{"id":"F2018L01685","name":"Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018","slug":"therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98327,"registerId":"commonwealth-F2018L01685-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  (1) This instrument is the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018;\n  (2) This instrument may also be cited as Therapeutic Goods Order 100, or TGO 100.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in the Act, including the following:\n\n    (a) British Pharmacopoeia;\n    (b) default standard;\n    (c) European Pharmacopoeia;\n    (d) export only medicine;\n    (e) medicine;\n    (f) standard;\n    (g) United States Pharmacopeia-National Formulary.\n  In this instrument:\n\nacceptance criteria, in relation to microbiological quality, are interpreted as:\n\n(a) 101 CFU: maximum acceptable count is 20;\n\n(b) 102 CFU: maximum acceptable count is 200;\n\n(c) 103 CFU: maximum acceptable count is 2000, and so forth.\n\nAct means the Therapeutic Goods Act 1989.\n\nantimicrobial preservation means the presence of an ingredient(s) in a medicine that inhibits the growth of microorganisms in the medicine.\n\nCFU means colony forming units.\n\ncomplementary medicine has the same meaning as in the Regulations.\n\nherbal substance has the same meaning as in the Regulations.\n\nmonograph means the requirements of an individual or general monograph in a default standard read in conjunction with the General Notices contained in the same edition that are applicable to that monograph.\n\nRegulations means the Therapeutic Goods Regulations 1990.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Incorporation by reference","content":"#### 5 Incorporation by reference\n\n  Where a default standard adopts a different name or number for a test or method that is referenced in this instrument, this instrument incorporates that renamed or renumbered test or method.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Application","content":"#### 6 Application\n\n  (1) The requirements set out in this instrument apply to all therapeutic goods that are medicines.\n  (2) However, the requirements set out in this instrument do not apply to a medicine that is exempt under section 7 of this instrument.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"General exemptions","content":"#### 7 General exemptions\n\n  The requirements of this instrument do not apply to a medicine that:\n    (a) is an export only medicine; or\n    (b) is imported into Australia for use in the treatment of the importer or the importer’s immediate family, in accordance with item 1 of Schedule 5 to the Regulations; or\n    (c) is a starting material used in the manufacture of medicines, except when:\n    (i) pre-packaged for supply for other therapeutic purposes; or\n    (ii) formulated as a dosage form; or\n    (d) the starting material has not reached its final stage of manufacture; or\n    (e) is a medicine to which the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 applies.\n\n> Note: Microbiological standards for medicinal cannabis products are outlined in the Therapeutic Goods Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.","sortOrder":5},{"sectionNumber":"9","sectionType":"section","heading":"Sterility and Bacterial Endotoxin testing","content":"#### 9 Sterility and Bacterial Endotoxin testing\n\n  Where:\n    (a) a medicine is required to be sterile or to comply with a bacterial endotoxin test by an individual or general monograph of a default standard; or\n    (b) a medicine through its labelling or packaging states or implies that the medicine is sterile,\n    the medicine must comply with the Test for Sterility and, if applicable, the Bacterial Endotoxin Test, of a default standard.","sortOrder":6},{"sectionNumber":"10","sectionType":"section","heading":"Efficacy of antimicrobial preservation of a multidose medicine","content":"#### 10 Efficacy of antimicrobial preservation of a multidose medicine\n\n  A medicine that is an aqueous multidose medicine must comply with the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3), except that an aqueous multidose medicine that is a liquid oral antacid medicine may comply with the relevant test in the United States Pharmacopeia – National Formulary, chapter <51> Antimicrobial Effectiveness Test including its acceptance criteria.","sortOrder":7},{"sectionNumber":"11","sectionType":"section","heading":"Microbiological attributes of a non-sterile medicine","content":"#### 11 Microbiological attributes of a non-sterile medicine\n\n  (1) A non-sterile medicine, other than a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin, must comply with the relevant acceptance criteria for microbiological quality of one of the following:\n    (a) the British Pharmacopoeia, Appendix XVI. D Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use; when tested by the methods of:\n    (i) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 2. Microbial Enumeration Tests; and\n    (ii) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 1. Test for Specified Micro-organisms; or\n    (b) the European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4); when tested by the methods of:\n    (i) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests (2.6.12); and\n    (ii) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms (2.6.13); or\n    (c) the United States Pharmacopeia – National Formulary, chapter <1111> , MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE, when tested by the methods of:\n    (i) the United States Pharmacopeia – National Formulary, chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS; and\n    (ii) the United States Pharmacopeia – National Formulary, chapter <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS.\n  (2) A complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin must comply with the acceptance criteria for microbiological quality specified in Schedule 1 when tested by a method stated in subsection 11(1), other than a herbal medicine consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use, which must comply with the acceptance criteria specified in Schedule 2 when tested with a method mentioned in subsection 11(1).\n\n  \n\nSchedule 1— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin\n\n(subsection 11(2))\n\n1 Table of acceptance criteria\n\n| Microbiological Quality              | Acceptance Criteria                           |\n| ------------------------------------ | --------------------------------------------- |\n| Total aerobic microbial count        | Less than or equal to 104 CFU per g or per mL |\n| Total yeast and mould count          | Less than or equal to 102 CFU per g or per mL |\n| Bile-tolerant Gram negative bacteria | Less than or equal to 102 CFU per g or per mL |\n| Salmonella                           | absent in 10 g or 10 mL                       |\n| Escherichia coli                     | absent in 1 g or 1 mL                         |\n| Staphylococcus aureus                | absent in 1 g or 1 mL                         |\n\nSchedule 2— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (vegetal) origin that is a herbal medicinal product consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use\n\n(subsection 11(2))\n\n1 Table of acceptance criteria\n\n| Microbiological Quality              | Acceptance Criteria                 |\n| ------------------------------------ | ----------------------------------- |\n| Total aerobic microbial count        | Less than or equal to 107 CFU per g |\n| Total yeast and mould count          | Less than or equal to 105 CFU per g |\n| Bile-tolerant Gram negative bacteria | Less than or equal to102 CFU per g  |\n| Escherichia coli                     | absent in 1 g                       |\n| Salmonella                           | absent in 10 g                      |","sortOrder":8}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation maintains its original focused scope. It was clearly intended from the outset to establish microbiological quality standards for all medicines, with specific carve-outs for complementary medicines and herbal products. The exemptions (export-only, personal import, starting materials, medicinal cannabis) are standard regulatory exclusions rather than scope creep. The two-schedule approach for complementary medicines reflects a deliberate, contained expansion to address natural product characteristics rather than uncontrolled growth beyond the original purpose."},"complexity_factors":["Multiple nested exemption clauses in section 7 (5 separate exemption categories with sub-clauses)","Extensive incorporation by reference to three different international pharmacopoeias (British, European, US) with different chapter/appendix numbering systems","Conditional logic requiring cross-referencing between the Order and external default standards (e.g., 'when tested by the methods of...')","Two-tiered schedule system with different microbial limits for complementary medicines based on preparation method (Schedule 1 vs Schedule 2)","Specific technical terminology requiring definitions (CFU, monograph, antimicrobial preservation, etc.)","Exception within an exception in section 10 (multidose antacid medicines may use USP instead of BP/EP)","Cross-reference to separate legislation (TGO 93 for medicinal cannabis)"],"plain_english_summary":"This law sets Australia’s microbiological safety standards for medicines, telling manufacturers and importers how clean products must be to protect consumers from contaminated drugs. It distinguishes sterile and non‑sterile products, requires effective preservatives in multidose items, and allows higher (but still safe) microbe limits for many natural or tea products because of processing.\n\nExemptions include exports, personal imports, raw starting materials and medicinal cannabis with separate rules."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"No alteration of scope beyond what the instrument itself states. The instrument declares it applies to all medicines except specific exemptions and sets microbiological standards by adopting pharmacopeial monographs (s6–7, s5, s9–11)."},"complexity_factors":["Incorporation by reference to external pharmacopeias creates cross‑document complexity (s5).","Multiple, standard‑specific testing routes (British, European, USP) with different method citations (s10, s11).","Detailed microbiological acceptance criteria and CFU interpretation in definitions and Schedules (s4; Schedule 1; Schedule 2).","Several targeted exemptions that affect scope and compliance obligations (s6, s7).","Mandatory sterility and endotoxin testing where labelled or required, tying label claims to testing duties (s9).","Different preservation efficacy standards for aqueous multidose products, with a USP exception for oral antacids (s10).","Interplay with the Act and Regulations for defined terms and enforcement (s3, s4).","Compliance burden rests on sponsors/manufacturers to perform or commission tests and meet acceptance criteria (implied by ss9–11)."],"plain_english_summary":"This instrument sets mandatory microbiological standards and test methods for medicines supplied in Australia, requiring sterility, endotoxin, antimicrobial‑preservation and microbial‑count criteria to follow specified monographs in the British, European or United States pharmacopoeias (ss5,9–11).\n\nIt applies to medicine sponsors and manufacturers who must arrange testing and compliance, lists targeted exemptions (export‑only, certain starting materials, medicinal cannabis, private import), and creates testing and formulation costs while providing regulators with clear acceptance criteria (s6–7, s10–11)."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018","history":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018/history","analysis":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018/analysis","conflicts":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018/conflicts","importantCases":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018/important-cases","documents":"/api/acts/therapeutic-goods-microbiological-standards-for-medicines-tgo-100-order-2018/documents"}}