POISONS STANDARD AMENDMENT No. 5 OF 2011

I, ANTHONY GILL, a delegate of the Secretary to the Department of Health and Ageing for the purposes of paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, hereby amend the Poisons Standard 2011 in the manner set out in Schedule 1.

The amendments to the Poisons Standard 2011 as set out in Schedule 1 commence on 1 January 2012.

(signed by)

ANTHONY GILL

Delegate of the Secretary to the Department of Health and Ageing

Dated this 28^th day of November 2011

Schedule 1-Amendments to the Poisons Standard 2011

STANDARD

FOR THE

UNIFORM SCHEDULING

OF

MEDICINES AND POISONS

No. 2

AMENDMENT No. 3

Effective Date – 1 January 2012

© Commonwealth of Australia 2011

Online ISBN: 978-1-74241-636-6

This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Online, Services and External Relations Branch, Department of Health and Ageing, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.

Published by the Australian Government under the Therapeutic Goods Act 1989.

Publication Approval Number: D0631

The amendments listed in this document are a result of a decision made by the Secretary of the Department of Health and Ageing or the Secretary’s delegate.  The basis of these amendments can be found in the ‘Reasons for delegate’s final decisions’, which can be accessed from the scheduling website www.tga.gov.au/industry/scheduling-decisions-final.htm.

Further inquiries should be directed to:

The Secretary

Medicines and Poisons Scheduling Secretariat

Office of Chemical Safety (MDP 88)

GPO Box 9848

CANBERRA  ACT  2601

or by email to SMP@health.gov.au

Media Liaison Unit

Australian Government Department of Health and Ageing

TABLE OF CONTENTS

PART 1 – INTERPRETATION                                                                                                                                   1

SUBPARAGRAPH 1(1) – NEW ENTRY                                                                                                                1

PART 2 – LABELS AND CONTAINERS                                                                                                                 1

PARAGRAPH 17 – AMENDMENT                                                                                                                        1

PARAGRAPH 28 – AMENDMENT                                                                                                                        1

PARAGRAPH 29 – AMENDMENT                                                                                                                        2

Part 4 – The Schedules                                                                                                                                      2

SCHEDULE 2 – AMENDMENT                                                                                                                              2

SCHEDULE 4 – NEW ENTRIES                                                                                                                             2

SCHEDULE 4 – AMENDMENT                                                                                                                              2

SCHEDULE 5 – NEW ENTRIES                                                                                                                             2

SCHEDULE 6 – NEW ENTRIES                                                                                                                             2

SCHEDULE 6 – AMENDMENTS                                                                                                                           3

SCHEDULE 7 – NEW ENTRY                                                                                                                                 4

SCHEDULE 7 – AMENDMENT                                                                                                                              4

Part 5 – APPENDICES                                                                                                                                               4

APPENDIX C – NEW ENTRY                                                                                                                                  4

APPENDIX E, PART 2 – NEW ENTRIES                                                                                                              4

APPENDIX F, PART 3 – AMENDMENTS                                                                                                             5

Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons

The Secretary of the Department of Health and Ageing directs that the amendments below be applied to the Standard for the Uniform Scheduling of Medicines and Poisons No. 2 and recommends that these amendments be adopted by the States and Territories with effect from 1 January 2012.

PART 1 – INTERPRETATION

SUBPARAGRAPH 1(1) – NEW ENTRY

“Oromucosal” means the oral mucosa, specifically the oral cavity and/or the pharynx.

PART 2 – LABELS AND CONTAINERS

PARAGRAPH 17 – AMENDMENT

Camphor and naphthalene – amend entry to read:

17.     The labelling requirements of sub-paragraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:

(1)     complies with paragraph 28; and

(2)     is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.

PARAGRAPH 28 – AMENDMENT

Camphor and naphthalene – amend entry to read:

28.     The container requirements of paragraph 21 do not apply to a device that contains only camphor or naphthalene in block, ball, disc, pellet or flake form for domestic use, if the device:

(1)     in normal use, prevents removal or ingestion of its contents; and

(2)     is incapable of reacting with the poison; and

(3)     is sufficiently strong to withstand the ordinary risks of handling, storage or  transport; and

(4)     has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.

PARAGRAPH 29 – AMENDMENT

Prohibitions – amend entry to read:

29.     A person must not sell or supply camphor or naphthalene in ball, block, disc, pellet or flake form for domestic use unless the balls, blocks, discs, pellets or flakes are enclosed in a device which prevents removal or ingestion of its contents.

Part 4 – The Schedules

SCHEDULE 2 – AMENDMENT

NICOTINE – delete entry.

SCHEDULE 4 – NEW ENTRIES

5-AMINOLEVULINIC ACID.

CABAZITAXEL.

CATUMAXOMAB.

CEFQUINOME.

IPILIMUMAB.

SCHEDULE 4 – AMENDMENT

NICOTINE – amend entry to read:

NICOTINE in preparations for human therapeutic use except for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal or transdermal use.

SCHEDULE 5 – NEW ENTRIES

FLAZASULFURON.

MESOTRIONE.

SAFLUFENACIL in water dispersible granule preparations.

SCHEDULE 6 – NEW ENTRIES

DERQUANTEL.

METOFLUTHRIN.

PYROXASULFONE in water dispersible granule preparations when for pre-emergence herbicide use.

SCHEDULE 6 – AMENDMENTS

LAURETH CARBOXYLIC ACIDS – amend entry to read:

LAURETH CARBOXYLIC ACIDS (excluding its salts and derivatives) except:

(a)     in leave-on preparations containing 1.5 per cent or less of laureth carboxylic acids;

(b)     in wash-off preparations containing 30 per cent or less of laureth carboxylic acids and, if containing more than 5 per cent laureth carboxylic acids, when labelled with a warning to the following effect:

          IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

(c)     in other preparations containing 30 per cent or less of laureth carboxylic acids and, if containing more than 5 per cent laureth carboxylic acids, when labelled with warnings to the following effect:

          IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

          IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

NAPHTHALENE – amend entry to read:

NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.

SODIUM LAURYL SULFATE – amend entry to read:

SODIUM LAURYL SULFATE (excluding its salts and derivatives) except:

(a)     in wash-off preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent sodium lauryl sulfate, when labelled with a warning to the following effect:

          IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

(b)     in leave-on preparations containing 1.5 per cent or less of sodium lauryl sulfate;

(c)     in toothpaste and oral hygiene preparations containing 5 per cent or less of sodium lauryl sulfate;

(d)     in other preparations for animal use containing 2 per cent or less; or

(e)     in other preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent sodium lauryl sulfate, when labelled with warnings to the following effect:

          IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

          IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

SCHEDULE 7 – NEW ENTRY

PYROXASULFONE except when included in Schedule 6.

SCHEDULE 7 – AMENDMENT

SAFLUFENACIL – amend entry to read:

SAFLUFENACIL except when included in Schedule 5.

Part 5 – APPENDICES

APPENDIX C – NEW ENTRY

DIETHYLHEXYL PHTHALATE for cosmetic use.

APPENDIX E, PART 2 – NEW ENTRIES

POISON                                                                                STANDARD STATEMENTS

Laureth carboxylic acids

·        leave-on or wash-off preparations above 5 per cent     E1

·        other preparations above 5 per cent                              E1,S1

Sodium lauryl sulfate

·        leave-on or wash-off preparations above 5 per cent     E1

·        other preparations above 5 per cent                              E1,S1

APPENDIX F, PART 3 – AMENDMENTS

POISON                                                                      WARNING              SAFETY

                                                                               STATEMENTS              DIRECTION

Camphor – amend entry to read:

Camphor

(a)          in block, ball, disc, pellet or flake                            9

form, enclosed in a device which,

in normal use, prevents removal

or ingestion of its contents.                                        

              (b)     in other forms.                                                          9              1

Naphthalene – amend entry to read:

Naphthalene

(a)           in block, ball, disc, pellet or flake                     9,105

form, enclosed in a device which,

in normal use, prevents removal

or ingestion of its contents.                                                      

(b)     in other forms.                                                   9,105              1