FDA regulatory event · Docket FDA-2025-N-6895

The FDA peptide decision: July 23-24, 2026

The FDA's Pharmacy Compounding Advisory Committee meets to review whether a set of peptides - including BPC-157, TB-500 and Semax - should join the Section 503A list that governs what pharmacies may legally compound. Here is what is actually being decided, what a vote does and does not mean, and where each compound stands today - every claim dated and linked to its primary source.

7days until the committee meets
When
July 23-24, 2026 ET
Who decides
FDA advisory committee (PCAC)
The question
Add these peptides to the 503A list?
Tracked here
7 compounds
See the agendaGet the outcome by email

What is being decided

The only federal pathway for a pharmacy to compound one of these peptides is theSection 503A Bulk Drug Substances List. A substance on the list (Category 1) may be compounded under FDA enforcement discretion; a substance that is not on it hasno affirmative federal authorization, regardless of how it is marketed. Over this two-day meeting, the committee reviews the science on each nominated peptide and votes to recommend - or not recommend - adding it.

The vote is advisory. The FDA is not bound by it, and even a favorable recommendation would still have to clear formal rulemaking before anything changes in practice. That gap between what a headline implies and what the law actually does is the exact thing this reference exists to make clear.

On the agenda

The compounds Peptlas tracks that are scheduled for review, by day. Tap any one for the full, sourced picture. See the FDA meeting notice for the complete official agenda.

Jul 23, 2026Day 1

BPC-157

Under review

Body Protection Compound 157 · Bepecin · PL 14736

Not on the 503A Bulks List; before the FDA advisory committee Jul 23, 2026

Next Jul 23, 2026 · in 7 daysChanged Apr 16, 20262 primary sources

KPV

Under review

Lysine-proline-valine · Lys-Pro-Val · KPV acetate

Removed from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 23, 2026

Next Jul 23, 2026 · in 7 daysChanged Apr 16, 20262 primary sources

MOTS-c

Under review

MOTs-C · Mitochondrial-derived peptide · MOTS-c acetate

Removed from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 23, 2026

Next Jul 23, 2026 · in 7 daysChanged Apr 16, 20262 primary sources

TB-500 (Thymosin Beta-4)

Under review

TB-500 · Thymosin Beta-4 · TB-4

Removed from Category 2 in April 2026; now before the FDA committee, not on the 503A list

Next Jul 23, 2026 · in 7 daysChanged Apr 22, 20261 primary source
Jul 24, 2026Day 2

Emideltide (DSIP)

Under review

Delta sleep-inducing peptide · DSIP · Emideltide acetate

Removed from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 24, 2026

Next Jul 24, 2026 · in 8 daysChanged Apr 16, 20262 primary sources

Epitalon

Under review

Epithalon · Epithalone · AEDG

Removed from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 24, 2026

Next Jul 24, 2026 · in 8 daysChanged Apr 16, 20262 primary sources

Semax

Under review

Semax acetate

No approved product; before the FDA committee Jul 24, 2026

Next Jul 24, 2026 · in 8 daysChanged Apr 16, 20261 primary source

Related deadline - same window, separate process

This is a 503A compounding review. Separately, the public comment period on the FDA's proposal to permanently exclude the 503B GLP-1 drugs, including Semaglutide and Tirzepatide, from the outsourcing-facility bulks list closes July 30, 2026 (Docket FDA-2018-N-3240). Semaglutide (compounded)Tirzepatide (compounded)

What happens after the vote

  1. Jul 23-24, 2026

    The committee votes. A recommendation for or against each peptide. Advisory only - nothing is legalized on the day.

  2. Weeks after

    The FDA responds. The agency weighs the advice and signals its direction. Peptlas records each step, dated and sourced.

  3. ~12-24 months

    Rulemaking. Any change to the 503A list goes through notice-and-comment rulemaking before it takes legal effect.

  4. On any change

    The status moves - and you hear about it. The moment a compound's official status actually changes, its page updates and every subscriber is emailed.

One human-verified email when any status changes. No spam, no selling - we have nothing to sell.

Sources & transparency

Last verified by a human
Jul 16, 2026 (ET)
Who runs this
Peptlas Research Team - independent. About us

Informational only - not medical or legal advice, and no health claim. Always confirm against the linked primary source. Full disclaimer.