Health Canada Authorizes UK and US Imports of Injectable Cyclophosphamide Amid Tier 3 Shortage
Health Canada has authorized the exceptional importation of UK- and US-labelled cyclophosphamide for injection to relieve a Tier 3 shortage of this essential chemotherapy drug, first declared in February 2026. Hospital and oncology pharmacists need to know the differences between the Canadian, UK, and US-labelled products before dispensing or preparing doses.
In this article & details
Health Canada declared a Tier 3 shortage — the most severe classification, reserved for shortages with the greatest potential impact on Canada's drug supply and health care system — for Cyclophosphamide for Injection, USP on February 20, 2026. Cyclophosphamide is a foundational alkylating agent used in chemotherapy regimens for lymphoma, leukemia, multiple myeloma, and several solid tumours, as well as in conditioning regimens before stem cell transplant, and has no therapeutic substitute in most of these protocols. With the Canadian market's suppliers unable to keep pace with demand, Health Canada has since authorized the temporary importation and sale of foreign-labelled cyclophosphamide from two additional sources to prevent treatment interruptions in oncology and transplant units.
Comparing the Canadian and imported products
| Canadian-authorized product | UK-authorized import (added Mar 3, 2026) | US-authorized import (added Apr 10, 2026) | |
|---|---|---|---|
| Distributor | Multiple DIN-holders (Baxter, Sterimax, Andone) | Cyclophosphamide Seacross, via Andone Pharmaceutical Inc. | Cyclophosphamide for Injection, USP, via Sandoz Canada Inc. |
| Regulatory authority | Health Canada | UK Medicines and Healthcare products Regulatory Agency | US Food and Drug Administration |
| Strength / form | Varies by DIN-holder | Powder for solution, 2000 mg/vial, IV | Powder for solution, 1 g/vial and 2 g/vial, IV |
| Labelling language | English and French | English only | English only |
| Authorized sale window | Ongoing | Until May 1, 2026 | Until May 31, 2026 |
Practice guidance for pharmacists
- Confirm which product (Canadian, UK, or US-labelled) is on hand before preparing or verifying a dose — vial strengths differ (1 g and 2 g for the US product versus 2000 mg for the UK product) and reconstitution instructions on the foreign inserts may not match the Canadian monograph.
- Apply auxiliary labelling in French where imported stock carries English-only labelling, particularly in Quebec institutions, to support safe handling by all staff.
- Flag imported lots separately in the pharmacy system or barcode-scanning workflow, since foreign pack barcodes will not match the Canadian DIN used for automated verification.
- Direct prescribers and nursing staff to the Canadian product monograph rather than the UK or US package insert for dosing, stability, and compatibility information.
- Report any adverse events or quality complaints involving the imported product directly to Health Canada, since routine post-market surveillance differs from that of the domestic product.
Cyclophosphamide joins a growing list of chemotherapy and hospital-critical injectables that have required exceptional importation to stay ahead of Tier 3 shortages in 2026, alongside etoposide capsules and calcitriol injection. Hospital and oncology pharmacy teams should check Health Canada's current list of drugs for exceptional importation and sale regularly, since authorized foreign stock, sale windows, and available strengths continue to change as the shortage evolves.
References
- Tier 3 drug shortages — Health Canada, Tier 3 designation, Feb 20, 2026
- List of drugs for exceptional importation and sale — Health Canada, Current list — cyclophosphamide entries added Mar 3 and Apr 10, 2026
