West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which law made a clear distinction between OTC and Rx drugs?

1. Adulteration and Misbranding Act

2. Durham-Humphrey Amendment of 1951

3. Federal False Claims Act of 1982

4. Pure Food and Drug Act of 1906

The correct answer is: Durham-Humphrey Amendment of 1951

The Durham-Humphrey Amendment of 1951 is indeed the correct answer because this legislation specifically established the framework to differentiate between over-the-counter (OTC) drugs and prescription (Rx) drugs. Prior to this amendment, there was no formal classification, leading to potential confusion about whether certain medications required a prescription for safe use. The amendment defined two categories of drugs: those that could be safely used by consumers without a prescription when used according to the label, and those that required a healthcare provider's oversight due to their potential risks or side effects. This distinction was crucial for public health and safety, ensuring that patients only received prescription medications when necessary. The other options, while relevant to pharmaceutical law, do not focus on creating this distinction. The Adulteration and Misbranding Act deals primarily with the purity and labeling of drugs, the Federal False Claims Act pertains to fraud against the government, and the Pure Food and Drug Act of 1906 focused on the regulation of food and drug safety more generally, without establishing a clear boundary for OTC vs. Rx classification.