POISONS STANDARD AMENDMENT No. 3 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 2012 in the manner set out in Schedule 1.
The amendments to the Poisons Standard 2012 as set out in Schedule 1 commence on 1 September 2012.
(signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health and Ageing
Dated this 8th day of August 2012
Schedule 1-Amendment to the Poisons Standard 2012
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 3
AMENDMENT No. 2
Effective Date – 1 September 2012
© Commonwealth of Australia 2012
Online ISBN: 978-1-74241-779-0
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: D0892
The amendments listed in this document are a result of decisions made by a delegate of the Secretary of the Department of Health and Ageing in May 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 1 – INTERPRETATION 1
Subparagraph 1(1) – New Entry 1
Part 4 – The Schedules 1
Schedule 2 – Amendments 1
Schedule 3 – Amendment 1
Schedule 4 – New Entries 1
Schedule 4 – Amendments 1
Schedule 5 – New Entries 2
Schedule 6 – New Entries 2
PART 5 – appendices 2
Appendix B – New Entry 2
Appendix C – Amendments 2
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. 3 and recommends that these amendments be adopted by the States and Territories with effect from 1 September 2012.
Part 1 – INTERPRETATION
Subparagraph 1(1) – New Entry
“Free formaldehyde” includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol.
Part 4 – The Schedules
Schedule 2 – Amendments
CICLOPIROX – Amend entry to read:
CICLOPIROX:
(a) in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for tinea pedis; or
(b) in preparations for application to the nails containing 8 per cent or less of ciclopirox.
LORATADINE – Amendment to read:
LORATADINE in solid dose preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(a) in a primary pack containing 5 dosage units or less; and
(b) labelled with a recommended daily dose not exceeding 10 mg of loratadine.
Schedule 3 – Amendment
ADRENALINE – Amend entry to read:
ADRENALINE in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.
Schedule 4 – New Entries
AXITINIB.
COBICISTAT.
ELVITEGRAVIR.
Schedule 4 – Amendments
ADRENALINE – Amend entry to read:
ADRENALINE except:
(a) when included in Schedule 3; or
(b) in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.
CICLOPIROX – Amend entry to read:
CICLOPIROX except:
(a) when included in Schedule 2 or 3; or
(b) in preparations for the treatment of tinea pedis.
LORATADINE – Amend entry to read:
LORATADINE except
(a) when included in Schedule 2; or
(b) in solid dose preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing 5 dosage units or less; and
(ii) labelled with a recommended daily dose not exceeding 10 mg of loratadine.
Schedule 5 – New Entries
CYFLUFENAMID.
SEDAXANE.
Schedule 6 – New Entries
FLONICAMID.
ZINC BORATE (excluding its derivatives) for use as an agricultural chemical.
PART 5 – appendices
Appendix B – New Entry
Substance Date Of Reason Area
Entry For Of
Listing Use
BISTRIFLURON Sep 2012 a 1.1.2
Appendix C – Amendments
DIETHYLPHTHALATE – Amend entry to read:
DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.
DIMETHYLPHTHALATE – Amend entry to read:
DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.
