WOOHOO!! CBD oil will be made available to the public OVER THE COUNTER in pharmacies ....
BREAKING NEWS
I've been taking CBD Oil for a year or 2 now & I believe it has really helped my manage the side effects of my AIs. I only started taking it after I'd already swapped from Letrozole to Examestane to Arimidex ... and I am coping much better on Arimidex.
They reckon that up to 40% of women STOP taking AIs due to the side effects .... so if there is an effective 'buffer' that makes taking it tolerable - it is worth a try, I reckon!
https://www.tga.gov.au/media-release/over-counter-access-low-dose-cannabidiol?fbclid=IwAR0Qln7kCKCfNk5yJASBPEPShQwp9FY1pyfhth9x8V72IGL58sr9et6xSmQ
Over-the-counter access to low dose cannabidiol
Today the Therapeutic Goods Administration (TGA) announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).
The decision will allow TGA approved low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.
There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.
The decision was made following an earlier TGA safety review of low dose CBD which indicated that the known adverse events of CBD at low doses were not serious. The decision was made by a senior medical officer at the TGA acting as a Delegate of the Secretary of the Department of Health, following extensive public consultation.
In the final decision, the Delegate has increased the maximum daily dose proposed in the interim decision from 60 mg/day to 150 mg/day. This increase follows further consideration of safety information, the public submissions on the interim decision and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at the November 2020 meeting.
Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG. Applications are individually evaluated for safety, efficacy and quality. Further information on the application process and data requirements is available in the Australian Regulatory Guidelines for OTC Medicines (ARGOM).
Medicines not included on the ARTG are known as 'unapproved' medicines. Importantly, unapproved medicines have not been evaluated by the TGA for quality, safety and effectiveness. Unapproved CBD medicines can continue to be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme on prescription only. Any Australian registered medical practitioner can apply to the TGA for approval to access unapproved medicines through the SAS or AP scheme if they believe it is right for their patient. More information on this process is available on the TGA website at: Medicinal cannabis.
The TGA can be contacted at info@tga.gov.au(link sends e-mail) or, for supplier and sponsor enquiries, at OTC.medicines@health.gov.au(link sends e-mail).
Comments
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@Dory65 para. 3 of the TGA statement: There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.
Para. 6 of the TGA statement: Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG. Applications are individually evaluated for safety, efficacy and quality.
Currently there no approved CBD oil products available for legal OTC sale in Australia. With the down-scheduling of certain formulations from Schedule 4 to Schedule 3, companies must apply for approval for their formulas to meet the criteria for Schedule 3 OTC sales.
BTW, the TGA recently approved the down-scheduling to Schedule 3 of melatonin (up to 2mg) for OTC sale to people age 55+ from 01 June 2021. I will start a new thread about this.
https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-relation-melatonin
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Yes, sadly the wheels will turn slowly. I can’t understand how the TGA wasn’t in discussion with these companies in the lead up to the announcement @NoShrinkingViolet to make sure supply was available .... sheer stupidity in my eyes2
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Cheers1
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I found some through a wonderful lady, so I’ve started taking some recently 👌🏻
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Unfortunately, those who have been supplying it in the past, have not been able to legally test the levels in their products so how much is in the stuff that works is mostly unknown. It also means that Australian doctors have not been able to get accurate information on this as a method to manage pain. But all steps in the right direction.4
