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FDA PCAC · 23–24 Jul 202615 required sources acquiredOfficial-record edition

The FDA peptide hearing, explained.

See where FDA staff and the advisory committee disagreed—and what the 14 votes actually mean for access, research and compounding today.

Six peptides received favorable recommendations. FDA has not taken final action.

Explore the 7 peptides →Open the vote table
The hearing in one view
6 of 7subjects received favorable PCAC recommendations
BPCKPVTBMOTSEPISEMXDSIP
PCAC recommendation12 favorable · 2 unfavorable votes
FDA action pendingAdvice—not approval
Peptide subjects
7
each with two form-level questions
Formal votes
14
free base + acetate
Favorable PCAC
12
of 14 form-level questions
Unfavorable PCAC
2
both concerned Emideltide
Legal change now
0
votes are advisory, not FDA approval

Read the votes precisely. “Favorable” means PCAC recommended inclusion on the 503A Bulks List. It does not mean FDA approval, proof of safety or effectiveness, or permission to compound today.

Verified core recordVote tallies, FDA findings, meeting scope and official sources are ready for reader use. Meeting: FDA Pharmacy Compounding Advisory Committee, July 23–24, 2026.
Publication-safe scopeThis edition publishes the verified official record plus named, recording-checked speaker moments. Unreconciled public-comment summaries stay withheld.
Start here

What this means today

The hearing produced advice to FDA—not an approval, ban, prescription rule or immediate change in access.

Approval
None approved

No peptide became FDA approved because of this hearing. PCAC reviewed whether nominated bulk drug substances should be eligible for certain compounding.

Legal status
No immediate change

The votes did not themselves add or remove a substance from the 503A Bulks List and did not authorize a product for sale.

Committee result
12 of 14 favorable

PCAC recommended inclusion on six peptide subjects and recommended against both emideltide questions.

FDA staff
Opposed all 14

FDA staff recommended against listing both forms of every subject, creating the central disagreement readers should understand.

For peptide consumersStart with the peptide you care aboutSee what FDA evaluated, the exact committee vote and what the result does—and does not—mean.For researchersCompare FDA findings with the vote recordInspect the four regulatory criteria, form-level tallies and the precise points where FDA staff and PCAC diverged.For journalists and policy readersGo directly to the primary recordOpen the agenda, questions, roster, briefing packages, presentation decks and regulation.
What the official record shows

One hearing. Two sharply different judgments.

These findings are calculated only from the 14 formal questions, FDA’s published recommendations and the official meeting record.

Official sources only
14/14FDA staff opposed

FDA recommended against including both forms of every subject.

12/14PCAC voted favorably

The committee reached the opposite result on 6 of 7 subjects.

7/7Form pairs matched

Free-base and acetate outcomes matched within every subject, while remaining legally separate votes.

0/14Immediate legal changes

The advisory votes did not approve a drug or change the 503A Bulks List.

THE DEFINING SPLIT

FDA staff and PCAC disagreed on six subjects.

FDA staff found the submitted record insufficient under the applicable criteria for all 7 subjects. PCAC nevertheless recommended inclusion for BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. Emideltide was the sole subject where the committee also voted unfavorably.

Compare all seven results ↓
HOW TO READ IT

A favorable vote is a recommendation—not a finding of safety or effectiveness.

PCAC advises FDA. Any later agency action must follow the applicable regulatory process; the committee vote alone does not authorize compounding or create an FDA-approved product.

See the evidence rules ↓
Next PCAC peptide review
Exact date not announced
FDA timing windowBY FEB
2027

Five more peptides are next.

FDA says PCAC will meet again before the end of February 2027 to consider five additional bulk drug substances for possible inclusion on the 503A Bulks List.

01Cathelicidin
(LL-37)
02GHK-Cu
03Dihexa acetate
04Melanotan II
05Pegylated MGF
(PEG-MGF)

Confirmed by FDA

The five substances, a meeting before March 2027, a public participation opportunity, and online access to the meeting.

Still to be announced

The exact date and time, formal notice, comment docket and deadlines, speaker-request instructions, briefing materials, and webcast link.

July 2026 hearingComplete · 7 subjects
FDA actionPending · current record
View FDA meeting page ↗Check FDA calendar ↗Source checked 30 Jul 2026 · FDA
Peptide-by-peptide guide

Find the peptide you care about

Start with the result, then open the record to inspect FDA findings, reviewed uses, primary sources and each form-level vote.

/
BPC-157
Use(s) listed by FDA for this hearing: ulcerative colitis
favorable
free base
8–6–1
YES · NO · ABSTAIN · n=15
acetate
8–6–1
YES · NO · ABSTAIN · n=15
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
KPV
Use(s) listed by FDA for this hearing: wound healing · inflammatory conditions
favorable
free base
8–6–1
YES · NO · ABSTAIN · n=15
acetate
8–6–1
YES · NO · ABSTAIN · n=15
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
TB-500
Use(s) listed by FDA for this hearing: wound healing
favorable
free base
8–6–1
YES · NO · ABSTAIN · n=15
acetate
8–6–1
YES · NO · ABSTAIN · n=15
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
MOTS-c
Use(s) listed by FDA for this hearing: obesity · osteoporosis
favorable
free base
7–5–2
YES · NO · ABSTAIN · n=14
acetate
7–5–2
YES · NO · ABSTAIN · n=14
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
Emideltide (DSIP)
Use(s) listed by FDA for this hearing: chronic insomnia · narcolepsy · opioid withdrawal
unfavorable
free base
6–7–1
YES · NO · ABSTAIN · n=14
acetate
6–7–1
YES · NO · ABSTAIN · n=14
FDA vs PCACFDA staff and PCAC both opposed inclusion of both forms.
Hearing-specific record
Read full report →
Epitalon
Use(s) listed by FDA for this hearing: insomnia
favorable
free base
7–4–1
YES · NO · ABSTAIN · n=12
acetate
7–4–1
YES · NO · ABSTAIN · n=12
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
Semax
Use(s) listed by FDA for this hearing: cerebral ischemia · migraine · trigeminal neuralgia
favorable
free base
8–5–1
YES · NO · ABSTAIN · n=14
acetate
8–5–1
YES · NO · ABSTAIN · n=14
FDA vs PCACFDA staff recommended against both forms; PCAC voted favorably on both form-level questions.
Hearing-specific record
Read full report →
Hearing-specific record

Verified vote tracker

All 14 form-level questions

Each free-base and acetate question remains a separate row—even when the result was identical. “Favorable” describes the advisory committee’s response to a 503A Bulks List question; it is not FDA approval and did not itself change legal status.

Official record acquired
7Peptide subjectstwo questions each
14Formal questionsfree base + acetate
12Favorable12/14 · PCAC recommended inclusion
2Unfavorable2/14 · both Emideltide forms
14 of 14 questions
All fourteen form-level questions put to the committee, with the exact tally, the yes/no margin, the FDA staff position and a link to the recording.
SubjectFormPCAC resultVote tallyMarginCompositionFDA staffRecording
BPC-157DAY 1 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion04:43:06.628
BPC-157DAY 1 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion04:52:49.520
KPVDAY 1 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion07:06:35.280
KPVDAY 1 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion07:14:04.400
TB-500DAY 1 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion09:48:41.276
TB-500DAY 1 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable8–6–1YES · NO · ABSTAIN · n=15+2
Recommended against inclusion09:54:13.756
MOTS-cDAY 1 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable7–5–2YES · NO · ABSTAIN · n=14+2
Recommended against inclusion11:33:43.680
MOTS-cDAY 1 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable7–5–2YES · NO · ABSTAIN · n=14+2
Recommended against inclusion11:38:51.840
Emideltide (DSIP)DAY 2 · QUESTION 1/2 · OPEN DOSSIERfree baseUnfavorable6–7–1YES · NO · ABSTAIN · n=14-1
Recommended against inclusion03:15:17.600
Emideltide (DSIP)DAY 2 · QUESTION 2/2 · OPEN DOSSIERacetateUnfavorable6–7–1YES · NO · ABSTAIN · n=14-1
Recommended against inclusion03:22:37.359
EpitalonDAY 2 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable7–4–1YES · NO · ABSTAIN · n=12+3
Recommended against inclusion04:54:31.680
EpitalonDAY 2 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable7–4–1YES · NO · ABSTAIN · n=12+3
Recommended against inclusion05:01:31.680
SemaxDAY 2 · QUESTION 1/2 · OPEN DOSSIERfree baseFavorable8–5–1YES · NO · ABSTAIN · n=14+3
Recommended against inclusion07:52:36.958
SemaxDAY 2 · QUESTION 2/2 · OPEN DOSSIERacetateFavorable8–5–1YES · NO · ABSTAIN · n=14+3
Recommended against inclusion08:04:42.558

Member-level roll-call ballots

8 ballots captured from the vote boards and the live webcast, showing who voted how. These are a different unit from the fourteen form-level questions above, and do not map one-to-one onto them.

Filter

BPC-157 (free base)

Jul 23, 2026 · 12:39 PM
✓ Recommended
Yes 8No 6Abstain 1

BPC-157 (acetate)

Jul 23, 2026 · 12:49 PM
✓ Recommended
Yes 8No 6Abstain 1

KPV

Jul 23, 2026 · 3:03 PM
✓ Recommended
Yes 8No 6Abstain 1

TB-500

Jul 23, 2026 · 5:45 PM
✓ Recommended
Yes 8No 6Abstain 1

MOTS-c

Jul 23, 2026 · 7:30 PM
✓ Recommended
Yes 7No 5Abstain 2

Emideltide / DSIP

Jul 24, 2026 · 11:11 AM
Provisional✕ Not recommended
Yes 6No 7Abstain 1

Epitalon

Jul 24, 2026 · 12:50 PM
Provisional✓ Recommended
Yes 7No 4Abstain 1

Semax

Jul 24, 2026 · 3:50 PM
Provisional✓ Recommended
Yes 8No 5Abstain 1
How to read the table. Tally order is Yes · No · Abstain. “Favorable” means PCAC recommended inclusion on the 503A Bulks List; it is not FDA approval and does not change legal status by itself. The recording link opens the announced result.
Member-level ballot record published8 captured ballots across 19 listed members, under “By voter”. Abstentions and not-eligible ballots are shown, never inferred.
Regulatory path

Where the process stands

PCAC has advised. FDA controls every remaining agency step. Committee advice is complete; the final FDA determination is pending.

  1. 1
    NominatedSubstances submitted for evaluation
  2. 2
    FDA evaluationStaff reviewed the four criteria
  3. 3
    PCAC recommendation14 advisory votes recorded
  4. 4
    FDA actionNext agency decision is pending
  5. 5
    Public commentIf FDA proposes rulemaking
  6. 6
    Final ruleOnly a later final action changes the list
What changed

PCAC created an advisory record

  • Fourteen formal questions were decided across seven peptide subjects.
  • 12 questions received favorable recommendations; 2 received unfavorable recommendations.
  • The committee diverged from FDA staff on six of the seven subjects.
What did not change

No substance became FDA approved

  • The votes did not themselves add any substance to the 503A Bulks List.
  • The committee did not establish safety or effectiveness for clinical use.
  • FDA is not legally bound to follow the committee’s recommendations.
The central event-level finding

FDA staff versus PCAC

FDA staff opposed inclusion of both forms for every subject. PCAC disagreed on six.

Peptide subjectFDA staffPCAC
BPC-157Opposed both formsFavorable · 2/2
KPVOpposed both formsFavorable · 2/2
TB-500Opposed both formsFavorable · 2/2
MOTS-cOpposed both formsFavorable · 2/2
Emideltide (DSIP)Opposed both formsUnfavorable · 2/2
EpitalonOpposed both formsFavorable · 2/2
SemaxOpposed both formsFavorable · 2/2
“Favorable” describes the committee recommendation only. FDA action remains pending.
01 · DIVERGENCE

Six subjects split FDA staff and PCAC

The committee’s evidentiary judgment differed from FDA staff on 12 of 14 questions.

02 · CONSISTENCY

Forms moved together

Within every subject, free-base and acetate outcomes matched. The records remain separate because the questions were legally distinct.

03 · SCOPE

FDA evaluated defined uses

Broader uses associated with a peptide were not necessarily part of this proceeding. Each record identifies the reviewed use.

Primary record

Inspect every official source

These 15 required sources establish the meeting, formal questions, FDA analysis, presentation record and governing regulatory framework.

Source architecture
15

Primary documents acquired from FDA and the electronic Code of Federal Regulations.

04
Meeting administrationEvent page, voting questions, roster and final agenda
02
FDA presentationsComplete Day 1 and Day 2 presentation files
08
Scientific analysisIntroduction plus seven substance-specific briefing documents
01
Governing standard21 CFR § 216.23 criteria for the 503A Bulks List
July 23–24 2026 Meeting of the Pharmacy Compounding Advisory CommitteeFDA · html
Formal voting questionsFDA · pdf
Final committee rosterFDA · pdf
Final agendaFDA · pdf
Day 1 FDA presentationsFDA · pdf
Day 2 FDA presentationsFDA · pdf
21 CFR Part 216 Subpart B § 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic ActeCFR · xml
FDA Briefing Document IntroductionFDA · pdf
FDA briefing document — BPC-157FDA · pdf
FDA briefing document — EmideltideFDA · pdf
FDA briefing document — EpitalonFDA · pdf
FDA briefing document — KPVFDA · pdf
FDA briefing document — MOTS-cFDA · pdf
FDA briefing document — SemaxFDA · pdf
FDA briefing document — TB-500FDA · pdf
How to use this record

What readers can rely on

Official results, primary-source findings and unfinished work are kept visibly separate.

Official record
15 sources

FDA materials, the agenda, roster and governing regulation are available from the source list.

Vote results
14 tallies

Separate results for the free-base and acetate forms, linked to the recorded announcements.

FDA findings
35 findings

Five official findings for each subject: characterization, effectiveness, safety, historical use and recommendation.

Still being analyzed
Q&A

Committee questions and individual voting rationales are indexed but not yet summarized. The tally does not reveal why each member voted.

Publication scope: Only named speaker moments reconciled against a word-timestamped machine transcript of the official recording appear here. The method is two-pass transcript reconciliation: both passes read that same transcript, so this is not audio review and not independent primary-source confirmation. Where the two passes disagreed about who was speaking, the moment was withheld rather than published. Statements remain attributed arguments unless the underlying evidence was independently established from a named source outside the hearing record, and each moment carries its own disclosed limitations.

How labels work
  • Verbatim quotation · wording checked against audio
  • Recording-checked paraphrase · attributed argument
  • FDA staff finding · official briefing or presentation
  • PCAC member statement · from the meeting record
  • Public testimony · speaker’s own claim, not verified
  • Editorial analysis · PeptideBase assessment, labelled as such
Decision boundaryPCAC advice is not FDA approval, does not establish safety or effectiveness, and did not itself place either form on the 503A Bulks List.
How this record earns trust

Every conclusion should lead back to evidence.

PeptideBase separates FDA’s published findings, the committee’s advisory votes and work that is not yet publication-ready—so readers can inspect the record without confusing one layer for another.

01
Official facts come from official records

Vote totals, FDA findings, meeting questions and regulatory criteria link to the source that establishes them.

02
Attributed argument is never rendered as evidence

Named speaker moments are labelled as recording-checked paraphrase and kept separate from FDA findings and committee votes.

03
Unfinished work stays visibly unfinished

Pending FDA action, unresolved sources and analysis still in progress are labelled rather than silently completed.

15 official sources acquired · corrections remain visible
Inspect the sourcesFollow what happens next →

Member-level ballots and industry-ties profiles are also published on the PCAC vote tracker. Both surfaces read the same data modules. FDA introduction

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