LL-37

Regulatory record

LL-37, also called cathelicidin in the docket record, is one of five bulk drug substances scheduled for a second Pharmacy Compounding Advisory Committee meeting before the end of February 2027. The other four are Dihexa acetate, GHK-Cu, PEG-MGF, and Melanotan II. The April 2026 FDA action that scheduled the July 2026 meeting scheduled this later one as well. As of 1 June 2026 there was no public docket for the February meeting, and no primary Federal Register agenda naming the day. Federal Register notice 2026-07361 is the July record. It names BPC-157, KPV, TB-500, and MOTs-C for July 23, and Emideltide (DSIP), Semax, and Epitalon for July 24. LL-37 is not on it. The February names come from secondary coverage of the April announcement, not from that notice.

Nothing in that record gives LL-37 a Category 1 or Category 2 move. Dihexa acetate came off Category 2, the do-not-compound list. GHK-Cu was split by route, and the two routes moved in opposite directions. LL-37 has neither of those notes. Category 1 is the under-evaluation list, the one that had temporarily allowed compounding under enforcement discretion. Category 2 is the do-not-compound list. They are not the same list, and this compound is not described as leaving either one.

The committee recommends. FDA decides afterward, by rulemaking. Being named for February is not an approval and not a finding that LL-37 works in people. No reviewed use is on file for it, because the July notice's use chart covers only the seven substances at that meeting. The meeting-by-meeting account is the July 2026 PCAC review.