The Therapeutic Goods Administration (TGA) – Australia’s regulatory body for pharmaceuticals and medical devices – is proposing to reclassify low dose cannabidiol (CBD) preparations under the Australian Poisons Standard from Prescription Only Medicine to Pharmacist Only Medicine. If adopted, this proposal would permit the supply of CBD-containing medicines by a pharmacist, without the need for a prescription, and bring Australia more closely into line with other jurisdictions such as the United Kingdom and the United States where over-the-counter CBD products are available.
The TGA’s review into the safety of low dose CBD (which underlies the new proposal), concluded that doses in the range of 1 mg/kg/day (up to approximately 60 mg/day), and less when administered orally, may have possible clinical utility in the management of some conditions that do not require the oversight of a medical practitioner and these could be considered for rescheduling under the Poisons Standard. The TGA is now proposing to reschedule low doses of CBD in preparations for therapeutic use from Schedule 4 to Schedule 3 of the Poisons Standard thereby reducing access controls to permit over-the-counter sales of CBD-containing medicines in pharmacies without the need for a prescription.
Initial public consultation regarding this proposal has commenced and will close on 22 May 2020. Further details about the proposal, and how to make submissions, are available on the TGA website.
A safety review conducted by the TGA has established that low doses of CBD may have possible clinical utility when used via the oral route in the management of some conditions that do not require medical practitioner oversight.