{"id":"F2007B00463","name":"Therapeutic Goods Order No. 29 - Standards for Ethanol (10/04/1986)","slug":"therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62321,"registerId":"commonwealth-F2007B00463-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 29 - Standards for Ethanol (10/04/1986)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\ntitle: THERAPEUTIC GOODS ACT 1966\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n \n\n \n\nTHERAPEUTIC GOODS ACT 1966\n\nTHERAPEUTIC GOODS ORDER NO. 29\n\nSTANDARDS FOR ETHANOL\n\n \n\nI, NEAL BLEWETT, Minister of State for Health, pursuant to section 11 of the Therapeutic Goods Act 1966, by this Order,  DETERMINE –\n\n \n\na)      that the standard for Ethanol (95 per cent), when prepared by a fermentation process, shall be as specified in the monograph for Alcohol (95 per cent) of the British Pharmacopoeia, 1973; and\n\n \n\nb)     that the standard for Ethanol (96 per cent), when prepared by a synthetic process, shall be as specified in the monograph for Ethanol (96 per cent) of the British Pharmacopoeia, 1980.\n\n \n\n \n\n \n\nDated this tenth day of April 1986\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n       NEAL BLEWETT\n\n                  Minister of State for Health\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":2230},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"The Order remains focused on its original purpose of establishing quality standards for ethanol used in therapeutic goods. No expansion of scope is evident."},"complexity_factors":["Only two operative paragraphs","Adopts external standards by reference without additional conditions","No definitions, exceptions, or procedural requirements","Single purpose: setting manufacturing standards for one substance"],"plain_english_summary":"**What this does:** This Order sets the purity and quality standards for ethanol (alcohol) used in making therapeutic goods (medicines and medical products) in Australia.\n\n**The two standards:**\n- **Fermentation ethanol (95% alcohol):** Must meet the specifications in the *British Pharmacopoeia 1973* under the monograph for 'Alcohol (95 per cent)'.\n- **Synthetic ethanol (96% alcohol):** Must meet the specifications in the *British Pharmacopoeia 1980* under the monograph for 'Ethanol (96 per cent)'.\n\n**Why it matters:** This ensures that any alcohol used in medicines is pure and safe for patients. By adopting the British Pharmacopoeia standards (an internationally recognised authority on pharmaceutical ingredients), Australia ensures its ethanol quality matches global medical benchmarks."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986","history":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986/history","analysis":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986/important-cases","documents":"/api/acts/therapeutic-goods-order-no-29-standards-for-ethanol-10-04-1986/documents"}}