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

What did the Durham-Humphrey Amendment create?

1. Over-the-counter and prescription drug categories

2. Regulations for drug advertising

3. Increased fees for drug applications

4. Patents for new drug formulations

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

The Durham-Humphrey Amendment, enacted in 1951, established a crucial classification system for medications by creating two categories: prescription drugs and over-the-counter (OTC) drugs. This amendment was significant because it clarified the distinction between drugs that require a prescription from a licensed healthcare provider to ensure safe use and those that can be safely used by the general public without a prescription. This classification was important in promoting patient safety and ensuring that individuals have access to appropriately regulated medications. Prescription drugs are subject to more stringent regulations due to their potential risks and the need for professional guidance in their use, while OTC drugs can be self-administered by consumers, who can follow the labeling instructions for safe and effective use. The other choices address topics that are relevant to the pharmaceutical industry but are not directly created by this amendment. Regulations on drug advertising are primarily managed by the Federal Trade Commission and the FDA but were not a direct result of the Durham-Humphrey Amendment. Similarly, increased fees for drug applications and patents for new drug formulations relate more to FDA processes and intellectual property laws rather than the specific efforts to differentiate drug categories established by the Durham-Humphrey legislation.