Pure Food and Drug Act

of 1906

Enacted in 1906 to prohibit the interstate transportation or sale of adultered and misbranded food or drugs.

FDCA 1938

(Food, Drug, and Cosmetic Act of 1938)

Required that all new drug applications be filed with the FDA.

Adulteration

• Consisting in whole or in part of any filthy, putrid, or decomposed substance.
• Prepared, packed or held under unsanitary conditions.
• Prepared in poisonous containers.
• Contained unsafe color additives.
• Claimed to be something they are not.

Kefauver-Harris

Amendment of 1962

The K-H Amendment requires all medications in the U.S. to be pure, safe,

and effective.