Off-label prescribing is legal if there is scientific evidence for the use
Off-label usage of a medicine refers to its use contrary to its intended use.
It is crucial to be aware that the FDA must receive clinical data and other information from a company before a medicine can be approved. The manufacturer of the drug must demonstrate that it is both effective and safe when used as directed. A medicine being "safe" does not imply that it has no side effects. In its place, it indicates that the FDA has decided the advantages of using the medicine for a certain purpose exceed the possible hazards.
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