FDA peptide meeting results:
July 23-24, 2026.
PCAC recommended six families and recommended against one.
BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax received favorable recommendations. Emideltide received a 6-7-1 recommendation against inclusion. Each family covered separate free-base and acetate questions. These are advisory results, not FDA approval, immediate list action, or a final FDA determination.
- 01Proposal publishedOfficial record
- 02Committee advice14 of 14 form votes recorded
- 03FDA actionNot issued
Times shown in the FDA's Eastern Time schedule.
Seven names, fourteen forms, fourteen completed vote questions. PCAC recommended both reviewed forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for inclusion, and recommended against both Emideltide forms. FDA staff proposed non-inclusion for all fourteen forms, and no final FDA determination has been posted.
All fourteen form-level votes, attached to the final schedule.
01 / Day one / July 23Recommendation recorded BPC-157
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 8-6-1Reported for paired free-base and acetate questions. Nonbinding.02 / Day one / July 23Recommendation recorded KPV
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 8-6-1Reported for paired free-base and acetate questions. Nonbinding.03 / Day one / July 23Recommendation recorded TB-500
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 8-6-1Reported for paired free-base and acetate questions. Nonbinding.04 / Day one / July 23Recommendation recorded MOTS-c
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 7-5-2Reported for paired free-base and acetate questions. Nonbinding.05 / Day two / July 24Recommendation recorded Emideltide
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend against inclusion · 6-7-1Reported for paired free-base and acetate questions. Nonbinding.06 / Day two / July 24Recommendation recorded Epitalon
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 7-4-1Reported for paired free-base and acetate questions. Nonbinding.07 / Day two / July 24Recommendation recorded Semax
- Public hearing
- FDA presentation
- Discussion and vote
Committee recommendationRecommend inclusion · 8-5-1Reported for paired free-base and acetate questions. Nonbinding.
Schedule and result are separate records. All fourteen counts were populated only after the official broadcasts and reviewable reporting supported them. Final FDA action remains a separate source check.
Seven names. Fourteen separate vote questions.
FDA asks one question for each free-base form and one for each acetate form. The reviewed-use column is not an approved indication, treatment recommendation, or evidence that a compounded product is safe or effective.
BPC-157
BPC 157 · Body Protection Compound 157- Forms FDA evaluated
- BPC-157 free baseBPC-157 acetate
- Use FDA reviewed
- Ulcerative colitis
KPV
Lys-Pro-Val · KPV peptide- Forms FDA evaluated
- KPV free baseKPV acetate
- Use FDA reviewed
- Wound healing and inflammatory conditions
TB-500
TB500 · Thymosin beta-4 fragment- Forms FDA evaluated
- TB-500 free baseTB-500 acetate
- Use FDA reviewed
- Wound healing
MOTS-c
MOTS-C · MOTS c- Forms FDA evaluated
- MOTS-c free baseMOTS-c acetate
- Use FDA reviewed
- Obesity and osteoporosis
Emideltide
DSIP · Delta sleep-inducing peptide · Delta sleeping-inducing peptide- Forms FDA evaluated
- Emideltide free baseEmideltide acetate
- Use FDA reviewed
- Opioid withdrawal, chronic insomnia, and narcolepsy
Epitalon
Epithalon · AEDG peptide- Forms FDA evaluated
- Epitalon free baseEpitalon acetate
- Use FDA reviewed
- Insomnia
Semax
ACTH(4-7)-PGP · Semax peptide- Forms FDA evaluated
- Semax free baseSemax acetate
- Use FDA reviewed
- Cerebral ischemia, migraine, and trigeminal neuralgia
Fourteen vote results are recorded. Final FDA action remains pending.
PCAC recommended both reviewed forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for inclusion. It recommended against both Emideltide forms. The committee advice is nonbinding and does not itself change the 503A Bulks List or approve any drug.
- 01FDA proposalPublished in briefing materials
- 02Committee process14 form results recorded
- 03FDA determinationNot issued as of July 27, 2026
What is happening, and when.
July 23: 8:00 a.m. to 6:20 p.m. Eastern Time. BPC-157, KPV, TB-500, and MOTS-c.
July 24: 8:00 a.m. to 4:15 p.m. Eastern Time. Emideltide, Epitalon, and Semax.
The meeting took place at FDA’s White Oak Campus in Silver Spring, Maryland, with an online option and official YouTube broadcasts. The public-comment deadline passed July 22 at 11:59 p.m. Eastern Time.
Track the stage, not just the headline.
Each later stage can change the answer. Peptide Local will date and label updates instead of silently replacing the pre-meeting record.
- Jul 17FDA briefing documents posted
Introduction plus seven substance-specific evaluations became public.
- Jul 22Final agenda and presentation decks posted
FDA published exact hearing, presentation, discussion, and vote times along with fourteen form-specific questions.
- Jul 23Committee day one results
PCAC recommended both reviewed forms of BPC-157, KPV, TB-500, and MOTS-c for inclusion. The recommendations are nonbinding.
- Jul 24Committee day two results
PCAC recommended against both Emideltide forms, then recommended both reviewed forms of Epitalon and Semax for inclusion. The recommendations are nonbinding.
- Jul 27Official record rechecked
FDA's event page includes both broadcasts and the presentation materials. It does not yet post meeting minutes or a final FDA determination.
- LaterFinal FDA action
Any final determination belongs in a separate status field after the agency publishes it.
503A list status is not drug approval.
FDA’s briefing explains that section 503A sets conditions for certain drug products compounded by a state-licensed pharmacist, federal facility, or licensed physician to qualify for exemptions from specified provisions of federal law. One condition concerns which bulk drug substances may be used.
If no applicable USP or NF monograph exists and a substance is not a component of an approved drug, inclusion on the 503A Bulks List can be relevant to that condition. The agency evaluates physical and chemical characterization, safety issues, available evidence of effectiveness or lack of effectiveness, and historical use, then balances the criteria substance by substance.
Seven questions, answered from the current FDA record.
Each answer preserves the difference between the agency proposal, committee advice, and any later final FDA determination. The record is current through July 27, 2026.
When is the FDA peptide meeting?
FDA's Pharmacy Compounding Advisory Committee met July 23 and 24, 2026. The committee recommended including both reviewed forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax, and recommended against including both Emideltide forms. The official broadcasts and exact substance schedule are linked above.
Did FDA ban BPC-157 or the other six substances?
No final FDA determination has been issued. The committee recommended including both reviewed forms of six substance families and recommended against including both Emideltide forms. These advisory recommendations are nonbinding. They do not approve a drug, immediately add or exclude a substance from the 503A Bulks List, or create a blanket ban.
Is the FDA proposal already a final decision?
No. FDA's briefing introduction says it does not intend to issue a final determination until committee input has been considered and all reviews are finalized. The proposal is the agency's pre-meeting position for committee discussion.
What is the 503A Bulks List?
Section 503A describes conditions under which certain patient-specific compounded drugs may qualify for exemptions from specified federal requirements. When a bulk drug substance has no applicable USP or NF monograph and is not a component of an approved drug, appearance on the 503A Bulks List is one route addressed by the statute. Other legal and professional requirements still apply.
Does inclusion on the list mean FDA approved?
No. FDA states that compounded drugs are not FDA approved. A 503A Bulks List decision concerns a condition for qualifying compounding, not approval of a finished drug, proof of safety or effectiveness, or permission for a research seller to market a vial for human use.
When will this page be updated?
All fourteen form-level vote results were added after the official broadcasts and reviewable contemporaneous reporting became available. Every committee recommendation remains separate from any later final FDA determination or rulemaking.
Where can I watch the FDA peptide meeting live?
FDA has posted separate official YouTube broadcasts for July 23 and July 24 on its meeting page. The meeting desk at the top of this tracker converts both start times to the visitor's local time. Use the day-specific broadcast links, then return here for the substance-by-substance proposal, committee recommendation, and later final determination fields.
This page will preserve every decision stage.
The live agenda can mark a scheduled window as active or ended, but it cannot populate a result. A committee-recommendation field will record each verified form-level vote with its source. Any later final FDA determination will receive a separate date, source, and status. Compare each named peptide against destination records in the global peptide country index, or send corrections through the contact form.