• The Federal Pure Food and Drug Act of 1906: Requires that drugs be free of adulterants.  This regulation was aimed at patent medicines.

• The Food, Drug and Cosmetic Act (1938): Requires that all new drugs be tested for safety, and mandates FDA approval of any new drug before marketing.

• Kefauver-Harris Amendment (1962):  This amendment to the Food, Drug and Cosmetic Act stipulates that a drug must prove useful before marketing.  Started clinical trials.

• The Controlled Substances Act (1970):  This Act concerned itself with drug abuse.  In addition to setting up programs to research and prevent drug addiction, the Controlled Substances Act divided drugs into categories called schedules.

  • Schedule I:  Drugs that have no accepted use in medicine, and have high abuse potential ( e.g. marijuana, LSD)  

  • Schedules II - V : Drugs in Schedules II - V are medically useful drugs that have some abuse potential.  Schedule II has the highest level of abuse potential for these medically accepted drugs.  It includes such drugs as injectable narcotics for pain relief.  Abuse potential decreases as we reach Schedule V.

Drug Testing

When new drugs are developed, they are first tested in animals (preclinical testing).  Clinical testing is done in human beings after FDA approval is given following the preclinical tests.  

Four Phases of Clinical Trials:

        Phase 1: Uses normal volunteers  to evaluate drug metabolism and determine effects of                 drug on humans.

        Phases 2 and 3:  Uses patients to determine a drugs therapeutic effects, dosage range and         safety.

        Phase 4: Drug is released for general use, following a conditional approval granted by the                 FDA.  

There are three types of drug names:

Chemical Name:  The extremely long, tongue-tying name of the precise chemical compound.

Generic Name:  Often a shortened form of the chemical name.

Trade Name:  The proprietary or brand name.  This name is chosen by the drug company so it is often short, catchy and easy to remember.  A drug may have many different trade names, but will have only one generic name, making the generic name more conducive to communication.

Information regarding the properties of any drug can be obtained for several sources.   Health care professionals may have knowlege to share, but probably the best place to go for info would be published  references like the Physician's Desk Reference (PDR) or nursing journals and textbooks.