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
- Guidances for the use of medicinal cannabis in Australia, December 2017 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.
- Standard for security of medicinal cannabis stock – June 2019 (PDF 514 kB): how to secure and store medicinal cannabis products, under the regulation.
- The Health (Drugs and Poisons) Regulation 1996 describes the requirements for dispensing, recording, packaging, labelling and reporting associated with schedule 4 and schedule 8 medicines (including medicinal cannabis products).
Importation and export of medicinal cannabis products is tightly controlled. The Office of Drug Control provides information on how to access these products.
Standard for secure storage of medicinal cannabis
All 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 Health (Drugs and Poisons) Regulation 1996 outlines the requirements for storing controlled drugs. If the controlled drug is medicinal cannabis it must be stored in a way that complies with the Standard for security of medicinal cannabis stock – June 2019 (PDF 514 kB) or otherwise Appendix 6 of the regulation.
Quality Standard for dispensing controlled drugs
Section 81 A of the Health (Drugs and Poisons) Regulation 1996 requires that a pharmacist prepares or adopts and complies with a Quality Standard
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 Health (Drugs and Poisons) Regulation 1996 (HDPR)
- ensure any excess or unused stock is disposed of and destroyed in line with the requirements under the Health (Drugs and Poisons) Regulation 1996 (HDPR)
- report any adverse events, adverse reactions, serious adverse reactions and unexpected reactions to the prescribing medical practitioner.
Under the Health (Drugs & Poisons) Regulation, 1996 all dispensed controlled (Schedule 8) drugs are required to be reported to the Department of Health on a weekly basis in the approved electronic form.
The S8 controlled drug submission day is every Monday to ensure consistency across the state, and to ensure the quality of the data that is captured upon receipt. The weekly reporting of S8 controlled drugs is required under the Health (Drugs and Poisons) Regulation.
The reporting should include the dispensing from open of business Sunday until after close of business Saturday. Pharmacists are required to send the completed weekly report before the close of business every Monday for the week prior.
Visit Schedule 8 drug reporting for further information.
Healthcare Approvals and Regulation Unit
Healthcare Approvals and Regulation Unit (HARU):
Telephone: (07) 3708 5264