October 2019

Message from the Ministry of Health:

New regulatory approach to Schedule 8 cannabis medicines

NSW Health is simplifying the requirements for prescribers of Schedule 8 (S8) cannabis medicines under the Poisons and Therapeutic Goods Regulation 2008 (Regulation).  

From 30 September 2019, the NSW authority reference number does not need to be shown on a prescription for a S8 cannabis medicines or other unregistered S8 medicines, unless the medicine is extemporaneously compounded.

Prescriptions for a S8 medicine issued prior to 30 September 2019, with a NSW authority reference number shown on the prescription, remain valid for six months from the date of prescribing, unless cancelled.

Under the amended Regulation, only a Therapeutic Goods Administration (TGA) issued approval will be required in most cases, as the additional NSW authority will only be needed in limited circumstances.

Prescribers will require a NSW authority when prescribing for or supplying a S8 cannabis medicine:

• to a drug dependent person*, or
• for a clinical trial (if it is an unregistered cannabis medicine), or
• to a child (aged under 16 years), or
• when extemporaneously compounded.

* A drug dependent person means a person who has acquired, as a result of repeated administration of any of the following drugs, an overpowering desire for the continued administration of a drug of addiction (Schedule 8), or a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 (including but not limited to heroin, methylamphetamine or cocaine). A person treated under the Opioid Treatment Program is a drug dependent person.

A pharmacist must ensure Schedule 8 medicines including those requiring refrigeration are stored compliant with the Regulation.

Further details on the Regulation change and application requirements can be found on the NSW Health website. 

If you would like to provide feedback or make a complaint about our administrative and business processes, email us at mail@pharmacycouncil.nsw.gov.au