Durham-Humphrey Amendment

Durham-Humphrey Amendment

The Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) is a significant piece of legislation in the United States that was enacted on October 26, 1951. This amendment, officially known as Public Law 82-215, is named after its sponsors, Senator Hubert H. Humphrey of Minnesota and Representative Carl Durham of North Carolina. It plays a crucial role in the regulation of prescription drugs and over-the-counter (OTC) drugs, establishing a clear distinction between the two categories for the first time in U.S. history.

Background

Prior to the enactment of the Durham-Humphrey Amendment, the distinction between prescription and non-prescription drugs was not clearly defined. This ambiguity often led to confusion among consumers and healthcare providers alike. The amendment was introduced as a response to the need for clearer regulation of drug sales and distribution, ensuring that certain drugs could only be dispensed with a valid prescription.

Provisions

The Durham-Humphrey Amendment made several key changes to the FD&C Act, including:

• Establishing two distinct categories of medications: prescription (or "legend") drugs and over-the-counter drugs.
• Requiring that prescription drugs bear a label stating, "Caution: Federal law prohibits dispensing without a prescription."
• Authorizing oral prescriptions and refills on prescriptions as permissible practices.
• Delegating the authority to the Food and Drug Administration (FDA) to decide which drugs would require a prescription based on their potential for harm, the method of use, or the necessity for a healthcare provider's supervision.

Impact

The Durham-Humphrey Amendment has had a lasting impact on the pharmaceutical industry and healthcare practice in the United States. By clearly distinguishing between prescription and OTC drugs, it has helped to ensure the safety and efficacy of medications by controlling their distribution. The amendment has also facilitated the development of the pharmacy profession, as pharmacists play a key role in managing and dispensing prescription medications.

Contemporary Relevance

Today, the Durham-Humphrey Amendment continues to be relevant as the landscape of drug regulation evolves. With the advent of telemedicine and online pharmacies, the principles established by the amendment guide the dispensation of medications in a digital age. The FDA regularly reviews and updates its list of drugs that require a prescription, adapting to new scientific evidence and changes in healthcare practice.

See Also

• Federal Food, Drug, and Cosmetic Act
• Prescription Drug
• Over-the-counter Drug
• Food and Drug Administration
• Pharmacy