Classification of Drug Information Questions Related

Review Classification of Drug Information Questions related questions and content

Which of the following legislative acts allowed the Food and Drug Administration (FDA) to tighten control over the quality of drugs and required that safety and efficacy standards be established?

  • A. Pure Food and Drug Act of 1906
  • B. Federal Food, Drug, and Cosmetic Act of 1938
  • C. Durham Humphrey Amendment of 1951
  • D. Kefauver-Harris Act of 1962
Correct Answer: D

Rationale: The Kefauver-Harris Act was the result of the use of the 1960s drug thalidomide (Thalomid). The public concern led to the legislation that gave the FDA regulatory control over testing and evaluating of drugs and allowed it to set standards for efficacy and safety. The Pure Food and Drug Act required labeling to eliminate false claims. The Federal Food, Drug, and Cosmetic Act gave the FDA the power to enforce standards for testing drug toxicity and monitoring labeling. The Durham-Humphrey Amendment enforced prescriptions for distribution.