FEDERAL LEGISLATION AFFECTING THE CLINICAL USE OF DRUGS

Question 1

Prevented the marketing of adulterated drugs; required
labeling to eliminate false or misleading claims

Answer 1

Pure Food and Drug Act (1906)

Question 2

Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for introducing new drugs; gave FDA
the power of enforcement

Answer 2

Federal Food, Drug and Cosmetic Act (1938)

Question 3

Tightened control of certain
drugs; specified drugs to be
labeled “may not be distributed without a prescription

Answer 3

Durham Humphrey Amendment (1951)

Question 4

Tightened control over the quality of drugs; gave FDA regulatory power over the procedure of drug investigations; stated that efficacy as well as safety of drugs had to be established

Answer 4

Kefauver Harris Act (1962)

Question 5

Defined drug abuse and
classified drugs as to their
potential for abuse; provided strict controls over the
distribution, storage, and
use of these drugs

Answer 5

Controlled Substances Act (1970)

Question 6

Provided incentives for the
development of orphan
drugs for treatment of rare
diseases

Answer 6

Orphan Drug Act (1983)