Can I prescribe an unlicensed drug?

You can prescribe unlicensed drugs or use drugs for unlicensed indications. You should usually prescribe licensed medication in accordance with the terms of their license.

But remember, you're legally responsible for the decision to prescribe. You must be satisfied there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy and that a licensed alternative would not suit the patient's needs.

You should discuss proposed medications, and other options, with your patient - including the fact that the medication is unlicensed. However, it may not always be practical or necessary to explain that to the patient - for example, when treating children or in emergencies, or where there is no viable alternative treatment. This discussion, the patient's consent and your reasons for prescribing an unlicensed medicine should always be clearly recorded.

There may be other cases when prescribing unlicensed medications is supported by certified clinical guidance, and here you can explain to the patient why the medication is not licensed for its particular use.

Always answer questions about medications from patients, their parents or carers fully and honestly.

For further information, see paragraph 108 of the GMC guidance.

You can also read our guides for more advice:

This page was correct at publication on 13/05/2022. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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