[regulatory]US status (2026): Melanotan II was among the ~12 peptides removed from FDA Category 2 (Feb 2026), but it is not on the July 23–24 2026 PCAC 503A agenda — no active 503A review. Not FDA-approved; the melanoma/melanocyte caution above stands regardless of compounding status. — SOURCE-fda-pcac-503a-peptide-review-2026