FDA advisory panel votes to add three unapproved peptides to compounding list
An FDA advisory committee narrowly approved three of four peptides for inclusion on the agency's bulk-drug list, allowing compounding pharmacies to prepare them despite limited safety data.
The Food and Drug Administration’s advisory committee voted on Thursday to place three unapproved peptides—BPC-157, KPV and TB-500—on the agency’s bulk-drug list, enabling compounding pharmacies to create custom formulations for patients. The vote was eight in favor, six against, with one abstention; a fourth peptide, MOTs-C, received a narrower seven-to-five vote with two abstentions. The panel, which includes members with ties to peptide manufacturers and telehealth firms, will consider three additional peptides at a meeting on Friday.
Committee members heard presentations from FDA staff on the four peptides and testimony from health-care providers, patients, pharmacies and clinics. FDA scientists on the panel recommended against allowing compounding of any of the seven peptides under review, citing insufficient evidence of safety and efficacy. Proponents argued that regulated compounding would give patients a safer alternative to the unregulated “research-only” market, where products are often sold online with no guarantee of purity.
"I'm not going to tell you that the evidence for BPC-157 is strong. It isn't, and I won't overclaim it," said Anant Vinjamoori, chief medical officer of telehealth provider Hims & Hers, adding that the company is preparing to launch peptide treatments pending FDA clearance.
The peptides have gained popularity through endorsements by podcasters, wellness influencers and public figures, despite a lack of robust clinical data. BPC-157 and TB-500 are frequently marketed together as a “Wolverine stack” for injury recovery, a claim the World Anti-Doping Agency says lacks human-study evidence. Critics warned that adding the peptides to the bulk list could create the impression of FDA endorsement, potentially confusing patients and sustaining a gray market for unregulated products.
John Hertig, chair of the Collaborative for Evidence-Based Medicines, cautioned that allowing compounding does not eliminate the gray market and may send mixed signals to consumers. The Biden administration had previously barred compounding of 20 peptides in 2023 over safety concerns, and the current vote marks a shift toward limited regulatory access for a subset of these substances.