Durham–Humphrey Amendment

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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 into law 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 Durham-Humphrey Amendment, the distinction between prescription and non-prescription drugs was not explicitly defined in U.S. law. The Federal Food, Drug, and Cosmetic Act of 1938 required that drugs be labeled with adequate directions for safe use, but it did not require that some drugs be sold only by prescription. This ambiguity led to confusion and potential safety issues, as some drugs that were potent or potentially dangerous were available without professional supervision.

Provisions

The Durham-Humphrey Amendment addressed these concerns by amending the FD&C Act to introduce two key provisions:

• It established two classes of drugs: (1) those that could not be used safely without professional supervision and were thus required to be dispensed by prescription only, and (2) those that could be safely used without supervision and could be sold over the counter.
• It authorized pharmacists to refill prescriptions as indicated by the prescribing physician, without the need for a new prescription each time, unless specifically prohibited by the doctor.

The amendment also allowed for oral prescriptions and prescriptions to be called in by telephone, which were significant changes from the previous requirement for written prescriptions for all drugs.

Impact

The Durham-Humphrey Amendment has had a lasting impact on the pharmacy profession, the pharmaceutical industry, and public health. By clearly distinguishing between prescription and OTC drugs, it has helped ensure that more potent and potentially dangerous medications are dispensed under the supervision of a healthcare professional. This has enhanced drug safety and efficacy, reduced medication errors, and improved public health outcomes.

Furthermore, by allowing for prescription refills and the acceptance of oral prescriptions, the amendment has made it more convenient for patients to access their medications and for pharmacists to serve their customers efficiently.

Contemporary Relevance

Today, the Durham-Humphrey Amendment continues to be a foundational element of drug regulation in the United States. It has set a precedent for how drugs are classified and regulated, influencing subsequent legislation and regulatory practices. The distinction between prescription and OTC drugs remains a critical aspect of drug safety and public health policy.

See Also

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