What the Down-Scheduling of CBD from a Schedule 4 to a Schedule 3 Medicine Really Means

Stakeholders of the medicinal cannabis industry were thrilled to find out that Cannabidiol, or CBD, both synthetic and natural will be downgraded from a schedule 4 (prescription only) to a schedule 3 (pharmacist only) medicine.  Greater accessibility, convenience and likely reduced costs are all expected with the change. However, whilst it is still good news, the immediate impact may not be quite as large as anticipated. 

Low Maximum Dose of CBD Only

The decision only includes products containing up to a maximum dose of 150mg/day. Many current prescriptions exceed this by up to 4 times the amount (source). This means that only some current/prospective CBD users would benefit from the rescheduling. 

Limit to the form and packaging of CBD Medicine

In order to be considered for schedule 3, CBD must conform to certain packaging requirements, include child resistant closures. Moreover, product forms are limited to oral, oral mucosal, and sublingual formulations only (i.e. no vaping, no topicals, no cosmetics). This means that not all CBD products are applicable. 

Products must be included on the Australian Register of Therapeutic Good (ARTG)

To be considered a schedule 3 medicine, the product must be approved by the TGA and included on the ARTG.  To be on the register, products must be approved for a specific indication. This means that medicinal cannabis companies like Cannatrek must provide efficacy, safety, and quality assessment data for the product, for a particular medical condition, to enable the product approval. This is reasonable, and research is increasing, being carried out by most of us. However, there is not a large amount of product and indication-specific research that is complete: much of it is in progress. 

As a result, there are currently no TGA approved products on the ARTG that meet the schedule 3 criteria. Therefore, nobody can actually benefit from the schedule change at this point. 

So What Does This All Mean?

The decision to downgrade CBD to schedule 3 is still a good thing, showing an overall forward movement of the industry in favour of patients. Over time, product and indication specific research will be completed and medicinal cannabis companies will apply for their products to be on the ARTG and for TGA approval. 

However, there won’t be many changes to begin with, and CBD users will need to continue getting doctors’ prescriptions for their medicine. For those looking to gain access to medicinal cannabis, head to https://access.cannatrek.com/ to book an appointment with an experienced doctor.