The TGA has announced a final decision to downschedule certain low dose cannabidiol (CBD) preparations
These preparations are set to be downscheduled 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,” says the TGA.
“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 ARTG that meet the Schedule 3 criteria.
The TGA says that 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.
Consumer Healthcare Products Australia welcomed the decision.
The organisation also said it commends the Delegate’s decision to increase the maximum daily dose limit from what was proposed in the interim decision, enabling Australians to have greater access to effective CBD products.