Notice

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The Peptide Docket

What the FDA did about peptides in 2026, and what it does not cover

In April the agency moved 12 peptide substances off its Category 2 list. In July an advisory committee heard seven of them. Every line below cites a dated public source.

Compiled from public recordsLast checked 21 September 2026

The scope of the action

What it covers

  • Bulk drug substances used by compounding pharmacies under section 503A.
  • Whether a substance may be placed on the 503A bulks list, which the advisory committee advises on.
  • Pharmaceutical-grade material made under cGMP for use in a patient product.

What it does not cover

  • Research-use-only chemicals sold online. Those are not approved for human use, and this process does not change that.
  • Approval of any peptide as a drug. Inclusion on a compounding list is not an approval.
  • Any claim that a peptide is safe or effective. The nominated uses listed are proposals, not findings.

This distinction is the whole point of the page. The FDA process concerns pharmacy-compounded medicines. It says nothing about the research chemicals sold online, which remain not for human use.

Compiled by The Peptide Docket. Not an FDA publication.

See which vendors publish their lab reports

The record, in order

  1. 01

    FDA moves to remove 12 peptides from the Category 2 list

    The agency announced it would remove 12 peptide bulk drug substances from Category 2, the list of substances that raise significant safety concerns for compounding.

    The 12 named substances are BPC-157, Cathelicidin LL-37, Dihexa acetate, Emideltide (DSIP), Epitalon, GHK-Cu (injectable routes), KPV, pegylated Mechano Growth Factor (PEG-MGF), Melanotan II, MOTS-C, Semax and Thymosin Beta-4 fragment (TB-500).

    Removal from Category 2 does not by itself make a substance eligible for compounding. A law-firm analysis of the announcement describes the immediate consequence as limited, because current policy covers Category 1 substances.

    Source: frierlevitt.com, FDA peptide update 2026
  2. 02FDA-2025-N-6895

    Meeting noticed and a public docket opened

    A Federal Register notice announced the Pharmacy Compounding Advisory Committee meeting, established a public docket and requested comments on bulk drug substances nominated for the section 503A list.

    The docket number is FDA-2025-N-6895. The FDA meeting page records that the docket closed on 22 July 2026.

    Source: federalregister.gov, notice of meeting
  3. 03FDA-2025-N-6895

    Committee hears BPC-157, KPV, TB-500 and MOTS-C

    Day one of the Pharmacy Compounding Advisory Committee meeting covered four peptide bulk drug substances nominated for the 503A bulks list.

    The FDA page lists the nominated use discussed for each: BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-C for obesity and osteoporosis.

    A nominated use is what the nominator proposed. It is not an approved use, and it is not evidence that the substance works.

    Source: fda.gov, advisory committee calendar
  4. 04FDA-2025-N-6895

    Committee hears Emideltide, Semax and Epitalon

    Day two covered three further substances, again as nominations for inclusion on the 503A bulks list.

    The nominated uses listed are Emideltide (DSIP) for opioid withdrawal, chronic insomnia and narcolepsy; Semax for cerebral ischemia, migraine and trigeminal neuralgia; and Epitalon for insomnia.

    We read the FDA meeting page on 21 September 2026. It listed briefing documents, the agenda and the roster. It did not list votes or formal recommendations, so this site states none.

    Source: fda.gov, advisory committee calendar
  5. 05

    Five remaining substances await consultation

    Five of the 12 substances are scheduled for advisory committee consultation at a later meeting.

    The five are Cathelicidin LL-37, Dihexa acetate, GHK-Cu (injectable), pegylated Mechano Growth Factor (PEG-MGF) and Melanotan II.

    This entry describes a schedule, not a decision. We will update it when a dated FDA source says otherwise.

    Source: frierlevitt.com, FDA peptide update 2026

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