{"id":"F2026L00041","name":"Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026","slug":"therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":443129,"registerId":"F2026L00041-fast-fetch-1775958041208","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) (Labetalol) Instrument 2026","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) (Labetalol) Instrument 2026\n\nI, George Vuckovic, as delegate of the Minister for Health and Ageing, make the following instrument.\n\nDated 22 January 2026\n\n \n\nGeorge Vuckovic\n\nActing First Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health, Disability and Ageing\n\n \n\n \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 of medicine\n\n6  Substitution of scarce medicine by pharmacists\n\n7  Period of enforcement\n\n8  Repeals\n\nSchedule 1—Scarce medicine, substitutable medicine, dose unit equivalence, specific circumstances of substitution\n\nSchedule 2—General permitted circumstances\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Labetalol) Instrument 2026.\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instrument 28 January 2026. 28 January 2026\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 meaning given by section 5.\n\nsubstitutable medicine has the meaning given by section 6.\n\ntablet has the same meaning as in the Therapeutic Goods (Standard 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 the 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, a pharmacist is permitted to dispense the medicine specified in column 3 (the substitutable medicine) 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 in force\n\n  This instrument remains in force until 31 May 2026.\n\n8  Repeals\n\n  Unless repealed earlier, this instrument is repealed at the start of 1 June 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 PRESOLOL 200 labetalol hydrochloride 200mg tablet bottle, registration number 56476 a registered medicine, or a medicine that is the subject of an approval under section 19A of the Act, that:(a) contains 100 mg labetalol as the only active ingredient; and(b) is manufactured in the dosage form of a tablet two 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 the substitutable medicine—suitable instructions for cutting a tablet of the substitutable medicine; and(c) the differences between the scarce medicine and the substitutable medicine; and(d) either:(i) suitable instructions for administering the substitutable medicine; or(ii) to obtain instructions for administering the substitutable medicine from the prescriber or a general practitioner\n- 2 PRESOLOL 100 labetalol hydrochloride 100mg tablet bottle, registration number 56475 a registered medicine, or a medicine that is the subject of an approval under section 19A of the Act, that:(a) contains 200 mg labetalol as the only active ingredient; and(b) is manufactured in the dosage form of a tablet half a tablet 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 the substitutable medicine—suitable instructions for cutting a tablet of the substitutable medicine; and(c) the differences between the scarce medicine and the substitutable medicine; and(d) either:(i) suitable instructions for administering the substitutable medicine; or(ii) to obtain instructions for administering the substitutable medicine from the prescriber or a general practitioner\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 medicine shortage (labetalol) using the established serious scarcity framework under section 30EK of the Therapeutic Goods Act 1989. The instrument does not expand beyond its intended purpose of enabling temporary pharmacist substitution during a declared shortage."},"complexity_factors":["Short, single-purpose instrument (8 sections plus 2 schedules)","Only 2 defined terms specific to this instrument ('scarce medicine' and 'substitutable medicine')","Straightforward tabular structure for substitution rules with clear dose equivalences","Limited cross-references (only to parent Act section 30EK and TGO 101 for definition of 'tablet')","No nested exceptions or conditional logic beyond simple 'and' requirements","Sunset clause provides automatic repeal (no ongoing regulatory burden)"],"plain_english_summary":"This temporary law declares two PRESOLOL labetalol products in nationwide shortage and lets pharmacists legally substitute different strengths of the same drug so patients don’t miss doses (e.g., 200mg → two 100mg tablets; 100mg → half a 200mg tablet). It affects patients, pharmacists and prescribers and requires pharmacist counselling, patient/carer consent, checking for “do not substitute,” notifying the prescriber and keeping records. It runs from 28 Jan 2026 to 31 May 2026."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not amend the Therapeutic Goods Act; it exercises the Act’s existing power (s30EK) to declare a scarcity and to permit temporary substitution for specific labetalol products (section 5; section 6; Schedule 1). The measure temporarily shifts substitution authority and imposes counselling, recordkeeping and notification duties on pharmacists but does not change long‑term regulatory scope or payment arrangements."},"complexity_factors":["Narrow, product‑specific scope limited to two labetalol presentations (Schedule 1) — reduces breadth of issues to consider.","Cross‑reference to primary Act power (s30EK of the Therapeutic Goods Act 1989) — requires understanding interaction with parent statute (see section 3).","Dual-condition substitution rule: substitution permitted only where both specific permitted circumstances (Schedule 1, column 5) and general permitted circumstances (Schedule 2) are satisfied — logical conjunction increases procedural steps.","Dose unit equivalence arithmetic (Schedule 1, column 4) and practical instructions (tablet cutting guidance) create modest clinical/dispensing complexity.","Professional discretion and clinical suitability requirements (Schedule 2, item 4) create variable, case‑by‑case application and potential liability/records considerations.","Operational obligations: patient advice, consent, contemporaneous record‑keeping and prescriber notification (Schedule 1 column 5; Schedule 2 items 6–8) add compliance burden for pharmacies.","Time‑limited effect and automatic repeal (sections 7–8) mean implementation is temporary, requiring short‑term operational changes."],"plain_english_summary":"This instrument declares a national serious scarcity of specified PRESOLOL (labetalol) tablets and temporarily allows pharmacists to substitute different-strength, registered labetalol tablets where a stated dose‑equivalence and both specific and general conditions are met. It affects pharmacists, prescribers and patients by moving some substitution decisions to pharmacists (subject to patient consent, prescriber instructions, pharmacist professional judgement, counselling and record/notification duties) and operates until 31 May 2026."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026","history":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026/history","analysis":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026/analysis","conflicts":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026/conflicts","importantCases":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026/important-cases","documents":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-labetalol-instrument-2026/documents"}}