POISONS STANDARD AMENDMENT No. 1 OF 2013
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 May 2013.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health and Ageing
Dated this 14th day of March 2013
Schedule 1-Amendments to the Poisons Standard 2012
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 3
AMENDMENT No. 5
Effective Date – 1 May 2013
ISBN: 978-1-74241-893-3
© Commonwealth of Australia 2013
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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.
PART 4 – THE SCHEDULES
SCHEDULE 2 – AMENDMENT
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.
SCHEDULE 4 – NEW ENTRIES
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.
SCHEDULE 4 – AMENDMENT
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.
SCHEDULE 5 – NEW ENTRY
CYANTRANILIPROLE.
SCHEDULE 6 – NEW ENTRY
THYMOL when packed and labelled for the control of Varroa mites in bee hives.
PART 5 – THE APPENDICES
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
APPENDIX K – NEW ENTRY
RETIGABINE
APPENDIX L – NEW ENTRY
Column 1 Column 2
Substance Warning statement
Teriflunomide. 7, 62 and 87
EDITORIAL AMENDMENTS AND ERRATA
PART 4 – THE SCHEDULES
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.
SCHEDULE 4 - AMENDMENTS
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
