**BPC-157, a synthetic gastric pentadecapeptide studied primarily in animal models for tissue repair, gut healing, and anti-inflammatory effects, remains unapproved by the FDA as a finished drug with only limited small-scale human data available.** It was placed in Category 2 in 2023 due to concerns over immunogenicity, peptide impurities, and insufficient safety information for compounding under Section 503A. Recent policy signals from HHS, including announcements by Secretary Robert F. Kennedy Jr., indicate intent to shift several peptides including BPC-157 back toward Category 1 (“under evaluation”), enabling licensed compounding pharmacies to prepare it under prescription pending final review. The key near-term catalyst is the FDA Pharmacy Compounding Advisory Committee meeting scheduled for July 23–24, 2026, which will evaluate BPC-157 and related substances for the 503A bulks list. Trader sentiment reflects uncertainty around whether formal Category 1 placement occurs before or after that meeting, given the distinction between removal from Category 2 and affirmative listing, as well as ongoing questions about manufacturing standards and clinical evidence thresholds.