Compliance campaign Cyclophosphamide
Cyclophosphamide [50-18-0]
Between August and November 2025, principal advisors from Workplace Health and Safety Queensland’s (WHSQ) Occupational Health, Hygiene and Asbestos Unit (OHHA) conducted a statewide compliance campaign, assessing all known holders authorised to use, handle or store cyclophosphamide, as well as all identified suppliers and wholesalers.
The campaign aimed to verify that persons conducting a business or undertaking (PCBUs) complied with the Work Health and Safety Regulation 2011 (WHS Regulation) and eliminated or minimised worker exposure to cyclophosphamide so far as is reasonably practicable.
Background
Cyclophosphamide is classified as a restricted carcinogen under Schedule 10 of the WHS Regulation and as a Category 1 carcinogen, known to cause cancer in humans. Organisations primarily use it for cancer research and to prepare therapeutic doses in oncological facilities, hospitals and veterinary practices.
Health risks
Workers can be exposed to cyclophosphamide through inhalation or absorption through the skin and mucous membranes.
Chronic exposure may lead to significant health problems affecting:
- blood and bone marrow
- bladder, lungs, liver and kidneys
- reproductive system including impacts such as irregular menstrual cycles, miscarriages, and infertility.
Given these risks, it is critical that PCBUs implement effective control measures to eliminate or minimise worker exposure.
Legislative requirements
PCBUs must not use, handle, or store cyclophosphamide unless they hold an authorisation or exemption.
Suppliers must not supply cyclophosphamide without first confirming that the PCBU holds a valid authorisation.
Campaign overview
The campaign focused on how PCBUs used, handled and stored cyclophosphamide across manufacturing, research, healthcare and veterinary industries.
Campaign scope
- Review – complete the intial assessment and evaluation phase.
- Supplier checks – verify and validate supplier credentials.
- Identification – identify and verify unauthorised use.
- Authorisation management – control and manage access permissions.
Campaign snapshot
- Twelve authorisations reviewed
- Seven non-compliant suppliers
- Seven unauthorised veterinarians
- Fourteen remaining authorisations
Regulatory response
The campaign resulted in several regulatory actions:
- Eight cancellations, where businesses confirmed they no longer used cyclophosphamide.
- Eight amendments to address changes in operations or risk profiles.
- One new application submitted following regulatory engagement that identified non‑compliance.
Campaign phases
Phase 1: Authorisation holder assessments
OHHA advisors conducted unannounced site visits for all known authorisation holders.
At the start of the campaign, 22 businesses held authorisations.
Key findings
- Operational changes were identified at eight sites, altering the level of risk to workers due to increases or decreases in quantities used.
- Eight amendments were processed to reflect these changes.
- Eight authorisations were cancelled after holders confirmed that cyclophosphamide use had stopped.
Phase 2: Suppliers
Thirteen businesses supplying cyclophosphamide in Queensland were identified and reviewed.
Section 155 notices were issued to obtain supply records.
Key findings
- Supplier records showed that supply of cyclophosphamide to PCBUs without authorisation occurred primarily within the pharmacy sector.
- In the veterinary sector, unauthorised supply came primarily from wholesalers.
- One unauthorised hospital obtained cyclophosphamide and supplied it on prescription to a local veterinarian.
All suppliers were contacted and advised of their obligations under the WHS Regulation. Each supplier indicated they would improve their systems or stop supplying cyclophosphamide in Queensland.
Phase 3: Unauthorised users
Supplier records identified significant numbers of Queensland PCBUs that had previously obtained cyclophosphamide without a valid authorisation between 2012 and 2025.
Key findings
- One healthcare PCBU was found to be actively using cyclophosphamide without authorisation and immediately stopped use.
- Seven veterinarians had used cyclophosphamide in recent years; two intend to continue use, and one has submitted an authorisation application.
- Many authorised and unauthorised users have transitioned to purchasing patient‑ready doses from manufacturers, reducing the need for preparation and significantly minimises the risk of worker exposure.
Outcomes
The compliance campaign successfully achieved three key outcomes.
- Stopping unauthorised supply
Suppliers have stopped providing cyclophosphamide to unauthorised PCBUs. - Reducing risk
Authorisations holders improved their safety controls and compliance with legislation. Industry awareness increased regarding safer alternatives. Industry also gained better understanding of the availability and benefits of patient-ready doses from manufacturers which eliminate the need to prepare cyclophosphamide and significantly reduce exposure risks. - Ongoing monitoring
WHSQ will continue to closely monitor the supply and authorised use of cyclophosphamide in Queensland workplaces to ensure that worker exposure to restricted carcinogens remains effectively controlled.