{"id":"F2025L01614","name":"Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025","slug":"therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":443103,"registerId":"F2025L01614-fast-fetch-1775958025619","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Ageing, make the following instrument.\n\nDated 18  December 2025\n\nNicholas Henderson\n\nFirst Assistant Secretary  Medicines Regulation Division  Health Products Regulation Group  Department of Health, Disability and Ageing\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Declaration of serious scarcity\n\n6  Substitution of scarce medicine by pharmacists\n\n7  Period instrument is in force\n\n8  Repeals\n\nSchedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances\n\nSchedule 2—General permitted circumstances\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025.\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 22 December 2025. 22 December 2025\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 30EK 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) medicine;\n\n(b) pharmacist;\n\n(c) registration number.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nprescriber means the person who:\n\n (a) is authorised under a law of a State or Territory to prescribe medicine; and\n\n (b) prescribed the scarce medicine for the patient.\n\nscarce medicine has the same meaning given by section 5.\n\nsubstitutable medicine has the same meaning given by section 6.\n\ntablet has the same meaning as in the Therapeutic Goods (Standards for Tablets, Capsules and Pills) (TGO 101) Order 2019.\n\nNote: TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.\n\n5  Declaration of serious scarcity\n\n  For paragraph 30EK(1)(a) of the Act, a serious scarcity of medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.\n\n6  Substitution of scarce medicine by pharmacists\n\n  For paragraph 30EK(1)(b) of the Act, in relation to each item in the table in Schedule 1, the medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:\n\n (a) column 5 of that item (the specific permitted circumstances); and\n\n (b) the table in Schedule 2 (the general permitted circumstances).\n\nNote: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.\n\n7  Period instrument is in force\n\n  This instrument remains in force until 28 April 2026.\n\n8  Repeals\n\n  Unless repealed earlier, this instrument is repealed at the start of 29 April 2026.\n\n\n\n\nSchedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances\n\nNote: See sections 5 and 6.\n\n- Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances\n- Column 1 Column 2 Column 3 Column 4 Column 5\n- Item Scarce medicine Substitutable medicine Dose unit equivalence Specific permitted circumstances\n- 1 CATAPRES 150 Clonidine hydrochloride 150 microgram tablet blister pack, registration number 78376 any of the following:(a) CATAPRES 100 clonidine hydrochloride 100 microgram tablet blister pack, registration number 17921;(b) APO-CLONIDINE clonidine hydrochloride 100 micrograms tablet bottle, registration number 265776;(c) CLONIDINE Lupin clonidine hydrochloride 100 micrograms tablet bottle, registration number 265778 one and a half tablets of the substitutable medicine is equivalent to one tablet of the scarce medicine the pharmacist has advised the patient, or person acting on behalf of the patient, of:(a) the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence in column 4; and(b) where cutting of a tablet is required to obtain the correct dose of substitutable medicine, suitable instructions for cutting a tablet of the substitutable medicine; and(c) the differences between the scarce medicine and the substitutable medicine\n\n\n\n\n\nSchedule 2—General permitted circumstances\n\nNote: See section 6.\n\n- General permitted circumstances\n- Column 1 Column 2\n- Item Circumstances\n- 1 the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law\n- 2 the pharmacist does not have access to the scarce medicine\n- 3 the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted\n- 4 the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine\n- 5 the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine\n- 6 the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine\n- 7 the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing\n- 8 the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine\n\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument maintains its original narrow scope. It addresses a specific, time-limited medicine shortage (CATAPRES 150 clonidine tablets) with targeted substitution rules. The mechanism aligns precisely with the legislative intent of section 30EK of the Therapeutic Goods Act 1989, which was designed to enable temporary pharmacist substitution during declared scarcities. No scope creep is evident."},"complexity_factors":["Short, focused instrument (8 sections plus 2 schedules)","Only 4 defined terms in section 4, with 3 referring to external definitions","Single medicine scarcity declaration with 3 specific substitutable alternatives","Clear tabular format for substitution rules in Schedule 1","Straightforward conditional logic: 8 cumulative requirements in Schedule 2 that must all be met (simple 'AND' logic, no nested exceptions)","No cross-references to other legislation beyond the parent Act (Therapeutic Goods Act 1989) and one standards order (TGO 101)","Fixed sunset clause (automatic repeal after 4 months) with no renewal mechanisms or complex temporal provisions"],"plain_english_summary":"This law declares CATAPRES 150 µg clonidine tablets in short supply and lets pharmacists, between 22 Dec 2025 and 28 Apr 2026, substitute three 100 µg clonidine products (1.5 tablets = 1 original tablet) when the pharmacy cannot obtain the prescribed product. Substitution requires a valid prescription, no “do not substitute” instruction, pharmacist judgment and patient/carer consent, dose/duration parity, record-keeping and doctor notification — ensuring continued treatment with professional oversight."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"The instrument temporarily expands pharmacists' authority to dispense specified clonidine 100 µg products in substitution for a listed scarce clonidine 150 µg product where defined conditions are met (s.5–s.6; Sch1; Sch2). It shifts the decision to substitute onto pharmacists (subject to professional judgement and prescriber non‑prohibition) and creates new stepwise compliance obligations (patient advice, consent, dosing instructions, record and notification) for the substitution period, which ends 28 April 2026 (s.7)."},"complexity_factors":["Narrow scope: applies to one scarce product and a small list of substitutable products (Sch1 columns 2–3)","A precise dose‑unit equivalence is mandated (Sch1 column 4) requiring calculation and possible tablet cutting","Dual‑condition test: substitution only where both specific permitted circumstances and general permitted circumstances exist (s.6)","Pharmacist discretion and professional judgement required to determine patient suitability (Sch2 item 4)","Administrative requirements: patient advice, consent, recordkeeping and prescriber notification (Sch1 col5; Sch2 items 6–8)","Temporary duration and automatic repeal dates restricting operational horizon (s.7–s.8)","Specific legal basis under s30EK of the Therapeutic Goods Act 1989 (s.3)"],"plain_english_summary":"This instrument declares a national serious scarcity of CATAPRES 150 (clonidine 150 µg tablets) and temporarily permits pharmacists to substitute listed clonidine 100 µg products, using a specified dose‑unit equivalence (one and a half 100 µg tablets = one 150 µg tablet). Pharmacists decide to substitute only where both the specific and general conditions are met and must give dosing and tablet‑cutting instructions, obtain consent, record the substitution and notify the prescriber (s.6; Sch1 col5; Sch2 items 4,6–8). It runs until 28 April 2026 (s.7)."},"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-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025","history":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025/history","analysis":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025/analysis","conflicts":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025/conflicts","importantCases":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025/important-cases","documents":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-clonidine-instrument-2025/documents"}}