Section II. The Durham-Humphrey Amendment

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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

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INTRODUCTION

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.

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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

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INTRODUCTION

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.

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