MOLRECORD
NEWS BRIEF REGULATION Regulation and policy

Six peptides recommended for the 503A bulks list

The advisory committee's vote is a recommendation; the agency has not acted on it.

Published 5 Oct 2026 Event 23–24 Jul 2026 Sources 5 REGULATORY · ADVISORY VOTESTATUS · FDA DECISION PENDINGNEXT · PCAC BY FEB 2027

Over two days of public meetings on 23 and 24 July 2026, the Pharmacy Compounding Advisory Committee reviewed seven peptide bulk drug substances whose nominations had earlier been withdrawn. It voted to recommend six of them for the list of substances that state-licensed pharmacies may use in compounding under section 503A: BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax. Emideltide (DSIP) was not recommended. [1][2]

The margins were narrow. BPC-157, KPV and TB-500 each passed 8 to 6 with one abstention; MOTS-c passed 7 to 5 with two abstentions; epitalon passed 7 to 4 with one abstention; Semax on a similar margin. [3][5]

A committee vote is not a listing. The recommendations go to the agency, and the Secretary of Health and Human Services must approve any addition to the bulks list. Reporting since the meeting says the agency's own staff scientists argued against listing, citing the absence of human clinical data for several nominees. [1][4]

A second peptide meeting, covering five further substances, is scheduled before the end of February 2027. [2]

SOURCES

  1. NCPA. FDA advisory committee nominates six peptides for pharmacies to compound. 31 Jul 2026. News report. https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound
  2. GoodRx Health. Peptide FDA updates: compounding advisory committee votes to recommend 6 peptides. 24 Jul 2026. News report. https://www.goodrx.com/health-topic/peptides/what-peptides-are-fda-approved
  3. Fuse Health. What peptides are FDA approved? The 2026 list (vote counts, citing FDA meeting materials). Sep 2026. Secondary summary. https://www.fusehealth.com/blogs/what-peptides-are-fda-approved-2026-list
  4. AJMC. Peptide regulation debate intensifies after FDA advisory panel's controversial vote. 25 Sep 2026. News feature. https://www.ajmc.com/view/peptide-regulation-debate-intensifies-after-fda-advisory-panel-s-controversial-vote
  5. CNN. FDA advisers support easing restrictions on six peptides (epitalon vote 7–4, one abstention). 31 Jul 2026. News report. https://www.cnn.com/2026/07/31/health/what-are-peptides-fda-next-steps-wellness

CHANGELOG · 5 Oct 2026 FIRST PUBLISHED · CORRECTIONS ARE ADDED HERE, NEVER HIDDEN