FDA Public Comment Period on the April 30, 2026 Proposed Rule to Permanently Exclude Semaglutide, Tirzepatide, and Liraglutide From the Section 503B Bulks List Closed Thursday July 30, 2026 After a Federal Register-Extended Deadline From the Original June 29 Cutoff; The FDA Found No Clinical Need for Outsourcing Facilities to Compound the Three GLP-1 Molecules From Bulk Drug Substances; Finalization of the Rule Would Close the Last Legal Pathway for Large-Scale FDA-Registered 503B Outsourcing Facility Compounding of the Branded GLP-1s, Following the December 2024 Semaglutide Shortage Resolution and February 2025 Tirzepatide Shortage Resolution
The FDA public comment period on the April 30, 2026 proposed rule to permanently exclude semaglutide, tirzepatide, and liraglutide from the Section 503B Bulks List closed Thursday July 30, 2026 after a Federal Register-extended deadline from the original June 29 cutoff. The FDA's underlying finding: no clinical need for FDA-registered outsourcing facilities to compound the three GLP-1 molecules from bulk drug substances. Section 503B outsourcing facilities are the FDA-registered large-scale compounding manufacturers (as distinct from state-licensed 503A pharmacies that compound for individual patient prescriptions). Finalization of the proposed rule would close the last legal pathway for large-scale FDA-registered 503B outsourcing facility compounding of the branded GLP-1 molecules, following the December 2024 semaglutide shortage resolution and February 2025 tirzepatide shortage resolution that ended the shortage-based compounding pathway. FDA rulemaking to finalize the exclusion after comment-period close typically takes 3-9 months depending on the volume and substance of received comments. Telehealth platforms including Hims & Hers Health (NYSE: HIMS) and LifeMD have already migrated to branded supply through Novo Nordisk and Eli Lilly commercial channels ahead of the expected 503B closure. FDA Adverse Event Reporting System (FAERS) data as of the July 2026 safety statement: 990 adverse events linked to compounded semaglutide, over 730 for compounded tirzepatide.