Which law distinguishes between prescription and over-the-counter drugs?

The Durham-Humphrey Amendment is significant because it established a clear distinction between prescription drugs and over-the-counter (OTC) medications. This amendment, passed in 1951, amended the Federal Food, Drug, and Cosmetic Act, explicitly defining the criteria for prescription medications, which require a healthcare provider's authorization for dispensing. It outlined that drugs labeled as prescription must be dispensed by a pharmacist only upon receiving a legitimate prescription from a licensed healthcare professional.

This differentiation is crucial for ensuring patient safety, as prescription medications often require supervision due to their potential for adverse effects or need for monitoring by healthcare professionals. Conversely, over-the-counter drugs are generally considered safe to use without a prescription, as their benefits outweigh their risks for the average consumer.

The other options, while important in their own rights within pharmacy and drug regulation, do not specifically address the distinction between prescription and OTC drugs. The Kefauver-Harris Amendment focuses on drug efficacy and safety standards, the Pure Food and Drug Act was primarily concerned with preventing adulteration and misbranding of foods and drugs, and the Controlled Substances Act regulates substances with potential for abuse but does not create a classification for prescription versus OTC drugs.