FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

The Durham-Humphrey Amendment split drugs into which two categories?

1. Controlled and uncontrolled

2. Over-the-counter and prescription

3. Generic and brand-name

4. Pharmacy-only and supermarket drugs

The correct answer is: Over-the-counter and prescription

The Durham-Humphrey Amendment, enacted in 1951, is significant in the regulation of drugs as it established a clear distinction between prescription medications and over-the-counter (OTC) drugs. This amendment was pivotal in ensuring that certain medications could only be dispensed with a prescription from a licensed healthcare provider. The rationale behind this split is to safeguard patient health by requiring professional oversight for potentially more dangerous or complex medications that may require monitoring, dosage adjustment, or patient education regarding their use. On the other hand, the amendment also allowed drugs deemed safe enough for consumer use to be available directly to the public without a prescription, thus classifying those as over-the-counter drugs. This classification has implications for how drugs are marketed, sold, and regulated within the healthcare system, with the goal of optimizing patient access while ensuring safety. The other answer choices do not accurately reflect the classification established by the Durham-Humphrey Amendment. For instance, the distinction between controlled and uncontrolled substances pertains more to the Controlled Substances Act than to the Durham-Humphrey Amendment. The terms generic and brand-name refer to drug formulation and marketing, which also fall outside the scope of the amendment. Finally, the concept of pharmacy-only versus supermarket drugs does not align with the legally