The public comment docket (FDA-2025-N-6895) remains open through July 22, 2026.10 KPV is being reviewed specifically for wound healing and inflammatory conditions the two areas best supported by existing preclinical data.910 What a Positive Outcome Means If the PCAC recommends adding KPV to the 503A Bulk Drug Substances List and the FDA acts on that recommendation, compounding pharmacies would have clear legal standing to prepare KPV formulations oral capsules, topical creams, and injectable preparations under physician prescription
This does not mean more copper is always better, but it helps explain why copper shows up again and again in skin science
Human data is still very limited, including small pilot work such as the knee pain survey of 16 patients, plus a few other early studies and reviews calling out the lack of large, rigorous trials
doi: 10.1161/01.atv.20.6.1595
After fixation, the specimens were embedded in paraffin and subjected to routine tissue processing