Australia's Therapeutic Goods Administration has just announced its final decision to down-schedule cannabidiol (CBD), making these products available over the counter in pharmacies, without the need for a doctor's prescription. This significant change in regulation could pave the way for similar access improvements in New Zealand.
Patients, pharmacists and the medicinal cannabis industry have praised Australia's Therapeutic Goods Administration (TGA) for its decision yesterday to not only allow cannabidiol (CBD) sales without a prescription at pharmacies, but also to provide a higher limit on daily dosage, along with an earlier roll-out date.
CBD will become a pharmacist medicine
The TGA made its final decision to down-schedule low dose cannabidiol (CBD) products to Schedule 3, which refers to pharmacist-only medicine, rather than its previous status as a prescription-only drug.
Doses of up to 150mg per day
After a safety review showed any known adverse effects from CBD were not serious at low doses, a TGA senior medical officer determined the maximum daily dose could be lifted from the earlier proposed 60mg/day limit to 150mg/day – 2.5 times the daily dose put forward in the interim decision. This means that many popular products, such as 100mg/ml CBD sublingual drops, will be sold without a script to anyone in Australia.
Effective from 1 February 2021
This has been hailed as a breakthrough for patients. The decision will be enacted on 1 February 2021, five months earlier than the previously proposed date of 1 June 2021.
Affordability for patients is set to improve
With greater access comes improved economies of scale. Down-scheduling CBD is expected to lower pricing, improving affordability for patients – a major issue that has restricted patient access in Australia and New Zealand.
Criteria set for product registrations
CBD products still need to be approved as meeting Schedule 3 criteria on the TGA's 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.
The world is turning green
These significant milestones, whereby the United Nations have reclassified cannabis for medicinal use globally, and now the down-scheduling of CBD products in Australia, show solid progress for the industry and are testament to the positive recognition of the medicinal benefits of cannabis, supported by extensive research.
New Zealand could be next
Australia's decision to down-schedule CBD is expected to help New Zealand's medicinal cannabis industry make a case to follow suit across the Tasman. Many Kiwi patients have struggled with poor access to CBD products, due particularly to challenges in gaining a prescription and with a high cost associated with imported products.
Want to know more? Here's a full copy of the notice regarding the TGA's decision to down-schedule CBD in Australia.