POISONS STANDARD AMENDMENT No. 3 OF 2011
 
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 September 2011.
 
 
(signed by)
 
 
ANTHONY GILL
Delegate of the Secretary to the Department of Health and Ageing
 
 
Dated this 30th             day of AUGUST 2011
 
 
 
 
Schedule 1-Amendments to the Poisons Standard 2011
 
 
 
 
 
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
 
No. 2
 
 
 
AMENDMENT No. 1
 
 
Effective Date – 1 September 2011
© Commonwealth of Australia 2011
 
ISBN : 978-1-74241-532-1
 
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Published by the Australian Government under the Therapeutic Goods Act 1989.
 
Publication approval number: D0507
 
 
 
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.  The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the scheduling website:
 
www.tga.gov.au/industry/scheduling-decisions.htm
 
Further inquiries should be directed to:
 
The Secretary
Medicines and Poisons Scheduling Secretariat
Office of Health Protection (MDP 88)
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
Part A – AMENDMENTS TO THE SUSMP No. 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. 2 and recommends that these amendments be adopted by the States and Territories with effect from 1 September 2011.
 
Part 4 – The Schedules
SCHEDULE 2 – AMENDMENTS
 
FEXOFENADINE – Amend entry to read:
FEXOFENADINE in 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 10 dosage units or less; and
(b)     labelled with a recommended daily dose not exceeding 120 mg fexofenadine.
IBUPROFEN – Amend entry to read:
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
(a)     in liquid preparations when sold in the manufacturer’s original pack containing 8 grams or less of ibuprofen; or
(b)     in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
(i)           as the only therapeutically active constituent other than an effervescent agent;
(ii)          packed in blister or strip packaging or in a container with a child resistant closure
(iii)         in a primary pack containing not more than 25 dosage units;
(iv)         not labelled for the treatment of children 6 years of age or less; and
(v)          compliant with the requirements of the Required Advisory Statements for Medicine Labels.
Schedule 3 – NEW ENTRY
PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less.
SCHEDULE 4 - AMENDMENTS
 
DIMETHYL SULFOXIDE – Amend entry to read:
DIMETHYL SULFOXIDE (excluding dimethyl sulfone) for therapeutic use except:
(a)     when included in Schedule 6; or
(b)     in in vitro test kits.
FEXOFENADINE – Amend entry to read:
 
FEXOFENADINE except:
 
(a)     when included in Schedule 2; or
(b)     in 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 10 dosage units or less; and
(ii)          labelled with a recommended daily dose not exceeding 120 mg fexofenadine.
PARACETAMOL – Amend entry to read:
PARACETAMOL:
(a)     when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
(b)     when combined with ibuprofen in a primary pack containing more than 30 dosage units;
(c)     in slow release tablets or capsules containing more than 665 mg of paracetamol;
(d)     in non-slow release tablets or capsules containing more than 500 mg of paracetamol;
(e)     in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol; or
(f)      for injection.
SCHEDULE 4 – New Entries
APIXABAN.
CANAKINUMAB.
ECULIZUMAB.
FINGOLIMOD.
MAVACOXIB.
TICAGRELOR.
TOCERANIB.
VERNAKALANT.
SCHEDULE 5 – NEW ENTRY
BISPYRIBAC except in preparations containing 10 per cent or less of bispyribac.
SCHEDULE 5 – AMENDMENT
EMODEPSIDE – Amend entry to read:
 
EMODEPSIDE in preparations:
(a)     for external treatment of animals containing 2.5 per cent or less of emodepside; or
(b)     for oral treatment of animals containing 30 mg or less of emodepside per dosage unit.
SCHEDULE 6 – NEW ENTRIES
 
FLUMIOXAZIN when contained in water soluble bags individually packed in sealed sachets.
PROQUINAZID.
 
SCHEDULE 6 – AMENDMENT
DIMETHYL SULFOXIDE – Amend entry to read:
DIMETHYL SULFOXIDE (excluding dimethyl sulfone):
(a)     when not for therapeutic use; or
(b)     for 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 methyl salicylate as the only other therapeutic substances; or
(iii)         in clay poultice containing 2 per cent or less of dimethyl sulfoxide.
SCHEDULE 7 – AMENDMENT
 
FLUMIOXAZIN – Amend entry to read:
FLUMIOXAZIN except when included in Schedule 6.
Part 5 – The APPENDIces
APPENDIX K – NEW ENTRIES
ASENAPINE
 
RUPATADINE
 
TAPENTADOL
 
EDITORIAL AMENDMENTS AND ERRATA
 
SCHEDULE 2 – AMENDMENT
 
MERCUROCHROME – Amend entry to read:
MERCUROCHROME in preparations for external use containing 2 per cent or less of mercurochrome except when included in Schedule 6.
APPENDIX B – AMENDMENT
 
PRAZIQUANTEL – delete entry.
APPENDIX H – AMENDMENT
 
AMOROLFINE – delete entry.