FDA Advisory Panel Peptide Vote (July 2026): Evidence Cards for BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, and Emideltide

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) met July 23–24, 2026 to discuss seven peptide-related bulk drug substances being considered for the 503A Bulks List. That list is one of three bulk-substance pathways described in section 503A; appearing on it is not the only condition a compounder must satisfy. After the meeting, contemporaneous news reports said the committee recommended six of the seven.

A committee recommendation is not FDA approval, a final rule, a prescription, a safety finding, or proof that a clinic can offer a peptide today. This page gives one dated evidence card per compound, separates what FDA staff reviewed from what the committee recommended from what the law actually is, and lists what the vote did not do.

Read this first: as of 2026-08-16, the current text of 21 CFR 216.23 lists six other substances and none of the seven discussed at this meeting. An advisory vote does not amend that regulation. See the peptide tracker for the live status of every compound covered here.

The three steps patients mix up

Every claim about this vote should be tested against three separate things:

1. FDA written review. FDA published a briefing that proposed not adding either form of all seven substances after reviewing characterization, historical use, effectiveness, and safety. That was the agency’s written proposal, not a staff roll-call vote.
2. Advisory-committee recommendation. The PCAC — independent outside experts — voted. Its advice is non-binding; FDA “generally follows the recommendations but is not legally bound to do so.”
3. Current regulation. FDA addresses additions to the 503A list through notice-and-comment rulemaking. The committee vote itself did not change the current list in 21 CFR 216.23.

Seven evidence cards (current as of 2026-08-16)

1. BPC-157

Field	Finding
Use FDA evaluated	Ulcerative colitis
FDA’s evidence conclusion	The official briefing found insufficient evidence to conclude that BPC-157 is effective for ulcerative colitis and identified characterization, safety, and immunogenicity concerns.
Committee recommendation	Recommended (reported 8–6 with one abstention).
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not approve BPC-157, prove it works for ulcerative colitis, or validate recovery, injury, or anti-aging marketing.

2. KPV

Field	Finding
Use FDA evaluated	Wound healing and inflammatory conditions
FDA’s evidence conclusion	The official briefing said neither the nomination nor FDA’s search identified clinical studies of KPV administered in humans for the evaluated uses.
Committee recommendation	Recommended.
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not turn a broad “anti-inflammatory” claim into an FDA-reviewed indication.

3. TB-500

Field	Finding
Use FDA evaluated	Wound healing
FDA’s evidence conclusion	The official briefing found no clinical evidence for wound healing and no human-use information sufficient to assess safety or effectiveness.
Committee recommendation	Recommended.
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not convert athletic-recovery language into human-outcome proof.

4. MOTS-c

Field	Finding
Use FDA evaluated	Obesity and osteoporosis (FDA lists the spelling “MOTs-C”)
FDA’s evidence conclusion	The official briefing found no clinical studies administering MOTS-c-related substances to humans for the evaluated uses.
Committee recommendation	Recommended.
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not create a longevity, metabolism, or energy promise.

5. Semax

Field	Finding
Use FDA evaluated	Cerebral ischemia, migraine, and trigeminal neuralgia
FDA’s evidence conclusion	The official briefing found insufficient evidence for cerebral ischemia, migraine, or trigeminal neuralgia; the limited studies had major design and reporting problems.
Committee recommendation	Recommended.
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not give FDA-reviewed support to focus, mood, or productivity claims.

6. Epitalon

Field	Finding
Use FDA evaluated	Insomnia
FDA’s evidence conclusion	The official briefing found no clinical safety data for human use and insufficient evidence of effectiveness for insomnia.
Committee recommendation	Recommended.
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the advisory recommendation did not amend the list.
What the vote did not do	Did not endorse anti-aging or longevity language as the reviewed use.

7. Emideltide (DSIP)

Field	Finding
Use FDA evaluated	Opioid withdrawal, chronic insomnia, and narcolepsy
FDA’s evidence conclusion	The official briefing found limited, poorly controlled evidence and insufficient safety and effectiveness information for chronic insomnia, narcolepsy, and opioid withdrawal.
Committee recommendation	Not recommended (rejected).
Current regulatory status	Not listed in the current text of 21 CFR 216.23; the unfavorable advisory recommendation did not amend the list.
What the vote did not do	“Sleep peptide” marketing is not committee support; the committee declined to recommend access.

Comparison table

Peptide	Use FDA evaluated	Committee recommendation	Legal/rulemaking status (2026-08-16)
BPC-157	Ulcerative colitis	Recommended (reported 8–6, one abstention)	Not in current 21 CFR 216.23
KPV	Wound healing / inflammatory conditions	Recommended	Not in current 21 CFR 216.23
TB-500	Wound healing	Recommended	Not in current 21 CFR 216.23
MOTS-c	Obesity / osteoporosis	Recommended	Not in current 21 CFR 216.23
Semax	Cerebral ischemia / migraine / trigeminal neuralgia	Recommended	Not in current 21 CFR 216.23
Epitalon	Insomnia	Recommended	Not in current 21 CFR 216.23
Emideltide (DSIP)	Opioid withdrawal / chronic insomnia / narcolepsy	Not recommended	Not in current 21 CFR 216.23

What the vote did not do

• It did not approve any peptide as an FDA-approved drug.
• It did not declare any peptide safe or effective for any use.
• It did not put any peptide on the 503A Bulks List or change its legal status.
• It did not override state medical-board, pharmacy, or prescription requirements.
• It did not remove adverse-event risk or the need for a prescription and a licensed pharmacy.
• It did not validate clinic sales language — a committee recommendation is not clinical evidence.

How to use this when comparing clinics

Ask each clinic to be specific. A precise clinic answer separates an advisory vote from a 503A Bulks List decision from an FDA-approved medicine and an off-label or compounded-care discussion. If a clinic collapses all of that into “FDA approved,” slow down. Run the same test with our verification methodology and 8-check 503A guide, then see the procedural walkthrough in what the vote fallout means for patient questions. When you are ready to compare providers, use the clinic finder.

Questions to ask before you book

1. Did FDA issue a final rule, or did an advisory committee make a non-binding recommendation?
2. Is this an FDA-approved drug, a compounded drug, or research context?
3. Does the evidence match the exact use being marketed — for this molecule, route, dose form, and patient group?
4. Can the clinic name the licensed clinician, the pharmacy path, the follow-up plan, and the total cost before payment?

Compound pages and the live tracker

• Peptide tracker — live compound status
• BPC-157
• KPV
• TB-500
• MOTS-c
• Semax
• Epitalon
• Emideltide (DSIP)

Compare peptide clinics by city

Use the same questions locally. Start with the city page closest to you, then ask each clinic to explain its evidence, license, pharmacy path, and follow-up plan in plain language.

• Austin peptide clinics
• Beverly Hills peptide clinics
• Charlotte peptide clinics
• Chicago peptide clinics
• Columbus peptide clinics
• Dallas peptide clinics
• Denver peptide clinics
• Fort Worth peptide clinics
• Houston peptide clinics
• Indianapolis peptide clinics
• Jacksonville peptide clinics
• Las Vegas peptide clinics
• Los Angeles peptide clinics
• Louisville peptide clinics
• Nashville peptide clinics
• New York peptide clinics
• Oklahoma City peptide clinics
• Philadelphia peptide clinics
• Phoenix peptide clinics
• Portland peptide clinics
• San Antonio peptide clinics
• San Diego peptide clinics
• Sarasota peptide clinics
• Scottsdale peptide clinics
• Seattle peptide clinics
• West Chester peptide clinics

Sources and further reading (retrieved 2026-08-16)

• FDA — July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting (agenda, uses evaluated, non-binding advisory language)
• FDA — PCAC briefing introduction and the agency’s proposals for all seven substances
• FDA — Bulk Drug Substances Used in Compounding Under Section 503A
• eCFR — current 503A Bulks List in 21 CFR 216.23
• FDA — Compounding and the FDA: Questions and Answers
• Federal Register — PCAC Notice of Meeting (FR Doc 2026-07361)
• ABC News — FDA advisers narrowly vote to add 6 peptides to a drug compounding list
• AP News — FDA panel narrowly backs unapproved peptide drugs

Medical-information disclaimer

This page is educational information, not medical advice, a diagnosis, or a treatment recommendation. It does not recommend any peptide, medication, pharmacy, clinic, or treatment plan, and it makes no claim that an advisory-committee vote changed the law. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness, or quality before they are marketed. Talk to a licensed clinician about your own situation. See our full medical disclaimer.