What does “Off-label” mean?
Use of a licensed medicine for a purpose, population or dose outside the terms of its licence.
Off-label in plain English
Use of a licensed medicine for a purpose, population or dose outside the terms of its licence.
Off-label prescribing is lawful and common across medicine. It differs from unlicensed prescribing: an off-label medicine has a marketing authorisation, just not for the use in question.
The prescriber carries additional responsibility in both cases, and GMC guidance sets out what is expected.
Frequently asked questions
What does off-label mean?
Use of a licensed medicine for a purpose, population or dose outside the terms of its licence.
Sources and further reading
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