On 15 December 2020, the Australian Therapeutic Goods Administration (TGA) published its decision to down-schedule certain low dose cannabidiol (CBD) medicines from their current classification under the Australian Poisons Standard as Prescription Only Medicines (Schedule 4) to Pharmacist Only Medicines (Schedule 3).
As a result, certain low dose CBD medications that are included on the Australian Register of Therapeutic Goods (ARTG) will be able to be supplied over-the-counter by Australian pharmacists, without the need for a prescription from 1 February 2021.
To be able to be supplied in this way, the CBD medications must satisfy the following requirements:
- the CBD must be either plant derived, or when synthetic, only contains the (-) CBD enantiomer; and
- the CBD must comprise 98 per cent or more of the total cannabinoid content of the preparation; and
- any cannabinoids, other than CBD, 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 must be 150 mg or less of CBD; and
- the medication must be packed in blister or strip packaging or in a container fitted with a child-resistant closure; and
- the pack must not contain more than 30 days’ supply; and
- the medication must be for adults aged 18 years or over.
These CBD medications will also need to be labelled with the following warning statements: “Do not use if pregnant or likely to become pregnant” and “Do not use if breastfeeding or planning to breastfeed”.
This decision is a step towards the liberalisation of medicinal cannabis regulation at the Federal level in Australia.