What labeling requirement was established by the Durham-Humphrey Amendment of 1951?

The Durham-Humphrey Amendment of 1951 established important distinctions between prescription drugs and over-the-counter (OTC) drugs, primarily focusing on the labeling requirements for prescription medications. One of the key components of the amendment was the requirement that legend drugs—those that cannot be dispensed without a prescription—must be accompanied by the specific labeling: “Caution: Federal law prohibits dispensing without a prescription.” This statement serves to inform both pharmacists and patients that a prescription is necessary to obtain these medications, reinforcing the idea that these drugs require professional oversight for safe usage.

The labels for prescription medications must clearly convey this information to ensure compliance with federal regulations and also provide protection for patients by emphasizing the need for medical guidance in their use. This requirement plays a crucial role in preventing misuse and ensuring safe dispensing practices in pharmacy practice.

Other labeling elements, such as side effects, warnings about addiction for OTC drugs, or expiration dates for all drugs, do not specifically originate from the Durham-Humphrey Amendment but may be covered under different regulations or amendments. Thus, the labeling requirement established by the Durham-Humphrey Amendment is uniquely focused on the need for a prescription for legend drugs, making the specific wording about prohibition without a prescription the correct aspect to highlight.