Dotterweich (D) was the president of the Buffalo Pharmacal Company, Inc. His company purchased drugs, repackaged them with their own label, then reshipped them. D had no knowledge of these shipments. The Federal Food and Drug, and Cosmetic Act prohibited the introduction or delivery of misbranded and adulterated drugs. The Act made this behavior a strict liability offense. D was convicted, but the court of appeals reversed. The Government (P) appealed.

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