Is TB-500 legal?
Medically reviewed by Dr. Jonathan Snipes, MD
Reviewed for clinical accuracy · Last reviewed September 23, 2026 · Review policy
Quick answer
TB-500 is not FDA-approved and is prohibited in sport. FDA staff recommended against listing it, but the PCAC voted on July 23, 2026 to recommend TB-500 for wound healing (reported as 8-6-1). The vote is advisory and FDA has not yet acted.
- FDA status
- Not FDA-approved; PCAC recommended for 503A list July 2026 (advisory, FDA decision pending)
- Prohibited in sport (WADA)
- Yes
TB-500 is not an FDA-approved drug. Like BPC-157, it has been available through compounding and, more commonly, the research-chemical market. From 2023 the FDA placed it in an interim category of bulk substances with significant safety risks, which did not provide a lawful 503A compounding route; secondary sources report it was removed from that category in April 2026. It is not on the 503A Bulks List. It is prohibited in sport under the WADA framework.
TB-500 was one of the seven peptides the FDA's Pharmacy Compounding Advisory Committee reviewed on July 23, 2026, for the 503A Bulks List, with FDA briefing documents recommending against listing. The committee voted to recommend TB-500 for wound healing anyway, in a vote reported as 8 to 6 with 1 abstention. The vote is advisory: adding it to the list would still need FDA rulemaking, and nothing about its legal status changed on the day of the vote. See our coverage of the vote.
Frequently asked questions
Is TB-500 legal in the US?+
TB-500 is not FDA-approved and is prohibited in sport. FDA staff recommended against listing it, but the PCAC voted on July 23, 2026 to recommend TB-500 for wound healing (reported as 8-6-1). The vote is advisory and FDA has not yet acted.
Do you need a prescription for TB-500?+
TB-500 is not FDA-approved. Where it is available through a compounding pharmacy it requires a prescription; research-chemical versions are sold outside the regulated, prescription-based system.