The TGA has down-scheduled Medicinal CBD in low doses over-the-counter in Australia. However, there are no products that meet the required criteria for approval to be stocked in pharmacies without a doctors prescription.
As of February 1st 2021, ARTG listed, low-dose cannabidiol (CBD) has been approved for over-the-counter sale in pharmacies across Australia by the Therapeutic Goods Administration. Once a company completes all the required clinical and safety trials, we will start seeing these products available without prescription.
Accordingly, buyers over the legal age (18) would no longer need a referral, official approval or prescription to purchase. They would however, only be able to buy a maximum daily dose of 150mg of over-the-counter CBD. Further, over-the-counter CBD only encompasses low-dose oral, oral mucosal and sublingual formulations only. Hence, vaping and topical cream products can only be accessed commercially through a prescription from a doctor.
CBD is a naturally occurring substance extracted from the marijuana plant, which unlike tetrahydrocannabinol (THC) is not psychoactive, or in layman terms, CBD does not give users the high. In December 2020, the Therapeutics Goods Administration (TGA) confirmed the lowering of low-dose CBD from a schedule 4 (Prescription Only Medicine) to a schedule 3 (Pharmacist Only Medicine) substance in 150mg/day dosing up from the initial suggestion of 60mg/day.
As part of medicinal marijuana therapy, low-doses of CBD have therapeutic effects such as reducing anxiety, insomnia, PTSD and chronic pain.
While low-dose Schedule 3 CBD oil is technically legal for over-the-counter sale in pharmacies, there are specific requirements set by the TGA that these products have to meet. One of the most important yet tricky requirements that these products must meet is to be listed on the Australian Register of Therapeutic Goods (ARTG).
For a product to satisfy all requirements and be successfully listed on the ARTG, it would cost the companies a lot of time and money. A sponsoring company (medical cannabis company) must put the product through a series of clinical trials and prove that it is efficacious to cure some specific conditions, safe for consumption, and meet all quality and consistency standards. Because of this, clinical trials usually take several years before allowing the tested product to be listed on the ARTG.
That is not the end. Once the product has passed the trial stage to test for efficacy and safety, the companies must submit the findings to the TGA for approval. The TGA will then assess whether the product meets its requirements. This assessment can take up to 330 days and anywhere throughout that process, the product is still subjected to rejection from the TGA. If a product meets the TGA’s clinical trial requirements, before it can be distributed commercially, the company must make sure it also meets dosing requirements, packaging requirements and more.
At the moment, there are only two cannabis products currently listed on the ARTG (Epydiolex and Sativex) and they are both Schedule 8 (Controlled Drug) products, meaning they are strictly legislated as they inhibit risks of addiction and abuse.
There are a few important differences between over-the-counter, low-dose CBD products to be distributed at pharmacies, and CBD or cannabis prescribed by a doctor. The main differences include the ARTG listing, patient eligibility, conditions treated by the cannabis, product types and cannabinoid content.
Prescribed CBD
Most cannabis prescribed by doctors in Australia is unregistered medicine. These products are prescribed through special access pathways called the Special Access Scheme or via Authorised Prescribers (APs). These products do not need to go through clinical trials or meet critical requirements.
Any general practitioner in Australia can prescribe medical cannabis, with the exception of Tasmania where you need a specialist. The conditions in which cannabis can be used to treat are flexible since there are no specific requirements. To be eligible for cannabis, a patient must have a chronic medical condition and must have tested other forms of treatment that have been unsuccessful or result in side effects. Any doctor may prescribe any product for any chronic condition.
Medical cannabis can be oil form, flower, lozenges and so on. Prescribed products can be CBD only, high CBD & low THC, THC only, high THC & low CBD and THC only.
Over The Counter CBD
On the other hand, the low-dose CBD products to be sold over the counter in the future will have to pass clinical trials and be proven to be safe and efficacious for a specific condition.
Over-the-counter CBD products will be sold in a different way. When available, your pharmacist will screen you to see if you qualify for a specific product. And, specific CBD products will be sold for specific indications or conditions.
Patients will need to be 18+ years old to purchase CBD at pharmacies. The pharmacist will screen patients to qualify for a specific product. Specific CBD products will be sold for specific indications or conditions.
According to the TGA requirements, over-the-counter CBD products must be 98% or more CBD (cannabidiol). There may only be 1% or less THC (tetrahydrocannabinol) and 2% or less of any other cannabinoid. For the medicine form, the CBD must be in preparations of oral, oromucosal & sublingual only.
While CBD oil is technically legal to be sold over the counter in pharmacies Australia-wide, you might expect to wait for a while before being able to purchase them over the counter.
Once the product is available to be purchased at pharmacies, it will be in low doses and only for short-term relief. Until then, keep yourself educated and updated on the latest news and insights on medicinal cannabis with Altmed’s inspiring stories from the frontiers of our rapidly-changing industry. Each week we further the discussion around natural and alternative medicinal solutions. Subscribe now!
Sources:
https://www.tga.gov.au/media-release/over-counter-access-low-dose-cannabidiol
https://www.canberratimes.com.au/story/7256200/cbd-now-over-the-counter-down-under/
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