Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

The Kefauver-Harris Amendment of 1962 introduced which key requirement for drugs?

1. Efficacy

2. Manufacturing standards

3. Safety

4. Labeling requirements

The correct answer is: Efficacy

The Kefauver-Harris Amendment of 1962 introduced the requirement for drug manufacturers to prove the efficacy of their drugs before it could be approved for sale. This amendment was enacted after the thalidomide tragedy, where thousands of babies were born with birth defects due to a drug that had not been properly tested for its effects on pregnant women. Option B, manufacturing standards, was already required by the Food, Drug, and Cosmetic Act of 1938. Option C, safety, was also already addressed under the same act. Option D, labeling requirements, was not the main focus of the Kefauver-Harris Amendment, although it did require drug manufacturers to include information about side effects and contraindications on their product labels.