Can off label or unlicensed products be sold, supplied or administered under Schedule 17 of the Human Medicines Regulations 2012 exemptions?

· NHS PGD Website

Exceptions to the general rule for which certain healthcare professionals can sell, supply, and/or administer medicines to patients under Schedule 17 of the Human Medicines Regulation 2012 are also known as exemptions. Further information on exemptions can be found on the MHRA website.

Specific information relating to the supply/administration of unlicensed and off label medicines when practising under Schedule 17 of the Human Medicines Regulation 2012 exemptions are given below.

 

Question 1: Can an unlicensed product be administered when a Human Medicines Regulation exemption is being used?

No.

The MHRA has confirmed that an unlicensed product can only be supplied in response to the order of a doctor, dentist, independent nurse or pharmacist prescriber, or a supplementary prescriber for use by their individual patients on their direct personal responsibility. It could then be administered by a health professional but the administration would have to be in accordance with the patient specific directions of the doctor, dentist or independent nurse/pharmacist prescriber or supplementary prescriber.

Question 2: Can medicines listed in the exemptions can be used off-label?

Yes.

The MHRA has confirmed that medicines listed in the exemptions can be used off-label.

To be considered only when such use is clearly justified and supported by best clinical practice, such as national guidance. Health professionals should consider informing patients about the license for their medicines, in line with prescribing guidance published by the General Medical Council (2013).

Question 3: Is a written instruction for the use of an unlicensed medicine permissible within an Occupational Health Service (OHS)?

No.

As stated in the answer to question 1 an unlicensed product can only be supplied in response to the order of a doctor, dentist, independent nurse or pharmacist prescriber, or a supplementary prescriber for use by their individual patients on their direct personal responsibility.  Specifically for an OHS an unlicensed product could be administered by a healthcare professional working within the OHS but the administration would have to be in accordance with the specific directions of the prescriber for a named individual (i.e. as a patient specific direction (PSD)).

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