The FDA may be moving closer to establishing a legal pathway for compounding certain wellness peptides after the Pharmacy Compounding Advisory Committee (PCAC) recommended adding six non-FDA-approved peptides to the agency’s 503A Bulks List. The FDA is likely to pursue notice-and-comment rulemaking, a process that could take a year or longer and face legal challenges over the scientific evidence supporting the peptides.
In an article with The Capital Forum, Edgar Asebey highlighted the tension between those scientific concerns and the growing unregulated market for peptides.
“People are injecting themselves tens of thousands of times a day with compounds that came from China, that didn’t need to be from an FDA-regulated or registered facility.”
He noted that even formal FDA rulemaking could face litigation, while the agency must also consider how to address the expanding “research use only” peptide market.
