The ______ established the criteria for determining whether a drug should be classified as a prescription or non-prescription.

• A. Harrison Act of 1914
• B. Anti-Drug Abuse Act of 1988
• C. Drug Abuse Control Amendment Act of 1965
• D. Durham-Humphrey Amendment of 1951

Answer: (D)

The key idea here is how drugs are categorized for how they’re obtained and used. The Durham-Humphrey Amendment of 1951 created the formal split between prescription (legend) drugs and non-prescription (OTC) drugs. It clarified that drugs needing medical supervision or careful dosing must be dispensed only with a physician’s prescription, and it allowed prescriptions to be written, given orally, and renewed with proper authorization. It also required labeling that guides safe use, including the familiar warning that federal law prohibits dispensing without a prescription on prescription drugs. This amendment gave the FDA and prescribers clear rules about who can access certain medicines and how they should be used, establishing the criteria that determine whether a drug is prescription or OTC. Other acts addressed different policy goals, but they did not establish these prescription-versus-over-the-counter criteria.