Regulation of MDMA and Psilocybine

Overview of regulations relating to MDMA and psilocybine

Last updated

25 July 2023

From 1 July 2023 MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine, as preparations, are listed under Schedule 8 of the Poisons Standard for use in the treatment of certain mental health conditions. This change allows specifically authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybine for treatment-resistant depression from 1 July 2023.

The decision to reschedule MDMA and psilocybine, acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses and comes following applications made to the Therapeutic Goods Administration (TGA) to reclassify the substances within the Poisons Standard, extensive public consultation and a report from an independent expert panel which evaluated the therapeutic value, benefits, and risks of both MDMA and psilocybine for the treatment of relevant conditions.

Within Australia we, the Office of Drug Control (ODC), regulate the import and export of psychotropic substances under the Convention on Psychotropic Substances of 1971. State and territory governments also regulate psychotropic substances, such as MDMA and psilocybine, under their poisons legislation.

We also report on quantities of MDMA and psilocybine manufactured, sold, used and held in stock, to meet Australia’s obligations under the international drug conventions.

Manufacture of MDMA and Psilocybine

With the change to the scheduling of MDMA and psilocybine there is increased interest in domestic manufacture.

It should be noted however that the scheduling change applies to final preparations, so the raw material or active pharmaceutical ingredient (API) remains classified as Schedule 9 (Prohibited Drugs) in the Poisons Standard. Subject to each state and territory, the controls over manufacture and supply of these drugs (not in the final preparation form) may vary between jurisdictions and could be prohibited in some cases.

Under Commonwealth law, we do not have the power to grant permission to manufacture (synthesise) MDMA, cultivate psilocybine-containing mushrooms, or manufacture (synthesise) psilocybine in Australia.

Regulation of manufacture may be the responsibility of states and territories, however since most of the manufacturing and supply chain is classified as schedule 9 (Prohibited Drugs) the jurisdiction may only have limited powers in specific circumstances (e.g. research).

The TGA does have powers to licence the manufacture of MDMA and psilocybine as therapeutic goods under a GMP (Good Manufacturing Practice) Licence.

We will endeavour to assist in responding to enquiries on manufacture, however you should check with your state or territory Health Department for advice on whether they have the legal powers to grant permission to manufacture in your jurisdiction.

The regulation of MDMA and psilocybine may change in the future so you should monitor for any updates on our website.

To learn more about our role see our About us page.

Access to MDMA or Psilocybine

How to obtain MDMA or psilocybine for use in a clinical trial or for prescription by an Authorised Prescriber

MDMA and psilocybine may be used in Australia for research and restricted medical purposes. Therapeutic goods supplied in clinical trials conducted in Australia are regulated by the TGA. Clinical trials are also subject to various regulatory controls including the Good Clinical Practice (GCP) Inspection Program to ensure the safety of participants. For more information regarding what is needed to undergo a clinical trial please see the Clinical trials page on the TGA website.

All psychiatrists who wish to prescribe MDMA for the treatment of post-traumatic stress disorder or psilocybine for treatment-resistant depression must be approved under the Authorised Prescriber (AP) Scheme by the TGA following the approval of a human research ethics committee. This allows for the prescription of these psychotropic substances under strict controls that ensure the safety of patients whilst allowing those in need to have access to essential medications.

For more information, please see the Access to MDMA and psilocybin for therapeutic purposes page on the TGA website.

Importation

The importation of MDMA and psilocybine is prohibited unless the importer holds a licence and permit issued by the ODC. A permit to import is required for each specific consignment of goods entering Australia and cannot be used for multiple shipments.

Authorised Prescribers can apply to import MDMA and psilocybine directly, by completing the Special Access Scheme/AP import application available on our website.

We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.

Pharmacists
Depending on state and territory requirements, pharmacies may be able to import MDMA or psilocybine on behalf of Authorised Prescribers by completing the Special Access Scheme/AP import application available on our website.

Pharmacists must provide details of the AP who will be prescribing the imported goods. We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.

Wholesalers
Depending on state and territory requirements, wholesalers may be able to import MDMA or psilocybine on behalf of AP’s through a licence and permit application.

Wholesalers must provide details of the AP who will be prescribing the imported goods and confirm where the drugs will be held until dispensed. Wholesalers of MDMA and psilocybine in these circumstances can only supply the drugs in relation to the AP’s provided in their applications.

We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.

Licence application

Find out how to Apply for a licence to import narcotic and psychotropic drugs and precursor substances.

Permit application

Find out how to Apply for a permit to import narcotic and psychotropic substances to Australia.

Import licence applications must be accompanied by the requisite Schedule 8 and Schedule 9 (if applicable) approval from the state/territory Health Department in the relevant jurisdiction.

Clinical Trials involving MDMA and psilocybine require a separate import licence and permit.

Licence application

Find out how to Apply for a licence to import narcotic and psychotropic drugs and precursor substances.

Permit application

Find out how to Apply for a permit to import narcotic and psychotropic substances to Australia.

Import licence applications must be accompanied by the requisite Schedule 8 and and Schedule 9 (if applicable) approval from the state/territory Health Department in your jurisdiction.

Reporting

The ODC, on behalf of Australia, is responsible for ensuring Australia meets all international reporting obligations under the three international drug conventions: the Single Convention on Narcotic Drugs of 1961; the Convention on Psychotropic Substances of 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.

As part of this, we are required to provide information to the International Narcotics Control Board (INCB) regarding the manufacture, cultivation, and production of internationally controlled substances, including MDMA and psilocybine.

Please contact us for advice on reporting obligations at ncs@health.gov.au