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AlphaMedStore.com violated the Federal Food, Drug, and Cosmetic Act by introducing unapproved and misbranded opioid drug products into interstate commerce without FDA approval, specifically violating sections 301(a), 301(d), 301(k), 503(b), and 505(a). The company's unapproved drugs lacked the safety and efficacy assurances of FDA-regulated products and posed risks of contamination, counterfeiting, inconsistent active ingredient amounts, or substitution with different ingredients altogether. The FDA emphasized that the easy availability of unapproved opioids via the internet presented significant public health risks, particularly given the severity of the ongoing opioid epidemic and related mortality crisis.