What does the label on prescription drugs often warn according to the regulations after the Durham-Humphrey Amendment?

The label on prescription drugs often includes the warning that "Federal law prohibits dispensing without a prescription." This statement is a direct result of the Durham-Humphrey Amendment, which established a clear distinction between prescription medications and over-the-counter (OTC) drugs. This amendment allows certain medications to be dispensed only when there is a valid prescription from a licensed healthcare provider, reinforcing the requirement that these medications should not be available for self-dispensing without professional guidance.

This warning is crucial because it helps ensure that patients receive medications only when necessary and under the supervision of a healthcare professional, thereby promoting safety and appropriate use. The emphasis on the necessity of a prescription also emphasizes the regulatory structure set in place to protect consumers from potential misuse or adverse effects that may arise from unsupervised access to prescription drugs.

While the other options may themselves be warnings found on certain types of labels, they do not specifically relate to the regulation changes prompted by the Durham-Humphrey Amendment regarding the dispensing of prescription medications. For instance, "May cause drowsiness" might be seen on labels of a specific medication that has sedative effects, but it is not a requirement for all prescription drugs. "Caution: harmful if used incorrectly" is a general safety warning