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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2-2 - SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

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.

2-2-1.Animal Drug User Fee (ADUFA), Aug 14, 2008. Information is available on CVM’s ADUFA page.
2-2-2.Animal Medicinal Drug Use Clarification Act (AMDUCA), Oct 22, 1994. Information is available on CVM’s Acts, Rules and Regulations page.
2-2-3.Anti-Drug Abuse Act, Nov 11, 1988. Violators are subject to the Controlled Substances Act.
2-2-4.Best Pharmaceuticals for Children Act, Jan. 4, 2002. Reauthorizes the pediatric studies provision of the Food and Drug Administration Modernization and Accountability Act (FDAMAA) of 1997. Information is available on the Pediatric Product Development page.
2-2-5.Dietary Supplement and Nonprescription Drug Consumer Protection Act, Dec. 22, 2006. Information is available on the OTC Products and Dietary Supplements page.
2-2-6.Dietary Supplement Health and Education Act (DSHEA), Oct. 25, 1994. Information is available the Dietary Supplements page. NOTE: DSHEA does not apply to products intended for animal use. The FDA’s Center for Veterinary Medicine (CVM), Division of Compliance at 240-276-9200 should be consulted for appropriate guidance on these products for animal use.
2-2-7.Drug Price Competition and Patent Term Restoration Act (DPCPTRA), Sept. 24, 1984. This Act consists of two titles:
  • 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.

Information is available on the summary of the bill and FDA testimony on the bill. Patent information is available on the Orange Book page.

2-2-8.Drug Quality and Security Act (DQSA), Nov 27, 2013. The act contains two titles:

Information is available on the Drug Supply Chain Integrity page.

2-2-9.Electronic Product Radiation Control Act of 1990, 21 U.S.C. 360hh-360ss, is the new name for the Radiation Control for Health and Safety Act, Oct. 18, 1968 (formerly at 42 U.S.C. 263c-263n). The change was made as part of the Safe Medical Devices Act of 1990 (SMDA) which was itself amended by the FDA Amendments Act. Information is on the Summary of the Electronic Product Radiation Control Provisions page.
2-2-10.Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), June 22, 2009. Information is available on the Tobacco Control Act page.
2-2-11.Food Allergen Labeling and Consumer Protection Act (FALCPA), Aug. 2, 2004. Additional related information available on the page for Food Allergens Guidance documents and Regulatory Information.
2-2-12.Food and Drug Administration Amendments Act of 2007 (FDAAA), Sept. 27, 2007.
2-2-13.Food and Drug Administration Export Reform and Enhancement Act, April 26, 1996.
2-2-14.Food and Drug Administration Modernization Act of 1997 (FDAMA), Nov. 21, 1997.
2-2-15.Food and Drug Administration Safety and Innovation Act (FDASIA), July 9, 2012. Additional information is available on the FDASIA page.
2-2-16.Food Quality Protection Act (FQPA), Aug. 3, 1996.
2-2-17.Food Safety Modernization Act (FSMA), Jan. 4, 2011.
2-2-18.Generic Drug Enforcement Act (GDEA), May 13, 1992. Additional information is available on the debarment  page.
2-2-19.Health Promotion and Disease Prevention Amendments, Oct. 30, 1984.
2-2-20.Infant Formula Act (IFA), Sept. 26, 1980. Subsequent amendments in 1986 (Section 412) establish nutrient requirements for infant formulas. Information is available on the Guidelines Concerning Notification and Testing of Infant Formulas page and Briefing Materials for the Food Advisory Committee Meeting on Infant Formula page.
2-2-21.Medical Device Amendments, May 24, 1976. Information is available on the Overview of Device Regulation  and Overview of Medical Device Classification and Reclassification pages.
2-2-22.

Medical Device User Fee and Modernization Act (MDUFMA III), July 9, 2012 is included in FDASIA. Additional information is available on the MDUFMA and on MDUFMA III pages.

2-2-23.Minor Use and Minor Species Animal Health Act (MUMS), Aug. 2, 2004. Information is available on the MUMS resource page.
2-2-24.Nutrition Labeling and Education Act (NLEA), Nov. 8, 1990. Information is available on the Labeling & Nutrition Guidance Documents & Regulatory Information and Inspection Guide to NLEA Requirements pages.
2-2-25.Orphan Drug Act (ODA), April 18, 1988. Information is available on the regulatory history of Orphan Drugs and requirements for industry pages. The ODA of 1988 amended the Orphan Drug Act of 1983, Jan. 4, 1983.
2-2-26.Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), March 13, 2013. The PAHPRA resource page is available on the MCM-related Legislation page.

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.

2-2-27.Pediatric Research Equity Act. (PREA) Dec. 2, 2003 has been amended by subsequent legislation. See the Pediatric provisions in FDASIA page and the Food and Drug Administration Amendments Act (FDAAA), Sept. 27, 2007, page.
2-2-28.Prescription Drug Marketing Act of 1987 (PDMA), April 22, 1988.
2-2-29.Prescription Drug User Fee Act (PDUFA), Oct. 29, 1992. Information about PDUFA is available on the PDUFA pages for industry and for small business.
2-2-30.Project Bioshield Act. July 21, 2004. Information about emergency preparedness and response, and the more recent counter-terrorism legislation is available on the MCM-related Legislation page.

 

 
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