ISBN: 978-1-74241-893-3
© Commonwealth of Australia 2013
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.
Publications approval number: 10085
The amendments listed in this document are a result of decisions made by a delegate of the Department of Health and Ageing in November 2012 and in February and March 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 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
Amendments to the Standard for the Uniform Scheduling of Medicines and Poisons
The Secretary to 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 (SUSMP 3) and recommends that these amendments be adopted by the states and territories with effect from 1 May 2013.
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;
(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; or
(c) in transdermal preparations for topical use containing 140 mg or less of diclofenac.
SCHEDULE 3 – NEW ENTRY
VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.
ALOGLIPTIN.
BESIFLOXACIN HYDROCHLORIDE.
CANAGLIFLOZIN.
CROFELEMER.
DIMETHYL FUMARATE.
ENOBOSARM.
IVACAFTOR.
MICAFUNGIN.
OLODATEROL.
PASIREOTIDE.
PASIREOTIDE DIASPARTATE.
PRUCALOPRIDE.
RETAPAMULIN.
RETIGABINE.
#SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM).
TERIFLUNOMIDE.
TILDIPIROSIN.
VILANTEROL.
VILANTEROL TRIFENATATE.
VITAMIN D – Amend entry to read:
VITAMIN D for human internal therapeutic use except:
(a) in preparations containing 25 micrograms or less of vitamin D per recommended daily dose ; or
(b) when included in Schedule 3.
CYANTRANILIPROLE.
SCHEDULE 6 – NEW ENTRY
THYMOL when packed and labelled for the control of Varroa mites in bee hives.
Appendix C – New entries
CARBAMIDE PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 18 per cent of carbamide peroxide except in preparations manufactured for, and supplied solely by, registered dental practitioners as part of their dental practice.
HYDROGEN PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 6 per cent (20 volume) of hydrogen peroxide except in preparations manufactured for and supplied solely by registered dental practitioners as part of their dental practice.
Appendix D, PARAGRAPH 5 – New entrY
SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM), including those separately specified in Schedule 4.
APPENDIX F, PART 3 – NEW ENTRY
Poison Warning statement
Teriflunomide 7, 62, 87
RETIGABINE
APPENDIX L – NEW ENTRY
Column 1 Column 2
Substance Warning statement
Teriflunomide. 7, 62 and 87
SCHEDULE 2 - AMENDMENT
FEXOFENADINE – Amend entry to read:
FEXOFENADINE in preparations for oral use except in divided 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 10 dosage units or less and not more than 5 days’ supply; and
(b) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.
FEXOFENADINE – Amend entry to read:
FEXOFENADINE except:
(a) when included in Schedule 2; or
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing 10 dosage units or less and not more than 5 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.
FORMOTEROL – Amend entry to read:
EFORMOTEROL.
PART 5 – THE APPENDICES
APPENDIX L – amendments
Column 1 Column 2
Substance Warning statement
Acitretin – Amend entry to read:
Acitretin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Adapalene – Amend entry to read:
Adapalene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Ambrisentan – Amend entry to read:
Ambrisentan 7, 62 and 76
Bexarotene – Amend entry to read:
Bexarotene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Bosentan – Amend entry to read:
Bosentan 7, 62 and 76
Etretinate – Amend entry to read:
Etretinate:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Appendix L – Amendments (continued)
Column 1 Column 2
Substance Warning statement
Isotretinoin – Amend entry to read:
Isotretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Leflunomide – Amend entry to read:
Leflunomide 7, 62 and 76
Lenalidomide – Amend entry to read:
Lenalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Sitaxentan – Amend entry to read:
Sitaxentan 7, 62 and 76
Thalidomide – Amend entry to read:
Thalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Tretinoin – Amend entry to read:
Tretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
