Off label drug

November 25, 2008 at 2:56 am | Posted in medicine | Leave a comment
Off-label use is the practice of prescribing pharmaceuticals for a purpose outside the scope of a 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. More detail is included in the drug’s package insert.

However, once the FDA approves a drug for prescription use, they do not attempt to regulate the usage of the medicine, and so the physician makes decisions based on her or his best judgment. It is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates, even though it is a common misconception that it is unlawful to do so. Actiq, for example, is commonly prescribed off-label even though it is a Schedule II controlled substance. However, it is unlawful to market, advertise or otherwise promote the off-label use of drugs, including controlled substances.


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