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National Association of Pharmaceutical Manufacturers v. Food and Drug Administration

637 F.2d 877 (1981)

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National Association of Pharmaceutical Manufacturers v. Food and Drug Administration

United States Court of Appeals for the Second Circuit
637 F.2d 877 (1981)

AR

Facts

After a notice-and-comment period, the Food and Drug Administration (defendant) issued regulations that stated that a drug was deemed adulterated if it failed to conform to current good manufacturing practice. The National Association of Pharmaceutical Manufacturers (plaintiff) sued, arguing that the Food and Drug Administration did not have the power to make substantive regulations that had the force of law.

Rule of Law

Issue

Holding and Reasoning (Friendly, J.)

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Casebooks

Food and Drug Law
Healthcare Law

Key Terms