The Pharmacy Compounding Advisory Committee's July 2026 recommendation for BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax moves the needle, but pharmacies still cannot legally compound these peptides until FDA formally amends the 503A Bulks List.
In a narrow vote in July 2026, the FDA's Pharmacy Compounding Advisory Committee recommended that six research peptides be added to the agency's approved list of bulk substances available to compounding pharmacies. The six are BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax — all previously banned from compounding under FDA enforcement guidance.
The advisory vote went against the FDA's own staff scientists, who unanimously opposed addition on the grounds that the available clinical trials for these compounds were small, short, and insufficient to establish safety or efficacy. The committee's recommendation is nonbinding, meaning the 503A Bulks List is unchanged until the FDA issues a formal rulemaking action. Compounding pharmacies that have paused these preparations remain in regulatory limbo.
Separately, reporting in October 2026 suggested the Trump administration was considering interim mechanisms to temporarily permit compounded sales of certain unapproved peptides while longer-term rules are developed. The FDA is simultaneously tightening oversight of compounding facilities and continuing to oppose the compounded GLP-1 pathway, with semaglutide, tirzepatide, and liraglutide all facing permanent closure of that route.
Source: AJMC
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