For Australians eager to more easily gain access to cannabidiol, the prospect of CBD without a prescription is edging closer to reality.
Currently, cannabidiol is a Schedule 4 (S4) Prescription Only Medicine in Australia – and getting a script is only one hurdle to clear. Back in January, we mentioned the prospect of regulations concerning cannabidiol (CBD) being relaxed in Australia, to the point it could be purchased over the counter.
Last Friday, the Therapeutic Goods Administration (TGA) kicked off a consultation on proposed amendments to the Poisons Standard. One of the amendments would see the Schedule 4 listing for cannabidiol altered and a new entry added, Schedule 3; where:
- 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.
According to the TGA’s “Scheduling Basics“, a Schedule 3 medicine is a “Pharmacist Only Medicine”. The Pharmacy Guild of Australia defines a Schedule 3 medicine as:
“Medicines, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.”
So, what about the maximum 60 mg daily recommended dose limit – is this high enough to be of benefit? While not incredibly high, it appears it may be. Bear in mind there’s still a lot of research needing to be done on dosing levels – but a major plus is cannabidiol’s pretty good safety profile. Any decision on dosage should be made in consultation with a doctor, or in the case of CBD becoming available without a prescription; a pharmacist.
There are many Australians who would welcome being able to source cannabidiol over the counter – and it’s important they have their say. Another group that will be watching progress of this very closely are manufacturers of cannabidiol preparations as Australia’s CBD market would be quite lucrative under such a change.
Both the proposal (item 2.5 on this page) and the application to amend the scheduling of cannabidiol as outlined in the Public Notice of 17 April 2020 (item 2.2) will be referred to the June 2020 Joint ACMS/ACCS meeting. The due date for feedback is at the close of business 22 May 2020. Instructions on how to respond can be found here.
