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Review pending Dispatch · 503a-bulks · Feb 28, 2027

PCAC ~Feb 2027 — reported second 503A peptide batch

Substances under review: ghk-cu, melanotan-ii, ll-37, dihexa, peg-mgf

Status: PENDING and PROVISIONAL as of 2026-07-02. Trade/association reporting describes a second PCAC session (~Feb 2027) to review five more peptides. This is not yet confirmed by a Federal Register notice — it is labeled provisional until one is published, and the provisional framing must stay prominent if shown publicly.

What is happening

Following the July 23–24, 2026 PCAC session, FDA is reported to be convening a second Pharmacy Compounding Advisory Committee session around February 2027 to review five more peptides for the 503A Bulks List: GHK-Cu, Melanotan II, Cathelicidin (LL-37), Dihexa, and PEG-MGF S1. Several of these currently sit in the "nominated but withdrawn" portion of Category 2 S2.

What was decided

<!-- OUTCOME PENDING. Do not fill until an FDA record exists. Removal from Category 2 is not the same as 503A eligibility; a recommendation is not a rule. -->

Why it matters

As with the July session, PCAC only advises; FDA decides, and adding a substance to the 503A Bulks List requires rulemaking. Removal from Category 2 is not eligibility to compound S2.

What's next

Watch for a Federal Register notice formally scheduling this session and listing the substances and evaluated uses — that notice is what turns this from reported to confirmed S1S2.

Sources

Every reference below is a primary/official source for this event.

  1. 01 RAPS — FDA considers adding a dozen peptides to its bulk drug compounding list
  2. 02 FDA — Certain Bulk Drug Substances… (Category 2)