pharmtest 1-DLaws Flashcards

Associated with birth defects secondary to intake of thalidomide.

1962: Kefauver Harris Amendment to 1938 Act

First law to required proper labeling.

1938: Food Drug & Cosmetic Act of

Requires that drugs be tested for harmful effects before marketing.

1938: Food Drug & Cosmetic Act of 1938

Requires agencies to maintain record of narcotics.

1970: Controlled Substance Act

Law distinguishing prescription from non-prescription drugs.

1952: Durham Humphrey Amendment to 1938 Act

Requires literature related to adverse effects accompany drug.

1938: Food Drug & Cosmetic Act of 1938

Promotes drug research for rare diseases.

1983: The Orphan Drug Act

Law designed to facilitate drug investigational process for new drugs.

1978: Drug Regulation Reform Act

Established categories for controlled substances.

1970: Controlled Substance Act

Allows for regulation of cigarettes.

2009:Family Smoking and Prevention and Tobacco Control Act