PCAC ~Feb 2027 — second 503A peptide batch (FDA early announcement)

Status: CONFIRMED BY FDA (early announcement), OUTCOME PENDING as of 2026-08-23. FDA has posted an early announcement for this session on its own advisory-committee pages S3. The exact date and time are not yet set, and the Federal Register notice (which will open the public docket) has not yet published.

What is happening

FDA has announced a Pharmacy Compounding Advisory Committee meeting to be held before the end of February 2027. Per FDA's early announcement, the committee will discuss five bulk drug substances being considered for inclusion on the 503A Bulks List: Cathelicidin (LL-37), GHK-Cu, Dihexa acetate, Melanotan II, and Mechano Growth Factor, Pegylated (PEG-MGF) S3. This follows the July 23–24, 2026 PCAC session that reviewed the first peptide batch S1. Several of these substances currently sit in the "nominated but withdrawn" portion of Category 2 S2.

FDA intends to publish a Federal Register notice and establish a public-comment docket for the meeting; presentation-slot instructions for the open public hearing will come with that notice. The meeting will be publicly viewable via live webcast S3.

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 2026 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 the Federal Register notice, which will fix the meeting date and time, open the public docket, and give instructions for requesting open-public-hearing presentation slots S3. Meeting materials and the webcast link are due no later than two business days before the meeting on FDA's 2027 PCAC meeting-materials page S3.