Durham-Humphrey Amendment: The Distinction between Prescription and Over-the-Counter Drugs

Durham-Humphrey Amendment (FDCA)

Piece of legislature that created the OTC and prescription drug categories

The Durham-Humphrey Amendment is an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) passed by the United States Congress on October 10, 1951. The amendment established two categories of drugs: prescription and over-the-counter (OTC).

Prior to this amendment, all drugs were available without a prescription. The amendment was named after Senator Hubert Humphrey and Congressman Carl Durham, who sponsored it.

Under the Durham-Humphrey Amendment, a prescription drug is one that is unsafe for use except under the supervision of a licensed healthcare provider due to potential harm to patients if not used properly or due to potential for misuse. Examples of prescription drugs include antibiotics, opioids, and drugs used for the treatment of chronic conditions such as diabetes and hypertension.

On the other hand, OTC drugs are those that have been approved by the FDA for use by the general public without a prescription. These drugs are considered safe and effective when used according to their labeling instructions. Examples of OTC drugs include aspirin, ibuprofen, and allergy medications.

The Durham-Humphrey Amendment also established that prescriptions can be either written or oral, with the latter requiring that the healthcare provider reduces the prescription to writing and maintains it in the patient’s medical record.

In summary, the Durham-Humphrey Amendment provides a clear distinction between prescription and over-the-counter drugs, which helps ensure that prescription drugs are only used under the supervision of a healthcare provider and prevents patients from accessing potentially harmful drugs without proper oversight.

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