In a September 2023 update to its evaluation of bulk drug substances nominated for use in pharmacy compounding under section 503A, the FDA placed BPC-157 in Category 2 — substances that raise significant safety risks and that the agency does not intend to permit for compounding under interim policy.
The FDA said compounded BPC-157 may pose a risk of immunogenicity for certain routes of administration and noted complexities around peptide-related impurities and characterisation of the active ingredient. It concluded there was insufficient safety information for the proposed routes of administration.
BPC-157, a synthetic peptide marketed in the grey market as a 'healing' agent, has been studied mainly in animal models, with little published human clinical data. The Category 2 designation was part of a broader FDA action addressing a group of nominated peptides.
The practical effect is that US compounding pharmacies operating under the interim 503A policy should not compound BPC-157. The substance remains widely sold as a research chemical outside the regulated drug supply.