POISONS STANDARD 2011 I, ANTHONY GILL, a delegate of the Secretary to the Department of Health and Ageing for the purposes of paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary‘s power under that paragraph of the Act, prepare this new Poisons Standard, in substitution for the current Poisons Standard. (signed by) ANTHONY GILL Delegate of the Secretary to the Department of Health and Ageing Dated this 2nd day of August 2011 Federal Register of Legislative Instruments F2011L01612 ii 1. Citation This instrument is the Poisons Standard 2011. 2. The New Poisons Standard The Poisons Standard 2011 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No 2 (the SUSMP 2) as set out in Schedule 1. 3. Commencement The Poisons Standard 2011 commences on the day after registration. Federal Register of Legislative Instruments F2011L01612 iii Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 2 Federal Register of Legislative Instruments F2011L01612 iv STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS No. 2 August 2011 Federal Register of Legislative Instruments F2011L01612 © Commonwealth of Australia 2011 ISBN: 978-1-74241-472-0 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the: Commonwealth Copyright Administration Attorney-General's Department Robert Garran Offices National Circuit BARTON ACT 2600 or posted at http://www.ag.gov.au/cca Published by the Australian Government under the Therapeutic Goods Act 1989. Publication approval number: D0408 This publication consolidates the previous Standard for the Uniform Scheduling of Medicines and Poisons and the subsequent amendments to that document. It records decisions made by the Secretary of the Australian Department of Health and Ageing, or the Secretary's delegate, with implementation dates up to and including 8 July 2011. The basis of these decisions can be found in the ‗Record of the Reasons‘, which can be accessed from the TGA website: http://www.tga.gov.au/industry/scheduling-decisions-final.htm Further inquiries should be directed to: The Secretary Medicines and Poisons Scheduling Secretariat GPO Box 9848 CANBERRA ACT 2601 Or by email: [email protected] Media Liaison Unit Australian Government Department of Health and Ageing Federal Register of Legislative Instruments F2011L01612 iii CONTENTS INTRODUCTION v PRINCIPLES OF SCHEDULING vii PART 1 INTERPRETATION 2 PART 2 LABELS AND CONTAINERS 10 LABELS 10 General requirements 10 Immediate wrapper 10 Primary packs and immediate containers 10 Statements of quantity, proportion or strength 16 Exemptions 17 Selected containers and measure packs 17 Ampoules, pre-filled syringes and injection vials 18 Transport containers and wrappings 18 Dispensary, industrial, laboratory and manufacturing poisons 19 Exemptions from label requirements in certain circumstances 19 Dispensed medicines 19 Gas cylinders 19 Paints 20 Camphor and naphthalene 20 Prohibitions 20 CONTAINERS 21 Containers for poisons other than Schedule 5 poisons 21 Containers for Schedule 5 poisons 21 Approved containers 22 Child-resistant closures 22 Schedule 8 poisons 24 Exemptions 25 Camphor and naphthalene 25 Prohibitions 25 PART 3 MISCELLANEOUS REGULATIONS 26 Advertising 26 Sale or Supply 26 Schedule 2 poisons 26 Schedule 3 poisons 26 Schedule 4 poisons 26 Schedule 7 poisons 27 Prohibitions on sale, prescribing and possession 27 Storage 28 PART 4 THE SCHEDULES 29 Schedule 1 30 Schedule 2 31 Schedule 3 46 Schedule 4 52 Schedule 5 127 Schedule 6 155 Schedule 7 192 Schedule 8 202 Schedule 9 205 Federal Register of Legislative Instruments F2011L01612 iv PART 5 APPENDICES 211 Appendix A General Exemptions 212 Appendix B Substances considered not to require control by scheduling 215 Appendix C Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use 224 Appendix D Additional Controls on possession or supply of poisons included in Schedule 4 or 8 228 Appendix E First Aid instructions for poisons 230 Appendix F Warning Statements and general safety directions for poisons 247 Appendix G Dilute Preparations 275 Appendix H Schedule 3 poisons permitted to be advertised 276 Appendix I Uniform Paint Standard 277 Appendix J Conditions for availability and use of Schedule 7 poisons 279 Appendix K Drugs required to be labelled with a sedation warning 283 Appendix L Requirements for dispensing labels for human and veterinary medicines 286 Index 288 Federal Register of Legislative Instruments F2011L01612 v INTRODUCTION The Standard for Uniform Scheduling of Medicines and Poisons (the Standard), or SUSMP, is established under Section 52D of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under Section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. Further information on the scheduling amendments and the SPF can be accessed from the following website: www.tga.gov.au. Refer to Part 1 Interpretation on page 2 below, for definitions of specific terms used in this document including ―medicine‖ and ―poison‖ (noting that the definition of poison includes medicine). The SUSMP serves two key purposes. Firstly, the SUSMP contains the decisions of the delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling but are the subject of other Commonwealth registration schemes. Secondly, the SUSMP includes model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemical products, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. Other government agencies may also impose controls on certain products, for example cosmetics. The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation. Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by the Safe Work Australia National Code of Practice for the Labelling of Workplace Substances1 (the SWA Code). Note, however that this exemption does not extend to controls on supply of these poisons. The SUSMP is presented with a view to promoting uniform: scheduling of poisons throughout Australia; signal headings on labels for poisons throughout Australia; labelling and packaging requirements for poisons throughout Australia; additional controls on the availability and use of poisons in Australia. The various Commonwealth legislative instruments which integrate with the SUSMP include: the Agricultural and Veterinary Chemicals Code Act 1994 the Agricultural and Veterinary Chemicals Code Regulations 1995 the Therapeutic Goods Act 1989 TGO 65 – Child-resistant packaging for therapeutic goods TGO 69 – General requirements for labels for medicines TGO 80 – Child-Resistant Packaging Requirements for Medicines The Required Advisory Statements for Medicine Labels (RASML) 1The SWA Code (NOHSC:2012 (1994)) can be accessed from www.safeworkaustralia.gov.au Federal Register of Legislative Instruments F2011L01612 vi CLASSIFICATION Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with each relevant State or Territory Authority. Schedule 1. This Schedule is intentionally blank. Schedule 2. Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person. Schedule 3. Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription. Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription. Schedule 5. Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label. Schedule 6. Poison – Substances with a moderate potential for causing