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Description

Chaudhury, C

Indications: the management of

Coping with sterile inflammation: between risk and necessity

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

Compounded semaglutide and tirzepatide became widely available during 2023 and 2024 shortages, but as commercial supply returned, most compounding of these specific molecules is no longer permitted