Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 (Cth)

Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024

I, Tracey Duffy, as delegate of the Minster for Health and Aged Care make the following Order.

Dated 19 August 2024

Tracey Duffy First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health and Aged Care

Contents Part 1Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions 5 Standard 6 Application Part 2Requirements for plant derived psilocybine 7 Application of this Part 8 Assay limits 9 Identification 10 Tests Part 3Requirements for plant derived psilocybine products 11 Application of this Part 12 General 13 Assay limits 14 Tests Part 4Requirements for synthetic psilocybine 15 Application of this Part 16 Assay limits 17 Tests Part 5Requirements for synthetic psilocybine products 18 Application of this Part 19 General 20 Assay limits 21 Elemental impurities 22 Tests Part 6Labelling requirements 23 Application of this Part 24 Information to be included on the label Schedule 1—Specified tests for plant derived psilocybine Part 1—Psilocybine extract Part 2—Psilocybine isolate Schedule 2—Specified tests for plant derived psilocybine products Part 1—Psilocybine extract product Part 2—Psilocybine isolate product Schedule 3—Specified tests for synthetic psilocybine Schedule 4—Specified tests for synthetic psilocybine products

Part 1Preliminary

1 Name (1) This instrument is the Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024. (2) This instrument may also be cited as TGO 113.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.