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Australian Poisons Standard - 2010

Apr 16, 2015

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Australian Poisons Standard - 2010

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POISONS STANDARD 2010 I, RUTH LOPERT, 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 Secretarys power under that paragraph of the Act, prepares this new Poisons Standard, in substitution for the current Poisons Standard.

(signed by) RUTH LOPERT Delegate of the Secretary to the Department of Health and Ageing Dated this 23rd day of August 2010

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Citation This instrument is the Poisons Standard 2010.

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The New Poisons Standard The Poisons Standard 2010 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No 1 (the SUSMP 1) as set out in Schedule 1.

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Commencement (1) Subject to subsection (2), the Poisons Standard 2010 commences on 1 September 2010. (2) Amendments in relation to the entries of the following substances commence on 1 January 2011: (a) the inclusion of Leptospermum scoparium oil in Part 2 Labels and Containers, Schedule 6 and Appendix E to the SUSMP 1 as set out in Schedule 1; (b) the inclusion of Sodium lauryl sulphate in Schedule 6 to the SUSMP 1 as set out in Schedule 1; (c) the inclusion of Laureth carboxylic acids in Schedule 6 to the SUSMP 1 as set out in Schedule 1; (d) the omission of Carbendazim in Schedule 6 and its corresponding inclusion in Schedule 7 to the SUSMP 1 as set out in Schedule 1; (e) the inclusion of Sitaxentan in Appendix F to the SUSMP 1 as set out in Schedule 1; (f) the inclusion of Ambrisentan in Appendix F to the SUSMP 1 as set out in Schedule 1; and (g) the inclusion of Lenalidomide in Appendix F to the SUSMP 1 as set out in Schedule 1.

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Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 1

Federal Register of Legislative Instruments F2010L02386

STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS No. 1 1 SEPTEMBER 2010

Federal Register of Legislative Instruments F2010L02386

Commonwealth of Australia 2010 ISBN: 978-1-74241-294-8 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: 6878

This publication is a consolidation of the amendments resulting from decisions made at meetings of the National Drugs and Poisons Schedule Committee (NDPSC) up to and including the June 2010 meeting. The basis of these amendments can be found in the Record of the Reasons, which can be accessed from the NDPSC website: www.tga.gov.au/ndpsc/records.htm Further inquiries should be directed to: The Secretary Medicines and Poisons Scheduling GPO Box 9848 CANBERRA ACT 2601 Or by email: [email protected] Media Liaison Unit Australian Government Department of Health and Ageing

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CONTENTSINTRODUCTION PRINCIPLES OF SCHEDULING PART 1 INTERPRETATION PART 2 LABELS AND CONTAINERS LABELS General requirements Immediate wrapper Primary packs and immediate containers Statements of quantity, proportion or strength Exemptions Selected containers and measure packs Ampoules, pre-filled syringes and injection vials Transport containers and wrappings Dispensary, industrial, laboratory and manufacturing poisons Exemptions from label requirements in certain circumstances Dispensed medicines Gas cylinders Paints Camphor and naphthalene Prohibitions CONTAINERS Containers for poisons other than Schedule 5 poisons Containers for Schedule 5 poisons Approved containers Child-resistant closures Schedule 8 poisons Exemptions Camphor and naphthalene Prohibitions PART 3 MISCELLANEOUS REGULATIONS Advertising Sale or Supply Schedule 2 poisons Schedule 3 poisons Schedule 4 poisons Schedule 7 poisons Prohibitions on sale, prescribing and possession Storage PART 4 THE SCHEDULES Schedule 1 Schedule 2 Schedule 3 Schedule 4 Schedule 5 Schedule 6 Schedule 7 Schedule 8 Schedule 9 v vii 2 10 10 10 10 10 16 17 17 18 18 19 19 19 19 20 20 20 21 21 21 22 22 24 25 25 25 26 26 26 26 26 26 27 27 28 29 30 31 46 52 127 155 192 202 205

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PART 5 APPENDICES Appendix A General Exemptions Appendix B Substances considered not to require control by scheduling Appendix C Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use Appendix D Additional Controls on possession or supply of poisons included in Schedule 4 or 8 Appendix E First Aid instructions for poisons Appendix F Warning Statements and general safety directions for poisons Appendix G Dilute Preparations Appendix H Schedule 3 poisons permitted to be advertised Appendix I Uniform Paint Standard Appendix J Conditions for availability and use of Schedule 7 poisons Appendix K Drugs required to be labelled with a sedation warning Appendix L Requirements for dispensing labels for human and veterinary medicines Index

211 212 215 224 228 230 247 275 276 277 279 283 286 288

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INTRODUCTIONThe 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 predecessor to this document, the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), as decisions of the former National Drugs and Poisons Schedule Committee, formed the basis of this Standard. 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)

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The SWA Code (NOHSC:2012 (1994)) can be accessed from www.safeworkaustralia.gov.au

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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. Schedule 2. This Schedule is intentionally blank. 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 n

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