Pharmacy Technician PTCB Practice Test

Which legislation defined the distinct categories of prescription and over-the-counter medications?

1. Kefauver-Harris Amendment

2. Food, Drug, and Cosmetic Act

3. Durham-Humphrey Amendment

4. Pure Food and Drug Act

The correct answer is: Durham-Humphrey Amendment

The Durham-Humphrey Amendment is the correct answer because it specifically defined the distinct categories of prescription and over-the-counter medications. This amendment, also known as the Prescription Drug Amendment, was passed in 1951 and established regulations around which drugs could be dispensed with or without a prescription. This legislation helped to ensure the safe use of medications by clearly distinguishing between those that require a prescription from a healthcare provider and those that can be sold over the counter. The other options are incorrect: A. The Kefauver-Harris Amendment focused on drug efficacy and safety, requiring drug manufacturers to provide scientific evidence of a drug's effectiveness. B. The Food, Drug, and Cosmetic Act mainly deals with preventing misbranded and adulterated foods, drugs, devices, and cosmetics from being sold in interstate commerce. D. The Pure Food and Drug Act, while an important piece of legislation in the history of pharmaceutical regulation, primarily aimed to prevent the manufacture, sale, or transportation of adulterated or misbranded foods and drugs.