The PEPTIDE-L Wave Rolls On! PCAC Adds Two More Bulk Drug Substances for the 503A List July 28, 2026 By Charles D. Snow & Karla L. Palmer & Mary Bass —

https://www.thefdalawblog.com/2026/07/the-peptide-l-wave-rolls-on-pcac-adds-two-more-bulk-drug-substances-for-the-503a-list/?utm_source=rss&utm_medium=rss&utm_campaign=the-peptide-l-wave-rolls-on-pcac-adds-two-more-bulk-drug-substances-for-the-503a-list Well, don’t say we didn’t tell you what was coming. Day 2 of the Pharmacy Compounding Advisory Committee (PCAC or the Panel) Meeting (mostly) followed in the footsteps and at the pace of Day 1 (see our prior coverage of Day 1). Over the course of the day, the Panel worked through three more nominated peptides for possible inclusion on the Section 503A bulk drug substances list, ultimately recommending two—Epitalon and Semax—for inclusion, while declining to recommend Emideltide (the delta sleep-inducing peptide, aka “DSIP”). Was the DSIP “no-vote” the sacrificial lamb here? As on Day 1, the real drama was less in the vote counts than in the recurring, and still-unresolved, question that FDA pressed from the outset: When a prescriber writes a prescription for one of these peptides, does anyone actually know what the patient is receiving?