Did the FDA approve BPC-157 and TB-500?

No. An FDA advisory committee met on 23–24 July 2026 and voted on whether seven peptides should be eligible for pharmacy compounding. That is not drug approval, the vote is not binding, and FDA has not published the result.

No. The FDA did not approve any of these peptides. On 23–24 July 2026, FDA's Pharmacy Compounding Advisory Committee met and voted on whether seven substances should be added to a list of bulk drug substances that pharmacies may use in compounding. Three things follow from that, and all three get lost in the coverage.

What was actually voted on

FDA's own questions document puts it plainly. For each substance the committee was asked: "VOTE: Should [substance] be placed on the list?" A yes vote favours allowing compounding.

There were fourteen votes, not seven — each substance was voted on twice, once as a free base and once as an acetate salt.

The seven substances

SubstanceWhat FDA evaluated it for
BPC-157Ulcerative colitis
KPVWound healing and inflammatory conditions
TB-500Wound healing
MOTS-cObesity and osteoporosis
Emideltide (DSIP)Opioid withdrawal, chronic insomnia, narcolepsy
SemaxCerebral ischaemia, migraine, trigeminal neuralgia
EpitalonInsomnia

Why we are not publishing the vote tallies

Numbers are circulating — reporters were in the room, and STAT, NPR and the FDA Law Blog have all reported outcomes. We are not repeating those tallies as fact here, for one reason: FDA has published no vote record, and the figures already disagree between sources on at least one substance.

This site's rule is that every number links to its source. These numbers have no FDA source to link to yet. When FDA publishes the roll call, this page will carry it with the link.

What we can say without qualification is that reports agree on the direction: the committee recommended in favour for six substances and against for one, Emideltide. We have not independently verified that, and we are telling you so.

What has not changed

All seven substances remain where they were before the meeting: in FDA's table of bulk drug substances nominated but withdrawn. None is on the 503A Bulks List. None is an FDA-approved drug. Each compound page on this site shows its current registered trial count and regulatory status.

What would change this page

FDA publishing the roll call or meeting minutes; FDA issuing a final determination on any of these substances; or any of them moving onto the 503A Bulks List. We check the source page and will update this with the date.

Sources

Checked against FDA's published materials on 2026-07-30. Suggested citation: What's Actually Known, "Did the FDA approve BPC-157 and TB-500?", 2026-07-30.

← See every compound and its trial record