ECRI & ISMP Statement in Response to PCAC Decision on Compounding Peptides

The FDA Pharmacy Compounding Advisory Committee (PCAC) decided to recommend adding most of the peptides under consideration during its July 23-24, 2026, meeting to the 503A Bulks List, despite substantial gaps in evidence for the peptides’ safety or efficacy. Demand for these peptide products has grown rapidly, but the science has not kept pace and data on their safety and efficacy remains limited or absent.  

The risks that have been identified remain unresolved. Repeated injections of synthetic peptides can trigger immune reactions. Impurities from the manufacturing process can cause the body to treat the product as a foreign invader, a risk well-documented in the scientific literature. Across the entire class of growth-promoting and angiogenic peptides, which includes two of those under review at the July PCAC meeting, potential risks include tumor growth in people with undiagnosed cancer and other metabolic complications. 

These concerns, which were raised in ECRI and ISMP’s white paper and shared by the FDA,  remain unresolved despite the committee recommending these peptides to be added to the bulks list –- a move that could expand legal access to these products. ECRI and ISMP continue to believe that compounding access should only be granted when there is clear evidence of safety and efficacy, proof of robust quality controls, and appropriate pharmacovigilance requirements. Drug policy must be based on sound clinical evidence in order to protect patients.