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6h ago

FDA Advisory Panel Narrowly Backs Compounding of Four Unapproved Peptides

The nonbinding vote forces the FDA to decide over coming months whether to allow regulated pharmacy compounding despite agency scientists’ warnings about limited safety data.

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A U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025. REUTERS/Dado Ruvic/Illustration/File Photo
Glass medical ampoule vial for injection. Medicine is liquid sodium chloride with of aqueous solution in ampulla. Close up. Bottles ampule multicolor on background color and water. Human plasma.
Glass medical ampoule and vials. Black background. Virus vaccination and social health.

Overview

  • An FDA Pharmacy Compounding Advisory Committee voted Thursday to recommend adding BPC‑157, KPV, TB‑500 and MOTS‑C to the agency’s bulks list, with several votes split and a few abstentions.
  • Those panel recommendations are nonbinding so FDA staff will review the record, public comments and internal analyses before the agency makes any formal change to compounding rules, a process likely to take months.
  • FDA career scientists urged the committee to keep restrictions in place because the peptides lack robust human clinical data and pose safety concerns such as contamination, dose uncertainty and immune reactions.
  • The meeting featured testimony from telehealth firms, wellness influencers and clinics and included multiple panel members with financial ties to peptide businesses, prompting conflict‑of‑interest concerns.
  • If the FDA ultimately allows compounding, pharmacies could legally make custom peptide preparations for patients with prescriptions but that would not mean the peptides are FDA‑approved and may not eliminate the existing online gray market.