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SemaBio was cited for unlawfully selling unapproved and misbranded compounded drug products, specifically semaglutide, directly to U.S. consumers via its website. The company falsely marketed these compounded products as "generic semaglutide," implying they were equivalent to FDA-approved drugs when compounded drugs are not FDA-approved, violating sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. This misleading labeling and advertising resulted in the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FDCA.