Australia Making CBD Available without a Prescription. Rescheduling it!

The Australian government on September 9th, 2020 amended the current Poisons Control Standard, the Therapeutic Goods Administration (TGA) reached an interim decision to amend the country’s Poisons Standard and down-schedule CBD to a Schedule 3 product in oral, oral mucosal, and sublingual formulas for therapeutic use.

CBD is currently a Schedule 4 which means it can only given through a prescription. This is an interesting move as around the world Hemp and Cannabis regulations are being shifted to allow more of the plant based medicine to be accessible to all.

The Committee identified the following risks:
– CBD, being an inhibitor of CYP3A4, CYP2D6, CYP2C19, CYP2C9 and P-glycoprotein, is likely to have interactions with many pharmaceuticals available for human use. Pharmacodynamic interactions with drugs that cause CNS depression (opioids, benzodiazepines, antipsychotics, gabapentinoids, sedating antihistamines), are likely.
– CBD can have adverse reactions including somnolence, decreased appetite, diarrhoea, fatigue and liver dysfunction.
– The current lack of approved indications would prevent a pharmacist being able to determine appropriate supply.
– The Committee noted the potential for use, outside of that legally permitted by the Poisons Standard, particularly in children/adolescents, if CBD were to be available as a Schedule 3 medicine.

– The Committee noted that it was difficult to assess the benefits in the absence of an approved product or clearly defined indications.
– The Committee noted that the TGA Safety Review concluded that doses up to 60 mg/day may potentially be used safely in adults.

Here are guidelines that must be followed:

• restrictions on the preparation and dose, dosage form, pack size, age and limiting supply to Australian registered products
• a requirement for a child-resistant closure unless the product is packed in blister or strip packaging
• creation of an Appendix F listing to include a requirement for specific warning statements on the labeling of CBD-containing Schedule 3 products available to the public
• exclusion of medicine including CBD from Appendix H, that is those medicines are excluded from being advertised directly to consumers
• creation of an Appendix M listing to limit supply to medicines including CBD which are entered on the Australian Register of Therapeutic Goods.

More to come as this gets going in Austrialia.

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