As of 1 July 2023, Schedule 8 of the Poisons Standard includes:
There are currently no psilocybine or MDMA products registered on the Australian Register of Therapeutic Goods.
More information on the rescheduling decision can be found on the TGA website.
Only psychiatrists authorised under the Authorised Prescriber scheme are permitted to prescribe psilocybine or MDMA in NSW.
Psilocybine is a psychedelic substance derived from a type of mushroom and MDMA is a synthetic psychedelic substance. There is emerging evidence for the controlled use of psilocybine in the treatment of treatment resistant depression (TRD) and MDMA in the treatment of post-traumatic stress disorder (PTSD).
There are currently no registered psilocybine or MDMA products. Unregistered products have not been assessed for quality, safety or efficacy by the Therapeutic Goods Administration (TGA). Access to Schedule 8 psilocybine or MDMA is limited to the treatment of TRD and PTSD respectively, by authorised registered psychiatrists. Registered psychiatrists are best placed to prescribe these substances given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions with therapies for which evidence of efficacy is not well established.
The use of psilocybine and MDMA to treat conditions other than TRD and PTSD respectively remains experimental and hence limited to medical and scientific research, including clinical trials.
There are currently no TGA-approved products containing psilocybine or MDMA on the Australian Register of Therapeutic Goods (ARTG) that the TGA has evaluated for quality, safety and efficacy. However, a registered psychiatrist approved as an Authorised Prescriber will be able to access and legally supply an unregistered therapeutic product containing psilocybine or MDMA to patients under their care for specific uses if all other clinically appropriate treatment options on the ARTG have been considered. Specific uses include psilocybine for treating treatment resistant depression and MDMA for treating post-traumatic stress disorder. Access to psilocybine or MDMA outside these conditions and uses is only permitted under medical and scientific research, including participating in clinical trials as a Schedule 9 substance. More information is available at Clinical trial schemes.
To become an Authorised Prescriber, approval must be granted by a Human Research Ethics Committee (HREC) and then by the Therapeutic Goods Administration (TGA). A senior medical officer at the TGA in their capacity as a delegate of the Secretary of the Department of Health and Aged Care, will review applications and grant approvals under the Authorised Prescriber scheme. For further details on how to apply for authorisation under the Authorised Prescriber Scheme, see Authorised Prescriber Scheme.
Authorised prescribers are required to apply for an approval to prescribe and supply in NSW.
In NSW psilocybine and MDMA are Type A drugs of addiction. Only a medical practitioner may prescribe or supply Type A drugs of addiction, and only with an authority under section 29 of the Poisons and Therapeutic Goods Act 1966 (NSW authority). To apply for a NSW approval, psychiatrists authorised under the Authorised Prescriber scheme need to complete the following Application for Approval to Prescribe or Supply Psilocybine or MDMA.
Once all authorisations are obtained, unapproved products containing psilocybine or MDMA may be available to be imported. To import therapeutic goods that contain a Schedule 8 product the Authorised Prescriber, or a person acting on their behalf, will require to apply to the Office of Drug Control for a license and permit to import.
For further information please visit the TGA website.
Treatment with psilocybine and MDMA in NSW must be administered in an appropriately supervised healthcare setting with good clinical governance practices, established administration and patient monitoring procedures and protocols. This includes the ability to manage any behavioural and/or medical emergencies.
The NSW Ministry of Health requires that the applicant submits treatment and adverse event data using the Data collection form at 3, 6 and 12 months following treatment.
The treatment will be prescribed and delivered in accordance with the Authorised Prescriber approval, TGA Guidelines and any RANZCP guidance including the Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybine for treatment resistant depression.
From 1 July 2023, certain psychiatrists will be able to access psilocybine or MDMA to treat specific mental health conditions that other medicines or therapies have been unable to treat.
The Therapeutic Goods Administration (TGA) will permit authorised psychiatrists to use psilocybine to treat depression that is resistant to other treatments and MDMA to treat post-traumatic stress disorder. There are no other approved uses for these two substances.
To help keep patients safe there are strict rules in place which determine who can use these substances and where they can be used.
Only certain psychiatrists, registered under Australian law, will be able to apply for approval to prescribe psilocybine and MDMA. These psychiatrists will have permission from a human research ethics committee who will make sure a treatment protocol will be used that is right for the patient and has the required safety measures in place. The psychiatrist will also have authorisation from the TGA and NSW Health before they can obtain and administer these substances to their patients.
Patients will not be given a prescription for psilocybine or MDMA as the substance will be available at the place of treatment. The treatment will occur in an appropriate healthcare setting, under the supervision of the approved psychiatrist who will remain present throughout the treatment session. Other appropriately qualified and trained health professionals such as psychologists and a medical practitioner may be present to assist with the therapy. Patients will not be able to use the medicine without the supervision of their psychiatrist and will not be able to take the medicine with them or access it outside this health setting.
Your regular General Practitioner can advise and refer you to a suitable psychiatrist if they consider that psilocybine or MDMA may be an appropriate treatment option for you.
You may also be able to participate in a clinical trial of psilocybine or MDMA. More information about how to be part of a clinical trial is available at Australian Clinical Trials.
