded sterile, to <797> and <800>.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.