Which act established the classification of Legend drugs?

The Durham-Humphrey Act is the legislation that established the classification of Legend drugs, which are medications that require a prescription to be dispensed. This act, passed in 1951, created a distinction between over-the-counter (OTC) medications and prescription medications, commonly referred to as Legend drugs. It specified that certain drugs could only be dispensed with a valid prescription from a licensed healthcare provider, ensuring that drugs with potential for misuse or that require professional supervision are properly managed.

The significance of this classification lies in the safety and efficacy of drug distribution, allowing pharmacists to ensure that patients receive appropriate guidance and monitoring while using prescription medications. By understanding this regulatory framework, pharmacists and healthcare practitioners can better navigate the requirements for prescribing, dispensing, and patient education surrounding these medications.

In contrast, other legislative acts mentioned play different roles in the regulation of pharmaceuticals. The Kefauver-Harris Act focused on drug efficacy and safety following the thalidomide tragedy, the Orphan Drug Act is aimed at encouraging the development of treatments for rare diseases, and the Prescription Drug Marketing Act targets the distribution and marketing of prescription drugs.