As described in the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations (MDR) 2001, any company wishing to possess, manufacture, produce or supply controlled drugs in England, Wales or Scotland will need to apply for a domestic licence – this includes where you are not physically handling but are directing and / or taking ownership.
If you are in the NHS in England or Scotland, you will also need to consider The Controlled Drugs (Supervision of Management and Use) Regulations 2013.
So, what are the main requirements for controlled drugs?
What is a controlled drug?
The term ‘controlled drug’ is defined by the Misuse of Drugs Act 1971 as ‘any substance or product for the time being specified in Part I, II or III of Schedule 2 of the Misuse of Drugs Act 1971’. These products tend to be a high risk of misuse, abuse or theft and as a result have tighter regulatory requirements around their storage, supply and destruction.
The most commonly encountered controlled drugs can be located here however this is not exhaustive and is updated periodically.
For a full list of controlled drugs, reference should be made to Parts I, II, III and IV of Schedule 2 to the Misuse of Drugs Act 1971 and in Schedules 1 to 5 to the Misuse of Drugs Regulations 2001.
Who is the governing body for Controlled Drugs?
In the UK, the Home Office monitor and regulate organisations that possess, manufacture, produce or supply controlled drugs. Companies must obtain a domestic controlled drug license from the Home Office, before being able to perform any activities.
If you are part of the NHS in England or Scotland you will also need to inform CQC / HIS of any changes to your Controlled Drug Accountable Officer (CDAO).
What are the exceptions?
In a few, very specific situations, a controlled drug license may not be required. The Home Office have published additional advice for healthcare settings which can be accessed here however companies should always ensure that any guidance they are following maintains compliance with the Misuse of Drugs Regulations (MDR) 2001.
What is a Controlled Drug Accountable Officer (CDAO)?
Organisations providing health care services within England and Scotland who have been assigned “designated body” status must appoint a fit, proper and suitably experienced person to be its CDAO*.
*For information about health care services with less than 10 employees or health care services that do small volume CDs, exemptions may also apply as described in Regulation 3 and Regulation 4.
The key duties of the CDAO are listed under Regulation 11 – 13 and include:
- Ensuring compliance with the Misuse of Drugs legislation
- Systems for recording and reporting concerns or untoward incidents about CD use
- a range of up-to-date standard operating procedures to support those governance arrangements.
- Ensure that relevant staff within their organisation receives, as appropriate, information, education or training about these arrangements
What personnel are responsible for CDs outside of a health care service (e.g. in a wholesaler or pharma company)?
The Home Office have provided additional guidance for non-health care services which is available here. Companies will need to list a person in charge, an authorised witness, a person responsible for security and a person responsible for regulatory compliance as part of their Home Office application. The same person may hold multiple roles. An in-date Disclosure and Barring Service (DBS) will also be needed for those named staff.
How can we help?
Pharmacy Consulting Limited offers a range of training to those organisations that possess, manufacture, produce or supply controlled drugs which includes the role of the CDAO, storage and transport obligations, import and export of CDs as well as have a team of expert staff on hand. If you would like to discuss your business training needs then you can contact us.