Is off-label prescribing legal?

The GMC guidelines state that, ‘You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.’

Because the legal responsibility lies with the clinician who signs the prescription, it is important for GPs and other prescribers to ensure that the patient can give fully informed consent to their treatment. Professionals who are prescribing off-label should always inform their patients that this is the case and explain what it is being prescribed for, why it is being prescribed off-licence, and any risks or side-effects that could result. Patients should be advised of any alternatives that exist and have all their questions answered fully before they can consent.

If, as is the case with transgender healthcare, there are established guidelines for best practice with the use of unlicensed medication, then these should be followed.

Full information about off-label prescribing can be found on our website.