Legal status by country
Is Testosterone legal?
Written by Aaron CuhaReviewed Sep 2026
How Testosterone 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 male hypogonadism and a Schedule III controlled substance. No product is approved for women, so any use in women is off-label and usually involves a male product dosed down. | Licensed for male hypogonadism. A testosterone cream licensed for women in some markets is not available in all. | TGA-registered for male hypogonadism. Australia is one of the few countries with a testosterone product approved for women. | Approved for male hypogonadism. Controlled substance. |
US FDA status: FDA-approved for male hypogonadism in multiple formulations. Schedule III controlled substance in the United States. No testosterone product is approved for women in the United States, which is a documented gap rather than a judgement on the evidence.. 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.