BPC-157 left FDA's Category 2 list in April 2026. It still cannot be lawfully compounded
FDA moved BPC-157 out of Category 2 in April 2026 after its nomination was withdrawn. It is not on the 503A bulks list, so no lawful 503A compounding route exists, and it has no human efficacy trials.
The FDA's 503A bulk drug substances lists signal whether a substance may be used in compounding. Category 1 substances may be used while under evaluation. Category 2 substances have been identified as raising significant safety risks. A substance on neither list, and not on the 503A bulks list, has no lawful 503A route.
BPC-157 was in Category 2 until April 2026, when FDA moved it to a “nominated but withdrawn” table after the nomination was withdrawn. It did not move into Category 1, is not on the 503A bulks list and has no human efficacy trials. It continues to be sold widely, generally under "research use only" labelling — which states the product is not for human use. That is a legal position, not a safety finding.
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Filed by the Peptides Editorial research desk. Corrections: the corrections log.
Frequently asked questions
Is BPC-157 legal to compound?
Not as of October 15, 2026. It is not on the 503A bulks list or in Category 1. An FDA advisory committee voted 8-6 in July 2026 to recommend listing it for ulcerative colitis, and an interim access policy reached White House review on October 14, but neither is law.