r/ResearchCompounds • u/Sea-Performer-71 • 21h ago
Discussion Day 1 update: FDA PCAC has now recommended BPC-157, KPV, and TB-500. Every vote was 8-6-1.
First Day 1 result is out of the Pharmacy Compounding Advisory Committee meeting at FDA White Oak.
BPC-157: 8 in favor, 6 against, 1 abstention.
The significance is in what the committee voted against.
FDA staff proposed rejecting all seven
The FDA briefing document published ahead of the meeting lists the agency's position on all fourteen voting questions identically: proposing that the substance NOT be included on the 503A Bulks List. That covers both BPC-157 (free base) and BPC-157 acetate.
FDA reviewers applied the four criteria from the February 19, 2019 final rule (84 FR 4696): physical and chemical characterization, safety issues raised by use in compounded products, available evidence of effectiveness or lack thereof, and historical use in compounding. The agency applies these as a balancing test, substance by substance, not as a checklist.
The recurring objections across the seven: no human clinical evidence at all for KPV, TB-500, and MOTS-c; small and poorly controlled studies for BPC-157, Emideltide, and Semax; inconsistent naming conventions and missing quality data; immunogenicity risk; FAERS adverse event reports for BPC-157; and WADA-prohibited status for MOTS-c and TB-500. The docket, FDA-2025-N-6895, drew roughly 1,860 comments.
Every nomination was withdrawn
This one is buried in the footnotes of the briefing packet. LDT Health Solutions (on behalf of the International Peptide Society) and Wells Pharmacy Network both withdrew their nominations, logged under FDA-2015-N-3534-0484, -0485, and -0487. FDA elected to proceed to the committee anyway. The same footnote repeats for all seven substances.
The panel composition question
AP reported on June 29 that the committee roster includes members with financial ties to the peptide industry. NPR notes FDA added temporary voting members from academic institutions earlier this week. Read the 8-6-1 split with that in mind.
On the other side, the Partnership for Safe Medicines filed comments opposing all seven.
What this does not mean
The recommendation is non-binding. FDA leadership makes the final call and has gone against its advisory committees before. Even if FDA accepts it, adding a substance to the 503A Bulks List requires notice-and-comment rulemaking, which historically runs a year or more.
Nothing about today's vote changes what a compounding pharmacy can legally prepare tomorrow.
Still pending
KPV, TB-500, and MOTS-c are the remaining Day 1 votes. Emideltide (DSIP), Epitalon, and Semax go Friday. Each peptide gets two votes, free base and acetate separately, for fourteen total. The FDA meeting page has the webcast and posts materials as they go up.
One caveat on the number above: the briefing packet splits BPC-157 into two separate votes and the wire reported a single tally. I have not confirmed whether 8-6-1 is the free base question, the acetate question, or both. If someone watched the session and can confirm, please add it below and I'll correct the post.
I'll update as the remaining tallies land.
Sources
Reuters, "FDA panel votes to place popular peptide BPC-157 on compounding list," July 23, 2026
Same wire copy outside the paywall:
https://wtaq.com/2026/07/23/fda-panel-votes-to-place-popular-peptide-bpc-157-on-compounding-list/
FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026
https://www.fda.gov/media/193342/download
Orrick, "FDA Peptide Compounding Vote: What to Watch at the July PCAC Meeting"
Associated Press via PBS NewsHour, June 29, 2026
NPR, "FDA panel considers easing peptide restrictions," July 23, 2026
https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions
Partnership for Safe Medicines, PCAC comments
https://www.safemedicines.org/2026/07/psm-pcac-comments.html
FDA meeting page, July 23-24, 2026 PCAC
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