Published in FDA’s meeting briefing packet.
KPV: committee recommended inclusion. FDA final is still pending.
The advisory committee recommended inclusion for KPV free base / KPV 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.
KPV (free base): Yes 8, No 6, Abstain 1. KPV 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 KPV free base or KPV acetate on the 503A Bulks List.
FDA says neither form is a component of an FDA-approved drug. The briefing identifies inconsistent naming and uncertainty about which substance a reference standard describes as characterization concerns.
- Wound healing
- Inflammatory conditions
The agenda names the uses FDA reviewed; it does not establish that KPV is effective for either use.
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 KPV (free base) be placed on the list?
Should KPV 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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