Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

Which act required a drug to be both safe and effective before it could be marketed?

1. Food, Drug, and Cosmetic Act (1938)

2. Durham-Humphrey Amendment (1951)

3. Kefauver-Harris Amendment (1962)

4. Medical Device Amendment (1976)

The correct answer is: Food, Drug, and Cosmetic Act (1938)

The correct answer is A. Food, Drug, and Cosmetic Act (1938). This act mandated that a drug must be proven both safe and effective before it can be marketed. This requirement is a crucial part of the regulatory process to ensure the safety and efficacy of medications before they are made available to the public. Option B, the Durham-Humphrey Amendment (1951), primarily focused on distinguishing between prescription and over-the-counter medications, rather than on the safety and efficacy requirements for marketing drugs. Option C, the Kefauver-Harris Amendment (1962), strengthened the regulatory control over the approval of new drugs and required drug manufacturers to provide evidence of effectiveness in addition to safety, but it did not institute the initial requirement for both safety and efficacy. Option D, the Medical Device Amendment (1976), primarily addressed the regulation of medical devices rather than pharmaceuticals and did not pertain specifically to the requirement of proving both safety and efficacy before marketing a drug.