LL-37 (Cathelicidin)
RestrictedAntimicrobial Peptide
Based on public FDA bulk-substance and shortage listings, it appears to be off the permitted bulk substances list, or a shortage-based exception has ended. That's our read that no established pathway currently applies — not a formal legal bar, and not a determination we're qualified to make. Confirm current status with FDA sources or counsel.
Not legal advice. Every status on this page is our own reading of public FDA guidance, shortage listings, and committee materials — it has not been reviewed by an attorney and is not a legal determination. "Contested" means pharmacies and regulators publicly disagree, not that we're resolving the disagreement. Verify independently, and check with counsel, before relying on any entry here.
Current status
An antimicrobial peptide, never FDA-approved and not on the 503A bulk substances list. FDA's April 2026 interim list update reportedly removed it from the stricter 'Category 2' tier, but it's scheduled for its own Pharmacy Compounding Advisory Committee review before February 2027 rather than having been voted on yet — and sources disagree on whether it's actually expected to end up in the more permissive tier or stay restricted. Treat this one as especially unsettled.
Last changed: 2026-04-15