Study wrapper · #1129
Compounded Semaglutide and Tirzepatide Products Use Unique Formulations but Efficacy and Safety Largely Unknown.
Editor's note
This is the clearest inventory yet of what "unique formulation" actually means in practice once the shortage exemption closed, and the answer is mostly additives with no stated rationale. The authors find little justification for the vitamin, amino acid, or stool-softener combinations, allow a pharmacological rationale for ondansetron while noting no evidence for giving it subcutaneously, and flag that sublingual and dissolving-tablet routes have not been shown to outperform the approved oral tablet. Fewer than one in five products documented a beyond-use date, which is a basic stability disclosure.
Plain-language abstract
With the shortages of brand-name semaglutide and tirzepatide resolved, US compounding pharmacies may legally sell only products that differ from the approved versions. Researchers searched compounding websites between February and March 2025 and catalogued 33 such products: two-thirds semaglutide, one-third tirzepatide. Nearly half combined the peptide with cyanocobalamin, glycine, niacinamide, docusate, or ondansetron. The 17 single-ingredient products were sublingual (82%) or orally disintegrating tablets. Only 18% listed a beyond-use date and storage conditions, and 28% listed storage conditions.