The Therapeutic Goods Administration (TGA) has down scheduled CBD oil from Schedule 4 to Schedule 3, making it available over the counter in pharmacies without a prescription.
The delayed decision comes after the original proposal of 60 mg/day was met with criticism, with many calling for an increase in the dosage given research suggested the low-dose was insufficient to provide any material benefits.
This increase follows further consideration of safety information, the public submissions on the interim decision and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at the November 2020 meeting.
Companies can now lodge applications for their CBD oil products to be included in the Schedule 3 listings. Various conditions will be required to be met in order to be be approved to be listed on the Australian Register of Therapeutic Goods:
- The cannabidiol is either plant derived, or when synthetic, only contains the (-)-CBD enantiomer; and
- The cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
- Any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation and of which tetrahydrocannabinol (THC) can only comprise 1 per cent of the total cannabinoid content; and
- The maximum recommended daily dose is 150 mg or less of cannabidiol; and
- Packed in blister or strip packaging or in a container fitted with a child-resistant closure; and
- In packs containing not more than 30 days’ supply; and
- For adults aged 18 years and over
The decision, which will come into effect on 1st February 2021, comes after many countries around the world have already made various CBD products available without a prescription – which was duly noted by the committee and its chair.
I have also considered the findings of a recent review, which found that all countries studied, except Australia and New Zealand, have CBD products available without a prescription in varying forms and strengths.
We’re glad to see the correct decision has been made and look forward to seeing the thousands of Australian currently sourcing CBD oil on the black market to be able to access their medicines through legitimate methods.
Unfortunately, given some of the TGA’s requirements in order to be approved, it’s unlikely we’ll see any medications available from February 1st. With some estimating products will only become available by 2022.