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FDA removes BPC-157 and 11 other peptides from its compounding safety-risk list

Regulatory

The FDA announced it would remove 12 peptides, including BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, DSIP, injectable GHK-Cu, LL-37, dihexa and melanotan II, from Category 2 of its 503A bulk substances list (substances flagged for significant safety risks) because the nominators withdrew their nominations. Removal is not approval and does not by itself permit compounding: the agency scheduled Pharmacy Compounding Advisory Committee reviews for July 2026 and before the end of February 2027. The move followed HHS Secretary Robert F. Kennedy Jr.'s February 2026 pledge to widen lawful access to about 14 peptides.

Sources

  1. 01FDA to weigh easing limits on unproven peptides favored by MAHA figures(opens the source in a new tab) Associated Press via Spectrum News
  2. 02FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List(opens the source in a new tab) Orrick
  3. 03FDA to Remove 12 Popular Peptides from the Category 2 Do Not Compound List(opens the source in a new tab) Frier Levitt

Peptides involved

  1. Not approvedBPC-157Synthetic gastric pentadecapeptide (research chemical)15 WADA banned
  2. Not approvedTB-500Thymosin beta-4 fragment (research chemical)7 WADA banned
  3. Not approvedKPVAlpha-MSH-derived tripeptide (research chemical)3 WADA banned
  4. Not approvedMOTS-cMitochondrial-derived peptide (research peptide)16 WADA banned
  5. Approved elsewhereSemaxACTH(4-10) fragment analogue (melanocortin-derived neuropeptide)7
  6. Not approvedEpitalonSynthetic pineal tetrapeptide (geroprotector candidate)4 WADA banned
  7. Not approvedDelta sleep-inducing peptideNonapeptide of uncertain physiological role, first described as a sleep factor9 WADA banned
  8. Cosmetic ingredientGHK-CuCopper-binding tripeptide (cosmetic ingredient)3
  9. Not approvedLL-37Human cathelicidin antimicrobial peptide37 WADA banned
  10. Not approvedDihexaAngiotensin IV derived dipeptide mimetic, described as a hepatocyte growth factor (HGF) and c-Met potentiator2 WADA banned
  11. Not approvedMelanotan IINon-selective melanocortin receptor agonist (research peptide)7 WADA banned