Which amendments differentiated prescription and nonprescription drugs?

• A. Biologics Control Act 1902
• B. FDA Act 1988
• C. Dietary Supplement Health and Education Act 1994
• D. Durham-Humphrey Amendments 1962

Answer: (D)

The key idea is how drug products are categorized for dispensing. The Durham-Humphrey Amendments established two clear classes: prescription (or legend) drugs that must be dispensed only with a licensed prescriber’s order, and nonprescription (OTC) drugs that can be sold with consumer directions. This amendment also allowed oral prescriptions and refills under a prescriber’s authorization and required that OTC products carry explicit directions for use on their labels. In short, it created the formal split between drugs needing a clinician’s order and those safe enough for consumer use without a prescription.

The other listed laws address different areas—biologics regulation, dietary supplements, or FDA structure—rather than establishing the prescription versus OTC distinction.