Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA) regulates about 25% of the U.S. economy.  This book is an indispensable reference for any attorney, regulatory affairs professional, regulator, or law student who has an interest in FDA law.  It provides the full text of the Federal Food, Drug, and Cosmetic Act and several other major statutes relevant to FDA’s regulatory responsibilities concerning food; human drugs (both prescription and nonprescription); animal drugs and animal feeds; medical devices; in vitro diagnostic products; clinical laboratories; biological products (including vaccines, blood, and blood products); radiation-emitting products (including x-ray and MRI systems, microwave ovens, television receivers, sunlamps, and more); mammography; cosmetics; tobacco; and more.


Chapters cover the following statutes — 

Federal Food, Drug, and Cosmetic Act — The complete text of the entire statute including tables and more than 225 footnotes.
Public Health Service Act — Selected provisions, including definitions; the Orphan Products Board; biological products; clinical laboratories; mammography facilities; and quarantine and inspection.
An overview of the Orphan Drug Act.
Federal Meat Inspection Act — Complete text.
Filled Milk Act — Complete text.
Fair Packaging and Labeling Act — Complete text.
Federal Trade Commission Act — Complete text.
Federal Advisory Committee Act — Complete text.
Administrative Procedure — Selected provisions, including the Freedom of Information Act; Privacy Act of 1974; Government in the Sunshine Act; Regulatory Flexibility Act; rulemaking; negotiated rulemaking; alternative means of dispute resolution; judicial review; and more.
An appendix provides explanations of the 2013 amendments to the Food, Drug, and Cosmetic Act; identifies enactments that have amended the Food, Drug, and Cosmetic Act since 1996; identifies sunset provisions affecting the Food, Drug, and Cosmetic Act; and provides the full text of the 1906 Pure Food and Drugs Act.



Each statute is accompanied by a detailed table of contents, and unique navigational tools make it easy to quickly find a specific section within a given statute.