Compounded Semaglutide and Tirzepatide Products Use Unique Formulations but Efficacy and Safety Largely Unknown

BACKGROUND: With the shortage of innovator semaglutide or tirzepatide products resolved, compounding pharmacies can only legally sell unique products. Unique products could have a different route of administration or dosing, or could include additional pharmaceutical ingredients. OBJECTIVE: To identify and characterize compounded semaglutide and tirzepatide products that differ from available FDA-approved products. METHODS: on Google looking for products with a strength, route of administration, and/or formulation that differed from commercially available products. RESULTS: We identified 33 unique semaglutide and/or tirzepatide products. Two-thirds contained semaglutide, and one-third contained tirzepatide. Forty-eight percent of products contained either semaglutide or tirzepatide with some combination of cyanocobalamin, glycine, niacinamide, docusate, or ondansetron. The 17 single active ingredient products were provided in sublingual (82%) or oral disintegrating tablet (ODT) (18%) formulations. Only 18% of included compounded products reported information about beyond use date and preferred storage conditions. Twenty-eight percent reported preferred storage conditions. CONCLUSION AND RELEVANCE: We found little justification for adding nutrients or docusate sodium to combination subcutaneous semaglutide or tirzepatide products. There is a rationale for adding ondansetron, but evidence for subcutaneous administration is lacking. There is a rationale for fashioning sublingual or ODT formulations, but whether these formulations offer advantages over innovator oral tablets has not been determined. The popularity of these products as an alternative to FDA-approved medications is concerning, given the lack of evidence for safety and efficacy.