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over the counter cbd oil

The product must also meet certain quality and consistency standards. Normally, clinical trials take multiple years before getting to a stage where a product is listed on the ARTG.

Over the counter products will have very strict requirements put in place by the TGA. Over the counter CBD products must be 98% or more CBD (cannabidiol). There may only be 1% or less THC (tetrahydrocannabinol) and 2% or less of any other cannabinoid and will be in preparations of oral, oromucosal & sublingual only.

Why can’t patients and customers find CBD oil in pharmacies?

When CBD oil is available in pharmacies, it will be a low dose product and only for short term relief. There will be a very limited product selection and your pharmacist will need to assess you to make sure the products that are available are right for you.

Most cannabis prescribed by doctors in Australia is unapproved, or unregistered medicine. These products are prescribed through special access pathways called the Special Access Scheme or via Authorised Prescribers (APs). Doctors can also prescribe compounded medical cannabis products. These products have not been clinically proven to treat specific conditions.

Over the counter CBD products will be sold in a different way. When available, your pharmacist will screen you to see if you qualify for a specific product. And, specific CBD products will be sold for specific indications or conditions.

“We have received Human Research Ethics Committee (HREC) approval to commence clinical trials for two sponsors creating S3 CBD products, with additional programs expected to soon be approved. Given our medicinal cannabis specialisation, this is a very exciting space for us,” he said.

Small Caps first reported the TGA’s interim decision to down-schedule certain CBD products in September from Schedule 4 (prescription medicine) to Schedule 3 (pharmacist-only medicine) of the Poisons Standard.

“But for now, 12 months or more is accurate,” he said.

Product registration can be a lengthy process

While this is expected to have a positive impact on many patients’ lives, there are myths circulating about this development that require clarification.

The expectation from a regulatory body to register a product is that safety, quality and efficacy targets are met.

Although Mr Azzopardi, who leads Cannvalate’s Medical Cannabis Research Centre, did admit that political pressure could be a motivation for the TGA to expedite its usual approval timeframe – in which case, this could change forecasts.

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), gave the go-ahead from 1 February, upping the daily dosage limit from its interim decision last year of 60mg to 150mg per day.