South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What significant act established the classification of prescription and over-the-counter drugs?

1. Pure Food and Drug Act

2. Durham Humphrey Amendment of 1951

3. Food Drug and Cosmetic Act

4. Comprehensive Drug Abuse Prevention and Control Act

The correct answer is: Durham Humphrey Amendment of 1951

The Durham-Humphrey Amendment of 1951 is key in establishing the classification of drugs into prescription and over-the-counter categories. This amendment was a significant change to the Federal Food, Drug, and Cosmetic Act and clarified the distinction between the two types of medications. Before this amendment, there was no formal classification for prescription versus over-the-counter drugs. The Durham-Humphrey Amendment introduced the concept that certain drugs could only be dispensed with a prescription, primarily those that require direct supervision of a healthcare professional for safe and effective use. This was pivotal for ensuring patient safety, as it allowed medications that posed risks if used unsupervised to be available only through a prescriber. Furthermore, the amendment also allowed for refills of certain medications to be authorized by the prescriber, which modernized the way prescriptions were handled, facilitating better patient management and access to necessary medications. In contrast, the Pure Food and Drug Act primarily focused on preventing adulteration and misbranding of foods and drugs, the Food, Drug, and Cosmetic Act provided broader regulatory authority but did not specifically categorize drugs, and the Comprehensive Drug Abuse Prevention and Control Act mainly addressed the control and regulation of narcotics and controlled substances instead of general drug classification. This further underscores the unique