Prescription Medicine (cont.)
Historical Background of Prescription Medications
- The regulation of drugs in the United States began with the Import
Drugs Act of 1846, enacted after Mexico sold the US Army tainted drugs to
- In 1906, the Food and Drug Administration (FDA) was formed, primarily
to regulate commerce and to combat the then rampant adulteration (debasement
or dilution of a substance by adding other material) of foods and drugs.
- The FDA was not empowered to address drug safety issues until 1938,
following the unnecessary deaths of 107 children from a new drug
preparation. This incident led to laws that required drugs be proven safe
before they were allowed on the market.
- The last major regulatory change was the provision of the FDA in 1962
that drugs be proven to be effective as well as safe before they could be
- Today, the FDA continues to regulate all drugs sold in the US,
both by insuring that they are safe and effective in what they do before
they are released and by limiting their distribution by deciding which
medications require a prescription to be sold.