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U.S. Food and Drug Administration (FDA)

Is BPC-157 legal in United States?

Not approvedNo FDA approval and not on the 503A list; an FDA advisory panel recommended considering it in July 2026, but that vote is not binding

Not approved as a medicine here.

BPC-157 is not approved for any use. FDA's Category 2 page lists it among substances whose bulk-substance nomination was withdrawn (after FDA had flagged immunogenicity risk and limited safety data); leaving Category 2 does not authorise compounding. FDA's Pharmacy Compounding Advisory Committee reviewed BPC-157 for ulcerative colitis on 23 July 2026 and, according to a law-firm report, voted 8 to 6 with one abstention to recommend it for the 503A bulks list; FDA must still decide and use rulemaking. The human evidence is very limited (mostly animal studies), and BPC-157 is prohibited in sport under the WADA list category S0, according to USADA.

Last verified 2026-09-29 · how we verify

Molecule

BPC-157 explained →

Country

All rules in United States →

BPC-157 elsewhere

Sources (5)

  1. 01Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (Category 2 and withdrawn nominations)U.S. Food and Drug Administration · 2026-04-22 · accessed 2026-09-29
  2. 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration · 2026-08-06 · accessed 2026-09-29
  3. 03Bulk list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte · 2026-07-27 · accessed 2026-09-29
  4. 04FDA's Advisory Committee Votes on Peptides: What It Does and Does Not MeanMintz · 2026-07-29 · accessed 2026-09-29
  5. 05BPC-157: What Athletes Should Know About the Prohibited Experimental PeptideU.S. Anti-Doping Agency · 2026-08-10 · accessed 2026-09-29