U.S. Food and Drug Administration
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Laws Enforced by the FDA and Related Statutes

Federal Food, Drug, and Cosmetic Act (FD&C Act)
United States Code (U.S.C.) Title 21, Chapter 9

Amendments to the FD&C Act

Other Laws

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Significant Amendments to the FD&C Act:

Since 1980, listed chronologically; date shown is when the Public Law was approved. "Summary" indicates link to a summary of the law; other links are to full text. Provisions of these Public Laws are incorporated into the FD&C Act.

Infant Formula Act of 1980 (summary)
Public Law (PL) 96-359 (Oct. 26, 1980)

Orphan Drug Act
PL 97-414 (Jan. 4, 1983)
More information about orphan drugs

Drug Price Competition and Patent Term Restoration Act of 1984 (summary)
PL 98-417 (Sept. 24, 1984)

Prescription Drug Marketing Act of 1987
PL 100-293 (Aug. 18, 1988)
More information about the PDMA

Generic Animal Drug and Patent Term Restoration Act of 1988 (summary)
PL 100-670 (Nov. 16, 1988)

Nutrition Labeling and Education Act of 1990 (summary)
PL 101-535 (Nov. 8, 1990)

Safe Medical Devices Act of 1990 (summary)
PL 101-629 (Nov. 28, 1990)

Medical Device Amendments of 1992 (summary)
PL 102-300 (June 16, 1992)

Prescription Drug Amendments of 1992
PL 102-353 (Aug. 26, 1992)
More information about the Prescription Drug Amendments

Prescription Drug User Fee Act (PDUFA) of 1992
PL 102-571 (Oct. 29, 1992)
More information about PDUFA

Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994
PL 103-396 (Oct. 22, 1994)
More information about AMDUCA

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 Administration Modernization Act (FDAMA) of 1997
PL 105-115 (Nov. 21, 1997)
More information about FDAMA

Best Pharmaceuticals 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)
More information about MDUFMA

Animal Drug User Fee Act of 2003 PDF (51 KB)
PL 108-130 (Feb. 20, 2003)
More information about ADUFA

Pediatric Research Equity Act of 2003
PL 108-155 (Dec. 3, 2003)

Minor Use and Minor Species Animal Health Act of 2004
Food Allergen Labeling and Consumer Protection Act of 2004

PL 108-282 (Aug. 2, 2004)

Dietary Supplement and Nonprescription Drug Consumer Protection Act (PDF 48 KB)
PL 109-462 (Dec. 22, 2006)

Food and Drug Administration Amendments Act of 2007
PL 110-85 (Sept. 27, 2007)
More information about FDAAA

Other Laws Affecting FDA:

Dates shown are when Public Law was first approved; laws may have been amended since original date

Federal Food and Drugs Act of 1906 (repealed; for historical reference)

Federal Meat Inspection Act (March 4, 1907)

Federal Trade Commission Act (Sept. 26, 1914)

Filled Milk Act (March 4, 1923)

Import Milk Act (Feb. 15, 1927)

Public Health Service Act (July 1, 1944)

Trademark Act of 1946 (July 5, 1946)

Reorganization Plan 1 of 1953 (March 12, 1953)

Poultry Products Inspection Act (Aug. 28, 1957)

Fair Packaging and Labeling Act (Nov. 3, 1966)

The National Environmental Policy Act of 1969 (Jan. 1, 1970)

Controlled Substances Act (Oct. 27, 1970)
Current regulations listing schedules of controlled substances

Controlled Substances Import and Export Act (Oct. 27, 1970)

Egg Products Inspection Act (Dec. 29, 1970)

Lead-Based Paint Poisoning Prevention Act (Jan. 13, 1971)

Federal Advisory Committee Act (Oct. 6, 1972)

Government in the Sunshine Act (Sept. 13, 1976)

Government Patent Policy Act of 1980 (Dec. 12, 1980)

Federal Anti-Tampering Act (Oct. 13, 1983)

Sanitary Food Transportation Act (Nov. 3, 1990)

Mammography Quality Standards Act (MQSA) (Oct. 27, 1992)

Bioterrorism Act of 2002 (June 12, 2002)
More information about the Bioterrorism Act

Project BioShield Act of 2004 (July 21, 2004)

Page last updated Mar. 17, 2008

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