Section III. THE HARRIS-KEFAUVER AMENDMENTS
The Harris-Kefauver Amendments were added to the Food, Drug, and Cosmetic
Act in 1962. Although the provisions of this amendment are probably not as well known
by many people as the Durham-Humphrey Amendment, the Harris-Kefauver
Amendment is still important in the area of pharmacy.
PROVISIONS OF THE HARRIS-KEFAUVER AMENDMENTS
The most important provisions of the Harris-Kefauver Amendments as applied to
pharmacy practice are:
a. A drug item must be proven safe and effective before it can be sold.
b. Drug manufacturers must register on an annual (yearly) basis with the Food
and Drug Administration (FDA). In addition, these manufacturers must be inspected
once every two years.
c. The generic name of the item must be written on the item's label and the
generic name must be used in the advertising for the item.
The Harris-Kefauver Amendments also have provisions that govern
the reporting of adverse drug reactions and the testing of investigational
drugs. In the Army, adverse drug reactions are reported following the
guidelines of AR 40-2.
An investigational drug is a new drug that has not yet been approved
by the Commissioner of Food and Drugs, Department of Health and
Welfare, (FDA) for general use by the public as a safe and effective
drug. No investigational drug will be used without the prior written
approval of the Surgeon General. See AR 40-7 Use of Investigational
Drugs in Humans) for specific information about investigational drugs.