Figure 2-3. An excerpt from an article on the use of a medical device.
Section II. THE DURHAM-HUMPHREY AMENDMENT
The Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act was
passed in 1952. The purpose of this amendment was to divide drugs into two basic
categories: legend drugs and over--the-counter drugs.
CATEGORIES OF DRUGS UNDER THE DURHAM-HUMPHREY AMENDMENT
a. Legend Drugs. Legend drugs can only be legally obtained by prescription.
Legend drugs are those drugs that are not considered safe for use without direct
medical supervision (that is, prescribed by a physician). It is against the law to give
legend drugs to persons who do not have a valid prescription. Legend drugs must have
the following statement printed on their label:
CAUTION: Federal law prohibits dispensing without a prescription."
b. Over-The-Counter Drugs. Over-the-counter drugs can be legally obtained
without a prescription. Generally, over-the counter (OTC) drugs are considered safe for
use without direct medical supervision. You should remember some important facts
about OTC drugs. One, OTC medications are drugs-care should be taken when the
drugs are being used. Two, patients should read and follow the label directions for both
legend and over-the-counter drugs. Three, patients should inform their health-care
providers (that is, physicians and physicians' assistants) of the OTC and legend drugs
they are taking.