ENFORCEMENT OF THE FOOD, DRUG, AND COSMETIC ACT
The Food and Drug Administration is the Government agency responsible for
enforcing the Food, Drug, and Cosmetic Act. The FDA employees perform a wide
variety of duties to ensure that the foods, drugs, and cosmetics we use are safe and
meet prescribed standards. When those standards of purity and safety are violated,
FDA officials have the authority to seize products to protect our lives and health. It is
not the intent of this subcourse to discuss in detail the FDA or its functions. However, if
you have a specific interest in the FDA, you should examine the FDA Consumer, a
journal of the organization.
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 (for example, 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 labels: "Caution:Federal law prohibits
dispensing without a prescription."
b. Over-the-Counter Drugs. Over-the-counter (OTC) drugs can be legally
obtained without a prescription. Generally, 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 (for example, physicians and physicians' assistants) of the OTC and legend
drugs they are taking.
Section III. THE HARRIS-KEFAUVER AMENDMENT
The Harris-Kefauver Amendment was added to the Food, Drug, and Cosmetic
Act in 1962. Although, the provisions of this amendment are probably not as well
known as the Durham-Humphrey Amendment, the Harris-Kefauver Amendment is still
important in the area of pharmacy.