off-label

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. 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 practice of medicine, and so the physician makes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label. Exceptions to this are certain controlled substances, such as opiates, which cannot be legally prescribed except for approved purposes (at least in the U.S.). In Australia, amphetamines are included in these drugs which cannot be prescribed off-label.
See more at Wikipedia.org...

Unter Off-Label-Use versteht man die Verordnung eines zugelassenen Fertigarzneimittels außerhalb des in der Zulassung beantragten und von den nationalen oder europäischen Zulassungsbehörden genehmigten Gebrauchs, beispielsweise hinsichtlich der Anwendungsgebiete (Indikationen), der Dosierung oder der Behandlungsdauer. Auf Deutsch spricht man vom zulassungsüberschreitenden Einsatz oder der zulassungsüberschreitenden Anwendung von Arzneimitteln.
Mehr unter Wikipedia.org...

Describes the legal use of a prescription drug to treat a disease or condition for which the drug has not been approved by the US Food and Drug Administration.

use of an FDA-approved drug for an indication other than that for which the drug was approved.

To treat a condition that is not among the conditions for which the U.S. Food and Drug Administration approved the treatment.