FDA Panel Clears 6 of 7 Peptides, Overruling the Agency’s Own Scientists

The vote is a win for HHS Secretary Kennedy and MAHA, opening a path for compounding pharmacies to prepare BPC-157, TB-500 and four other popular peptides by prescription.

On July 23 and 24, the Pharmacy Compounding Advisory Committee met at FDA headquarters in Maryland to decide whether seven peptide compounds belong on the 503A Bulk Drug Substances list, which governs what licensed pharmacies may legally prepare from a prescription.

On the first day of committee meetings, Thursday, one peptide, BPC-157, drew eight votes in favor with six against and one abstention. Two others – KPV and TB-500 – split the same way each time. MOTS-c, reviewed for obesity and osteoporosis, passed 7-5 with two abstentions. The panel evaluated BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, and TB-500 for tissue repair.

All four peptides are familiar names to athletes and longevity clinics, where they have been used for years through wellness practices, medical spas and online retailers operating under research-use-only labels.

“I voted yes because it’s time to put this decision back in the hands of the patient, the physician and the pharmacist,” committee member David Pope said Thursday, moments after the first vote.

Reporters in the room described an audible gasp when the first tally was read – eight in favor, six against, one abstention, for BPC 157. A compounding advisory panel almost never votes against the FDA staff’s written recommendation, and by Friday afternoon this one had done so six times.

Pope, chief pharmacy officer at Xifin Pharmacy Solutions, was among eight committee members who spent two days overruling the agency’s own scientists, clearing six of seven peptides for pharmacy compounding and handing Health and Human Services Secretary Robert F. Kennedy Jr. the win he has pushed for since February.

Friday’s voting brought a split. Epitalon, for insomnia, cleared 7-4, and Semax, for migraine, cerebral ischemia and trigeminal neuralgia, passed 8-5. Emideltide, better known as DSIP, failed 6-7 with one abstention. It’s used as a treatment for insomnia, narcotic dependence and opioid withdrawal.

Pope had voted with the majority all week and broke on DSIP, citing “potentially dangerous downstream consequences.” The FDA had flagged a theoretical concern that the compound stimulates endorphin release, a mechanism carrying addictive potential. Emideltide has the deepest human-study history of the group, with trials dating back to 1981, though the agency called them small, poorly controlled and inconsistent.

This week’s votes moved six compounds a step closer to licensed pharmacies, and to the standard Kennedy set for the agency: Do the science, publish it, and then respect the intelligence of the American people enough to let them choose.

Staff says ‘no’ and panel says ‘yes’

The agency’s scientists cited thin clinical evidence and inconsistent chemical naming that left unclear which version of a compound a pharmacy would actually prepare. They also noted that approved drugs already exist to treat the conditions for which these peptides were proposed.

The disagreements percolating beneath the votes had less to do with data than with questions about what happens to people who intend to use these compounds regardless of whether they are FDA approved. Days before the meeting, the FDA added members to the 20-member panel, including at least seven doctors and pharmacists with financial ties to the peptide industry — owners of wellness clinics that sell the compounds, pharmacies that produce them, and consulting businesses that promote them. Those members voted ‘yes.’ The academics mostly voted ‘no.’

Supporters kept returning to an argument Kennedy has made for two years, telling podcaster Joe Rogan in February that he is a “big fan” of peptides and has taken them himself, and that the 2023 restriction drove Americans into a black market.

Brigham Buhler, a wellness clinic owner whose clients include Rogan, put the case to the committee directly.

“It’s crucial to allow patients to have safe and effective access to these treatment options,” Buhler said. “Individuals who have gotten these resources are going to continue to utilize these products.”

A pharmacy operating under a prescription and a state board offers something a website or an unmarked vial from overseas cannot, and that comparison carried the day.

What actually changes, and when?

The committee votes are recommendations, and none of the compounds became an FDA-approved drug this week. The agency will make the final call, and while it usually follows the advisory committee vote, it has gone the other way before. Any change requires formal notice-and-comment rulemaking, and the agency has completed that process for only about ten substances since Congress created the list in 1997.

The agency can also issue a policy statement declining to act against pharmacies while rulemaking proceeds, and FDA watchers expect that faster route rather than formal listing. Even then, a patient would need a physician’s prescription and to pay out of pocket, since most insurance excludes compounded drugs. Providers currently charge roughly $150 to $400 for an initial consultation, and monthly compounded prescriptions in the $80 to $350 range, depending on the peptide.

A regulated pathway would not come with full visibility. Compounders face no requirement to report serious adverse events to the FDA, and agency officials said they lack the authority to impose one here.

Scott Brunner runs the Alliance for Pharmacy Compounding, the industry trade group. He testified in support of the peptides — and then said adverse-event reporting should be required.

In 2023, the FDA placed 19 popular peptides on its Category 2 restricted list, barring pharmacies from preparing them and directing consumers toward online sellers and overseas suppliers. Kennedy announced in February that roughly 14 would be reclassified. The formal removal took effect April 23, and this meeting decided whether a regulated pharmacy channel would reopen behind it. Five more compounds will go before the committee by the end of February 2027, including LL-37, GHK-Cu, Dihexa, Melanotan II and PEG-MGF.

Photo: Fox News, July 29, 2025

Kennedy has described what he wants from the agency in the meantime.

“The FDA has a job: Just do the science on these kinds of issues and then tell the public what they’ve learned from the science,” he said on the Ultimate Human podcast, hosted by Gary Brecka, who has regularly appeared on the MAHA Media Hub, “but don’t tell physicians what they can and cannot prescribe.”

Kennedy added, “We don’t want to have the Wild West. We want to make sure that information is out there. But we also want to respect the intelligence of the American people.”