TGA interim decision for over-the-counter access to medicinal cannabis, Cannabidiol or CBD Oil
Cannabidiol or CBD is currently listed as a Schedule 4 prescription only medicine on the Poisons Standard in Australia. Picture: David Zalubowski/Associated PressSource:AP
An interim decision by the government’s regulatory body for medicines could see a cannabis compound made accessible without a prescription.
Over the counter medicinal cannabis could be available in Australia from next year.
The Therapeutic Goods Administration has released a notice of interim decisions on proposed amendments to the Poisons Standard, which could give the green light for access to cannabidiol without a prescription at pharmacies.
Cannabidiol or CBD is the second most prevalent of the active ingredients in cannabis (marijuana) and is currently listed as a Schedule 4 “prescription only medicine”.
In relation to one proposed amendment, the TGA made an interim decision to “down schedule cannabidiol to allow greater access … in accordance with specified requirements and with additional supply requirements … to allow it to be provided by a pharmacist.”
The document, published on Wednesday, raised a suggested implementation date of June 2021.
As of September 3, the TGA had approved special access applications to medicinal cannabis products for chemotherapy-induced nausea and vomiting, refractory paediatric epilepsy, palliative care indications, cancer pain, neuropathic pain, spasticity from neurological conditions and anorexia and wasting associated with chronic illness (such as cancer).
“The (Advisory) Committee noted that currently there are no registered CBD products in Australia and unapproved CBD products are accessed via the Special Access Scheme,” the interim decision states.
The products would need to include warning statements or safety directions such as “do not use” if pregnant and/or breastfeeding or when likely to become pregnant or plan to breastfeed.
Limitations on the cannabidiol include a maximum daily dose of 60mg and no more than 30 days’ supply of CBD.
PROPOSED NEW ENTRY IN POISONS STANDARD
CBD would be down scheduled to a Schedule 3 product in oral, oral mucosal and sublingual formulations (under the tongue) preparations for therapeutic use, as per the following criteria:
* the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer
* the maximum recommended daily dose is 60 mg or less of cannabidiol
* in packs containing not more than 30 days’ supply
* cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation
* 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
* for adults aged 18 years and over
* packed in blister or strip packaging or in a container fitted with a child-resistant closure
Supply would also be limited to medicines that are entered on the Australian Register of Therapeutic Goods, the TGA document states.
The potential “major regulatory change” was welcomed by Althea Group, an ASX-listed Australian licensed producer, supplier and exporter of pharmaceutical grade medicinal cannabis.
“We applaud the TGA’s interim decision in this matter and see it as one of the biggest developments in our industry to date,” chief executive Josh Fegan said in a statement, describing it as a “big step forward”.
“The interim decision reflects the significant shift in community and government attitudes towards medicinal cannabis since it was legalised in Australia in late 2016, which has seen it move from a fringe alternative towards an accepted mainstream option.”
The TGA states consultation closes on October 13, 2020. Originally published here: https://www.news.com.au/lifestyle/health/health-problems/tga-interim-decision-for-overthecounter-access-to-medicinal-cannabis/news-story/31aca65f4ce3705802b5c15a54b86838