is a prescription required for cbd oil

Medicinal cannabis treatment

The Australian Government Department of Health regulates therapeutic medicines containing cannabinoids through the Therapeutic Goods Administration (TGA) and for importation or production, the Office of Drug Control.

Access is restricted to appropriate patients with medical conditions where there is evidence to support its therapeutic use.

For further information read the:

    or phone 1800 020 653 or phone (02) 6232 8740

Patients living in Queensland

A patient living in Queensland must access medicinal cannabis through a doctor who is authorised under the Special Access or Authorised Prescriber Scheme administered by the Commonwealth Therapeutic Goods Administration (TGA).

In Queensland, all doctors can prescribe Schedule 4 – cannabidiol (CBD) and Schedule 8 – tetrahydrocannabinol (THC) or tetrahydrocannabinol: cannabidiol (THC:CBD) products without a Queensland approval.

For further information read the TGA website’s Access to medicinal cannabis product page, or phone 1800 020 653.

Approvals doctors require to prescribe medicinal cannabis

Doctors require a Therapeutic Goods Administration (TGA) approval to prescribe unregistered medicinal cannabis products in Queensland. These approvals are granted under the Commonwealth Department of Health, Special Access Scheme Category B (SAS Cat B) or Authorised Prescriber Schemes. Please use TGA Online to make your application.

There are various regulatory requirements under the Medicines and Poisons (Medicines) Regulation 2021 regarding the prescribing of monitored medicines (including Schedule 8 medicinal cannabis), including prescription requirements, and compliance with relevant departmental standards.

Conditions that medicinal cannabis can be prescribed for

Queensland laws do not limit what symptoms or conditions may be applied for by your doctor. When making a TGA application the doctor will need to supply sufficient scientific evidence that supports the use of medicinal cannabis for the particular symptom or condition.

Research continues to be conducted on the potential uses of medicinal cannabis. The scientific evidence base suggests that medicinal cannabis may be suitable to treat:

  • severe muscular spasms and other symptoms of multiple sclerosis
  • chemotherapy-induced nausea and vomiting
  • some types of epilepsy with severe seizures
  • palliative care (cachexia, nausea and vomiting, pain)
  • some types of chronic non-cancer pain.

There is no evidence that medicinal cannabis is an effective primary treatment for cancer.

  • consider medicinal cannabis as an alternative treatment for cancer
  • delay starting standard cancer treatments in favour of using medicinal cannabis.

Restrictions

Patients are not approved to smoke cannabis as this exposes them to many of the same health risks as smoking regular cigarettes. Vaporisation using a TGA approved vaporiser is a possible alternative.

Doctors seeking approval to use a specific product will need to provide evidence of its safety and efficacy for the condition or symptom being treated to the TGA.

Participating in a clinical trial

Clinical trials are often run by pharmaceutical companies to find out about how their product behaves in patients.

Clinical trials often set entry criteria and use clinical protocols so that the results are as useful as possible. Recruitment for clinical trials is sought by a range of means including through the peak bodies for certain conditions, for example Epilepsy Queensland. Speak with your doctor to find out if there are any clinical trials for your condition.

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Queensland does not have amnesty for medicinal cannabis

Access to medicinal cannabis in Queensland must be for a legal product prescribed by an approved doctor and dispensed by an approved pharmacist.

Cannabidiol (CBD)

There is increasing interest, both in Canada and worldwide, in CBD. CBD is a compound found in the cannabis plant. It is regulated in Canada under the Cannabis Act.

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Where CBD comes from

The cannabis plant contains hundreds of chemical substances. Over 100 of these are known as cannabinoids. Cannabinoids derived from cannabis plants are sometimes called phytocannabinoids.

Cannabidiol (CBD) is one of these cannabinoids. CBD is not intoxicating and may reduce some of the effects of tetrahydracannabinol (THC); however, it does have an effect on the brain.

CBD can be found in different varieties of the cannabis plant, including hemp.

All phytocannabinoids are regulated under the new Cannabis Act. The Act came into force on October 17, 2018.

How we regulate CBD in Canada

CBD is a controlled substance under United Nations drug control conventions. Consistent with the controlled status of CBD internationally, CBD is a controlled substance in Canada and other jurisdictions.

As a result, CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This includes CBD derived from industrial hemp plants, as well as CBD derived from other varieties of cannabis.

Under the Cannabis Act activities with phytocannabinoids (including CBD) remain illegal, unless authorized.

Before the Cannabis Act came into force, CBD was:

  • regulated under the Controlled Drugs and Substances Act
  • strictly controlled

It was not legal to produce, sell, import or export CBD unless authorized for medical or scientific purposes.

Under the Cannabis Act, CBD products remain strictly regulated and are only legal when sold in compliance with the Act and its regulations.

The Act and accompanying regulations place strict controls on cannabis:

  • possession
  • production
  • distribution
  • sale

Health Canada oversees the production of cannabis products. Health Canada is also responsible for overseeing the distribution and sale of:

  • cannabis, including any CBD-containing cannabis products for medical purposes

The provinces and territories are responsible for determining how cannabis is distributed and sold within their jurisdictions.

They set rules around:

  • how cannabis products can be sold
  • where stores may be located
  • how stores must be operated

Growing cannabis plants containing CBD for commercial sale

To cultivate any cannabis plants that you intend to sell, you must have a federal licence issued under the Cannabis Act.

This licence could be:

  • a cultivation licence under the Cannabis Regulations
    • authorizing growing of cannabis plants with varying amounts of THC and CBD
    • authorizing cultivation of specific varieties of cannabis plants with a THC content of no more than 0.3% in the flowering heads, branches and leaves.

    Producing and selling CBD

    CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations.

    You must have a processing licence to manufacture products containing CBD for sale, no matter what the source of the CBD is.

    CBD and products containing CBD, such as cannabis oil, may only be sold by a:

    • provincially or territorially-authorized cannabis retailer
    • federally-licensed seller of cannabis for medical purposes

    Importing and exporting CBD products

    Movement of cannabis and cannabis products between countries is covered by 3 United Nations drug conventions, including the Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol.

    CBD is currently a controlled substance under the Single Convention. CBD products may therefore only be imported or exported under very specific conditions. Any import or export must meet all of these criteria and may only be done:

    • by a holder of a licence issued under the Cannabis Regulations
    • under an import or export permit issued to the licence holder by Health Canada for that shipment
    • for a legitimate scientific or medical purpose, as per international agreements

    Industrial hemp

    Industrial hemp is cannabis that contains 0.3% THC or less in the flowering heads and leaves.

    The Industrial Hemp Regulations under the Cannabis Act set out the requirements for cultivators of industrial hemp. As is currently the case, cultivators of industrial hemp must grow from the hemp varieties approved for commercial cultivation.

    Although it may not have more than 0.3% THC, there is no limit to the amount of CBD that may be contained in industrial hemp plants.

    The Cannabis Act and its regulations do not distinguish between CBD derived from industrial hemp and CBD derived from cannabis with greater than 0.3% THC.

    What industrial hemp licence holders may and may not do

    An industrial hemp licence holder may cultivate hemp to produce a number of different products. They may:

    • sell viable seeds
    • sell grain (i.e. non-viable seeds) or hemp seed derivatives for use in:
      • food
      • cosmetics
      • other products

      Hemp producers may not extract the CBD themselves, unless they also have a cannabis processing or research licence.

      Importing and exporting industrial hemp

      The Industrial Hemp Regulations authorize importing and exporting industrial hemp seed or grain, but not the flowering heads, branches or leaves.

      The flowering heads, branches and leaves may only be imported or exported by a licence holder under the Cannabis Regulations:

      • with a permit issued under those regulations
      • for legitimate medical and scientific purposes

      To import or export the industrial hemp seeds or grain, you must:

      • hold a licence from Health Canada
      • have an import or export permit issued by Health Canada

      When importing or exporting industrial hemp seeds or grain, you may also need to obtain an import or export permit from the other country, depending on their rules.

      The difference between cannabis oil and hemp-seed oil

      Cannabis oil is 1 of the 5 classes of cannabis that may currently be legally sold in Canada by provincially and territorially-authorized retailers:

      • cannabis oil
      • fresh cannabis
      • dried cannabis
      • cannabis seeds
      • cannabis plants

      Cannabis oil is a combination of:

      • cannabis:
        • usually in the form of a THC and/or CBD-rich extract from the leaves and flowering heads of the cannabis plant, which may include plants classified as industrial hemp
        • olive
        • canola
        • grape seed
        • hemp-seed oil

        Hemp-seed oil is oil made from pressing the grain of hemp plants. It is processed like other oil seeds, such as canola. In order for hemp-seed oil to be exempt from the Cannabis Act, it can’t contain more than 10 parts per million of THC.

        For hemp-seed oil to be exempted from the Cannabis Act, no phytocannabinoid including THC and CBD may be added or concentrated by processing.

        Hemp-seed oil is marketed in Canada in:

        • food
        • cosmetics
        • natural health products
        • veterinary health products

        CBD and prescription drugs

        All phytocannabinoids, with several exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations.

        CBD in natural health products, veterinary health products and cosmetics

        Only limited parts of cannabis or hemp plants may be used in a:

        • natural health product (NHPs)
          • under the Natural Health Product Regulations
          • under the Food and Drug Regulations

          NHPs and VHPs may only contain parts of the cannabis and hemp plants that are not considered cannabis under the Cannabis Act or that are excluded from the application of the Act. This includes things such as:

          • non-viable seeds
          • hemp-seed derivatives that are compliant with the Industrial Hemp Regulations
          • mature stalks that do not include any leaves, flowers, seeds or branches and fibre from such stalks are also excluded from the Cannabis Act, but they may not be used in veterinary health products.

          Deliberately adding phytocannabinoids to such products is not permitted.

          These same restrictions also apply to cosmetics, which may only contain hemp derivatives.

          CBD in human food or pet food

          Edible cannabis will not be permitted for sale until the Regulations Amending the Cannabis Regulations (New Classes of Cannabis) come into force on October 17, 2019.
          These regulations set out strict controls to reduce the: