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ElectRx and Health Solutions, LLC was cited for causing the introduction of unapproved new drugs and misbranded drugs into interstate commerce, violating sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company operated as a broker between foreign pharmacies and U.S. employer-sponsored health insurance plans, accepting U.S. prescriptions and facilitating dispensing by foreign pharmacies that shipped drugs directly to employees, without ensuring FDA approval or proper regulatory oversight. The compliance failures centered on distributing drugs that circumvented FDA regulatory safeguards, which posed risks of contamination, counterfeit products, inconsistent active ingredient amounts, or substitute ingredients. The FDA requested that ElectRx cease introducing unapproved and misbranded drugs for sale to U.S. consumers to protect public health.