What does the Durham-Humphrey Amendment of 1951 require for prescription medications?

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The Durham-Humphrey Amendment of 1951 is significant in the regulation of prescription medications as it established a clear distinction between prescription and over-the-counter (OTC) drugs. One of its key provisions mandates that prescription medications must bear the legend "Rx Only." This labeling requirement indicates that the drug is available only through a licensed healthcare provider and cannot be purchased directly by consumers without a prescription.

This amendment aimed to ensure that specific, potentially dangerous medications are used under medical supervision, thereby protecting public health. The "Rx Only" designation helps to inform patients and pharmacists of the requirement for a prescription, ensuring that individuals seeking these medications have appropriate guidance and monitoring from healthcare professionals.

Other options, while important aspects of pharmaceutical safety and communication, are not the central focus of the Durham-Humphrey Amendment. The amendment's primary role was to regulate the status of drugs as either prescription or OTC, with "Rx Only" being a clear marker of that status.

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