Cannabidiol manufacturers could face a long and expensive battle to sell low-dose products through pharmacies even if health authorities – as expected – down schedule CBD and make it available without a prescription.
The Advisory Committee on Chemicals Scheduling (ACCS) and Advisory Committee on Medicines Scheduling (ACMS) met in June to discuss the prospect of reclassifying low-dose CBD as a schedule 3 pharmacy-only medicine.
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It currently sits in schedule 4 of the Poisons Standard and is only available via prescription. A decision to down schedule will be made public on September 9 after which further consultations will take place ahead of a final ruling in November.
Submissions to the application remain confidential.
With a TGA review concluding that low-dose CBD – defined as a maximum daily dose of 60mg – had an “acceptable safety and tolerability profile”, and with the Department of Health behind the application to down schedule, a positive decision is expected.
But while the down scheduling would be welcomed by many, manufacturers have warned the public not to expect a glut of products any time soon.
Under tight TGA regulations, all schedule 3 medicines must be registered on the Australia Register of Therapeutic Goods (ARTG) and, critically, must be proven to work.
Yet according to the TGA safety review there is a “paucity of high-quality published trials”.