• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

What are unapproved drugs and why are they on the market?

The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety.  In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness.  To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.

Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.  This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug.  Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.

Basics Question toggle Show all related FDA Basics Questions

-

How helpful was this information?

                               

Not HelpfulArrow pointing to the rightVery Helpful


Please limit your feedback to 1000 characters.

Please limit your feedback to 1000 characters.

If you would like to ask a specific question, please visit our "Contact Us" page for more information about how to contact FDA.

Please note that any information you submit may become public or subject to release under the Freedom of Information Act (FOIA). For more information, read about our privacy policies and the FOIA.

-