It is important for any pharmacy technician and pharmacist to be extremely aware of the federal pharmacy laws set in place to ensure that they are followed accordingly. The Durham-Humphrey Amendment of 1951, also known as the Prescription Drug Amendment, required that prescription drugs bear the legend, “Caution: Federal law prohibits dispensing without a prescription.” (Johnston, 2014). This requirement is why prescription drugs are also known as legend drugs.
The amendment was created by Hubert H. Humphrey Jr. who was a pharmacist in South Dakota before his career in politics and Carl Durham, a pharmacist who represented North Carolina in the House of Representatives (Wikipedia, 2020). This law was then passed by Congress on October 26, 1951, which required any drug that was habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the said statement legend as mentioned in the previous paragraph (Career Step, 2016). Essentially, prior to this amendment, there was not an established method that was enforced to distinguish how drugs would be classified, legend (prescription) or over the counter (OTC). Until this amendment was brought about, the FDA was free to label them as they saw fit. After some time, succeeding amendments allowed for a simpler substitution that read, “Rx only” (Johnston, 2014). As anyone can imagine, this particular method can be seen as unsafe and unreliable due to the complications and consequences that could potentially take place. According to this amendment, regarding prescription drugs, supervision is required so as to ensure that the patient is taking the medication properly and as directed, instead of resorting to self-medication. Along with this, they are also referred to as legend drugs based on the requirement that each one must contain the caution label stated on the prescription provided by the pharmacist. After some time, succeeding amendments allowed for a simpler substitution that read, “Rx only” (Johnston, 2014). As for over the counter drugs, because they are not under medical supervision and no prescription is needed, they are easy to access. With this ease of accessibility, they must have clear instructions on how to properly utilize the medication for patients and consumers alike.
Overall, the Durham-Humphrey Amendment of 1951 would not have been possible if it were not for Durham and Humphrey’s active involvement in the pharmacy field. The amendment sought to give a more structured method of classifying over the counter drugs and legend drugs, along with enforcing the importance of a caution label on legend drugs that explicitly state that the medication is not to be dispensed without a formal prescription. This was one of the biggest improvements made that this law enforced.
