Re-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answers

Psilocybin and MDMA are currently included in Schedule 9 (Prohibited Substances) of the Poisons Standard.

Final decisions have been made to amend the current Poisons Standard in relation to psilocybin and MDMA. The amendments are to:

• add psilocybin and MDMA to Schedule 8, permitting their use as Controlled Drugs only for treatment resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively
• add entries in Appendix D to restrict access to the substances under Schedule 8 as follows:
  • they can only be prescribed for the above conditions by specialist psychiatrists who have obtained approval to use the substances for treating these conditions from a human research ethics committee (HREC), and then been authorised by the TGA under the Authorised Prescriber Scheme to prescribe the substances for these conditions
  • they can also be used in clinical trials into these conditions (they are currently only accessible for clinical trials as Schedule 9 substances)
  • the possession of the substances as Schedule 8 drugs without authority will be illegal (for example, possession other than in accordance with a legal prescription).
• change the entry in Schedule 9 to retain the current access restrictions for all other uses of psilocybin and MDMA as prohibited substances.

The changes to the scheduling of psilocybin and MDMA in the Poisons Standard will take effect on 1 July 2023.

This will occur through an update to the current Poisons Standard on the Federal Register of Legislation in June 2023.

Only specialist psychiatrists who:

• are registered under state or territory legislation that forms part of the Health Practitioner Regulation National Law
• have obtained approval to use the substances for treating these conditions from a human research ethics committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC), and then
• have sought and obtained authorisation by the TGA under the Authorised Prescriber Scheme (the AP scheme) to prescribe these substances for patients under their care. Authorisation can only be provided to prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.

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 Authorised Prescriber scheme allows authorised medical practitioners to supply therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) to specified patients under their immediate care with a particular medical condition.

Before being authorised by the TGA under this scheme, psychiatrists must obtain approval for the use of the substances for patients under their care by a human research ethics committee (HREC) that is registered by the National Health and Medical Research Council (NHMRC).

Approval by a HREC and authorisation by the TGA will ensure that sufficient measures are in place to protect patients. These can include robust patient selection and evidence-based treatment protocols, patient monitoring, practitioner training and governance requirements, and reporting. These measures are necessary because there is only limited evidence that the substances are of benefit in treating mental illnesses, and only in controlled medical settings. In addition, patients may be vulnerable during psychedelic-assisted psychotherapy because of their altered state of consciousness.

The AP scheme is a separate access pathway to the Special Access Scheme for accessing unapproved therapeutic goods. It was decided to not permit access to psilocybin and MDMA as Schedule 8 drugs under the Special Access Scheme at this time. This is because oversight of psychiatrist prescribing of these substances and treatment protocols by an HREC are considered necessary to ensure the safety of patients being treated for substances for which there is limited evidence of benefit.

The decision maker recognised there is a need for access to new therapies for treatment-resistant conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Psychotherapy involving psilocybin and MDMA has shown to be potentially beneficial in the treatment of these conditions.

However, as with all medicines, there are risks with psilocybin and MDMA. Although these substances are themselves relatively safe when administered in the doses used in conjunction with psychotherapy and in a medically controlled environment, patients are in an altered state of consciousness when undergoing psychedelic-assisted psychotherapy.

It was decided that by limiting prescribing to authorised psychiatrists and for TRD or PTSD the benefits for patients and public health will be greater than the risks.

The decisions were made by a senior medical officer at the TGA who has been delegated by the Secretary of the Department of Health and Aged Care to exercise their authority to make decisions about the scheduling of medicines in the Poisons Standard.

The decisions were not made by the Minister for Health and Aged Care, or Government.

The Delegate made their decision based on the matters they are required to consider under the Therapeutic Goods Act 1989.

These matters include the risks and benefits of the use of a substance, the purposes for which a substance is to be used, the substance's toxicity, and any potential for abuse. The Delegate must also comply with the Scheduling Policy Framework. The Delegate also considered the report of the Independent Expert Panel on MDMA and psilocybin, the advice of the Advisory Committee on Medicine Scheduling (ACMS) and the submissions received from individuals and organisations representing healthcare professionals, industry and consumers from two rounds of public consultation.

The decisions were made because the benefits for some patients from treatment with psilocybin or MDMA under the supervision of an authorised psychiatrist will outweigh the risks.

There are currently no products containing psilocybin or MDMA included in the Australian Register of Therapeutic Goods (ARTG) that have been evaluated by the TGA for safety, quality and efficacy. However, there is now sufficient evidence that psilocybin and MDMA will potentially be effective in the treatment of treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively, for certain patients. In particular, clinical trials have shown promise when they are used in combination with psychotherapy conducted in strictly controlled medical settings.

Psilocybin and MDMA are relatively safe when used in a medically controlled setting under the supervision of appropriately trained healthcare professionals and in the dosages that have been studied in clinical trials. However, patients may be vulnerable during psychedelic-assisted psychotherapy. For this reason, the Delegate decided that prescribing should be limited to psychiatrists who have been authorised under the Authorised Prescriber scheme and able to satisfy both a human research ethics committee and the TGA that robust protocols are in place to ensure the safety of patients.

Prior to making their final decisions, the Delegate made interim decisions in December 2022 to make no changes to the scheduling of psilocybin and MDMA in the Poisons Standard.

The Delegate changed their decisions because they were satisfied that sufficient controls on access to the substances as Schedule 8 drugs could be included in the Poisons Standard to ensure the benefits to patients and public health would outweigh the risks. These controls are more restrictive than what was proposed in the application to the TGA to change the scheduling of these substances but are consistent with the clinical evidence supporting the therapeutic use of the substances.

The Delegate decided to limit prescribing of psilocybin and MDMA as a Schedule 8 drug to treatment-resistant depression and post-traumatic stress disorder. This is because there is only sufficient evidence that the substances will be beneficial for these conditions.

If sufficient new evidence emerges that these substances will be beneficial in treating other conditions, the TGA can consider applications to make further amendments to the Poisons Standard to expand prescribing of psilocybin and MDMA for other conditions.

Until this time, access to psilocybin and MDMA other than for the treatment of TRD and PTSD, respectively, will continue to be captured by the existing Schedule 9 entries for the substances in the Poisons Standard. Schedule 9 is for substances that should generally be used only for medical and scientific research, including clinical trials.

The Poisons Standard is implemented by states and territories. State and territory governments decide whether to give effect to the recommended controls in the Poisons Standard through state and territory legislation or to decide to depart from the standard.

When the Poisons Standard is amended to include a substance in Schedule 8, the substance is then generally recognised by default as being in Schedule 8 under state and territory legislation. However, states and territories may not adopt amendments to the Poisons Standard in their entirety.

Furthermore, in some states and territories, it may be an offence to supply, use or possess psilocybin and MDMA due to their classification in state and territory legislation as drugs of dependence, dangerous drugs or prohibited drugs, even when they are in Schedule 8 of the Poisons Standard. It is a matter for states and territories to decide if and when to make any changes to offences under their legislation relating to accessing psilocybin and MDMA as Schedule 8 substances.

No. Both medicines are classified as Prescription Only Medicines which cannot be advertised to the public. Promoting the use or supply of these medicines, through any channel, is prohibited.

No prohibited or restricted representations have been authorised by the TGA in relation to these medicines.

Where non-compliant advertising of prescription medicines is conducted, including for example by influencers or a health service, the TGA will investigate.

Contraventions of the advertising laws set out by the Therapeutic Goods Act 1989 can result in criminal penalties of up to $1.1 million or imprisonment for individuals or $5.5 million for corporations, or civil penalties of up to $1.375 million for individuals or $13.75 million for corporations.

Psilocybin and MDMA are psychedelic substances that show promise in the treatment of treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively, in patients for whom other therapies have been ineffective. The evidence shows that there may be benefit when used in combination with psychotherapy under a strictly controlled treatment protocol.

From 1 July 2023, the Poisons Standard will allow certain patients to obtain a prescription for psilocybin or MDMA as Schedule 8 drugs. These prescriptions can only be from a specialist psychiatrist who has obtained specific authorisation under the Authorised Prescriber scheme from the TGA to prescribe these substances for patients under their care.

Under this authorisation, the substances will only be permitted to be administered to patients in a controlled medical setting, for example in combination with psychotherapy by appropriately qualified and trained healthcare professionals. The TGA will also expect that the psychiatrist first considers treatment with medications included on the Australian Register of Therapeutic Goods (ARTG) before prescribing psilocybin or MDMA. The psychiatrist will also be required to comply with any state and territory laws around access to these substances.

Your regular General Practitioner can advise and refer you to a suitable psychiatrist if they consider that psilocybin or MDMA may be an appropriate treatment option for you.

You may also be able to participate in a clinical trial of psilocybin or MDMA. More information about how to be part of a clinical trial is available here. 

Note that if you do not have a prescription, the Poisons Standard makes it illegal to possess these substances as Schedule 8 drugs. It may also be illegal to use or possess the substances as Schedule 9 (Prohibited substances) depending on state and territory law.

There are currently no TGA-approved products containing psilocybin or MDMA on the Australian Register of Therapeutic Goods (ARTG) that the TGA has evaluated for quality, safety and efficacy. However, authorised psychiatrists will be able to access and legally supply specified ’unapproved’ therapeutic products containing psilocybin or MDMA to patients under their care for these specific uses if all other clinically appropriate treatment options on the ARTG have been considered. There may be products containing these substances that can be imported. To import therapeutic goods that contain a controlled substance, a licence and/or permit to import from the Office of Drug Control is required. Alternatively, dosage forms may be able to be compounded within Australia by a pharmacist.

All medicines carry risks and specialist prescribers, such as registered psychiatrists are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding.

Adverse effects of psilocybin can include temporary increase in blood pressure and a raised heart rate. There may be some risk of psychosis in predisposed individuals. Adverse effects of MDMA include high blood pressure and pulse rate, faintness and panic attacks, and in some rare cases it can cause loss of consciousness and trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, detachment from one’s own mind or body, disorganised thoughts, restless legs, nausea, fever, headache, sweating and muscle/joint stiffness. These effects of psilocybin and MDMA are unlikely at low doses and in the treatment regimens used in psychedelic-assisted psychotherapy and appropriately managed in a controlled environment with direct medical supervision.

Before a psychiatrist can prescribe MDMA or psilocybin for their patients following rescheduling of the substances on 1 July 2023, they must obtain authorisation to do so from a human research ethics committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC) and from the TGA to become an Authorised Prescriber of the substances. A permit to import psilocybin or MDMA may also be required from the Office of Drug Control (ODC).

If you are a registered psychiatrist with approval as an Authorised Prescriber, you will be permitted to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for the treatment-resistant depression (TRD). This will be permitted when other clinically appropriate treatment options have been considered or were unsuccessful and you have decided they are an appropriate and suitable treatment for your patient. Psychiatrists should consider and discuss with their patients the suitability of treatment options that are included on the Australian Register of Therapeutic Goods (ARTG) before seeking to prescribe psilocybin or MDMA to them under the AP scheme.

To become an Authorised Prescriber, approval must be granted by both a Human Research Ethics Committee (HREC) and then the 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.

For further information about the AP scheme, see Authorised Prescriber Scheme.

The Authorised Prescriber scheme will allow authorisation to be given to prescribe psilocybin and MDMA only if a psychiatrist has an approval from a human research ethics committee and can demonstrate that robust protocols have been established to ensure the safety and efficacy of the treatments.

More information about the requirements for an application to become an Authorised Prescriber of psilocybin and MDMA will be provided before the expected implementation date of 1 July 2023.

Both a licence and a permit to import are required for psilocybin and MDMA. Once the import licence is in place, an application to obtain an import permit may be submitted for each shipment of a substance that are intended to be imported. More information on access to substances that are prohibited imports can be obtained through the Office of Drug Control (ODC) Licences and permits page.

As prescribing psilocybin or MDMA products is only permitted under the Authorised Prescriber scheme, any application to the ODC for an import permit should not be submitted in relation to the Special Access Scheme.

Advertising of health services is not regulated by the TGA. The TGA regulates the advertising of therapeutic products. However, caution is advised when preparing advertising content for health services so as to ensure that the use of a Prescription Only Medicine is not promoted.

Where non-compliant advertising of Prescription Only Medicines is conducted, even by a health service, the TGA will investigate.

Contraventions of the advertising laws set out by the Therapeutic Goods Act 1989 can result in criminal penalties of up to $1.1 million or imprisonment for individuals or $5.5 million for corporations, or civil penalties of up to $1.375 million for individuals or $13.75 million for corporations.