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Aquanest Biotic distributed unapproved veterinary drugs marketed for use in aquarium fish and birds, including antimicrobials such as amoxicillin, cephalexin, and ciprofloxacin under brand names like Fish Amoxi, Fish Kef, and Fish Cip. The products violated the Federal Food, Drug, and Cosmetic Act because they were not drug-listed with FDA, not manufactured in FDA-registered facilities, and misbranded under section 502(o) of the FD&C Act. Website claims describing the products' bactericidal action and therapeutic uses against conditions such as fin rot, pop-eye, and columnaris disease established their intended use as drugs, making their distribution without approval a violation of section 301(a) of the FD&C Act.