FDA Advisory Panel Narrowly Votes to Add Six Peptides to Compounding List

The United States Food and Drug Administration's Pharmacy Compounding Advisory Committee voted on 23-24 July 2026 to recommend adding six of seven unapproved peptides to the national bulk drug substances list. The votes, taken across two days of proceedings in Silver Spring, Maryland, narrowly approved BPC-157, KPV, TB-500, and MOTS-C on the first day, followed by Emideltide and Semax on the second. Only Epitalon, a peptide studied for sleep-related applications, was rejected.

The recommendations are non-binding. The FDA retains the authority to accept or reject them when it issues a final decision.

What the Panel Was Considering

The seven peptides had been referred to the committee to determine whether they should be added to the "503A Bulks List," a registry of active ingredients that licensed compounding pharmacies can legally use to prepare custom medications for individual patients. None of the seven have completed the FDA's standard drug approval process.

In 2023, the FDA had restricted access to these peptides, citing insufficient evidence of safety and efficacy. Since then, demand has grown through gray-market channels, aided by public endorsements from high-profile figures, including Health and Human Services Secretary Robert F. Kennedy Jr., who told podcaster Joe Rogan he is a "big fan" of peptides and has used them personally.

FDA Scientists Recommended Against

Agency reviewers filed briefing documents ahead of the meeting advising against broader access. The Centre for Drug Evaluation and Research argued that the evidentiary base for the seven peptides does not meet the threshold required for compounding authorisation. During presentations on 23 July, career scientists reiterated that most of the compounds lack controlled human trial data and that their true risk-benefit profiles remain unknown.

The panel's vote overrides this internal recommendation. Each vote was closely contested, with the final margins narrow enough that a single-vote shift in several instances would have changed the outcome.

Conflicts of Interest Draw Scrutiny

The advisory committee's composition drew scrutiny before the meeting began. Healio reported on 2 July that several panel members had financial ties to the peptide and compounding pharmacy industries, including clinicians who prescribe or sell peptide products. One panellist, Haleem Mohammed, identified himself during proceedings as Chief Medical Officer of Gameday Men's Health, a clinic network that offers peptide treatments, and voted in favour of broader access.

Dissenting panellists raised concerns about the precedent. Elizabeth Rebello, Executive Director of Anesthesiology, Critical Care and Pain Medicine at the University of Texas MD Anderson Cancer Center, said she was "concerned that we're responding to a market-induced demand rather than a decision based in solid science." Brian Lee, an associate professor of medicine at USC's Keck School of Medicine, voted against BPC-157 and called on the FDA to "standardise" decision-making on peptide products, arguing that such decisions "should be objective and based on facts, not subjective and based on opinion."

What Happens Next

The recommendations now go to the FDA for a final ruling. The agency usually, but not always, follows its advisory committees. If the FDA accepts the panel's advice, licensed compounding pharmacies would be authorised to prepare these six peptides for individual patients under physician prescription — a significant expansion from the current restrictions.

The outcome is expected to have implications beyond US borders. Regulatory bodies in other jurisdictions, including Australia's Therapeutic Goods Administration and the European Medicines Agency, monitor FDA actions as part of their own compound scheduling and enforcement processes. Any formal reclassification in the US could influence how other countries approach the same compounds.

The FDA has not indicated a timeline for its final decision.

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