KPV: Regulatory Status
Current legal and regulatory status for KPV across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to KPV overviewUnited States
Pending Reclassification
Prescription required
Recent Regulatory Action
Category 2 → Category 1 reclassification announced 2026-02-27, not yet finalized
Currently Category 2 (prohibited from compounding). HHS Secretary Kennedy announced expected reclassification to Category 1 on Feb 27, 2026 (Joe Rogan Episode #2461). Formal FDA guidance not yet published as of 2026-03-13. Monitor fda.gov/compounding for official update.
What This Means
Pending reclassification does not mean currently legal to compound.
Until formal FDA guidance is published, KPV remains under its current classification. The announcement indicates intent, not completed regulatory action. Patients and providers should monitor the FDA compounding page for official updates before making treatment decisions.
Reclassification is not the same as FDA approval.
Even if KPV moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.