KPV: legal status and evidence

Short answer: KPV is not FDA-approved. Since October 30, 2026, a state-licensed pharmacy may compound KPV acetate for one patient with a prescription under an interim HHS policy, in these forms only: topical, or oral (oral needs documentation that it is absorbed) [1], [2]. FDA’s own staff reviewed the evidence and recommended against it [2], [3].

At a glance

Legal status	HHS interim policy: compounding with a patient-specific prescription [1]
Form covered	KPV acetate [2]
Routes allowed	Topical, or oral (oral needs documentation that it is absorbed) [2]
FDA Category 2	September 2023 to April 22, 2026 [2]
FDA staff view	Recommended against adding it to the 503A bulks list [2], [3]
Advisory committee	Voted in favor [2]
Human evidence (FDA review)	No human data. None of the studies FDA reviewed gave KPV to people. [3]
Last checked	November 5, 2026

What FDA’s staff found

FDA’s drug center (CDER) reviewed KPV for the uses it was nominated for: wound healing and inflammatory conditions such as psoriasis and eczema [3].

• FDA found that none of the studies in the nomination gave KPV to people. [3]
• It found a lack of evidence to judge whether KPV works for the nominated uses. [3]
• FDA said it was particularly concerned about the lack of any human data, so the risks in people are unknown. [3]

Why HHS allowed it anyway

HHS gave three reasons in Appendix B to its policy [2]:

1. Use is now documented and counted, including substantial single-ingredient use;
2. Lots supplied to 503A pharmacies confirm the molecule by mass spectrometry and report the endotoxin and microbial results FDA’s review found missing;
3. FDA’s safety conclusion reflects an absence of information rather than an observed safety signal, and the policy’s conditions address it.

HHS may revisit the policy if a safety signal or a product quality problem appears, and the policy lasts until FDA decides in a final rule whether to add the peptide to the 503A bulks list [1].

How to get it legally

1. A licensed clinician decides it is right for you and writes a prescription in your name.
2. A state-licensed compounding pharmacy (503A) prepares it from an ingredient made at an FDA-registered facility, with a valid certificate of analysis [1].
3. The label says: “This is a compounded drug product. Not for resale.” It contains only one active ingredient [1].

See how to check a compounding pharmacy and how to read a peptide COA.

What is not known

FDA’s review found too little human data to describe how well KPV works or how safe it is over time [3]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [1]. Talk to a licensed clinician before you use any compounded peptide.

Change log

• November 5, 2026: page created from the HHS policy, Appendix B and FDA’s July 2026 briefing document.