FDA’s Fresh Look at Peptides Leaves Drug Compounders in Limbo

Drug compounders seeking to produce peptides are stepping into an unclear regulatory zone as the FDA reconsiders restrictions over the products that have gained popularity among wellness influencers.

The Food and Drug Administration this week said its expert advisory committee on pharmacy compounding will convene in July to discuss whether peptides should be added to the 503A bulk list, a classification that allows drugs to be legally customized, or formally known as compounded.

Peptides, which are chains of amino acids, act as building blocks for proteins and signaling molecules in the body. Many are being explored for a wide ...