FDA's Ongoing Review of Peptide Substances Leaves Industry in Limbo
The U.S. Food and Drug Administration (FDA) is actively revisiting its categorization of peptide substances under Section 503A of the Federal Food, Drug, and Cosmetic Act. This section allows state-licensed pharmacies and physicians to compound drugs without new-drug approval, provided certain conditions are met. The FDA is evaluating which peptides should be included on the 503A bulks list, which affects their legal status for compounding. Recently, the FDA removed 12 peptides from Category 2, which flags substances as significant safety risks, but has not yet placed them in Category 1, which allows for enforcement discretion. The Pharmacy Compounding Advisory Committee (PCAC) will review several peptides in upcoming meetings, but their recommendations are non-binding. 
