PROVISIONS OF THE HARRIS-KEFAUVER AMENDMENT
The most important provisions of the Harris-Kefauver Amendment 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 Amendment also has 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 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.
Section IV. THE CONTROLLED SUBSTANCES ACT
HISTORY OF CONTROL OF NARCOTIC SUBSTANCES
a. Controlled substances are legend drugs that have special rules and
regulations governing and controlling their use. This has not always been the case. At
one time, these substances were easy to obtain. Even in the late 1800s, opiates
(derivatives of opium) could be purchased without a prescription in general stores and
pharmacies. Opiates could also be ordered by mail. Furthermore, various patent
medicines (for example, "Grandma's Tonic") containing opiates could be purchased
without a prescription.
b. The Harrison Narcotic Act was passed in 1914 so these types of medications
could be better controlled. This Act established specific guidelines for the buying,
selling, dispensing, and storing of certain drugs. Drugs covered in this Act were divided
into four classes depending upon their abuse potential. These classes were designated
as "A, B, M, and X." Class "A" narcotics were considered to be the most dangerous.
Interestingly, this Act classified cocaine as a narcotic, although cocaine is not a narcotic
substance. As you might suppose, the passage of this Act did not stop the abuse of