FDA Expert Panel Backs Compounding of Six Peptides

An FDA advisory panel recommended adding six peptides to a drug compounding list, the first step in a process that could allow clinicians and telehealth providers to prescribe them and pharmacists to produce them as therapies for any disease or condition.Even if the agency follows the panel’s advice, compounded peptides would not be immediately legal in the US. The agency would need to issue a rule to add them to the 503A bulk compounding list, which could take a year or more.However, Health and Human Services Secretary Robert F. Kennedy, Jr — who has said he uses peptides — could also immediately legalize compounding, according to food and drug law experts at Hyman, Phelps & McNamara, PC.In briefing documents and presentations during the FDA’s Pharmacy Compounding Advisory Committee meeting, agency scientific staff firmly opposed allowing compounding of the peptides under consideration — BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon, and semax — citing a lack of safety and efficacy evidence.Even though the manufacture and sale of these peptides are currently restricted in the US, the substances are used by a growing number of Americans who order them on the gray market from vendors who label them as “research grade” to skirt federal restrictions.In hours of public comment over 2 days, pro-peptide speakers argued that FDA-regulated compounding was the only way to protect consumers already using the substances from black market peptides and unethical sellers.A majority of the 14 panelists agreed, voting in favor of adding all the peptides except emideltide to the compounding list. Eight panelists were appointed in April and May ahead of the meeting. Six of those are affiliated with clinics that offer peptides, and two others have ties to the industry.‘Our Patients Want Peptides’Panelist Haleem Mohammed, MD, global chief medical officer for Gameday Men’s Health, said he voted for allowing compounding as a means of ensuring more oversight.“Our patients want peptides,” he said. “We do not protect the patient by pushing them into the dark.”Committee members who voted against easing restrictions on the peptides voiced concerns about the lack of safety and efficacy data and the paucity of information on what is in the peptides, which are not standardized.“I’m concerned that we’re responding to a market-induced demand rather than decision-based and solid science,” said panelist Elizabeth Rebello, MD, professor of anesthesiology and perioperative medicine at The University of Texas MD Anderson Cancer Center in Houston.Josh Mailman, the panel’s consumer representative and president of the NorCal CarciNET Community, also voted no.“I’m voting on something here, but I don’t know what that something is. It’s kind of like a black box,” he said.Lee Rosebush, PharmD, JD, chair of the American Academy of Peptide Medicine, told the committee during the public comment period that under FDA regulations for bulk compounding, “there’s no requirement to prove safety or efficacy.”Few Rules for Compounded DrugsNone of the peptides have been approved for human use or have undergone rigorous clinical trials in humans. All are promoted for various conditions.The FDA panel evaluated BPC-157 for use in ulcerative colitis, Crohn’s disease, celiac disease, and tendonitis; KPV and TB-500 for wound healing and inflammatory conditions; MOTS-c for insulin resistance, obesity, osteoporosis, vascular calcification, muscle/fat metabolism, and longevity; emideltide for opioid withdrawal and chronic insomnia and narcolepsy; epitalon for insomnia; and semax for cerebral ischemia, migraine, and trigeminal neuralgia.In deciding whether a substance can be added to the 503A bulk compound list, the FDA assesses its physical and chemical characterization, safety issues, available evidence of effectiveness, and how it has historically been used in compounded products.A compounded drug is not FDA-approved. It can be compounded for any use or any route of administration and is not required to have a label. Manufacturers do not have to comply with FDA good manufacturing practices, but the substance must be produced under sanitary conditions. There’s no requirement to report adverse events.Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said during the open public comments that his members support reporting requirements.Unintended Consequences?Multiple commenters said that allowing compounding would likely be viewed by the public as a tacit, or even explicit, endorsement of peptides. They also said it would give the peptides a pass on proving safety or efficacy, as is required of medications that go through the FDA’s formal approval process.If peptides were required to go through the investigational new drug process, as FDA officials suggested during the meeting, it would “ensure that our patients get a safe and effective product that is actually proven safe and effective,” said John Hertig, PharmD, who identified himself as the chairman of the Collaborative for Evidence-Based Medicines.With the compounding route, “we are at risk of undermining the integrity of our entire FDA approval framework,” said Hertig.Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner, agreed. By allowing compounding of the peptides, “the result will be an influx of unproven products for which we will have little realistic prospect of ever knowing the clinical utility, if they have any,” he said during public comments.FDA officials said the agency would consider the more than 2000 comments it has received, along with additional information submitted by peptide makers and clinicians, as it formulates its final rule.The agency has announced that the Pharmacy Compounding Advisory Committee will meet before the end of February 2027 to consider five additional peptides — cathelicidin (LL-37), GHK-Cu, dihexa acetate, melanotan II, and pegylated mechano growth factor. These have a wide range of indications, including wound healing, cognitive enhancement, appetite suppression, and muscle repair.Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.