PCAC review · February 2027 panel
FDA's Pharmacy Compounding Advisory Committee scheduled to review the second cohort of peptides removed from Category 2 in April 2026. Panel votes whether to add each to the official 503A bulks list.
37-amino acid cathelicidin antimicrobial peptide. Direct membrane disruption against bacteria, fungi, viruses; modulates innate immune signaling.
Evidence is experimental. Most claims trace to limited human studies or animal models. Treat as a research direction, not a protocol.
Endogenous human host-defense peptide. Investigated as a topical antimicrobial and adjunct in chronic infections. Vitamin D status correlates with endogenous LL-37 expression. Synthetic supplementation is research-stage; biotech candidates target diabetic foot ulcers and chronic wounds.
Off-target inflammatory effects at high concentration. Most therapeutic value of cathelicidin in real life comes from optimizing vitamin D status, not exogenous LL-37.
Per-claim grading. Each claim is graded independently — same peptide, different claims can carry different grades.
External links to PubMed searches, ClinicalTrials.gov, and FDA materials. We do not host papers — we point at canonical sources.
Pre-filled with this compound's published dose range: varies — research stage · research-only
Calculator is a discussion tool. Verify reconstitution + dosing with a qualified provider. Stack is not a prescription source. Use sterile technique and inspect every vial.
FDA Cat. 2 removed Apr 2026 — PCAC review Feb 2027
FDA's Pharmacy Compounding Advisory Committee scheduled to review the second cohort of peptides removed from Category 2 in April 2026. Panel votes whether to add each to the official 503A bulks list.
FDA published a Federal Register notice on April 15 2026 removing 12 peptides from the Category 2 ('significant safety concerns') compounding list, paving the way for PCAC review for inclusion on the 503A bulks list. Peptides removed: BPC-157, TB-500, Epitalon, GHK-Cu (injectable), MOTS-c, DSIP, Dihexa Acetate, MK-677, Melanotan II, KPV, Semax, LL-37.
FDA's Pharmacy Compounding Advisory Committee categorized a wide list of peptides as Category 2 ('significant safety concerns'), effectively banning their compounding at 503A and 503B pharmacies. Affected: BPC-157, TB-500, Epitalon, GHK-Cu, MOTS-c, DSIP, Dihexa, MK-677, Melanotan II, KPV, Semax, Selank, LL-37 and others.