Comment from Hims & Hers Health Inc.
AnonymousSupportBusiness
Summary: Hims & Hers Health, Inc. supports the inclusion of the nominated peptides on the Section 503A Bulk Drug Substances List to provide a regulated, safer alternative to the unregulated "gray market." The company argues that regulated access ensures patient safety through clinician oversight, pharmacy licensure, and USP standards, and proposes additional measures like a "KnowYourPeptide" education campaign and a user fee program for compounders.
This comment is submitted by Hims & Hers Health, Inc. regarding Docket No. FDA-2025-N-6895 for the PCAC meeting on July 23–24, 2026, to support the regulated compounding of the evaluated peptides under Section 503A of the FD&C Act. We urge the Committee to consider that inclusion on the Bulk Drug Substances List provides a vital, safer alternative under the 503A framework to the unregulated gray market.