BPC-157, KPV, and TB-500 won favorable PCAC votes, building momentum toward the Section 503A Bulks List and a regulated path forward for peptide compounding.
BPC-157's two favorable 8–6–1 votes put peptide compounding policy into the national spotlight. KPV and TB-500 followed with favorable results, turning July 23 into a major day for peptide access.
Follow every result on Rebody's live PCAC peptide vote tracker, including direct links to the FDA webcasts.
The July 23 results
BPC-157: two favorable 8–6–1 recommendations
PCAC voted separately on BPC-157 free base and BPC-157 acetate. Each question received 8 yes votes, 6 no votes, and 1 abstention. That is a favorable recommendation for placing both forms on the 503A Bulks List.
16 million BPC-157 doses. Seven complaints.
Dr. Alex Tatem put more than 16 million doses of BPC-157 on the record. Across that substantial real-world use, just seven complaints were identified—and there was no clear attributable adverse safety signal.
Watch Dr. Alex Tatem present the BPC-157 data.
KPV wins a favorable recommendation
KPV followed BPC-157 with another favorable committee recommendation and another win for the peptide community.
TB-500 delivers another 8–6–1 win
TB-500 received 8 yes votes, 6 no votes, and 1 abstention—another favorable result for the 503A Bulks List.
Dr. Alex Tatem made the case for TB-500
Dr. Alex Tatem went off script during the TB-500 hearing and put four powerful points on the record.
Watch Dr. Alex Tatem make the case for TB-500.
First, the human data. Formal trials have studied full-length thymosin beta-4. Tatem argued that those trials belong in the safety discussion because TB-500 corresponds to its active 17–23 fragment. FDA treated the lack of trials on the isolated fragment as an empty record; Tatem challenged the panel to look at the related human evidence already available.
Then he put real-world scale behind the argument. One compounding-pharmacy network tracked nearly 190,000 vials containing TB-500. It recorded seven complaints. Only one involved standalone TB-500. None were serious.
FDA’s own searches were also empty. Its FAERS search retrieved no TB-500 adverse-event reports, and its literature search found no published human adverse-event cases.
Finally, Tatem expanded the quality record in front of the committee. He pointed to a 503A-quality certificate and proposed monograph submitted before the deadline.
Tatem’s argument: keeping TB-500 outside Category 1 pushes patients toward grey-market research products, while Category 1 would move production under regulated compounding oversight.
What PCAC actually voted on
The committee is advising FDA on whether each bulk drug substance should be included on the Section 503A Bulks List. That list is part of the federal framework governing which bulk drug substances may be used in certain patient-specific compounded drugs when other statutory conditions are met.
FDA scheduled 14 questions across two days: a free-base question and an acetate question for BPC-157, KPV, TB-500, MOTS-c, emideltide, Epitalon, and Semax. The agency's briefing materials proposed that none of the 14 forms be included, making the favorable committee votes a direct disagreement with the staff position presented before the meeting.
What the wins set in motion
The favorable recommendations move BPC-157, KPV, and TB-500 forward for FDA consideration on the 503A Bulks List. The next step is the federal process for updating the list and bringing these substances into a clearer regulated compounding framework.
What happens on July 24
Friday's agenda covers emideltide—also called DSIP—followed by Epitalon and Semax. As on Day 1, each peptide has a separate free-base and acetate question.
The July 24 meeting begins at 8 a.m. Eastern. The official FDA webcast is free, and Rebody's tracker will keep the status of all seven peptides in one place.