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Unapproved Drugs:
Drugs Marketed in the United States That Do Not Have Required FDA Approval
Background Information
Background Information
The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. The FDA's evidence-based system of drug approval and the OTC monograph system play essential roles in ensuring that drugs are both safe and effective. These processes provide great public health benefits to consumers and health professionals because patients are able to rely on the fact that medications they take have been evaluated for safety and effectiveness, and patients are able to avoid ineffective therapies or those for which the risks do not outweigh the benefits.
Physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective. For a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. For additional information, see the Marketed Unapproved Drugs – Compliance Policy Guide (CPG)  .
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Date created: September 23, 2008 |
