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Policies Regulating Pharmaceutical Drugs, U.S.

  • By: Michael Montagne
  • In: Encyclopedia of Drug Policy
  • Edited by: Mark A. R. Kleiman & James E. Hawdon
  • Subject:Public Policy, Drug Crimes

In the United States, pharmaceutical drugs are developed and produced by companies and legally classified in two categories: prescription and nonprescription (also called over-the-counter). Substances that are not FDA-approved pharmaceuticals and prescription drugs used nonmedically would be considered a third category simply called illicit drugs. Regulation of pharmaceutical drugs is authorized by the Federal Food, Drug, and Cosmetic Act of 1938 and ensuing acts and amendments. The U.S. Food and Drug Administration (FDA) has the responsibility to approve and license new drug entities for medical use and to monitor all information and labeling (which includes advertising) regarding prescription drugs. Monitoring of nonprescription drug advertising (including herbs, vitamins, and other dietary supplements as consumer products) is the responsibility of the Federal Trade Commission. Policies regulating the ...

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