New Market for Compounded Peptides Comes with Opportunity and Risk

Life Sciences attorney Sara Klock was cited in a Corporate Counsel article reviewing the risks ahead if the U.S. Food and Drug Administration (FDA) accepts a recommendation to allow compounding pharmacies to sell certain peptides. The recommendation from the Pharmacy Compounding Advisory Committee focuses on six currently unapproved peptides, which are short chains of amino acids that form the building blocks of proteins and have been promoted by wellness influencers for anti-aging and overall health benefits. Although FDA staff objected to the recommendation, Sara told Corporate Counsel she expects the agency to approve the substances, with the caveat that if the public notice and comment period extends beyond the current administration, that could change. Right now, she said, compounding pharmacies that want to enter a new peptide market should ready themselves for safety and sterility inspections from the government. In addition, she warned, companies should expect regulators to pay close attention to marketing claims, citing warning letters to some compounders of GLP-1s. Because peptides fall into a legal gray area with the lack of FDA approval and limited research, "it could get really tricky, really quickly" to determine what passes muster.

READ: New Market for Compounded Peptides Comes with Opportunity and Risk