World Intellectual Property Organization

United States of America

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

Year of Version: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 FD&C Act is a set of laws giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety and efficacy of food, drugs, and cosmetics. Since then, the FD&C Act 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 producers 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 (see Chapter V, Subchapter A - ‘New Drugs,’ section 505(j) (21 U.S.C. 355(j)). Also, first-to-file ANDA holders are granted 180 days of generic exclusivity (see Chapter V, Subchapter A - ‘New Drugs,’ section 505(j)(5)(B)(iv)).

Please note that section 505 appears in the U.S. Code as section number 21 U.S.C 355.

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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