{"id":"F2024L01036","name":"Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024","slug":"therapeutic-goods-standard-for-mdma-tgo-112-order-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442528,"registerId":"F2024L01036-fast-fetch-1775957507268","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Standard for MDMA) (TGO 112) 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 MDMA) (TGO 112) Order 2024\n\nI, Tracey Duffy, as delegate of the Minister 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\nUSP means the United States Pharmacopeia-National Formulary.5  Standard\n\n6  Application\n\nPart 2Requirements for MDMA hydrochloride\n\n7  Application of this Part\n\n8  Assay limits\n\n9  Tests\n\nPart 3Requirements for MDMA hydrochloride products\n\n10  Application of this Part\n\n11  General\n\n12  Assay limits\n\n13  Tests\n\n14  Information to be included on the label\n\nSchedule 1—Specified tests for MDMA hydrochloride\n\nSchedule 2—Specified tests for MDMA hydrochloride products\n\n \n\nPart 1Preliminary\n\n1  Name\n\n (1) This instrument is the Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024.\n\n (2) This instrument may also be cited as TGO 112.\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 MDMA hydrochloride or a MDMA hydrochloride 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\nMDMA hydrochloride means the substance 3,4-methylenedioxy-N-methylamphetamine hydrochloride with the chemical formula C11H15NO2, HCl.\n\nMDMA hydrochloride product means a therapeutic good that:\n\n (a) contains MDMA hydrochloride as the active ingredient; and\n\n (b) is manufactured in a dosage form for human therapeutic use.\n\nPh Eur means the European Pharmacopoeia.\n\nquantity of the MDMA hydrochloride product means the stated number of units in the container.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nstated content means the quantity of each substance that is stated on the label to be present in a MDMA hydrochloride product.\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) MDMA hydrochloride; and\n\n (b) MDMA hydrochloride products.\n\n6  Application\n\n (1) Subject to subsection (2) this instrument applies to:\n\n (a) MDMA hydrochloride; and\n\n (b) MDMA hydrochloride 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 MDMA hydrochloride\n\n7  Application of this Part\n\n  This Part applies to MDMA hydrochloride.\n\n8  Assay limits\n\n  The following assay limits apply in relation to MDMA hydrochloride:\n\n (a) the purity of MDMA hydrochloride must be not less than 98.0% and not more than 102.0%, calculated on an anhydrous basis;\n\n (b) the purity of chloride present in MDMA hydrochloride must be not less than 15.3% and not more than 15.9%.\n\n9  Tests\n\n  For each item in the table in Schedule 1, MDMA hydrochloride 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 MDMA hydrochloride products\n\n10  Application of this Part\n\n  This Part applies to MDMA hydrochloride products.\n\n11  General\n\n  A MDMA hydrochloride product must:\n\n (a) contain MDMA hydrochloride as the only active ingredient; and\n\n (b) be manufactured in the dosage form of a capsule for oral administration.\n\n12  Assay limits\n\n  The average content of MDMA hydrochloride 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 MDMA hydrochloride.\n\n13  Tests\n\n (1) Subject to subsection (2), for each item in the table in Schedule 2, a MDMA hydrochloride 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 MDMA hydrochloride product where:\n\n (a) the MDMA hydrochloride used in the manufacture of that product was tested in accordance with the requirements specified in section 9 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\n14  Information to be included on the label\n\n (1) The label of a MDMA hydrochloride product, other than a MDMA hydrochloride 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 MDMA hydrochloride 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 MDMA hydrochloride 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 MDMA hydrochloride product.\n\n (2) All of the information that is required to be included on the label of a MDMA hydrochloride 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 MDMA hydrochloride\n\nNote: See section 9.\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 purity of chloride Ph Eur 2.2.29 not less than 15.3% and not more than 15.9%\n- 3 test for purity MDMA hydrochloride Ph Eur 2.2.29 not less than 98.0% and not more than 102.0%, calculated on an anhydrous basis\n- 4 test for related substances Ph Eur 2.2.29 not more than the limits specified in Ph Eur 5.10\n- 5 test for residual solvents Ph Eur 2.4.24 not more than the limits specified in Ph Eur 5.4\n- 6 test for water content Ph Eur 2.5.12 not more than 2.0%\n\n\n\n\n\nSchedule 2—Specified tests for MDMA hydrochloride products\n\nNote: See section 13.\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 MDMA hydrochloride 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":4,"scope_assessment":{"changed":false,"description":"The instrument defines its own scope: it applies to MDMA hydrochloride and MDMA hydrochloride products, with explicit exclusions for goods subject to certain Act approvals and specified items in Schedules 5 and 5A of the Regulations (see section 6(1)–(2)). No earlier instrument or baseline is provided in the source text, so a change from prior scope cannot be determined from this document alone."},"complexity_factors":["Direct reliance on external compendia and guidelines (Ph Eur, USP, ICH Q3D) for methods and limits, creating operational dependency on those texts (see Schedules and Definitions).","Multiple technical laboratory tests required (heavy metals, residual solvents, related substances, water content, disintegration, uniformity) that require analytical capability and accredited methods (Schedules 1–2, sections 9 and 13).","Precise numerical assay limits and sampling rules (e.g. 98.0–102.0% purity; pooled sample of ≥20 capsules for average content) create technical compliance thresholds (sections 8, 12; Schedule 2 item 1).","Label content and format obligations impose administrative and packaging changes for sponsors (section 14).","Exclusions and conditional exceptions (goods with approvals under s19(1)(b); items in Schedules 5 and 5A to the Regulations; extemporaneous compounding exception tied to manufacture‑licence testing sites) add scope nuance (section 6(2); section 13(2)).","Commencement timing fixed to a future date requires transitional readiness (section 2).","Interplay with existing Act and Regulations references (defined terms, manufacturing licence, sponsor, etc.) requires cross‑referencing other instruments for full compliance assessment (sections 3–6)."],"plain_english_summary":"This Order sets compulsory quality, testing and labelling rules for MDMA hydrochloride and MDMA hydrochloride products used as therapeutic goods. It specifies purity and chloride assay limits, required laboratory tests (referencing European and United States pharmacopoeias and ICH Q3D), capsule dosage form only, and mandatory label elements.\n\nThe rules affect manufacturers, sponsors and testing laboratories by imposing specified tests, documentation, batch/expiry labelling and, for some compounding scenarios, manufacture‑licence site testing — creating predictable compliance costs and contracting needs with accredited test providers."},"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":4,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: establishing quality standards for MDMA hydrochloride and MDMA hydrochloride products. The scope is appropriately narrow, covering only pharmaceutical-grade MDMA for therapeutic use, with clear exclusions for non-standard approvals and certain therapeutic goods categories. There is no evidence of scope creep beyond the core objective of ensuring safe manufacture and labelling of medical MDMA."},"complexity_factors":["Moderate length (approximately 2,500 words across 14 sections and 2 schedules)","14 defined terms in section 4, plus 10 terms incorporated by reference from the parent Act","Extensive cross-referencing to external pharmacopoeias (European Pharmacopoeia and US Pharmacopeia) for test methods","Reference to international guidelines (ICH Q3D) for elemental impurity limits","Conditional exemptions in section 13(2) for extemporaneously compounded products","Nested definitions (e.g., 'batch number prefix' defined in terms of 'batch number')","Multiple exclusion clauses in section 6(2) referencing other parts of the Act and Regulations"],"plain_english_summary":"This instrument creates Australia’s first official quality standard for medical MDMA, specifying purity, testing methods, manufacturing and labelling requirements for MDMA hydrochloride used in therapeutic products. It applies to pharmaceutical manufacturers, compounding pharmacists, researchers and psychiatrists, and is enforced by the TGA. The standard ensures safe, consistent, contaminant-free MDMA for approved PTSD treatments, safeguarding patients and public confidence in psychedelic medicine."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024","history":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024/history","analysis":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-mdma-tgo-112-order-2024/documents"}}