Legal status by country
Is Erythropoietin legal?
Written by Aaron CuhaReviewed Sep 2026
How Erythropoietin is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved for anaemia of chronic kidney disease and certain chemotherapy-related anaemias, with a boxed warning stating that no haemoglobin target, dose or dosing strategy has been identified that avoids the increased risks of death, myocardial infarction, stroke, thromboembolism and tumour progression. Prohibited in sport. | None recorded | None recorded | None recorded |
US FDA status: FDA approved since 1989 for anaemia, with boxed warnings. Verified on 11 September 2026: EPOGEN and PROCRIT (epoetin alfa, BLA 103234) approved 1 June 1989; ARANESP (darbepoetin alfa, BLA 103951) approved 17 September 2001; MIRCERA (BLA 125164) approved 14 November 2007; RETACRIT (BLA 125545) approved 15 May 2018. All listed Prescription. The boxed warning covers increased death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis and tumour progression or recurrence.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.