The use of a drug for a purpose, or at a dose, other than that approved by the FDA Office for Human Research Protection (OHRP): U.S. government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions
Prescription of a medication outside its approved indication or prescription of a drug in a deviated dose other than recommended by the authorities.
Use of a drug for a disease or condition other than the specific disease or condition for which the FDA approved it.
A drug prescribed for conditions other than those approved by the FDA.
The prescribing of a medication for use not approved by the FDA (Federal Drug Administration).
The prescribing of medication for use not approved by the Federal Drug Administration (FDA). Drugs can only be prescribed for off-label use if recognized for that use by qualified, authoritative drug compendia or scientific evidence for the off-label use exists.
Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label.