Is TB-500 legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Not approved; research use only
- UK: Not licensed
- AU: Banned in sport (WADA); not approved
- CA: Not approved
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Legal category | Not approved; research use only | Not licensed | Banned in sport (WADA); not approved | Not approved |
| Note | None recorded | None recorded | None recorded | None recorded |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Not FDA-approved. In April 2026 the FDA took it off Category 2, its list of pharmacy ingredients with safety worries. In July 2026 the FDA's Pharmacy Compounding Advisory Committee voted 8 to 6, with one member abstaining, in favor of letting pharmacies make it. The FDA's own reviewers had advised against that. The FDA has not acted yet. Reviewed Sep 2026.
Country by country
Is TB-500 legal in the United States?
No. TB-500 is not an approved medicine in the United States. Its legal category is "Not approved; research use only". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, no completed trial in people is cited on its profile (1 human record with no result or no dose given).
The full United States answerIs TB-500 legal in the United Kingdom?
No. TB-500 is not an approved medicine in the United Kingdom. Its legal category is "Not licensed". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, no completed trial in people is cited on its profile (1 human record with no result or no dose given).
The full United Kingdom answerIs TB-500 legal in Australia?
No. TB-500 is not an approved medicine in Australia. Its legal category is "Banned in sport (WADA); not approved". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, no completed trial in people is cited on its profile (1 human record with no result or no dose given).
The full Australia answerIs TB-500 legal in Canada?
No. TB-500 is not an approved medicine in Canada. Its legal category is "Not approved". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, no completed trial in people is cited on its profile (1 human record with no result or no dose given).
The full Canada answerTB-500 in sport and the military
Whether TB-500 is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up TB-500 by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.