The TGA have 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 allows 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 provided that controls such as pack size (30 days), child resistant closures and others are followed.
An implementation date of 1 February 2021 has been provided in the final decision. There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria. 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, offering greater promise of achieving successful clinical trials of efficacy.
This increase in dose was based on concluding that the known adverse events of CBD at low doses were not serious and followed further consideration of safety information, the decision considering safety information, public submissions, and Committee advice (Joint ACMSACCS) at the November 2020 meeting, and the earlier TGA safety review of low dose CBD. Please see the TGA website for more information.