{"id":"F2024L01037","name":"Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024","slug":"therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442526,"registerId":"F2024L01037-fast-fetch-1775957507265","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024\n\nI, Tracey Duffy, as delegate of the Minster for Health and Aged Care make the following Order.\n\nDated 19 August 2024\n\nTracey Duffy\n\nFirst Assistant Secretary  Medical Devices and Product Quality Division  Health Products Regulation Group  Department of Health and Aged Care\n\n \n\n \n\n \n\nContents\n\nPart 1Preliminary\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Standard\n\n6  Application\n\nPart 2Requirements for plant derived psilocybine\n\n7  Application of this Part\n\n8  Assay limits\n\n9  Identification\n\n10  Tests\n\nPart 3Requirements for plant derived psilocybine products\n\n11  Application of this Part\n\n12  General\n\n13  Assay limits\n\n14  Tests\n\nPart 4Requirements for synthetic psilocybine\n\n15  Application of this Part\n\n16  Assay limits\n\n17  Tests\n\nPart 5Requirements for synthetic psilocybine products\n\n18  Application of this Part\n\n19  General\n\n20  Assay limits\n\n21  Elemental impurities\n\n22  Tests\n\nPart 6Labelling requirements\n\n23  Application of this Part\n\n24  Information to be included on the label\n\nSchedule 1—Specified tests for plant derived psilocybine\n\nPart 1—Psilocybine extract\n\nPart 2—Psilocybine isolate\n\nSchedule 2—Specified tests for plant derived psilocybine products\n\nPart 1—Psilocybine extract product\n\nPart 2—Psilocybine isolate product\n\nSchedule 3—Specified tests for synthetic psilocybine\n\nSchedule 4—Specified tests for synthetic psilocybine products\n\nPart 1Preliminary\n\n1  Name\n\n (1) This instrument is the Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024.\n\n (2) This instrument may also be cited as TGO 113.\n\n2  Commencement\n\n (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.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 6 January 2025. 6 January 2025\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) batch;\n\n(b) container;\n\n(c) European Pharmacopoeia;\n\n(d) label;\n\n(e) manufacture;\n\n(f) Secretary;\n\n(g) sponsor;\n\n(h) standard;\n\n(i) therapeutic goods;\n\n(j) United States Pharmacopeia-National Formulary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nactive ingredient has the same meaning as in the Regulations.\n\nbatch number means a number, or a combination of letters, numerals, or symbols, which is given by the manufacturer to a batch of synthetic psilocybine, plant derived psilocybine or a psilocybine product to uniquely identify that batch.\n\nNote: The batch number may be used to trace the batch through all stages of manufacture and distribution.\n\nbatch number prefix means the prefix which precedes the batch number, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the batch number.\n\nNote: Common forms of the batch number prefix include (either in capital letters, lower case letters, or a combination of capital and lower case letters):\n\n(a) Batch number;\n\n(b) Batch no.;\n\n(c) Batch;\n\n(d) B;\n\n(e) (B);\n\n(f) B/N;\n\n(g) Lot number;\n\n(h) Lot No.;\n\n(i) Lot.\n\ncapsule has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.\n\nNote: The Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.\n\ncontact details of the sponsor means information to enable a person to contact the sponsor that:\n\n (a) includes an address that is:\n\n (i) the sponsor’s physical address in Australia; and\n\n (ii) not a post office, cable, telegraphic or code address; and\n\n (b) may also include a telephone number, website or email address.\n\nexpiry date has the same meaning as in the Regulations.\n\nexpiry date prefix means the prefix which precedes the expiry date, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the expiry date (other than words indicating that the goods may be used after that date, including ‘Best by’ and ‘Best before’).\n\nNote: Common forms of the expiry date prefix include (either in capital letters, lower case letters, or a combination of capital and lower case letters):\n\n(a) Expiry date;\n\n(b) Expiry;\n\n(c) Expires;\n\n(d) Exp. Date;\n\n(e) Exp;\n\n(f) Use by;\n\n(g) Use before.\n\nICH Q3D guideline document means the ICH Harmonised Guideline: Guideline for Elemental Impurities Q3D, as in force from time to time.\n\nNote: The ICH Q3D Guideline is published by the International Council of Harmonisation at www.ich.org.\n\nmanufacturing licence has the same meaning as in subsection 38(1B) of the Act.\n\nPh Eur means the European Pharmacopoeia.\n\nplant derived psilocybine means the following substances:\n\n (a) psilocybine extract;\n\n (b) psilocybine isolate.\n\nplant derived psilocybine product means a therapeutic good that is:\n\n (a) a psilocybine extract product; or\n\n (b) a psilocybine isolate product.\n\nplant material means the dried or fresh fruiting body of the psilocybine mushroom that has not been homogenised.\n\npsilocin means the substance with the chemical formula C12H16N2O.\n\npsilocybine means the substance with the chemical formula C12H17N2O4P.\n\npsilocybine extract means a substance that is extracted from the psilocybine mushroom and that:\n\n (a) contains psilocybine and psilocin; and\n\n (b) may contain other components, including tryptamines.\n\npsilocybine extract product means a therapeutic good that:\n\n (a) contains psilocybine extract as the active ingredient; and\n\n (b) is manufactured in a dosage form for human therapeutic use.\n\npsilocybine isolate means psilocybine that is isolated from the psilocybine mushroom.\n\npsilocybine isolate product means a therapeutic good that:\n\n (a) contains psilocybine isolate as the active ingredient; and\n\n (b) is manufactured in a dosage form for human therapeutic use.\n\npsilocybine mushroom means a mushroom, or part of a mushroom, of the species Psilocybe cubensis, including, but not limited to, the fruiting body or mycelium.\n\npsilocybine product means a therapeutic good that is:\n\n (a) a psilocybine extract product; or\n\n (b) a psilocybine isolate product; or\n\n (c) a synthetic psilocybine product.\n\nquantity of the psilocybine product means the stated number of units in the container.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nstated content means the amount or quantity of each substance that is stated on the label to be present in a psilocybine product.\n\nsynthetic psilocybine means psilocybine that is produced using precursor ingredients, rather than compounds obtained from the psilocybine mushroom.\n\nsynthetic psilocybine product means a therapeutic good that:\n\n (a) contains synthetic psilocybine as the active ingredient; and\n\n (b) is manufactured in a dosage form for human therapeutic use.\n\ntryptamines mean the group of monoamine alkaloids, excluding psilocybine and psilocin, derived from the amino acid tryptophan.\n\nUSP means the United States Pharmacopeia-National Formulary.\n\n5  Standard\n\n  The matters specified in this instrument constitute a standard for the following:\n\n (a) plant derived psilocybine;\n\n (b) plant derived psilocybine products;\n\n (c) synthetic psilocybine;\n\n (d) synthetic psilocybine products.\n\n6  Application\n\n (1) Subject to subsection (2) this instrument applies to:\n\n (a) plant derived psilocybine; and\n\n (b) plant derived psilocybine products; and\n\n (c) synthetic psilocybine; and\n\n (d) synthetic psilocybine products.\n\n (2) This instrument does not apply to:\n\n (a) therapeutic goods that are the subject of an approval under paragraph 19(1)(b) of the Act; or\n\n (b) therapeutic goods mentioned in item 1 of Schedule 5 to the Regulations; or\n\n (c) therapeutic goods mentioned in items 3, 4, 8, 10, 11 or 12 of Schedule 5A to the Regulations, subject to compliance with the conditions specified in those items.\n\n\n\n\nPart 2Requirements for plant derived psilocybine\n\n7  Application of this Part\n\n  This Part applies to plant derived psilocybine.\n\n8  Assay limits\n\n (1) The following assay limits apply in relation to psilocybine extract:\n\n (a) the purity of psilocybine in psilocybine extract must be not less than 90.0% and not more than 110.0%, calculated on a dried basis;\n\n (b) the purity of psilocin in psilocybine extract must be not less than 80.0% and not more than 120.0%, calculated on a dried basis;\n\n (c) the purity of any tryptamines in psilocybine extract must be not less than 80.0% and not more than 120.0%, calculated on a dried basis.\n\n (2) The following assay limits apply in relation to psilocybine isolate:\n\n (a) the purity of psilocybine in psilocybine isolate must be not less than 98.0% and not more than 102.0%, calculated on a dried basis;\n\n (b) any psilocin that is present in psilocybine isolate must be at a level that is not more than 2.0%, calculated on a dried basis.\n\n9  Identification\n\n  Psilocybine mushroom used in the manufacture of psilocybine extract or psilocybine isolate must be able to be positively identified using each of the following identification methods:\n\n (a) macroscopic examination;\n\n (b) microscopic examination;\n\n (c) chromatographic procedures.\n\n10  Tests\n\n  For each item in the tables in Parts 1 and 2 of Schedule 1, plant derived psilocybine must comply with the requirements specified in column 4 using the test method specified in column 3, in relation to the test specified in column 2.\n\n\n\n\nPart 3Requirements for plant derived psilocybine products\n\n11  Application of this Part\n\n  This Part applies to plant derived psilocybine products.\n\n12  General\n\n (1) Psilocybine extract or psilocybine isolate used in the manufacture of a plant derived psilocybine product must be obtained from the psilocybine mushroom.\n\n (2) A plant derived psilocybine product that is a psilocybine extract product must:\n\n (a) contain psilocybine extract as the only active ingredient; and\n\n (b) be manufactured in the dosage form of a capsule for oral administration.\n\n (3) A plant derived psilocybine product that is a psilocybine isolate product must:\n\n (a) contain psilocybine isolate as the only active ingredient; and\n\n (b) be manufactured in the dosage form of a capsule for oral administration.\n\n13  Assay limits\n\n (1) The following assay limits apply in relation to psilocybine extract products:\n\n (a) the average content of psilocybine in a pooled sample of not fewer than 20 capsules must be not less than 90.0% and not more than 110.0% of the stated content of psilocybine;\n\n (b) the average content of psilocin in a pooled sample of not fewer than 20 capsules must be not less 90.0% and not more than 110.0% of the stated content of psilocin;\n\n (c) the average content of any nominated tryptamines in a pooled sample of not fewer than 20 capsules must be not less than 90.0% and not more than 110.0% of the stated content of the nominated tryptamine.\n\n (2) The following assay limits apply in relation to a psilocybine isolate product:\n\n (a) the average content of psilocybine isolate in a pooled sample of not fewer than 20 capsules must be not less than 90.0% and not more than 110.0% of the stated content of psilocybine isolate.\n\n14  Tests\n\nPsilocybine extract products\n\n (1) Subject to subsection (2), for each item in the table in Part 1 of Schedule 2, a psilocybine extract product must comply with the requirements specified in column 4 using the test method specified in column 3, in relation to the test specified in column 2.\n\n (2) This section does not apply to an extemporaneously compounded psilocybine extract product where:\n\n (a) the psilocybine extract used in the manufacture of that product has been tested in accordance with the requirements specified in section 10 of this instrument; and\n\n (b) the testing was conducted at a site that is covered by a manufacturing licence granted by the Secretary under Part 3-3 of the Act.\n\nPsilocybine isolate products\n\n (3) Subject to subsection (4), for each item in the table in Part 2 of Schedule 2, a psilocybine isolate product must comply with the requirements specified in column 4 using the test method specified in column 3, in relation to the test specified in column 2.\n\n (4) This section does not apply to an extemporaneously compounded psilocybine isolate product where:\n\n (a) the psilocybine isolate product used in the manufacture of that product has been tested in accordance with the requirements specified in section 10 of this instrument; and\n\n (b) the testing was conducted at a site that is covered by a manufacturing licence granted by the Secretary under Part 3-3 of the Act.\n\n\n\n\nPart 4Requirements for synthetic psilocybine\n\n15  Application of this Part\n\n  This Part applies to synthetic psilocybine.\n\n16  Assay limits\n\n  The following assay limits apply in relation to synthetic psilocybine:\n\n (a) the purity of psilocybine in synthetic psilocybine must be not less than 98.0% and not more than 102.0%, calculated on a dried basis;\n\n (b) any psilocin that is present in synthetic psilocybine must be at a level that is not more than 2.0%, calculated on a dried basis.\n\n17  Tests\n\n  For each item in the table in Schedule 3, synthetic psilocybine must comply with the requirements specified in column 4 using the test method specified in column 3, in relation to the test specified in column 2.\n\n\n\n\nPart 5Requirements for synthetic psilocybine products\n\n18  Application of this Part\n\n  This Part applies to synthetic psilocybine products.\n\n19  General\n\n  A synthetic psilocybine product must:\n\n (a) contain synthetic psilocybine as the only active ingredient; and\n\n (b) be manufactured in the dosage form of a capsule for oral administration.\n\n20  Assay limits\n\n  The average content of synthetic psilocybine in a pooled sample of not fewer than 20 capsules must be not less than 90.0% and not more than 110.0% of the stated content of synthetic psilocybine.\n\n21  Elemental impurities\n\n  A synthetic psilocybine product must comply with the requirements for elemental impurities specified in the ICH Q3D guideline document.\n\n22  Tests\n\n (1) Subject to subsection (2), for each item in the table in Schedule 4, a synthetic psilocybine product must comply with the requirements specified in column 4 using the test method specified in column 3, in relation to the test specified in column 2.\n\n (2) This section does not apply to an extemporaneously compounded synthetic psilocybine product where:\n\n (a) the synthetic psilocybine used in the manufacture of that product was tested in accordance with the requirements specified in section 17 of this instrument; and\n\n (b) the testing was conducted at a site that is covered by a manufacturing licence granted by the Secretary under Part 3-3 of the Act.\n\n\n\n\nPart 6Labelling requirements\n\n23  Application of this Part\n\n  This Part applies to psilocybine products.\n\n24  Information to be included on the label\n\n (1) The label of a psilocybine product, other than a psilocybine product that is extemporaneously compounded by a pharmacist for a particular patient, must contain all of the following information:\n\n (a) the name of the psilocybine product;\n\n (b) the name of the active ingredient;\n\n (c) the quantity of the active ingredient in mg;\n\n (d) the dosage form;\n\n (e) the quantity of the psilocybine product;\n\n (f) the batch number, preceded by the batch number prefix;\n\n (g) the expiry date, preceded by the expiry date prefix;\n\n (h) the name of the sponsor;\n\n (i) the contact details of the sponsor;\n\n (j) the storage conditions applicable to the psilocybine product;\n\n (k) for a psilocybine extract product—all of the following:\n\n (i) the quantity of psilocybine in mg;\n\n (ii) the quantity of psilocin in mg;\n\n (iii) the quantity of each nominated tryptamine in mg (if any);\n\n (iv) the quantity of the psilocybine extract and the minimum dry weight or fresh weight of the plant material from which it was prepared, including the word “minimum”;\n\n (v) the words “Psilocybe cubensis”;\n\n (vi) the plant part;\n\n (vii) the preparation type.\n\n (2) All of the information that is required to be included on the label of a psilocybine product must be:\n\n (a) in English; and\n\n (b) legible, clearly visible and not obscured; and\n\n (c) durable.\n\n\n\n\nSchedule 1—Specified tests for plant derived psilocybine\n\nNote: See section 10.\n\nPart 1—Psilocybine extract\n\n \n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for aflatoxins Ph Eur 2.8.18 not more than 4 ppb for the sum of aflatoxins B1, B2, G1 and G2\n- 2 test for heavy metals Ph Eur 2.4.27 not more than the limits specified in the ICH Q3D guideline document\n- 3 test for pesticide residue Ph Eur 2.8.13 not more than the limits specified in Ph Eur 2.8.13\n- 4 test for purity of psilocin Ph Eur 2.2.29 not less than 80.0% and not more than 120.0%, calculated on a dried basis\n- 5 test for purity of psilocybine Ph Eur 2.2.29 not less than 90.0% and not more than 110.0%, calculated on a dried basis\n- 6 test for purity of any tryptamines Ph Eur 2.2.29 not less than 80.0% and not more than 120.0%, calculated on a dried basis\n- 7 test for residual solvents Ph Eur 2.4.24 not more than the limits specified in Ph Eur 5.4\n\n\nPart 2—Psilocybine isolate\n\n \n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for heavy metals Ph Eur 2.4.27 not more than the limits specified in the ICH Q3D guideline document\n- 2 test for impurities Ph Eur 2.2.29 all of the following:(a) for psilocin—not more than 2.0%;(b) for any other single impurity—not more than 0.5%;(c) not more than 2.0% total impurities\n- 3 test for purity of psilocybine Ph Eur 2.2.29 not less than 98.0% and not more than 102.0%, calculated on a dried basis\n- 4 test for residual solvents Ph Eur 2.4.24 not more than the limits specified in Ph Eur 5.4\n\n\n\n\n\nSchedule 2—Specified tests for plant derived psilocybine products\n\nNote: See section 14.\n\nPart 1—Psilocybine extract product\n\n \n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for average content of psilocin Ph Eur 2.2.29 not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules\n- 2 test for average content of psilocybine Ph Eur 2.2.29 not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules\n- 3 test for average content of nominated tryptamines Ph Eur 2.2.29 not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules\n- 4 test for disintegration either:(a) Ph Eur 2.9.1; or(b) USP Chapter 701 complete disintegration of the capsule must occur in a period of not more than 30 minutes\n- 5 test for related substances Ph Eur 2.2.29 not more than the limits specified in Ph Eur 5.10\n- 6 test for uniformity of dosage units either:(a) mass variation; or(b) content uniformity;as specified in Ph Eur 2.9.40 not more than the limits specified in Ph Eur 2.9.40\n\n\nPart 2—Psilocybine isolate product\n\n \n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for average content of psilocybine isolate Ph Eur 2.2.29 not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules\n- 2 test for disintegration either:(a) Ph Eur 2.9.1; or(b) USP Chapter 701 complete disintegration of the capsule must occur in a period of not more than 30 minutes\n- 3 test for related substances Ph Eur 2.2.29 not more than the limits specified in Ph Eur 5.10\n- 4 test for uniformity of dosage units either:(a) mass variation; or(b) content uniformity;as specified in Ph Eur 2.9.40 not more than the limits specified in Ph Eur 2.9.40\n\n\n\n\n\nSchedule 3—Specified tests for synthetic psilocybine\n\nNote: See section 17.\n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for heavy metals Ph Eur 2.4.20 not more than the limits specified in the ICH Q3D guideline document\n- 2 test for impurities Ph Eur 2.2.29 all of the following:(a) for psilocin—not more than 2.0%;(b) for any other single impurity—not more than 0.5%;(c) not more than 2.0% total impurities\n- 3 test for purity of psilocybine Ph Eur 2.2.29 not less than 98.0% and not more than 102.0%, calculated on a dried basis\n- 4 test for residual solvents Ph Eur 2.4.24 not more than the limits specified in Ph Eur 5.4\n\n\n\n\n\nSchedule 4—Specified tests for synthetic psilocybine products\n\nNote: See section 22.\n\n- Specified tests\n- Column 1 Column 2 Column 3 Column 4\n- Item Test Test method Requirement\n- 1 test for average content of synthetic psilocybine Ph Eur 2.2.29 not less than 90.0% and not more than 110.0% of the stated content in a pooled sample of not less than 20 capsules\n- 2 test for disintegration either:(a) Ph Eur 2.9.1; or(b) USP Chapter 701 complete disintegration of the capsule must occur in a period of not more than 30 minutes\n- 3 test for related substances Ph Eur 2.2.29 not more than the limits specified in Ph Eur 5.10\n- 4 test for residual solvents Ph Eur 2.4.24 not more than the limits specified in Ph Eur 5.4\n- 5 test for uniformity of dosage units either:(a) mass variation; or(b) content uniformity;as specified in Ph Eur 2.9.40 not more than the limits specified in Ph Eur 2.9.40\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"The instrument itself defines its scope (s5–6) to cover plant‑derived and synthetic psilocybine and their products, and lists specific exclusions (s6(2)). No prior instrument or differing original scope is supplied here, so no change from earlier scope can be determined from this text alone."},"complexity_factors":["Multiple product categories and definitions introducing different rules for plant‑derived extracts, isolates and synthetic material (Definitions; ss5–6; Parts 2–5).","Diverse assay limits and tolerances that vary by category (e.g. ss8(1)–(2), 16, 13(1)–(2), 20).","Extensive cross‑references to external pharmacopeial standards and international guidelines (Ph Eur, USP, ICH Q3D) required for tests and impurity/solvent limits (Schedules 1–4; s21).","Detailed specified tests with method and requirement columns in four schedules, including aflatoxins, heavy metals, residual solvents and related substances (Schedules 1–4; s10, s17, s22).","Sampling and statistical requirements (pooled samples of not fewer than 20 capsules for average content testing) add operational complexity for QC labs (ss13(1), 20; Schedules 2,4).","Exemptions for extemporaneously compounded products conditional on prior testing and existence of a manufacturing licence impose conditional compliance pathways (ss14(2), 14(4), 22(2); s12(1)–(3)).","Detailed labelling obligations requiring multiple specific elements (including plant origin info for extracts) increase sponsor paperwork and packaging controls (s24(1)(a)–(k)).","Regulatory interaction with the Secretary’s manufacturing licence regime and exclusions for approved or listed goods creates administrative dependencies (s6(2); s12(2)(b); s14(2)(b); s22(2)(b))."],"plain_english_summary":"This Order (TGO 113) prescribes mandatory quality, testing and labelling standards for plant‑derived and synthetic psilocybine and their capsule products, setting assay ranges, identification methods and specified pharmacopoeial tests. (See ss5–6, 7–22, Schedules 1–4.)\n\nIt applies to sponsors, manufacturers and testing laboratories: sponsors must include detailed label and content information, manufacturers and labs must meet assay limits and perform the listed tests, and limited exemptions apply for extemporaneous compounding when testing is done at a licensed manufacturing site. (See ss12,14,17,22,24.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"The legislation appears tightly scoped to its original purpose. It establishes manufacturing and quality standards for psilocybine as a therapeutic good, covering both natural and synthetic sources with appropriate distinctions. The four-part structure (plant raw material, plant product, synthetic raw material, synthetic product) reflects a logical categorisation rather than scope creep. Exemptions for approved therapeutic goods and certain scheduled items in section 6(2) are standard regulatory carve-outs consistent with the Therapeutic Goods Act framework, not expansions beyond the original intent."},"complexity_factors":["Parallel structure with four distinct regulatory pathways (plant extract, plant isolate, synthetic substance, synthetic product) creating near-mirror provisions across Parts 2–5","19 defined terms in section 4, including nested definitions (e.g., 'psilocybine product' encompasses three sub-categories, each with their own definitions)","Extensive cross-referencing to external standards: European Pharmacopoeia (Ph Eur), United States Pharmacopeia (USP), and ICH Q3D guideline document, which are 'as in force from time to time' (dynamic incorporation)","Conditional exemptions for 'extemporaneously compounded' products in sections 14 and 22, requiring satisfaction of two cumulative conditions (prior testing + licensed manufacturing site)","Detailed tabular schedules (4 schedules, 8 parts total) specifying 27 distinct test requirements with precise numerical thresholds","Specific labelling requirements in section 24 with 11 mandatory items, including 7 additional items specifically for extract products","Dual calculation methods ('dried basis' for raw materials vs. 'stated content' for finished products) requiring careful attention to context"],"plain_english_summary":"This legislation establishes Australia’s first pharmaceutical-quality and safety standards for psilocybine medicines—covering plant-derived and synthetic psilocybine and final oral-capsule products. It mandates strict purity, contaminant testing, product identification and labelling, and batch/expiry controls. It affects manufacturers, compounding pharmacists, sponsors and patients (notably those treated under authorised prescriber schemes), creating a regulatory baseline to ensure consistency, safety and transparency for this emerging therapeutic."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024","history":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024/history","analysis":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-psilocybine-tgo-113-order-2024/documents"}}