Corrected: BPC-157 is not on the FDA's 503A list. It is still widely sold
Released: ·Last reviewed: ·Methodology v4.1
BPC-157 is not on the FDA’s 503A bulks list and is not in Category 1; FDA’s Category 2 page now lists it as “nominated but withdrawn”. It has no human efficacy trials. This item originally said it was in Category 2; see COR-005.
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 and may not be.
BPC-157 was moved off Category 2 when its nominator withdrew it, and FDA’s page now lists it as “nominated but withdrawn”, outside every category and off the 503A bulks list. It 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 Transparent Peptide research desk. Corrections: the corrections log.