FDA advisers review seven peptides for compounding

FDA's Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026, at FDA's White Oak campus in Silver Spring, Maryland ^{[1, 2]}. The question was whether seven peptides should go on the 503A Bulks List, the list of ingredients that compounding pharmacies may use ^[1]. The public docket is FDA-2025-N-6895 ^[1].

The seven peptides

FDA reviewed each peptide for the uses its nominators proposed ^[2]:

• BPC-157: ulcerative colitis ^[2].
• KPV: wounds and inflammatory conditions ^[2].
• TB-500: wounds ^[2].
• MOTS-c: obesity and osteoporosis ^[2].
• Emideltide, also called DSIP: opioid withdrawal, chronic insomnia and narcolepsy ^[2].
• Semax: cerebral ischemia, migraine and trigeminal neuralgia ^[2].
• Epitalon: insomnia ^[2].

The committee voted separately on the free base and the acetate salt of each peptide ^[3].

What FDA's own reviewers proposed

FDA's briefing document for each of the seven ends with the same proposal: do not add it to the 503A Bulks List ^{[4, 5, 6, 7, 8, 9, 10]}. For BPC-157, FDA said the substance is not well characterized chemically, there is little information on its safety or on immune reactions to it, the evidence is too thin to judge it for ulcerative colitis, and approved drugs already exist for that disease ^[4].

What the vote means

The committee gives advice; it does not decide. FDA says it does not intend to make a final determination until it has considered the committee's input and finished its reviews ^[11]. A peptide that is not part of an approved drug and has no USP monograph can be compounded under section 503A only if it appears on the 503A Bulks List, which FDA sets through regulations ^[11].

Update, October 28, 2026

HHS released an interim enforcement policy covering six of these peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500 ^[12]. It states that the committee voted in favor of listing them, and it lets pharmacies compound them under set conditions while FDA finishes its rule. It is not FDA approval. Details are in our HHS policy news post ^[12].

As of October 26, 2026, FDA's meeting page lists the agenda, briefing documents, presentations and webcast links, but not the committee's vote results or minutes ^[2]. We will add the official results when FDA posts them ^[2]. Until FDA changes the list, the status of each peptide is on the Status Tracker ^[2].

Peptides in this update

• BPC-157: FDA status, research and uses
• KPV: FDA status, research and uses
• TB-500 and Thymosin Beta-4: FDA status, research and uses
• MOTS-c: FDA status, research and uses
• Semax: FDA status, research and uses
• Epitalon: FDA status, research and uses

More news

• DEA telemedicine flexibilities run through 2026
• FDA proposes keeping GLP-1s off the 503B bulks list
• FDA warns 30 telehealth firms over compounded GLP-1 ads
• HHS interim policy covers 6 peptides for compounding
• Most peptides leave FDA's Category 2 list
• WADA 2027 List names peptides as S0 examples

Status of every peptide

• FDA Peptide Status Tracker

Sources

1. Federal Register: Pharmacy Compounding Advisory Committee; Notice of Meeting (April 16, 2026)
2. FDA: July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee
3. FDA: PCAC July 23-24, 2026, Questions
4. FDA: Briefing Document, BPC-157-related bulk drug substances
5. FDA: Briefing Document, KPV-related bulk drug substances
6. FDA: Briefing Document, TB-500-related bulk drug substances
7. FDA: Briefing Document, MOTS-c-related bulk drug substances
8. FDA: Briefing Document, emideltide-related bulk drug substances
9. FDA: Briefing Document, Semax-related bulk drug substances
10. FDA: Briefing Document, Epitalon-related bulk drug substances
11. FDA: Briefing Document Introduction, PCAC July 23-24, 2026
12. HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Oct 28, 2026)

Updated October 28, 2026. Educational information, not medical advice.