KPV
PeptideCompounding status of KPV — FDA 503A bulks-list standing, PCAC review history, and state overlays. Each entry links to its source; entries marked reported rest on trade-press coverage until the FDA primary record posts.
Current federal standing
Under review — not compoundable
as of Jul 23, 2026 · reported outcome, FDA primary record pending
Federal history
- Jul 23, 2026PCAC reviewFederalreported
Under PCAC review
Under PCAC review — not yet compoundable. On Jul 23, 2026 the Pharmacy Compounding Advisory Committee recommended adding KPV to the FDA 503A Bulks List, 8–6–1 (FDA meeting minutes pending; FDA staff had recommended against). A recommendation is not a legal change — FDA is not bound, and 503A compounding would require Category 1 placement via notice-and-comment rulemaking (commonly 8–12 months).
Note: FDA is not bound by PCAC recommendations. Category 1 placement — the event that would permit 503A compounding — requires notice-and-comment rulemaking, commonly 8–12 months.
PCAC 07/23/2026 · reported outcome — FDA record pending ↗ - Apr 16, 2026PCAC reviewFederal
Under PCAC review
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
Note: FDA is not bound by PCAC recommendations. Category 1 placement — the event that would permit 503A compounding — requires notice-and-comment rulemaking, commonly 8–12 months.
2026-07361 · primary source ↗
State overlays
No state-specific position on KPV tracked yet. State boards hold independent authority; legislation is monitored via LegiScan and board positions are added as they are verified.
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