The ______ allowed the manufacturer to determine whether a drug was to be labeled prescription or non-prescription.

• A. Harrison Act of 1914
• B. Food, Drug, and Cosmetic Act of 1938
• C. Anti-Drug Abuse Act of 1988
• D. Drug Abuse Control Amendment Act of 1965

Answer: (B)

Understanding how a drug’s status as prescription or non-prescription is determined depends on the regulatory framework for drug safety and labeling. The Food, Drug, and Cosmetic Act of 1938 gave the FDA the authority to regulate drug safety and to require labeling with adequate directions for use. This labeling framework creates the environment in which a drug’s labeling and the need for professional supervision are evaluated under FDA oversight, allowing a drug to be designated as Rx or OTC. While later amendments (such as the one that formally defined prescription versus non-prescription status) clarified the distinction, the 1938 act established the essential authority and labeling requirements that make such designation possible. The other listed laws focus on controlling drug abuse, taxation, or penalties and do not establish how drugs are labeled as prescription or non-prescription.