The following is a list of selected Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The amendments are listed in alphabetical order with the corresponding enactment date noted.
The Amendments may also be listed with Significant Amendments to the Act.
- Title I authorizes the approval of generic drugs under an Abbreviated New Drug Application (ANDA) procedure.
- Title II authorizes the extension of patent terms for approved new drug products (including antibiotics and biological drug products), some medical devices, food additives, and color additives.
- Title I of DQSA, Compounding Quality Act addresses compounding of human drugs. Information is available on the Compounding page.
- Title II of DQSA, Drug Supply Chain Security Act (DSCSA) outlines steps for an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Information is available on the Drug Supply Chain Integrity page.
- MDUFMA III amended the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Oct. 26, 2002.
- MDUFMA II was included in the Food and Drug Administration Amendments Act of 2007 (FDAAA), Sept. 27, 2007.
PAHPRA updated and reauthorized related provisions of the Pandemic and All-Hazards Preparedness Act of 2006, (PAHPA), Dec. 19, 2006; .the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act), Dec. 30, 2005; and Public Health Security and Bioterrorism Preparedness and Response Act (the Bioterrorism Act), June 12, 2002. General information about medical counter measures (MCM), emergency preparedness and response, and the various recent counter-terrorism legislation is available on the MCM-related Legislation page.