Pharmacist-Compounded and Other Unregistered Schedule 8 Medicines

From 1 August 2016, prior written authority from the Secretary of NSW Health is now required to prescribe or compound any unregistered S8 medicine i.e. any product other than a TGA-registered medicine (i.e. those labelled with an AUST R number. Compounding a registered medicine into another form, e.g. from tablets into a mixture, makes it an unregistered medicine.) Application for authority should be by a relevant medical specialist, and must include the rationale for the treatment and evidence to support it. A pharmacist can compound and dispense such a medicine only on receipt of an original written prescription including the NSW Health authority number issued to the prescriber.

Cannabis products for therapeutic use

The Poisons and Therapeutic Goods Regulation is amended effective 1 August 2016. Previously most cannabis products could be supplied only in clinical trials. Now doctors are able to apply for NSW Health authority to prescribe/supply a product, naturally derived from Cannabis, in other circumstances. The prescriber (expected to be a specialist in the management of patients with the disease being treated) must also be approved by the Commonwealth Department of Health to import and/or supply that particular product under the Commonwealth’s Special Access Scheme Category B or “Authorised Prescriber” schemes. The authority will specify the pharmacy or place where the medicine will be supplied. Prescribing, dispensing, recording, storage, supply and destruction must generally comply with the requirements for schedule 8 medicines.

The Schedule 8 synthetic cannabinoids nabilone and dronabinol, although not registered products in Australia, may similarly currently be prescribed only if the prescriber (expected to be a specialist in the management of patients with the disease being treated) is authorised  by NSW Health.

More information 


New authority reference number

NSW Health has implemented a new authority software system. In the new system the NSW Health prescribing authority number (a six digit –month - year reference number) has been replaced by a unique number prefixed with AU.
The new authority numbers are in the format AU56234.
The requirement for an authority reference number to appear on prescriptions applies to prescribing of dexamfetamine, lisdexamfetamine and methylphenidate where the prescriber is not generally authorised (ie approved psychiatrists and paediatricians practitioners issued with a CNS or s28c number) and Schedule 8 compounded medicines.
However where the prescriber is generally authorised, an additional authority number is not required for compounded dexamfetamine, lisdexamfetamine and methylphenidate.

Improved access to naloxone injection

To reduce deaths by opioid overdose, clients who attend drug and alcohol clinics and needle and syringe clinics in St Vincent’s Health Network and five Local Health Districts will have access to a take home naloxone injection kit.
This is in addition to access to naloxone injections on prescription by a doctor or by consulting with a community pharmacist.
Three hundred credentialled health workers have been trained to provide the kits and a brief intervention to clients on managing opioid overdose in the community as part of the Overdose Response and Take Home Naloxone project, led by Professor Nick Lintzeris and funded by a NSW Health Translational Research Grant.
Page Updated: Monday 13 November 2017