Which legislation authorizes the FDA to determine the safety of a drug before its marketing?
a. Federal Food, Drug, and Cosmetic Act (1938)
b. Durham Humphrey Amendment (1952)
c. Controlled Substances Act (1970)
d. Kefauver Harris Drug Amendment (1962)
ANS: A
The Federal Food, Drug, and Cosmetic Act of 1938 authorized the FDA to determine the safety of all drugs before marketing. Later amendments and acts helped tighten FDA control and ensure drug safety. The Durham Humphrey Amendment defines the kinds of drugs that cannot be used safely without medical supervision and restricts their sale to prescription by a licensed practitioner. The Controlled Substances Act addresses only controlled substances and their categorization. The Kefauver Harris Drug Amendment ensures drug efficacy and greater drug safety. Drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.
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