Some CBD meds downscheduled

The TGA has announced a final decision to downschedule certain low dose cannabidiol (CBD) preparations

These preparations are set to be downscheduled from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

“The decision will allow low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription,” says the TGA.

“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 ARTG that meet the Schedule 3 criteria.

The TGA says that 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.

Consumer Healthcare Products Australia welcomed the decision.

The organisation also said it commends the Delegate’s decision to increase the maximum daily dose limit from what was proposed in the interim decision, enabling Australians to have greater access to effective CBD products.

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1 Comment

  1. “Medicinal Cannabis downscheduled”

    My coimments on AJP

    Even with the down-scheduling of CBD, important questions remain with respect to driving whilst taking medicinal Cannabis, (which may or may not contain THC),

    The TGA Delegate noted that “there are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.

    However, we also know that Unapproved CBD medicines can continue to be accessed via the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme on prescription only. .

    In this context, I refer to an article on “Medicinal Cannabis and driving” by Vicroads 2/1/2020
    November 3, 2020 .

    In this article, it clarifies what roadside tests detect in Victoria( and presumably, similarly, in other Australian jurisdictions), as follows:

    How do Victoria Police test for THC?

    “Victoria Police conduct random roadside drug testing throughout Victoria. Roadside drug testing requires the driver to provide a small sample of saliva for testing. A saliva sample that is positive for THC at the roadside will be sent to a laboratory for confirmation. A confirmed positive test will result in a drug-driving charge.

    In Australia, THC is a controlled Schedule 8 drug under the Poisons Standard. Victoria has a zero-tolerance drug-driving policy for controlled drugs. This currently includes medicinal cannabis products that contain THC”.

    Furthermore, the article also notes that:

    ” All drivers involved in a crash in Victoria that results in death or injury are required by law to provide a blood sample to Victoria Police for analysis. The presence of THC (including THC from medicinal cannabis) in blood can be used as evidence for prosecution purposes and may also affect vehicle and personal injury insurance claims”.

    So, lots of issues still remain, regarding driving and roadside testing, with respect to medicinal Cannabis that may, albeit, be lawfully obtained and used.

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