POISONS STANDARD AMENDMENT No. 1 OF 2012
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 May 2012.
(signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health and Ageing
Dated this 19th day of April 2012
Schedule 1-Amendments to the Poisons Standard 2011
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 2
AMENDMENT No. 4
Effective Date – 1 May 2012
© Commonwealth of Australia 2012
Online ISBN 978-1-74241-688-5
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: D0709
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health and Ageing or the Secretary’s delegate in March 2011, September 2011 and February 2012. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at www.tga.gov.au/industry/scheduling-decisions.htm.
Further inquiries should be directed to:
The Secretary
Medicines and Poisons Scheduling Secretariat (MDP88)
Office of Health Protection
Department of Health and Ageing
GPO Box 9848
CANBERRA ACT 2601
or by email: SMP@health.gov.au
Media Liaison Unit
Australian Government Department of Health and Ageing
TABLE OF CONTENTS
Part 4 – The Schedules 1
SCHEDULE 2 – AMENDMENTS 1
SCHEDULE 3 – NEW ENTRY 1
SCHEDULE 3 – AMENDMENT 2
SCHEDULE 4 – NEW ENTRIES 2
SCHEDULE 4 – AMENDMENTS 2
SCHEDULE 5 – NEW ENTRIES 3
SCHEDULE 5 – AMENDMENTS 3
SCHEDULE 6 – NEW ENTRIES 4
SCHEDULE 9 – NEW ENTRIES 4
Part 5 – The APPENDIces 4
APPENDIX B – NEW ENTRY 4
APPENDIX D – NEW ENTRY 4
APPENDIX H – AMENDMENT 5
EDITORIAL AMENDMENTS AND ERRATA 5
PART 1 – INTERPRETATION 5
SUBPARAGRAPH 1(1) – AMENDMENT 5
PART 4 – THE SCHEDULES 5
SCHEDULE 5 – AMENDMENT 5
SCHEDULE 6 – 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 (SUSMP 2) and recommends that these amendments be adopted by the states and territories with effect from 1 May 2012.
Part 4 – The Schedules
SCHEDULE 2 – AMENDMENTS
AZELASTINE – Amend entry to read:
AZELASTINE:
(a) in preparations for nasal use; or
(b) in topical eye preparations containing 0.05 per cent or less of azelastine.
DICLOFENAC – Amend entry to read:
DICLOFENAC when:
(a) in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac; or
(b) in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 1 per cent or less of diclofenac or for the treatment of solar keratosis.
LOPERAMIDE – Amend entry to read:
LOPERAMIDE in divided preparations for oral use in packs of 20 dosage units or less except in preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.
SCHEDULE 3 – NEW ENTRY
FAMCICLOVIR for oral use, in divided preparations, containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).
SCHEDULE 3 – AMENDMENT
AZELASTINE – Delete entry.
SCHEDULE 4 – NEW ENTRIES
AFLIBERCEPT.
BELATACEPT.
CEFTAROLINE FOSAMIL.
DAPAGLIFLOZIN.
ERIBULIN MESYLATE.
#FOLLISTATIN.
INGENOL MEBUTATE.
LIXISENATIDE.
PITAVASTATIN.
RIFAXIMIN.
TALIGLUCERASE ALFA.
VELAGLUCERASE ALFA.
VEMURAFENIB.
SCHEDULE 4 – AMENDMENTS
AZELASTINE – Amend entry to read:
AZELASTINE except when included in Schedule 2.
DICLOFENAC – Amend entry to read:
DICLOFENAC except:
(a) when included in Schedule 2 or 3; or
(b) in preparations for dermal use unless:
(i) for the treatment of solar keratosis; or
(ii) containing more than 4 per cent of diclofenac.
FAMCICLOVIR – Amend entry to read:
FAMCICLOVIR except when included in Schedule 3.
LOPERAMIDE – Amend entry to read:
LOPERAMIDE except:
(a) when included in Schedule 2; or
(b) in divided oral preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.
SCHEDULE 5 – NEW ENTRIES
FLUXAPYROXAD.
PENTHIOPYRAD except in preparations containing 20 per cent or less of penthiopyrad.
SCHEDULE 5 – AMENDMENTS
DELTAMETHRIN – Amend entry to read:
DELTAMETHRIN:
(a) when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin;
(b) in aqueous preparations containing 5 per cent or less of deltamethrin when no organic solvent other than a glycol is present;
(c) in wettable granular preparations containing 25 per cent or less of deltamethrin when packed in child-resistant packaging each containing 3 grams or less of the formulation;
(d) in water-dispersible tablets each containing 500 mg or less of deltamethrin in child-resistant packaging; or
(e) in other preparations containing 0.5 per cent or less of deltamethrin,
except in preparations containing 0.1 per cent or less of deltamethrin.
SCHEDULE 6 – NEW ENTRIES
INDAZIFLAM.
PROSULFURON.
TRICLOSAN in cosmetic preparations for human use containing more than 0.3 per cent of triclosan.
SCHEDULE 9 – NEW ENTRIES
3,4-METHYLENEDIOXYPYROVALERONE *(MDPV).
BENZOYLINDOLES except when separately specified in these Schedules.
CYCLOHEXYLPHENOLS except when separately specified in these Schedules.
DIBENZOPYRANS except when separately specified in these Schedules.
NAPHTHOYLINDOLES except when separately specified in these Schedules.
NAPHTHYLMETHYLINDOLES except when separately specified in these Schedules.
NAPHTHOYLPYRROLES except when separately specified in these Schedules.
NAPHTHYLMETHYLINDENES except when separately specified in these Schedules.
PHENYLACETYLINDOLES except when separately specified in these Schedules.
SYNTHETIC CANNABINOMIMETICS except when separately specified in these Schedules.
Part 5 – The APPENDIces
APPENDIX B – NEW ENTRY
SUBSTANCE DATE OF REASON AREA
ENTRY FOR OF
LISTING USE
AMETOCTRADIN May 2012 a 1.3
APPENDIX D – NEW ENTRY
PARAGRAPH 5 – NEW ENTRY
FOLLISTATIN.
APPENDIX H – AMENDMENT
AZELASTINE – Delete entry.
EDITORIAL AMENDMENTS AND ERRATA
PART 1 – INTERPRETATION
SUBPARAGRAPH 1(1) – AMENDMENT
“Oromucosal” – Amend entry to read:
“Oromucosal use” means administration to the oral mucosa, specifically the oral cavity and/or the pharynx.
PART 4 – THE SCHEDULES
SCHEDULE 5 – AMENDMENT
EMODEPSIDE – Amend entry to read:
EMODEPSIDE in preparations:
(a) containing 2.5 per cent or less of emodepside for the external treatment of animals; or
(b) containing 30 mg or less of emodepside per dosage unit for the oral treatment of animals.
SCHEDULE 6 – AMENDMENTS
DIMETHYL SULFOXIDE – Amend entry to read:
DIMETHYL SULFOXIDE (excluding dimethyl sulfone):
(a) when not for therapeutic use; or
(b) for the treatment of animals:
(i) when combined with no other therapeutic substance(s);
(ii) in liquid preparations containing copper salicylate and 1 per cent or less of methyl salicylate as the only other therapeutic substances; or
(iii) in clay poultices containing 2 per cent or less of dimethyl sulfoxide.
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; or
(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.
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 of 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 of sodium lauryl sulfate; or
(e) in other preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent of 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.
