World Intellectual Property Organization

United States of America

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq.

Year of current version:2004
Date of Text (Enacted):December 31, 2004
Type of Text:IP-related Laws: enacted by the Legislature
Subject Matter:Competition, Enforcement of IP and Related Laws, Patents (Inventions), Transfer of Technology, Undisclosed Information (Trade Secrets)
Notes:
Originally passed by Congress in 1938, the FDCA is a set of laws giving authority to the U.S. Food and Drug Administration to oversee the safety and efficacy of food, drugs, and cosmetics. Since then, the FDCA has been amended numerous times, including by the Drug Price Competition and Patent Term Restoration Act (a.k.a. the Hatch-Waxman Act) of 1984. This federal law set forth a process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval before the patent protection period has expired for the branded counterpart (21 U.S.C. 355(j)). Also, first-to-file ANDA holders are granted 180 days of generic exclusivity under "Paragraph IV" (21 U.S.C. 505(j)(5)(B)(iv)).

Implementing regulations can be found in the Code of Federal Regulations Title 21.
Available Texts: 
English

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., Complete document (pdf) [1349 KB]

Related Legislation:
WIPO Lex No.:US200

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