Cannabis-based products

The Scheduling classification of CBP is derived from the National Poisons Standard (external site). Cannabis and any constituent cannabinoids that are psychoactive are included in Schedule 8. This includes:

• cannabis
• tetrahyrdocannabinol (THC)
• nabiximols
• dronabinol
• nabilone.

These substances must be treated as Schedule 8 (controlled drug) products for any prescribing.They must be treated as Schedule 8 products for all aspects of supply including: dispensing, packaging, labelling, storage, transport, recording, reporting, disposal and advertising.

The substance cannabidiol (CBD) is not psychoactive and is classified as a Schedule 4 (prescription only) substance where:

• there are no more that 2% of other cannabinoids, inclusive of THC
• legally imported or legally manufactured in Australia.

The prescribing and supply of CBD in this Schedule must comply with all Medicines and Poisons Regulations as for any other prescription medicine. A prescription from a medical practitioner is necessary in all instances for lawful supply to a patient.

As CBD is not a Schedule 8 substance, no specific approved is required for the WA Department of Health prior to prescribing. Various other Commonwealth approvals, including for unregistered therapeutic goods, may be required.

The Schedule 8 Medicines Prescribing Code (the Code) (PDF 268KB) governs the prescribing of Schedule 8 in Western Australia. The Code outlines responsibilities of prescribers and requirements of the Department of Health. It is a legal requirement to adhere to the Code when prescribing, at all times.

Approved prescribers

To prescribe a CBP in Schedule 8, a practitioner must apply to the WA Department of Health to become an approved CBP prescriber using the Application for prescriber authorisation: Cannabis-Based Products form (Word 799KB). Consultant medical practitioners may seek approval to prescribe in their respective specialist field.

Notification of treatment

Prescribers authorised for CBP may prescribe without seeking individual authorisation so long as prescribing is in accordance with the Code. Prescribing authorised within the Code includes:

• products registered with the Therapeutic Goods Administration (TGA)
• for the approved TGA indication
• by a specialist in a relevant field.

An approved CBP prescriber must provide a written Notification of Treatment form (Word 817KB) to the Department of Health when commencing treatment for each patient.

WA Department of Health Authorisation Required

Any treatment that is outside the Code requires prior authorisation of the Department of Health, for each patient. Prescribing that requires approval includes any Schedule 8 CBP that is:

• not registered with the TGA; or
• to a drug dependent or oversupplied person; or
• to a person with a history of substance misuse; or
• to a person with psychiatric co-morbidities.

Prescribers must apply in writing using the Application for authorisation: Cannabis-Based Products form (Word 870KB). Applications are considered by the Cannabis–based Products Assessment Panel.

A Prescribing approvals flowchart (Word 272KB) has been developed to illustrate the approval process for prescribing Cannabis-Based Products.  

Commonwealth law requires that any therapeutic good (all prescription medicines) must be registered before supply in Australia. Otherwise, the products must be exempt, approved or authorised.

Any practitioner prescribing an unregistered CBP or CBD product must first obtain the relevant approval from the TGA (external site).

The use of CBP and CBD in legitimate medical research is permitted. These clinical trials must be approved by a recognised Human Research Ethics Committee (HREC) and be conducted under the TGA CTN or CTX Scheme (external site).

Researchers must comply with all other relevant laws for the cultivation, manufacture, possession and supply of CBD. The prescribing of Schedule 8 CBP in a research setting requires authorisation by the WA Department of Health, as for other settings.

Cultivation and manufacture

The cultivation and manufacturing of cannabis or CBP products must be conducted under the appropriate Licence and Permit issued by the Office of Drug Control (external site).

Supply and dispensing

Scheduled medicines may only be supplied by a Licence holder, such as a pharmaceutical wholesaler. CBP and CBD may only be supplied to a patient by a pharmacist, authorised prescriber, or Permit holder (e.g. hospital), in accordance with the WA Medicines and Poisons Regulations. Schedule 8 CBP and Schedule 4 CBD must be prescribed to a patient by a registered (and authorised) medical practitioner.

Overseas importation

Schedule 8 CBP or Schedule 4 CBD products may by imported from overseas suppliers by authorised, registered health practitioners. The importation must be approved by the Office of Drug Control (external site).

Quality standards

Any unregistered therapeutic good imported into Australia must be also approved by the TGA prior to supply. All products must meet minimum standards for product quality.

Hospitals

Individual hospitals generally maintain policies relating to the use of unregistered therapeutic goods. Any drug formulary restrictions on prescribing or the funding of supply at a hospital are in addition to those required by the legislation outlined above. Hospital based practitioners should seek advice from their own institution on any additional internal restrictions.

A CBP or CBD product can only be lawfully prescribed and dispensed if:

• importation is in accordance with Australian Customs laws; or
• cultivation and manufacture is in accordance with Australian Narcotic Drugs laws; and
• manufacturing is according to Therapeutic Goods laws; and
• unregistered goods are approved for supply under Therapeutic Goods laws; and
• Schedule 8 items are approved by the WA Department of Health or as part of the S8 Prescribing Code; and
• Prescribing and dispensing meet all requirements of the WA Medicines and Poisons Act and Regulations.

Cannabis and any CBP that are not legally sourced or are not being used for legitimate medical or research purposes are classified as Schedule 9 substances. Schedule 9 (S9) substances are prohibited and captured by the Misuse of Drugs Act. The possession and trafficking of S9 substances is a Police matter and serious penalties exist under this legislation.

Recreational use is not permitted. Use of raw cannabis or the smoking of any product does not qualify as medical use.

Schedule 8 items may not be advertised to the public. The advertising of therapeutic goods is also regulated and unregistered therapeutic goods may not be promoted. Any website making therapeutic claims direct to the public, of any nature, is unlikely to be a lawful Australian supplier.

There is no facility for individuals to obtain Commonwealth licences to cultivate or manufacture medicinal cannabis. It is the responsibility of the individual practitioners to obtain any required approvals and comply with legislation. When dealing with any supplier practitioners are strongly encouraged to obtain sufficient evidence to satisfy themselves that the CBP is of lawful origin.

These products are always Scheduled and will always require a prescription irrespective of origin, intended use, form or grade.

Records of Schedule 8 medicines dispensed at all Western Australian Pharmacies are collected and maintained by the Department of Health. These records are routinely reviewed for compliance with the Regulations and the Schedule 8 Prescribing Code.

In particular, the records are scrutinised to identify instances of problematic patient use and bring these to the attention of prescribers. The Department will contact prescribers in any case of prescribing CBP which is not consistent with the Code, or where authorisation has not obtained.

Medical practitioners may be required to participate in routine audit assessments to monitor compliance with the Code. Serious non-compliance may result in regulatory actions such as restrictions or loss of medicines authorities, notification to the Medical Board of Australia, and/or prosecution under the legislation.