​Product requirements

Sativex® (nabiximols) is the only cannabis medicine currently registered in Australia on the ARTG, approved for the treatment of moderate to severe spasticity in multiple sclerosis.

Other cannabis medicines that have been registered by regulators outside of Australia, but are not registered in Australia, include:

  • Marinol® (dronabinol) synthetically manufactured, and registered in the US by the Food and Drug Administration (FDA) for the treatment of anorexia in patients with AIDS, and for the management of chemotherapy-induced nausea and vomiting where standard anti-nausea treatments have failed.
  • Cesamet® (nabilone) synthetically manufactured, and registered in the US by the FDA for the management of chemotherapy-induced nausea and vomiting.
  • Epidiolex® (cannabidiol) plant-derived, and registered in the US by the FDA for the management of Dravet and Lennox-Gastaut syndromes.

Applications to prescribe or supply cannabis medicines are not limited to such products. However the product applied for must be legally produced and manufactured to appropriate quality standards.

The product applied for must have been lawfully manufactured or imported, i.e. under a Commonwealth licence or an approval, unless exempted.

The Commonwealth’s Office of Drug Control (ODC) license cultivation, production and manufacture of cannabis for medicinal use. A NSW based manufacturer must also hold a licence issued by NSW Health to manufacture and supply a cannabis medicine.

Products that might be accessed from unregulated sources, including oils, tinctures and plant material, are of unknown safety and efficacy and may include harmful substances and contaminants. Use of these will not be authorised and may be unlawful.

A cannabidiol preparation for therapeutic use, where cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation, and which contains no more than 2% of other naturally-derived cannabinoids as impurities in the cannabidiol component, is a Schedule 4 medicine.

Currently, there are no registered cannabidiol preparations in Australia. Whilst a NSW Authority is not required to prescribe an unregistered Schedule 4 medicine, the other requirements for unregistered cannabis medicines apply, e.g. Commonwealth licences to import/manufacture and TGA approval (under SAS Category B, Authorised Prescriber or Clinical Trial schemes) are still required.

Writing a prescription

The medical practitioner must specify on the prescription for a Schedule 8 cannabis medicine all usual requirements for the form of a Schedule 8 prescription, such as adequate directions for use, handwritten quantity in words and figures and repeat intervals if repeat supplies are ordered (see Guide to Poisons and Therapeutic Goods Legislation for Medical, Nurse and Midwife Practitioners and Dentists for details).
 
The medical practitioner must make a prescribing record as for any Schedule 8 prescription.
 
Information Bulletin Schedule 8 Cannabis Medicines and Unregistered Schedule 8 Medicines provides guidance for NSW public health facilities on prescribing registered and unregistered Schedule 8 cannabis medicines.
 

Dispensing

A pharmacist can dispense a prescription for a Schedule 8 cannabis medicine (other than Schedule 4 cannabidiol) only if the prescriber is approved by the TGA to prescribe it.
 
From 30 September 2019, a prescription for a Schedule 8 cannabis medicine does not need to bear a NSW Authority number.
A NSW Authority number is required on prescriptions for certain Schedule 8 medicines, including extemporaneously compounded Schedule 8 medicines and psychostimulants.
 
A pharmacist can dispense a Schedule 8 cannabis medicine only on receipt of a hard copy written prescription. (Emergency supply provisions do not apply). Hospital pharmacies may supply for inpatients on a copy of a medication chart order.
 
The other usual requirements when dispensing Schedule 8 prescriptions apply, e.g. the pharmacist must verify the prescriber, must report any apparently forged or fraudulently altered prescriptions, and must retain the dispensed prescription, separately from other prescriptions.
 
Cannabis medicines supplied to a patient (by a pharmacy or medical practitioner) must be labelled with a dispensing label with the usual details for any dispensed medicine including name of the product, prescription number, patient name, directions for use, date of supply, name and address of supplier.
 
It should be noted that a pharmacy (or medical practitioner) cannot hold stock of any unregistered medicine unless it has been approved for supply by the Commonwealth.
 
All supplies and receipts of Schedule 8 cannabis medicines (whether dispensed on prescription or supplied directly by a medical practitioner) must be recorded in a drug register. If used in a clinical trial, a record of the NSW Authority number must be made in the clinical trial records.
 
 
Information Bulletin Schedule 8 Cannabis Medicines and Unregistered Schedule 8 Medicines provides guidance for NSW public health facilities on dispensing registered and unregistered Schedule 8 cannabis medicines.
 
Any loss or theft of Schedule 8 cannabis medicines must be reported to the Secretary, NSW Health, on the  Notification of Loss or Theft of Accountable Drugs (S8 and S4D substances) form as for all Schedule 8 drugs. Unwanted cannabis medicines may not be destroyed except by a person authorised to destroy Schedule 8 drugs.
 

Storage

Schedule 8 cannabis medicines must be stored separately and securely, as is required for any Schedule 8 medicine. All current cannabis medicines are Schedule 8 other than those that are Schedule 4 cannabidiol only.

In a retail pharmacy or hospital pharmacy, a Schedule 8 medicine that requires refrigeration may be kept in a refrigerator rather than a safe if all of the following requirements are met:
 
  • the refrigerator must be in a room (which includes a part of a room or an enclosure) to which the public does not have access,
  • the refrigerator, or any cupboard or receptacle in which the refrigerator is kept, must be securely attached to a part of the premises,
  • the refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be kept securely locked when not in immediate use,
  • a device (including a key) that is used to securely lock anything under this subclause must:
    • be kept on the person of a pharmacist who is at the premises, or
    • be securely locked in a safe that can be unlocked only by a pharmacist,
  • a code or combination that is used to securely lock anything under this subclause must not be disclosed to any person who is not a pharmacist,
  • the refrigerator must not be used to store any other item that is not a substance listed in Schedule 2, 3, 4 or 8 of the Poisons List or is not a therapeutic good.

Packaging and labelling

Cannabis medicines supplied in or from NSW (other than when dispensed to a patient) must be packaged and labelled as Schedule 8 medicines (unless a Schedule 4 cannabidiol), unless otherwise exempted by the Secretary, NSW Health.
 
It is illegal to label a product suggesting it is a cannabis product if it is not.
Page Updated: Wednesday 23 October 2019
Contact page owner: Pharmaceutical Services