FDA panel votes to add peptides to permitted compounding list despite opposition from agency scientists
An FDA advisory panel voted to recommend adding several peptides to the list of substances that US compounding pharmacies may use, despite FDA scientists’ objections. The recommendation could make prescription access easier for products promoted for areas such as recovery, inflammation and wound treatment, but it does not itself approve the peptides or make them immediately available.
The committee voted 8–6, with one abstention, in favour of including BPC-157, KPV and TB-500; votes covered both free-base and acetate forms. FDA staff had argued that the evidence on safety and effectiveness was insufficient, including a lack of robust clinical trials. The panel’s recommendation is non-binding, and the FDA must make the final decision.
- FDA advisers backed compounded access to three unapproved peptides.
- Agency scientists cited insufficient safety and effectiveness evidence.
- The FDA still has the final say.
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