Published in FDA’s meeting briefing packet.
TB-500: committee recommended inclusion. FDA final is still pending.
The advisory committee recommended inclusion for TB-500 free base / TB-500 acetate. The two form-specific votes are advisory and non-binding; FDA's final determination remains pending.
- Staff · against inclusion
- Committee · Recommend inclusion
- Final FDA action · pending
Three stages. The first two are complete.
This tracker separates the stages that headlines often collapse together.
TB-500 (free base): Yes 8, No 6, Abstain 1. TB-500 acetate: Yes 8, No 6, Abstain 1. Advisory and non-binding.
FDA says it will consider committee input and complete its review.
FDA staff says the evaluation criteria weigh against placing TB-500 free base or TB-500 acetate on the 503A Bulks List.
FDA says neither form is a component of an FDA-approved drug. Its briefing describes TB-500 as a common name used amid multiple salts, derivatives, and active moieties, creating identity and characterization concerns.
- Wound healing
The committee review is not a general finding on injury recovery or the “Wolverine peptide” marketing label.
What this committee recommendation does not change
The committee recommended inclusion for both forms.
The forms were separate questions and received separate tallies. This is advisory committee input, not FDA approval, final list placement, or FDA's final determination.
Should TB-500 (free base) be placed on the list?
Should TB-500 acetate be placed on the list?
Primary verification: July 25, 2026. Independent verification: Claude, July 25, 2026. FDA final action remains pending.
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