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An approval under the Poisons and Therapeutic Goods Act 1966 (ºÚÁϳԹÏÍø)​​ from the ºÚÁϳԹÏÍø Ministry of Health is required by a medical practitioner or nurse​ practitioner to prescribe or supply a Schedule 8 medicine (drug of addiction) in the circumstances listed below.

Note: An 'approval' is a reference to an authority under the Poisons and Therapeutic Goods Act 1966. An approval issued to a prescriber by the ºÚÁϳԹÏÍø Ministry of Health is separate to the authority required from Services Australia for a patient to receive a Commonwealth PBS subsidised medicine. 

To apply for approval, refer to Application forms for approval to prescribe or supply​.  

Schedule 8 medicines that require approval to prescribe or supply

Any Schedule 8 medicine for a drug dependent person​

A drug dependent person defined under section 27 of the Poisons and Therapeutic Goods Act 1966 (ºÚÁϳԹÏÍø)​​​â¶Ä‹â€‹â¶Ä‹ is a person who has acquired, as a result of repeated administration of:

• a drug of addiction
• ​a prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985​​​

​an overpowering desire for the​ continued administration of such a drug.

Certain Schedule 8 medicines for continuous or ongoing treatment of more than two months

This applies to the following medicines:

• Schedule 8 medicines in a formulation for injection,​ inhalation, spray, or application to mucous membranes.  Note: Schedule 8 cannabis, nabiximols, or tetrahydrocannabinols (when listed in Schedule 8 of the Poisons Standard) are exempt from the requirement for approval.
  
• Alprazolam.
  
• Flunitrazepam.
  
• Buprenorphine (except for transdermal preparations).
  
• Methadone.
• Hydromorphon±ð​.
• Dextromoramide.
  

Psychostimulant medicines 

• Dexamfetamine.
  
• Lisdexamfetamine.
  
• Methylphenidate.
  

For more information, see Prescribe a psychostimulant medicine.

Note: Nurse practitioners are not authorised under the Poisons and Therapeutic Goods legislation to supply or prescribe psychostimulant medicines.

Unregistered Schedule 8 medicines that are extemporaneously compounded

This includes Schedule 8 medicines that are extemporaneously compounded for a particular person for therapeutic application to that person. 

For more information see Restrictions on unregistered Schedule 8 medicines including compounded medicines.

Note: Nurse practitioners are not authorised under the Poisons and Therapeutic Goods legislation to supply or prescribe unregistered Schedule 8 compounded medicines.

Psilocybine and MDMA

An approval from the ºÚÁϳԹÏÍø Ministry of Health is required for authorised prescribers to prescribe or supply Schedule 8:

• ​psilocybine for treatment-resistant depression 
  
• MDMA for the treatment of post-traumatic stress disorder (PTSD). 

Authorised prescribers are those with approval under the TGA Authorised Prescriber scheme​​. For more information,​ see Prescribe MDMA or psilocybine (psychiatrists)​​.