FDA PCAC 2026 Peptide Review Tracker

Independent tracking of the Pharmacy Compounding Advisory Committee review of 12 peptides for the Section 503A Bulk Drug Substances List. Updated as the docket moves.

Last updated: April 24, 2026

On April 15, 2026, the FDA announced a two-day Pharmacy Compounding Advisory Committee meeting for July 23-24, 2026 to review seven peptides for inclusion on the Section 503A Bulk Drug Substances List. A second meeting, scheduled before the end of February 2027, will review five additional peptides.

July 23, 2026 — Day 1

Four peptides under review:

July 24, 2026 — Day 2

Three peptides under review:

Before End of February 2027 — Second Meeting

Five additional peptides scheduled for a second PCAC meeting. Exact date pending FDA announcement.

• GHK-Cu
• Melanotan II
• Cathelicidin (LL-37)
• Dihexa acetate
• PEG-MGF (Pegylated Mechano Growth Factor)

What a PCAC Vote Actually Means

The PCAC is an advisory committee. It reviews scientific evidence and makes recommendations. Its votes are not binding — the FDA decides what to do with each recommendation. FDA has historically followed PCAC recommendations in the majority of cases, but not all.

A recommendation FOR inclusion on the 503A Bulks List means that, if FDA finalizes the addition, licensed 503A compounding pharmacies can legally compound the peptide from bulk drug substance with a valid prescription. A recommendation AGAINST inclusion leaves the compound in its current regulatory status.

These 12 peptides were previously classified as Category 2 under the PCAC framework in 2023 — meaning FDA had identified potential safety concerns that made them ineligible for 503A compounding. The April 2026 notice marks the formal scientific review of those concerns.

How to Submit a Public Comment

Public comments on the proposed additions can be submitted through the Federal eRulemaking Portal at Regulations.gov. All electronic submissions received on or before July 9, 2026 will be provided to the advisory committee for the July meeting. The docket remains open until July 22, 2026, 11:59 PM ET — comments submitted after July 9 are still considered by FDA but will not be given to the committee for the meeting.

Comments must reference docket number FDA-2025-N-6895.

Submit a comment →

Primary Sources

• Federal Register notice 2026-07361 (91 FR 20465, published April 16, 2026)
• FDA advisory committee meeting page (July 23-24, 2026)
• Regulations.gov docket FDA-2025-N-6895

Kalios is an independent reference. We take no position for or against any peptide's inclusion on the 503A Bulks List. This tracker is updated as the docket moves and as primary sources publish new material.