Durham-Humphrey Act

The Food and Drug Administration (FDA) is the U.S. government agency that is responsible for enforcing the laws and rules of drug administrations. Since the FDA's establishment, changing understanding of the potency of different drugs has caused it to establish tougher regulations on the use of certain drugs as opposed to others. The Durham-Humphrey Act modified the FDA's treatment of certain drugs, allowing specific pharmaceuticals to be available to the public only with a physician's prescription.

The Food and Drug Act of 1906 created the FDA, and gave the federal agency authority to [Page 264]seize drugs that had been adulterated or where the strength, quality, or purity of the main ingredients was not clearly stated on the label. The Food, Drug and Cosmetic Act of 1938 further required the FDA to label those drugs that had habit-forming qualities and for those labels to specifically denote those properties of the drug that made it addictive. This act also gave the FDA power to determine the safety of drugs before they were marketed and required “dangerous” drugs to be issued only by prescription of a physician, dentist, or veterinarian. Although these changes represented an improvement, there was still ambiguity regarding what drugs could be prescribed to the public in what circumstances. Further modification of FDA policies was seen as necessary.

In 1951 this modification was enacted by what is popularly known as the Durham-Humphrey Act, which amended the Food, Drug and Cosmetic Act. The purpose of the Durham-Humphrey Act was to make a distinction between certain types of drugs. Pharmaceuticals were placed into two separate categories: legend and over-the-counter drugs. The Durham-Humphrey Act differentiates between legend drugs, which need a physician's prescription, and over-the-counter medications, which do not.

The Durham-Humphrey Act also identifies which original prescriptions and refills can be authorized over the telephone. When Congress passed the Durham-Humphrey Act, it sought to have the FDA define the difference between drugs that cannot be used safely without medical supervision. The amendment limits sale of legend drugs to those circumstances deemed necessary by a medical professional. All other drugs are to be available without a prescription.

Legend drugs are those that are not considered safe for use without direct medical supervision. Legend drugs must be prescribed by a physician or some type of medical professional, and their sale is prohibited to those who do not possess a valid prescription. Medical doctors must make a professional decision on whether or not the patient is in the serious medical need for the drug. Legend drugs must have the following statement on their labels, “Caution: Federal law prohibits dispensing without prescription.” The FDA uses such labels to ensure that the foods, drugs, and cosmetics sold are safe and meet the prescribed standards. To be used, legend drugs must be dispensed only if certain procedures are followed, such as the following:

• A written prescription to a pharmacist by a practitioner authorized by the laws of a state or laws of another jurisdiction to issue prescriptions
• An oral prescription of such practitioner that is reduced promptly to writing and filled by a duly licensed pharmacist
• Refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order that is promptly reduced to writing and filled by the pharmacist

Failure to comply with these requirements is dealt with through penalties for the physician, pharmacist, and patient.

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