MDMA and psilocybine

From 1 July 2023, psychiatrists can be authorised to prescribe products containing 3,4-methylenedioxymethamphetamine (MDMA) and psilocybine as Schedule 8 medicines (Drugs of Dependence), for use in psychedelic assisted psychotherapy to treat certain mental health conditions.

MDMA may be prescribed for the treatment of post-traumatic stress disorder (PTSD), and psilocybine may be prescribed for treatment-resistant depression. For these specific uses, MDMA and psilocybine have been listed as Schedule 8 medicines in the Poisons Standard. MDMA and psilocybine both remain Schedule 9 Controlled Drugs (illicit) when used for other indications. This follows the Therapeutic Goods Administration’s (TGA) decision to downschedule the substances in the Poisons Standard.

To be able to prescribe MDMA or psilocybine for these conditions, a psychiatrist must be an Authorised Prescriber under the TGA’s Authorised Prescriber scheme. Before seeking approval to be an Authorised Prescriber, the psychiatrist must first obtain approval from a Human Research Ethics Committee (HREC).

Read through the TGA’s Re-scheduling of psilocybine and MDMA in the Poisons Standard: questions and answers, and Understanding the changes to MDMA and psilocybine access.

Information for prescribers and health professionals

Prescribing, supply and administration of Schedule 8 MDMA and psilocybine is subject to additional controls in South Australia. This is to ensure that the substances are only used in controlled medical settings, protecting the safety of patients receiving treatment.

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has developed Clinical Memorandums on the Therapeutic Use of Psychedelic Substances, and the Therapeutic Use of MDMA for PTSD and Psilocybine For Treatment Resistant Depression to provide information for psychiatrists about use of the substances.

There are currently no products containing MDMA or psilocybine registered on the Australian Register of Therapeutic Goods (ARTG) that the TGA has assessed for quality, safety or efficacy. Access to the substances is only through the TGA’s Authorised Prescriber Scheme.

Authorised psychiatrists will also require a permit to import MDMA and/or psilocybine from the Office of Drug Control (ODC).

Read through the TGA’s Access to MDMA and Psilocybine for Therapeutic Purposes – Information for Psychiatrist Prescribers and the MDMA and psilocybine hub for more information.

Legal Requirements in South Australia

The Controlled Substances Act 1984 regulates the prescribing and supply of medicines in South Australia, and applies to Schedule 8 MDMA and psilocybine products.

Under South Australia’s Controlled Substances (Poisons) Regulations 2011, MDMA and psilocybine may only be prescribed by registered psychiatrists who are an Authorised Prescriber under the TGA’s Authorised Prescriber Scheme. Read how to become an Authorised Prescriber of MDMA and/or psilocybine on the TGA’s website.

Authorised psychiatrists prescribing MDMA and psilocybine are required to notify the Chief Psychiatrist, SA Health, within one business day of prescribing.

Supply and administration of MDMA and psilocybine may only occur at an approved treatment centre or authorised community mental health facility as defined in the Mental Health Act 2009, or other facility as determined by the Minister. MDMA and psilocybine may only be supplied or administered to a person by the prescribing psychiatrist, and must be in accordance with the psychiatrist’s approved treatment protocol.

Patients will not be able to use the MDMA or psilocybine without the supervision of the authorised psychiatrist. This also means they will not be able to take the medicine home, or access it outside of the health facility.

Schedule 8 Requirements in South Australia

The requirements that apply to prescribers of Schedule 8 drugs of dependence in South Australia apply for Schedule 8 MDMA and psilocybine.

Prescribers must take all reasonable steps to check relevant information in ScriptCheckSA before prescribing or supplying MDMA and/or psilocybine to a patient, unless an exemption applies.

It is an offence to prescribe or supply Schedule 8 drugs of dependence for a patient’s regular use for a period exceeding two months (unless an exemption applies) or to a patient who is dependent on drugs, without an authority from the Drugs of Dependence Unit. Treatment provided by other prescribers must be considered when calculating the two-month period.

Further information on prescribing drugs of dependence and authorities is available.

Further information

MDMA and psilocybine hub
Therapeutic Goods Administration (TGA)
Web: MDMA and psilocybin hub

Authorised Prescriber Scheme
Therapeutic Goods Administration (TGA)
Phone: 1800 020 653
Email: info@tga.gov.au
Web: Prescribe an unapproved therapeutic good (health practitioners)

Medicines access and legislation in South Australia
Office of the Chief Pharmacist, SA Health
Email: Health.OfficeoftheChiefPharmacist@sa.gov.au

Prescribing notifications
Office of the Chief Psychiatrist, SA Health
Email: HealthOCP@sa.gov.au

Schedule 8 Prescribing Authorities and ScriptCheckSA
Drugs of Dependence Unit, SA Health
Email: HealthDrugsofDependenceUnit@sa.gov.au