Poisons Standard June 2021 I, Avi Rebera, as delegate of the Secretary of the Department of Health, make the following Poisons Standard. Dated 26 May 2021 Avi Rebera Assistant Secretary Regulatory Engagement, Education and Planning Branch Health Products Regulation Group Department of Health Poisons Standard June 2021 i Authorised Version F2021L00650 registered 26/05/2021 1 Name This instrument is the Poisons Standard June 2021. 2 Commencement (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. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this 1 June 2021. 1 June 2021 instrument Note: This table relates only to the provisions of this instrument as originally made.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. (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. 3 Authority This instrument is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989. 4 Current Poisons Standard Schedule 1 to this instrument contains the Standard for the Uniform Scheduling of Medicines and Poisons No. 33, otherwise known as the current Poisons Standard. 5 Repeals Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule. Poisons Standard June 2021 ii Authorised Version F2021L00650 registered 26/05/2021 Schedule 1—Standard for the Uniform Scheduling of Medicines and Poisons No. 33 Poisons Standard June 2021 iii Authorised Version F2021L00650 registered 26/05/2021 STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS No. 33 June 2021 Poisons Standard June 2021 iv Authorised Version F2021L00650 registered 26/05/2021 Reasons for scheduling delegates’ final decisions can be accessed from the TGA website, at https://www.tga.gov.au/reasons-scheduling-delegates-final-decisions Further inquiries in relation to this document should be directed to: The Secretary Chemicals and Medicines Scheduling Secretariat (MD122) Scheduling and Committee Governance Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 or by email to [email protected] [email protected] Media Liaison Unit Australian Government Department of Health Poisons Standard June 2021 v Authorised Version F2021L00650 registered 26/05/2021 Table of Contents Table of Contents vi INTRODUCTION viii PART 1 1 INTERPRETATION ______________________________________________ 1 PART 2 11 CONTROL ON MEDICINES AND POISONS _______________________ 11 SECTION ONE LABELS __________________________________________ 11 SECTION TWO CONTAINERS _____________________________________ 22 SECTION THREE STORAGE ______________________________________ 28 SECTION FOUR DISPOSAL _________________________________________ 29 SECTION FIVE RECORD KEEPING ________________________________ 29 SECTION SIX SALE, SUPPLY, POSSESSION, or USE __________________ 29 SECTION SEVEN/Appendix I PAINT OR TINTERS ____________________ 30 PART 3 33 MISCELLANEOUS REGULATIONS ______________________________ 33 SECTION ONE ADVERTISING ____________________________________ 33 SECTION TWO SALE OR SUPPLY _________________________________ 33 SECTION THREE STORAGE ______________________________________ 34 PART 4 35 THE SCHEDULES ______________________________________________ 35 SCHEDULE 1 _____________________________________________________ 35 SCHEDULE 2 _____________________________________________________ 35 SCHEDULE 3 _____________________________________________________ 54 SCHEDULE 4 _____________________________________________________ 62 SCHEDULE 5 ____________________________________________________ 157 SCHEDULE 6 ____________________________________________________ 191 Poisons Standard June 2021 vi Authorised Version F2021L00650 registered 26/05/2021 SCHEDULE 7 ____________________________________________________ 246 SCHEDULE 8 ____________________________________________________ 259 SCHEDULE 9 ____________________________________________________ 263 SCHEDULE 10 ___________________________________________________ 271 PART 5 277 THE APPENDICES _____________________________________________ 277 APPENDIX A – GENERAL EXEMPTIONS ____________________________ 277 APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING ________________________________________________ 280 APPENDIX C (see SCHEDULE 10) __________________________________ 299 APPENDIX D – ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY OF POISONS INCLUDED IN SCHEDULE 4 OR 8 _________________________ 300 APPENDIX E – FIRST AID INSTRUCTIONS FOR POISONS _____________ 307 APPENDIX F – WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS _______________________________________ 334 APPENDIX G – DILUTE PREPARATIONS ____________________________ 373 APPENDIX H – SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED376 APPENDIX I _____________________________________________________ 379 APPENDIX J – SCHEDULE 7 POISONS REQUIRING ADDITIONAL CONTROLS ON AVAILABILITY AND USE __________________________ 380 APPENDIX K – DRUGS REQUIRED TO BE LABELLED WITH A SEDATION WARNING ______________________________________________________ 386 APPENDIX L – REQUIREMENTS FOR DISPENSING LABELS FOR HUMAN AND VETERINARY MEDICINES ___________________________________ 396 APPENDIX M – ADDITIONAL CONTROLS OR SUPPLY REQUIREMENTS FOR POISONS INCLUDED IN SCHEDULE 3 TO ALLOW THEM TO BE PROVIDED BY A PHARMACIST ___________________________________ 400 INDEX 401 Poisons Standard June 2021 vii Authorised Version F2021L00650 registered 26/05/2021 INTRODUCTION The Poisons Standard June 2021, which, under section 4 above contains the Standard for the Uniform Scheduling of Medicines and Poisons No. 33 (“the Standard” or “the SUSMP”), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (“SPF”) of the Australian Health Ministers' Advisory Council. Further information on the scheduling amendments and the SPF can be accessed at 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 Secretary of the Department of Health or the Secretary's 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 provisions for labelling, containers, storage, disposal, record- keeping, sale, supply and possession of poisons in general which are intended to be adopted for use in each jurisdiction of Australia. Other government agencies may also impose controls on certain products. 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 labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time. 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 Acts, legislative instruments and other documents, which integrate with the SUSMP include: the Agricultural and Veterinary Chemicals Code Act 1994; the Agricultural and Veterinary Chemicals Code Regulations 1995; Poisons Standard June 2021 viii Authorised Version F2021L00650 registered 26/05/2021 the Therapeutic Goods Act 1989; the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (Compilation No. 2); the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (Compilation No. 1); the Therapeutic Goods Order No. 95 – Child-resistant packaging requirements for medicines 2017 (TGO 95); the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 – Schedule 1 Required Advisory Statements for Medicine Labels (RASML). CLASSIFICATION Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For