Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

Which amendment distinguished prescription drugs from OTC drugs?

1. Durham-Humphrey Amendment

2. Kefauver-Harris Drug Amendment

3. Pure Food and Drug Act

4. Sulfanilamide Amendment

The correct answer is: Durham-Humphrey Amendment

The Durham-Humphrey Amendment is indeed the correct choice because it specifically established a legal distinction between prescription drugs and over-the-counter (OTC) drugs. Enacted in 1951, this amendment introduced the concept that certain drugs require a prescription for safe use due to their potential for misuse or the need for professional supervision in their administration. Consequently, this amendment outlined criteria for both categories, defining which medications could be dispensed without a healthcare provider's involvement and which required a prescription based on their safety profiles and usage instructions. The other amendments and acts mentioned do not focus primarily on distinguishing between prescription and OTC drugs. For instance, the Kefauver-Harris Drug Amendment addressed drug efficacy and safety and involved reporting requirements for side effects. The Pure Food and Drug Act aimed primarily at preventing adulteration and misbranding of food and drugs. The Sulfanilamide Amendment, prompted by a tragic poisoning incident, established stricter regulations but did not specifically categorize drugs into prescription and OTC groups.