In an exciting new development, Australia’s Therapeutic Goods Administration (TGA) has announced plans to reschedule low-dose CBD products in 2021.
Medical cannabis containing CBD (cannabidiol) is currently only available through TGA’s Special Access Scheme (SAS) as a Schedule 4 drug. To gain access, patients must apply to TGA with the application process taking several weeks before a prescription is granted. As of June 2020, over 50,000 Australians had access to SAS.
In 2021, cannabis medications with low doses of CBD will be rescheduled to Schedule 3 drugs. This will allow these medications to be sold over-the-counter in pharmacies. To be eligible, medications must be sold in packets with less than 1,800mg of CBD. That is a 30 day supply of the recommended maximum daily dose of 60mg CBD.
Rescheduled medications must also contain less than 2% other cannabinoids (like THC and CBG), as cannabinoids like THC are psychoactive.
Currently, 40% of Australia’s cannabis medications meet these criteria. These 17 medications may be rescheduled at TGA’s discretion. Only oral, oral mucosal and sublingual formulation medications will be available over the counter. Vaping, smoking and topical low-dose CBD medications will remain Schedule 4 drugs.
Pharmacists will also be required to warn patients about the potential medication reactions of CBD, and it can only be sold to patients over the age of 18.
This decision was part of a list of suggestions made in a proposal to TGA in April this year. The proposal also recommended making CBD an unscheduled medicine, which has not been accepted. However, TGA did clarify that their decision was swayed by 5,409 submissions from the public. (onya, fellas!)
Experts have predicted this decision will decrease the high black market demand for CBD oil.
TGA will release their full decision on November 25th. In the meantime, Freshleaf Analytics has predicted that this decision will lead to a $200 million market for over-the-counter CBD products in Australia.
Freshleaf’s managing director Cassandra Hunt was quoted as saying:
This will be the biggest thing to happen in the industry since the legalisation of medical cannabis. We expect it will result in more Australians benefiting from the healing properties of cannabis.