Over-the-counter access to low dose (CBD) cannabidiol approved

Today the Therapeutic Goods Administration (TGA) announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The decision will allow low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.

There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.

The decision was made following an earlier TGA safety review of low dose CBD which indicated that the known adverse events of CBD at low doses were not serious. The decision was made by a senior medical officer at the TGA acting as a Delegate of the Secretary of the Department of Health, following extensive public consultation.

In the final decision, the Delegate has increased the maximum daily dose proposed in the interim decision from 60 mg/day to 150 mg/day. This increase follows further consideration of safety information, the public submissions on the interim decision and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at the November 2020 meeting.

Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG. Applications are individually evaluated for safety, efficacy and quality. Further information on the application process and data requirements is available in the Australian Regulatory Guidelines for OTC Medicines (ARGOM).

Medicines not included on the ARTG are known as 'unapproved' medicines. Importantly, unapproved medicines have not been evaluated by the TGA for quality, safety and effectiveness. Unapproved CBD medicines can continue to be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme on prescription only. Any Australian registered medical practitioner can apply to the TGA for approval to access unapproved medicines through the SAS or AP scheme if they believe it is right for their patient. More information on this process is available on the TGA website at: Medicinal cannabis.

Originally published here: https://www.tga.gov.au/media-release/over-counter-access-low-dose-cannabidiol