What is off-label drug use?

When a health care provider prescribes medication for off-label use, this means that the provider is prescribing a drug in a way that is different than what is in the FDA approved labeling for the drug.

When the FDA approves a drug, the approved labeling specifies, among other things, the diseases or conditions for which the drug has been approved by the FDA.

However, health care providers are generally permitted to prescribe a drug for an “off label” or “unapproved” use when they determine it is medically appropriate for their patient.


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