Off-label use
Prescribing an approved drug for a condition, dose, or age group the FDA never approved it for — legal for doctors, illegal for manufacturers to promote.
Your prescriber writing an off-label prescription may be practicing good medicine. a company marketing that prescription has, more than once, been committing a crime. both halves are worth understanding.
What it is
When the FDA approves a drug, it approves specific uses — the indications on its label. Prescribing outside them is off-label: a different condition, age group, or dose. Off-label prescribing is legal, common, and sometimes well supported by evidence the label never caught up with.
Where the money in drug litigation comes from
Manufacturers promoting off-label uses is illegal, and that line produced the largest health-care-fraud settlements in US history — gabapentin promoted for a list of unapproved uses, olanzapine and quetiapine and risperidone in elderly dementia patients, paroxetine and Wellbutrin in GSK's criminal plea. The asymmetry is the point: the same prescription can be good medicine from a doctor and a felony from a marketing department.
Somewhere to put it
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Questions
Is off-label prescribing legal?
Yes — doctors may prescribe any approved drug for any use their judgment supports. What is illegal is manufacturers promoting unapproved uses.
How do I know if my prescription is off-label?
Ask, or check the drug's approved indications — our indications page lists what each drug in the library is actually approved for.
More from the glossary
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