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This section contains the nature of the case and procedural background.

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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