In many parts of the world CBD is not considered a registered medication and is easily obtained over the counter at pharmacies. In Australia, CBD is a Schedule 4 prescription medication, meaning you need to obtain a doctor’s prescription to get access to CBD products.
However, in December 2020, the TGA down scheduled certain CBD products from Schedule 4 to Schedule 3, theoretically allowing you to obtain CBD products over the counter without a doctor’s prescription. These down scheduled CBD products must:
- • not contain more than 1% THC,
- • must be 98% pure CBD (limiting other cannabinoid content),
- • have a maximum dose of 150mg per day, and
- • be listed on the Australian Register of Therapeutic Goods (ARTG).
The problem is that while low dose CBD Oil is now legally able to be sold over the counter in pharmacies, there are no products that meet the requirements. The biggest hurdle is that CBD products will need to be ARTG listed before they hit shelves in Australia. This is a big challenge for many suppliers that will require a lengthy and costly process of clinical trials to prove their products are efficacious for certain conditions and safe for consumption at specific dosages.
Many companies are reluctant to go through this lengthy and very expensive process, and for those who do, the final products to hit the shelves may be expensive in order to recoup that heavy investment.
Difference between full spectrum and isolate
These over the counter products will be limited to CBD isolates which is a subset of all the medical cannabis products available. CBD isolates don’t contain some of the other naturally occurring substances in cannabis such as other cannabinoids, terpenes and flavonoids. Many people believe in the ‘entourage effect’ where all these molecules work together to achieve a better therapeutic outcome.
Challenge of listing a product on the ARTG
The process of having a product listed on the ARTG can take many years and requires large investments in clinic trials to obtain the safety and efficacy data needed to submit to the TGA (Therapeutic Goods Association). These trials often take years and once completed the TGA will require time to review the data and may request further information. There are also packaging, advertising, distribution and educational requirements to take into consideration. For these reasons it is not expected that there will be any CBD products available over the counter until 2023 and even then may be limited in variety.
It will be some time before CBD products in Australia are actually available for over the counter purchase at your local pharmacy. Even when they are available, they will be limited to isolates and low dose options and may be expensive to recoup the large investment in research and development and all the regulatory hurdles required to list a product. In the meantime, if you think CBD oil may be a good option for your condition and you have tried at least one medication that has not worked or has caused side effects, you can book an appointment with one of our doctors and find out if you would be suitable. Our doctors are approved prescribers of CBD medication and can help you navigate the process. If you still have more questions, feel free to contact us on our homepage or call us at (02) 9098 9128.