Regulatory Information

Selected Amendments to the FD&C Act

To find these Public Laws, go to https://congress.gov/ and click on Public Laws.

Selected Amendments to the Federal Food, Drug and Cosmetic Act

  • Infant Formula Act of 1980 
    Public Law (PL) 96-359 (Oct. 26, 1980)
  • Orphan Drug Act 
    PL 97-414 (Jan. 4, 1983)
  • Drug Price Competition and Patent Term Restoration Act of 1984 
    PL 98-417 (Sep. 24, 1984)
  • Prescription Drug Marketing Act of 1987 
    PL 100-293 (Apr. 22, 1988)
  • Generic Animal Drug and Patent Term Restoration Act of 1988 
    PL 100-670 (Nov. 16, 1988)
  • Nutrition Labeling and Education Act of 1990 
    PL 101-535 (Nov. 8, 1990) 
  • Safe Medical Devices Act of 1990 
    PL 101-629 (Nov. 28, 1990)
  • Medical Device Amendments of 1992 
    PL 102-300 (June 16, 1992)
  • Prescription Drug Amendments of 1992; Prescription Drug User Fee Act of 1992 
    PL 102-571 (Oct. 29, 1992)
  • Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 
    PL 103-396 (Oct. 22, 1994)
  • Dietary Supplement Health and Education Act of 1994 
    PL 103-417 (Oct. 25, 1994)
  • FDA Export Reform and Enhancement Act of 1996
    PL 104-134 (April 26, 1996)
  • Food Quality Protection Act of 1996
    PL 104-170 (Aug. 3, 1996)
  • Animal Drug Availability Act of 1996
    PL 104-250 (Oct. 9, 1996)
  • Food and Drug Modernization Act (FDAMA) of 1997 
    PL 105-115 (Nov. 21,1997)
  • Best Pharmaceutical for Children Act
    PL 107-109 (Jan. 4, 2002)
  • Medical Device User fee and Modernization Act (MDUFMA) of 2002
    PL 107-250 (Oct. 26, 2002)
  • Animal Drug User Fee Act of 2003
    PL 108-130 (Nov. 18, 2003)
  • Pediatric Research Equity Act of 2003 
    PL 108-155 (Dec. 3, 2003)
  • Minor Use and Minor Species Animal Health Act of 2004 
    PL 108-282 (Aug. 2, 2004)
  • Dietary Supplement and Nonprescription Drug Consumer Protection Act 
    PL 109-462 (Dec. 22, 2006)
  • Food and Drug Administration Amendments Act (FDAAA) of 2007 
    PL 110-85 (Sept. 27, 2007)
  • Biologics Price Competition and Innovation Act of 2009 (BPCI),
    PL 111-148, Title VII, Subtitle A
  • Family Smoking Prevention and Tobacco Control Act (Public Law 111-31) 
    PL 111-31 (June 22, 2009)
  • Menu Labeling
    PL 111-148, Section 420 (2010)
  • FDA Food Safety Modernization Act 
    PL 111-353 (Jan. 4, 2011)
  • Drug Quality and Security Act
    PL 113-54 (2013)
  • Sunscreen Innovation Act
    PL 113-195 (2014)
  • 21st Century Cures Act
     PL 115-52 (2016)
  • FDA Reauthorization Act of 2017 (FDARA)
    PL 115-52 (2017)

 

Page Last Updated: 03/29/2018
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