At the urging of the public, the United States Congress passed the 1938 Food,
Drug and Cosmetic Act. This act required:
- Drugs must be proven save for use before they can be sold.
- Inspections of drug manufacturing facilities.
- Safe tolerance levels be identified to prevent the patient from being poisoned.
- Cosmetics and therapeutic devices be controlled.
1952 DURHAM-HUMPHREY AMENDMENT
TO THE FOOD, DRUG AND COSMETIC ACT
Until 1952, anyone could distribute drugs. With the passage of the Durham-
Humphrey amendment to the Food, Drug and Cosmetic Act of 1938, a group of
drugs was defined that could only be purchased if the patient had a prescription
from a licensed practitioner.
1962 KEFAUVER-HARRIS AMENDMENT
TO THE FOOD, DRUG AND COSMETIC ACT
The Food, Drug and Cosmetic Act of 1938 was amended once more in 1962 with
the passage of the Kefauver-Harris Amendment. This amendment tightened con-
trols on drug safety by requiring drug manufacturers to use standard labeling
of drug containers. The label lists adverse reactions and contraindications or
reasons why the drug should not be used.
1970 COMPREHENSIVE DRUG ABUSE
PREVENT AND CONTROL ACT
By 1970, there was widespread abuse of prescription drugs. In an effort to con-
tain this problem, Congress passed the Comprehensive Drug Abuse Prevent and
Control Act. This act categorized controlled substances according to a schedule
based on potential for abuse.
- Schedule I is reserved for the most dangerous substances that have no rec-
ognized medicinal use. - Schedule II drugs have high abuse potential with accepted medicinal use.
- Schedule III drugs have high abuse potential with accepted medicinal uses.
- Schedule IV and V drugs have lower abuse potential with accepted medic-
inal uses.
CHAPTER 1 An Inside Look at Pharmacology^3