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GLP-1 Solution, a Germany-based online pharmacy, sold unapproved and misbranded compounded drugs including retatrutide, semaglutide, and tirzepatide to U.S. consumers through their website, violating FDA drug approval requirements under sections 505(a), 502(f)(1), and 301(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to comply with compounding regulations under sections 503A and 503B of the FDCA, which require that compounded drugs be prepared by licensed pharmacists in state-licensed pharmacies or registered outsourcing facilities, and made false or misleading claims about their semaglutide and tirzepatide products. The FDA identified these violations during an August 2025 review of the company's website offering these products without proper FDA approval or adequate labeling for use.