USP 800 Hazardous Drug Handling: Equipment and Disinfection Requirements for Canadian Pharmacies
The cabinet was right, the paperwork was not
An oncology pharmacy can hold a containment ventilated enclosure, chemotherapy-tested gloves and a spill kit, and still have a surface cleaning procedure where two of the four steps leave no record behind.
What does USP 800 require of the containment equipment?
Hazardous drug work happens inside a containment primary engineering control, and that control sits inside a containment secondary engineering control — the room. For non-sterile compounding the primary control is a Class I biological safety cabinet or a containment ventilated enclosure, and it either vents to the outside or carries redundant HEPA filtration in series.
Two operational points follow. If the primary control loses power or is moved for major repair, work inside it stops until power is restored and the unit has been decontaminated, cleaned and, where required, disinfected, with the manufacturer's recovery time observed. And a unit that occasionally handles non-sterile hazardous drugs has to go through the same treatment before sterile compounding resumes in it.
What are the four surface steps, and how do they differ?
The chapter treats them as four jobs with four products, not as one wipe-down:
| Step | What it removes | Typical agent |
|---|---|---|
| Deactivation | The activity of the drug itself | An agent listed by the drug manufacturer, or a registered oxidiser such as a hydrogen peroxide formulation or sodium hypochlorite |
| Decontamination | Drug residue left on the surface | The decontamination agent named in the written procedure |
| Cleaning | Organic matter and soil | A cleaner compatible with the surface material |
| Disinfection | Micro-organisms, added in sterile compounding areas | A disinfectant validated for that surface |
Application matters as much as chemistry: wetted wipes, not a spray bottle, and a written procedure naming the agent, dilution, frequency and record.
Which gloves does a hazardous drug program need?
Gloves tested to ASTM D6978, powder-free, and worn in pairs while compounding. A tested product is the floor, not the ceiling — the facility still has to match the glove to the drugs on its own list, and to the change interval written into its procedure.
How often does the program come up for review?
At least every 12 months for the hazardous drug list, any assessment of risk, staff competency and the written procedures. Surface wipe sampling runs on its own rhythm: a baseline, then at least every six months, at points that include inside the primary control, the pass-through, adjacent work and storage areas and the administration area.
Where do Canadian rules sit alongside the chapter?
The chapter is a reference in Canada, not legislation. Provincial colleges write their compounding standards around the NAPRA hazardous preparation standards and set their own inspection route:
| Item | Canada | United States |
|---|---|---|
| Controlling text | Provincial college standards based on the NAPRA hazardous sterile preparation standards | USP General Chapter 800 |
| Status of the chapter locally | A reference the colleges work from; not legislation in Canada | Enforceable in the states that adopt it |
| Who reviews the record | Provincial college inspector or accreditation reviewer | State board inspector, alongside occupational health rules |
What does a hazardous drug order actually contain?
Three lines carry most of the compliance weight: gloves tested to ASTM D6978, a fluid-resistant gown for compounding and administration, and waste packaging that keeps the hazardous stream separate, such as red biohazard waste bags. The compliance log center carries the record templates that these lines feed.
Ordering for a pharmacy, clinic or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers.
References
- USP General Chapter 800, hazardous drugs in healthcare settings, official 1 December 2019 (checked 28 September 2026)
- NAPRA model standards for compounding of hazardous sterile preparations, November 2016 (checked 28 September 2026)
- Alberta College of Pharmacy, pharmacy compounding practice resources (checked 28 September 2026)
Related Reading
- Chemotherapy-Grade Nitrile Gloves: ASTM D6978 Explained
- Oncology Infusion Clinic Supplies: Chemo-Grade PPE for Canada
- Nitrile Gloves for Chemotherapy: What ASTM D6978 Testing Covers
Frequently Asked Questions
What are the four surface steps in USP 800?
Deactivation, decontamination, cleaning and, in sterile compounding areas only, disinfection. They are four different jobs: deactivation changes the drug itself, decontamination removes drug residue, cleaning removes organic matter and soil, and disinfection targets micro-organisms.
Can a spray bottle be used to clean a hazardous drug work surface?
The chapter directs wetted wipes rather than sprays, because aerosolised residue travels beyond the surface being cleaned. The written procedure still has to name the agent, the dilution, the frequency and the record it produces.
Which gloves does a hazardous drug program need?
Gloves tested to ASTM D6978 and powder-free, worn in pairs during compounding. In Canada the gloves are also regulated as medical devices, and the facility remains responsible for choosing a glove whose documented permeation testing covers the drugs on its list.
How often is the hazardous drug program reviewed?
The facility list of hazardous drugs, any assessment of risk, staff competency and the written procedures are each reviewed at least every 12 months. Surface wipe sampling starts with a baseline and then runs at least every six months.
Last updated: September 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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