Educational information only. Not medical advice, not a diagnosis, and not an offer to sell any product. These are experimental or unapproved substances; we do not provide dosage, sourcing, or use guidance. Consult a licensed clinician. We link to official sources only.
| Peptide | Nominated for | FDA staff position | Outcome |
|---|---|---|---|
| Body Protection Compound 157 | Ulcerative colitis (other referenced uses deemed insufficiently supported) | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 8 yes / 6 no / 1 abstain; acetate: 8 yes / 6 no / 1 abstain — favorable advisory votes |
| Thymosin beta-4 fragment | Wound healing (lyophilized powder for injection) | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 8 yes / 6 no / 1 abstain; acetate: 8 yes / 6 no / 1 abstain — favorable advisory votes |
| Mitochondrial-derived peptide | Obesity; osteoporosis | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 7 yes / 5 no / 2 abstain; acetate: 7 yes / 5 no / 2 abstain — favorable advisory votes |
| Lysine-proline-valine tripeptide | Wound healing; inflammatory conditions (topical cream/gel) | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 8 yes / 6 no / 1 abstain; acetate: 8 yes / 6 no / 1 abstain — favorable advisory votes |
| ACTH-fragment heptapeptide | Cerebral ischemia; migraine; trigeminal neuralgia | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 8 yes / 5 no / 1 abstain; acetate: 8 yes / 5 no / 1 abstain — favorable advisory votes |
| Epithalon | Insomnia (SC injection) | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 7 yes / 4 no / 1 abstain; acetate: 7 yes / 4 no / 1 abstain — favorable advisory votes |
| Delta Sleep-Inducing Peptide | Opioid withdrawal; chronic insomnia; narcolepsy | FDA staff proposed NOT adding (free base and acetate reviewed separately) | Free base: 6 yes / 7 no / 1 abstain; acetate: 6 yes / 7 no / 1 abstain — unfavorable advisory votes |
PCAC gave favorable advisory votes to the free-base and acetate forms of BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. It gave unfavorable advisory votes to both forms of Emideltide/DSIP. Each form was a separate vote; the table above preserves the form-specific tally.
PCAC recommendations are non-binding. A favorable vote is not FDA approval, does not itself place a substance on the 503A Bulks List, does not establish safety or effectiveness, and does not by itself create permission to compound, sell or market it. Formal list changes run through later FDA action and notice-and-comment rulemaking.
As of July 27, 2026, LabelDose found no FDA interim enforcement-policy update, proposed rule or final rule implementing these July votes. The accurate status is committee recommendation pending later FDA action—not “approved,” “listed,” or “available.”
No. An FDA advisory committee recommended both forms of six substances for possible inclusion on the 503A Bulks List. The recommendations are non-binding and are not drug approvals or final list additions.
The vote itself did not change the governing list or create new permission. Any later change requires separate FDA action; the applicable substance status and compounding rules still need to be checked.
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Educational information only. Not medical advice, not a diagnosis, and not an offer to sell any product. These are experimental or unapproved substances; we do not provide dosage, sourcing, or use guidance. Consult a licensed clinician. We link to official sources only.