Are we there yet? Not quite, but it’s still looking like over-the-counter cannabidiol could be available from pharmacies in Australia within the next year.
Cannabidiol (CBD) is a non-intoxicating cannabinoid extracted from hemp that has been the focus of significant research into its potential to treat or manage a wide range of conditions.
In April this year, the Therapeutic Goods Administration (TGA) commenced a consultation on proposed amendments to the Poisons Standard that included altering the Schedule 4 listing for cannabidiol to one that would enable CBD preparations meeting certain criteria be available over-the-counter from pharmacies without a prescription.
The Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) met in June to make an interim decision, but that decision wasn’t made public until yesterday.
The interim decision holds some positive news – that certain low dose CBD products will be downscheduled from Schedule 4 to Schedule 3, meaning over the counter sales from pharmacies could occur. Here’s how the Schedule 3 listing may look:
“Schedule 3 – New Entry
CANNABIDIOL in oral, oral mucosal and sublingual formulations preparations for therapeutic use when
a) the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer; and
b) the maximum recommended daily dose is 60 mg or less of cannabidiol; and
c) in packs containing not more than 30 days’ supply; and
d) cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
e) 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
f) for adults aged 18 years and over; and
g) packed in blister or strip packaging or in a container fitted with a child-resistant closure.”
Qualifying CBD products would need to be registered on the Australian Register of Therapeutic Goods (ARTG), which will thin out the number of products available and maintain upward pressure on pricing – but also ensure high quality standards.
CBD being available without prescription in Australia still isn’t set in stone – further consultation is to occur before a final decision is made. The proposed implementation date is 1 June 2021, so we’re still some way off should it get the final nod. Still, this is another move in the right direction and hopefully it will stay its course.
There was also a proposed amendment in a private scheduling application to amend the current Poisons Standard to exclude cannabidiol from scheduling altogether and allow its general sale, but this didn’t pass muster – which comes as no surprise.
The full text of the interim decision can be found here – it starts on page 22.
