FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings to Consider Adding Peptides to 503A Bulk Drug Substances List

On April 15, 2026, the U.S. Food and Drug Administration ("FDA") announced a major shift in the regulatory landscape for compounded peptides. FDA updated its Bulk Drug Substances Nominated for Use in Compounding Under Section 503A list, providing notice that after 7 days, it will remove 12 peptide bulk drug substances from Category 2 of its Section 503A bulk drug substances list— the category reserved for substances the agency has determined raise significant safety concerns — due to their... By: Orrick, Herrington & Sutcliffe LLP