POISONS STANDARD AMENDMENT No. 1 OF 2014
I, ANTHONY GILL, a delegate of the Secretary to the Department of Health 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 2013 in the manner set out in Schedule 1.
The amendment to the Poisons Standard 2013 as set out in Schedule 1 will commence on 1 February 2014.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health
Dated this 18th day of December 2013
Schedule 1-Amendment to the Poisons Standard 2013
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 4
AMENDMENT No. 2
Effective Date – 1 February 2014
© Commonwealth of Australia 2013
ISBN 978-1-74186-075-7
This work is copyright. You may 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, 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: 10538
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in November 2013. 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 http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further inquiries should be directed to:
The Secretary
Medicines and Poisons Scheduling Secretariat (MDP88)
Office of Health Protection
Department of Health
GPO Box 9848
CANBERRA ACT 2601
or by email to SMP@health.gov.au
Media Liaison Unit
Australian Government Department of Health
Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons
The Secretary of the Department of Health directs that the amendments below be applied to the Standard for the Uniform Scheduling of Medicines and Poisons No. 4 and recommends that these amendments be adopted by the States and Territories with effect from 1 February 2014 unless otherwise stated.
PART 4 – THE SCHEDULES
SCHEDULE 2 – AMENDMENT
HYDROQUINONE – Amend entry to read:
HYDROQUINONE (excluding monobenzone and alkyl ethers of hydroquinone included in Schedule 4) in preparations for human external therapeutic or cosmetic use containing 2 per cent or less of hydroquinone except:
(a) in hair preparations containing 0.3 per cent or less of hydroquinone; or
(b) in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.
SCHEDULE 4 – NEW ENTRIES
afatinib dimaleate.
DABRAFENIB MESILATE.
DOLUTEGRAVIR.
LURASIDONE.
MIRABEGRON.
OCRIPLASMIN.
PRADOFLOXACIN.
romidepsin.
trametinib dimethyl sulfoxide.
Trastuzumab emtansine.
vEDOLIZUMAB.
VORTIOXETINE.
SCHEDULE 4 – AMENDMENTS
ALPRAZOLAM – Delete entry.
BUPIVACAINE – Amend entry to read:
BUPIVACAINE except when included in Schedule 5.
HYDROQUINONE – Amend entry to read:
HYDROQUINONE (other than its alkyl ethers separately specified in this Schedule) in preparations for human therapeutic or cosmetic use except:
(a) when included in Schedule 2; or
(b) in hair preparations containing 0.3 per cent or less of hydroquinone; or
(c) in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.
LIGNOCAINE – Amend entry to read:
LIGNOCAINE except:
(a) when included in Schedules 2 or 5;
(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances per dosage unit; or
(c) in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit
MONOBENZONE – Amend entry to read:
MONOBENZONE and alkyl ethers of hydroquinone for human therapeutic use or cosmetic use except in cosmetic nail preparations containing 0.02 per cent or less of monobenzone or alkyl ethers of hydroquinone.
The following amended entry for tylosin has a delayed implementation date of 1 June 2014.
TYLOSIN – Amend entry to read:
TYLOSIN.
SCHEDULE 5 – NEW ENTRIES
BUPIVACAINE in aqueous gel preparations containing 0.5 per cent or less of bupivacaine, for the dermal spray-on treatment of wounds associated with 'mulesing' of sheep.
LIGNOCAINE in aqueous gel preparations containing 4.5 per cent or less of lignocaine, for the dermal spray-on treatment of wounds associated with 'mulesing' of sheep.
SCHEDULE 5 – AMENDMENTS
3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) – Amend entry to read:
3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) in preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate except:
(a) in aqueous preparations not for cosmetic use containing 10 per cent or less 3-iodo-2-propynyl butyl carbamate; or
(b) in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.
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:
(a) in factory prepared mosquito nets containing 1 per cent or less deltamethrin; or
(b) in preparations containing 0.1 per cent or less of deltamethrin.
The following amended entry for tylosin has a delayed implementation date of 1 June 2014.
TYLOSIN – Delete entry.
SCHEDULE 6 – NEW ENTRIES
1,2-benzenediol.
The following amended entry for cocoyl glycinate has a delayed implementation date of 1 February 2015.
COCOYL GLYCINATE in cosmetic preparations except:
(a) in leave-on preparations containing 5 per cent or less of cocoyl glycinate; or
(b) in wash-off preparations containing 30 per cent or less of cocoyl glycinate and, when containing more than 5 per cent of cocoyl glycinate labelled with a warning to the following effect:
IF IN EYES WASH OUT IMMEDIATELY WITH WATER.
HEXYLOXYETHANOL except in preparations containing 10 per cent or less of hexyloxyethanol.
SCHEDULE 6 – AMENDMENTS
3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) – Amend entry to read:
3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) except:
(a) when included in Schedule 5;
(b) in aqueous preparations not for cosmetic use containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate (Iodocarb); or
(c) in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.
DELTAMETHRIN – Amend entry to read:
DELTAMETHRIN:
(a) in aqueous preparations containing 25 per cent or less of deltamethrin, when no organic solvent, other than 10 per cent or less of a glycol, is present;
(b) in wettable granular preparations containing 25 per cent or less of deltamethrin;
(c) in water-dispersible tablets each containing 500 mg or less of deltamethrin;
(d) in emulsifiable concentrates containing 11 per cent or less of deltamethrin in a solvent containing 40 per cent or less of acetophenone and 45 per cent or less of liquid hydrocarbons; or
(e) in other preparations containing 3 per cent or less of deltamethrin,
except:
(a) when included in Schedule 5;
(b) in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or
(c) in preparations containing 0.1 per cent or less of deltamethrin.
SCHEDULE 7 – AMENDMENT
DELTAMETHRIN – Amend entry to read:
DELTAMETHRIN except:
(a) when included in Schedules 5 or 6; or
(b) in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or
(c) in preparations containing 0.1 per cent or less of deltamethrin.
SCHEDULE 8 - NEW ENTRY
ALPRAZOLAM.
PART 5 – THE APPENDICES
APPENDIX D, PARAGRAPH 5 - NEW ENTRY
BENZODIAZEPINE DERIVATIVES, including those separately specified in Schedule 4 and Schedule 8.
APPENDIX E, PART 2 – NEW ENTRIES
______________________________________________________________________________________
POISONS STANDARD STATEMENT
______________________________________________________________________________________
1,2-BENZENEDIOL (CATECHOL) A,E1,S1
COCOYL GLYCINATE E1
HEXYLOXYETHANOL A,G3,E2,S1
APPENDIX F, PART 3 – NEW ENTRIES
______________________________________________________________________________________
POISONS WARNING SAFETY
STATEMENT DIRECTION
______________________________________________________________________________________
1,2-BENZENEDIOL (CATECHOL) 51,59 1,4,8
HEXYLOXYETHANOL 2 1,4,8
APPENDIX I – NEW ENTRY
The Second Schedule
__________________________________________________________________________________
Substance Proportion
__________________________________________________________________________________
HEXYLOXYETHANOL more than 10 per cent by vol
APPENDIX K – NEW ENTRY
LURASIDONE.
INDEX – NEW ENTRY
catechol
see 1,2-benzenediol
EDITORIAL AMENDMENTS AND ERRATA
PART 4 – THE SCHEDULES
SCHEDULE 4 – AMENDMENTS
BESIFLOXACINE HYDROCHLORIDE – Amend entry to read:
BESIFLOXACINE.
LOTEPREDNOL ETABONATE – Amend entry to read:
LOTEPREDNOL.
PASIREOTIDE DIASPARTATE – Amend entry to read:
PASIREOTIDE.
VILANTEROL TRIFENATATE – Amend entry to read:
VILANTEROL
PART 5 – THE APPENDICES
APPENDIX B, PART 3 – AMENDMENT
BISTRIFLURON – Amend entry to read:
_____________________________________________________________________________________
REASON AREA
DATE OF FOR OF
SUBSTANCE ENTRY LISTING USE
BISTRIFLURON Feb 2014 a 1.2.2
