CBD-containing products and controlled cannabinoid content

12 Jul 2019

CBD-containing products and controlled cannabinoid content - Superintendent update

Dear Superintendent,

Following discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Home Office (HO) this week I would like to clarify information about the CBD-containing products and the controls to which these products are subjected.

If a product contains any amount (even trace amounts) of controlled cannabinoids — such as tetrahydrocannabinol (THC), even unintentionally — it will be subject to controls as it would be classified as a Schedule 1 Controlled Drug (CD) under The Misuse of Drugs Regulations (MDR) 2001.

Products containing controlled cannabinoids are only lawfully available for human consumption if the product is classified as one of the following:

  • Cannabis-based product for medicinal use in humans (CBPM)

Currently, CBPM are only available on prescription from a specialist doctor; as per the definition of cannabis-based products for medicinal use in humans (CBPM), they would be classified as Schedule 2 CDs, with the exception of Sativex® which is a licensed product as a Schedule 4 (Part 1) CD

  • An exempted product under Regulation 2 of the MDR 2001

The HO has confirmed to the NPA that food supplements containing any amount of controlled cannabinoids cannot be classified as exempted products

The HO has stated that cannabidiol (CBD), when isolated and in a pure form, is not subject to controls under The Misuse of Drugs Act 1971 or MDR 2001. However, it is very difficult to isolate CBD in its pure form and the HO has raised concerns that many CBD-containing products (such as those being sold as food supplements) do not disclose information on their full contents that is required to determine the control status of the product.

The HO has therefore advised caution based on the following presumption “ that a CBD containing product would be controlled under the MDA 1971 / MDR 2001 as a result of its other cannabinoid content”. Furthermore, a Certificate of Analysis stating the content of controlled cannabinoids within the product should be obtained from the manufacturer before a CBD product is sold or supplied.

  • If a product is found to contain any amount of controlled cannabinoids (for example, THC), the product must not be sold as it would be classified as a Schedule 1 CD; such a sale would be illegal
  • The HO should also be alerted

Table 1: Summary of the above information

Nature of the product Current CD Schedule Governing legislation
CBPM Schedule 2 (with the exception of Sativex®  which is a Schedule 4 (Part 1)) The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018
An exempted product N/A The Misuse of Drugs Regulations 2001
Product contains any amount of controlled cannabinoids (for example THC), and is not an exempted product or a CBPM Schedule 1 The Misuse of Drugs Regulations 2001
Pure CBD oil N/A Not governed by any Misuse of Drugs legislation

 

Professional indemnity

The NPA Legal Indemnity (NPAI) team has issued the following statement regarding NPA members selling/supplying cannabis oil and CBD-containing products, including those licensed as medicinal products or classed as food supplements:

  • “Members who are considering selling or supplying cannabis, cannabis-based products for medicinal use, cannabis oil products, or any CBD products or derivatives must ensure that they ascertain before doing so the status of such products, and whether they require a product licence (marketing authorisation), or otherwise.
  • Failure to do so (and to be able to satisfy this requirement to NPA Insurance), will mean that in the event that a third party claim is made against the member’s professional indemnity policy, or a request is made by the member for legal defence or representation to respond to a Regulatory or Criminal investigation, that indemnity, legal defence or expenses cover may not be provided.
  • If in any doubt, members are urged to contact the NPA Pharmacy Services team for advice in relation to selling or supplying of any cannabis product, or the NPAI team in respect of matters of policy cover.
  • In terms of the indemnity, this will be breached where the sale/supply of the product is illegal both under UK and EU law, or the product is being supplied for an unlicensed use, or the necessary permissions/authority to sell/supply the product have not been obtained.”

 

Further reading, resources and references

Department of Health and Social Care: https://www.gov.uk/government/collections/medicinal-cannabis-information-and-resources

Food Standards Agency: https://www.food.gov.uk/business-guidance/novel-foods

Home Office: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/778357/Factsheet_Cannabis_CBD_and_Cannabinoids_2019.pdf

Medicines and Healthcare products Regulatory Agency: https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials

The Misuse of Drugs Regulations 2001: http://www.legislation.gov.uk/uksi/2001/3998/contents/made

Regulation 2, The Misuse of Drugs Regulations 2001:

http://www.legislation.gov.uk/uksi/2001/3998/regulation/2/made

The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 http://www.legislation.gov.uk/uksi/2018/1055/contents/made

NHS England https://www.england.nhs.uk/medicines/support-for-prescribers/cannabis-based-products-for-medicinal-use/

Northern Ireland: https://www.health-ni.gov.uk/news/cannabis-based-medicinal-products-be-made-available-northern-ireland

Scotland: https://www.sehd.scot.nhs.uk/cmo/CMO(2018)15.pdf

Produced by the NPA Pharmacy Services team July 2019.