An approval under the Poisons and Therapeutic Goods Act 1966 (NSW) from the NSW 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 NSW 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 (NSW) is a person who has acquired, as a result of repeated administration of:
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.
-
Hydromorphone.
- 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 NSW 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).
