The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal framework within which FDA operates. The FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.
FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations. This typically involves a process known as "notice and comment rulemaking" that allows for public input on a proposed regulation before FDA issues a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. The Good Guidance Practice regulation can be found at 21 CFR 10.115.
Federal Food, Drug, and Cosmetic Act (FD&C Act)
FD&C Act Reference Information
United States Code, Title 21
The laws of the United States are organized by subject into the United States Code. The United States Code contains only the currently enacted statutory language. The official United States Code is maintained by the Office of the Law Revision Counsel in the United States House of Representatives. The Office of the Law Revision Counsel reviews enacted laws and determines where the statutory language should be codified related to its topic. The Federal Food, Drug, and Cosmetic Act and subsequent amending statutes are codified into Title 21 Chapter 9 of the United States Code.
The listing of FD&C Act sections presented here identifies both the FD&C Act and U.S. Code section numbers, which can be used to narrow your search on the Law Revision Counsel website.
To search the FD&C Act on the Law Revision Counsel website, use the Advanced Search to limit the your search to Title 21.
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