Guide for pharmacists dispensing medicinal cannabis
A patient or their medical practitioner may approach your pharmacy to assist with dispensing an approved medicinal cannabis product. Products may include both registered and unregistered medicines.
Only stock of medicinal cannabis for a named patient can be held in a pharmacy.
Guidance and regulations
- Guidance's for the use of medicinal cannabis in Australia are a suite of national guidance documents that cover a range of medical conditions, symptoms, and products to be used. The individual documents can be viewed on the TGA's website.
- Departmental Standard – Secure storage of S8 medicines (PDF 269 kB) details how to secure and store medicinal cannabis products, under the regulation.
The Medicines and Poisons (Medicines) Regulation 2021 describes the requirements for dispensing, recording, packaging, labelling and reporting associated with schedule 4 and schedule 8 medicines (including medicinal cannabis products).
Read more about Prescribing and dispensing unregistered medicinal cannabis products (PDF 267 kB)
The dispenser must:
- comply with the Departmental Standard – Monitored medicines when dispensing an S8 medicinal cannabis product
- check QScript prior to dispensing a monitored medicine, including S8 medicinal cannabis.
Importation
Importation and export of medicinal cannabis products is tightly controlled. The Office of Drug Control provides information on how to access these products.
Departmental Standard – Secure storage of Schedule 8 medicines
Medicinal cannabis products, particularly those containing tetrahydrocannabinol (THC), have a high diversion value, and must have comprehensive security controls in place to manage this risk.
The Departmental Standard – Secure storage of S8 medicines outlines the requirements for storing Schedule 8 medicines, including schedule 8 medicinal cannabis products. If the medicinal cannabis is a schedule 8 medicine, it must be stored in a way that complies with the Departmental Standard – Secure storage of S8 medicines (PDF 269 kB).
Your legal obligations
The dispenser must:
- adhere to all conditions as detailed in any TGA import licence or permit, if they are the importing party
- comply with any conditions imposed on a TGA approval relating to the medicinal cannabis product(s) being used
- only dispense medicinal cannabis in accordance with a prescription
- comply with the Guidelines for Dispensing of Medicines published by the Pharmacy Board of Australia
- comply with all reporting and recording requirements, as set down by the Medicines and Poisons (Medicines) Regulation 2021
- ensure any excess or unused stock is disposed of and destroyed in line with the requirements under the Medicines and Poisons (Medicines) Regulation 2021
- report any adverse events, adverse reactions, serious adverse reactions and unexpected reactions to the prescribing medical practitioner.
Under the Medicines and Poisons (Medicines) Regulation 2021, Community pharmacies and dispensing medical practitioners that dispense S8 medicinal cannabis are required to submit these dispensing records to QScript electronically via a Prescription Exchange Service (PES), along with all other dispensing records for monitored medicines prescriptions.
Read more about Prescribing and dispensing unregistered medicinal cannabis products (PDF 267 kB)
Visit Monitored medicines reporting requirements for further information.
