Definitions

from The American Heritage® Dictionary of the English Language, 5th Edition.

  • adjective Of or relating to a drug prescribed to treat a condition for which it has not been approved by the Food and Drug Administration.

from Wiktionary, Creative Commons Attribution/Share-Alike License.

  • adjective Alternative spelling of off label.
  • adverb Alternative spelling of off label.

Etymologies

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Examples

  • Using a drug in a capacity for which it was not specifically approved is called "off-label" use and is a common and legal practice in the medical community.

    The Globe and Mail - Home RSS feed CARLY WEEKS 2011

  • Paul Wicks , a co-author of the paper, said social network-run studies may be most useful for testing efficacy of so-called off-label or off-patent compounds that patients are using but are unlikely to ever attract pharmaceutical company interest.

    ALS Study Shows Social Media's Value as Research Tool Amy Dockser Marcus 2011

  • Glaxo has disclosed that investigators examined whether Glaxo promoted Wellbutrin for uses not approved by the Food and Drug Administration, an illegal practice known as off-label marketing.

    Glaxo to Pay U.S. $3 Billion to Settle Jeanne Whalen 2011

  • In 2008, the company agreed to pay about $425 million and plead guilty to a criminal charge to settle allegations that it promoted some drugs including Provigil for uses that weren't approved by the Food and Drug Administration, a practice known as off-label marketing.

    Cephalon Gets Second Subpoena in Week Peter Loftus 2011

  • Doctors are allowed to prescribe drugs for uses not approved by the Food and Drug Administration, a practice known as off-label prescribing.

    Analysis Flags Fears Over Avastin Goran Mijuk 2011

  • It's also not illegal to use drugs for purposes other than their approved use, known as "off-label" use.

    States moving quickly to switch execution drug 2011

  • Doctors often order medications that are tested and approved for a condition other than the one they are treating, a practice called "off-label prescribing."

    Yahoo! News: Business - Opinion 2011

  • While doctors can prescribe or use an FDA-approved drug or device for any purpose, U.S. law bars companies from promoting them for so-called off-label use.

    BusinessWeek.com -- Top News 2012

  • Doctors often order medications that are tested and approved for a condition other than the one they are treating, a practice called "off-label prescribing."

    Reuters: Top News 2011

  • The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company engaged in so-called off-label marketing of the medication, J&J has said in U.S. Securities and Exchange Commission filings.

    BusinessWeek.com -- Top News 2012

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