Which law states that drugs must be prescribed by a licensed practitioner?

The Durham-Humphrey Amendment is indeed the law that establishes the requirement for drugs to be prescribed by a licensed practitioner. This amendment, passed in 1951, distinguishes between prescription and over-the-counter (OTC) medications. It specifically defines the categories of drugs that require a prescription and those that can be sold without one. The amendment aims to ensure that certain medications, which may require a healthcare professional's expertise for safe and effective use, are dispensed only with a licensed practitioner’s authorization.

The other laws mentioned address different aspects of drug regulation. The Kefauver-Harris Amendment, for instance, primarily deals with the efficacy and safety of drugs, ensuring that they are not only safe but also provide therapeutic benefits. The Controlled Substances Act regulates the manufacture and distribution of narcotics and other drugs with potential for abuse, categorizing them into schedules based on their medical use and potential for addiction. The Food, Drug, and Cosmetic Act lays the foundational framework for the regulation of food, drugs, and cosmetics, including labeling and safety standards, but it does not specifically mandate prescription requirements.

Understanding the distinctions among these laws is critical for navigating pharmaceutical regulations, ensuring compliant practices in pharmacy operations.