TGA Reclassification of Psilocybin and MDMA: Implications for Prescribing in Psychiatry

Treatment options for mental health conditions resistant to treatment are currently limited.

The most recent clinical evidence suggests that psilocybin and methylenedioxy-methamphetamine (MDMA) may yield therapeutic benefits for treatment-resistant depression and PTSD within controlled clinical settings.  

From 1 July 2023, psychiatrists will be given specialist authorisation under the Therapeutic Goods Administration (TGA) to prescribe psilocybin for treatment-resistant depression and MDMA for post-traumatic stress disorder.  

Both drugs will be listed as schedule 8 (controlled) drugs in the Poisons Standard for these specific uses. However, the ‘Schedule 9 (prohibited substances) rule will be applied for other uses, restricted only to clinical trials.  

Psychiatrists will need approval under the TGA’s ‘Authorised Prescribers Scheme,’ which includes the scrutiny of a human research ethics committee.  

Products containing psilocybin or MDMA have not yet been evaluated for their quality, safety and efficacy. Still, it is recognised that this TGA amendment will allow psychiatrists to treat patients likely to benefit from their therapeutic effects legally. 

Further information. 

Further reading: 

Therapeutic Mechanisms of Psilocybin in Psychiatric Disorders

Psychedelics and Hallucinogens in Psychiatry – Mechanisms of Action and Clinical Application

Will Psychedelics and Hallucinogens Revolutionise Psychiatry? – Conversations with Prof David Nutt

Psychedelic Therapy – A Beginner’s Guide – Highlights from RCPsychIC 2019