The US Food and Drug Administration (FDA) has announced it will re-evaluate the regulatory status of several widely discussed therapeutic peptides, including BPC-157, KPV and Semax.
Under current US compounding rules, pharmacies and outsourcing facilities may only compound medicines using active pharmaceutical ingredients (bulk drug substances) that form part of an FDA-approved medicine, appear in an official United States Pharmacopeia or National Formulary monograph, or are included on the FDA’s bulk drug substance list.
As these peptides are not licensed medicines and lack monographs, their use has depended on their categorisation within the FDA’s evolving bulk substances framework. In 2023, many popular peptides were placed in Category 2 – substances for which the FDA has identified significant safety concerns – effectively restricting their compounding. In a letter, the FDA confirmed that nominations for several peptides had been withdrawn and that these substances would be removed from Category 2 from April 22.
However, they will not automatically move into Category 1, where the agency has stated it would generally not take action against compounders. The peptides will be reviewed by the Pharmacy Compounding Advisory Committee (PCAC), with consideration scheduled for the meeting on 23–24 July 2026 or by February 2027. Until the PCAC has issued its recommendations and the FDA has updated its bulk drug substances list, US compounding pharmacies will remain unable to use these peptides routinely in compounded preparations.