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Critical Regulatory Updates (2025-2026) GLP-1 Shortage Resolution & Compounding Restrictions The FDA made significant policy changes in 2024-2025 regarding compounded peptide medications: Tirzepatide (Mounjaro/Zepbound): Removed from FDA shortage list: October 2, 2024 Compounding deadline for 503A pharmacies: February 18, 2025 Compounding deadline for 503B facilities: March 19, 2025 Semaglutide (Ozempic/Wegovy): Shortage status resolved: February 21, 2025 Enforcement discretion ended for 503A compounders: April 22, 2025 503B compounders must cease: May 22, 2025 These changes mean that as of 2026, patients will require prescriptions for FDA-approved brand-name versions rather than compounded alternatives