Cannabidiol (CBD) is a Schedule 4 (S4) Prescription Only Medicine when the cannabinoids component in a preparation for therapeutic use contains at least 98% cannabidiol and 2% or less of other cannabinoids found in cannabis.
Tetrahydrocannabinol (THC) is a Schedule 8 medicine when extracted from cannabis and prepared or packed for human therapeutic use.
Nabiximols, nabilone and dronabinol are listed in Schedule 8 of the Poisons Standard (SUSMP).
The only cannabis medicines currently registered in Australia under the Australian Register of Therapeutic Goods (ARTG) is the Schedule 4 medicine Epidyolex® (cannabidiol), and the Schedule 8 medicine Sativex® (nabiximols).
The Therapeutic Goods Administration (TGA) has grouped unapproved cannabis medicine products into active ingredient categories based on the proportion of cannabidiol (CBD) and/or tetrahydrocannabinol (THC) content of the medicine. Unapproved medicinal cannabis products available in these categories can be found on the TGA website Medicinal cannabis products by active ingredients.
Approval letters issued to prescribers by the TGA under the Authorised Prescriber Scheme (AP) or Special Access Scheme (SAS) will include the category of cannabis medicine approved to be prescribed or supplied.
Before prescribing or supplying unregistered cannabis medicines to a patient refer to Access and approval process for cannabis medicines for guidance on the required approvals.
Prescriptions for unregistered cannabis medicines must accurately identify the name, strength (NOT a range of strengths), dosage, and quantity of each active cannabis medicine ingredient. Prescriptions must also include all other details as required for Schedule 8 medicines. In some cases, the use of a brand name may adequately identify the active ingredient and strength. Substitution of products is not allowed.
Prescriptions with instructions such as ‘CBD dominant medicinal cannabis product (CBD ≥60% and <98%)’ do not adequately identify the name and strength of each active ingredient to be administered and cannot be legally dispensed by a pharmacist.
The purpose and dosage of the medicine prescribed or supplied must be in accordance with therapeutic standards. The quantity of the cannabis medicine prescribed or supplied must conform with the dose and directions prescribed.
If the cannabis medicine is in Schedule 8 and needs to be extemporaneously compounded, the approval* number issued to the prescriber from the NSW Ministry of Health must be included on the prescription.
The prescriber must make a prescribing record for all Schedule 8 prescriptions provided in the patient record.
A pharmacist can dispense a prescription for an unregistered cannabis medicine if the prescriber holds an approval under the TGA AP scheme or SAS to prescribe it. If the cannabis medicine is in Schedule 8 and needs to be extemporaneously compounded the prescriber must also include on the prescription the NSW Health approval* number issued to them.
A pharmacist or authorised prescriber cannot hold stock of any unregistered medicine unless it has been approved for supply, to a particular patient, by the TGA.
Emergency supply provisions do not apply for unregistered Schedule 8 medicines. To dispense an unregistered Schedule 8 medicine a valid prescription is required. This includes prescriptions that are:
Cannabis medicines supplied to a patient by a pharmacist or authorised prescriber must be labelled with a dispensing label with the details required for any dispensed medicine.
Pharmacists must ensure they are practising within the Ahpra Shared Code of Conduct and not enter into arrangements for exclusive supply of prescriptions from a prescriber or other third party.
Schedule 8 cannabis medicines must be stored separately and securely with all transactions recorded in a drug register.
Schedule 8 medicines must be stored separate from other goods (other than cash or documents), in a steel safe meeting the specified requirements and fixed to the building. The safe must be kept securely locked when the medicines are not in immediate use. The key or code/combination of the safe must be kept by the prescriber or pharmacist and not left on the premises overnight or disclosed to a person who is not a prescriber or pharmacist.
All supplies and receipts for Schedule 8 cannabis medicines (whether dispensed on prescription or supplied directly by an authorised prescriber) must be recorded in a drug register. If used in a clinical trial, a record of the NSW Ministry of Health approval* number must be made in the clinical trial records.
Records of all transactions including any manufacturing, receipt, supply or use the Schedule 8 cannabis medicine must be entered in a drug register on the day of the transaction. A separate page of the register must be used for each brand name and each strength of the Schedule 8 medicine.
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 can only be destroyed by a person authorised to destroy Schedule 8 drugs. Information for community pharmacies can be found at Destruction of Schedule 8 medicines at community pharmacies.
*An approval has the same meaning as an authority under the Poisons and Therapeutic Goods Act 1966.
