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Features a C-18 fatty di-acid chain conjugated at position 26 (Lys26) enabling non-covalent albumin binding for extended pharmacokinetic half-life

22 Key Themes For Inspection-Based Warning Letters Compounding Two compounding pharmacies regulated under section 503A of the FDCA (503A pharmacies) and 10 outsourcing facilities regulated under section 503B of the FDCA (503B facilities) received warning letters in FY25

Pharmacies must: Cease production of compounded semaglutide that duplicates FDA-approved products Dispense compounded medications only when supported by a valid, patient-specific prescription that meets Section 503A criteria Remaining Legal Pathways for Compounded Semaglutide Compounded semaglutide may be prescribed only in rare cases where an FDA-approved product cannot be used, such as a documented allergy to an inactive ingredient