POISONS STANDARD AMENDMENT No. 2 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 June 2014.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health
Dated this 9th day of May 2014
Schedule 1 - Amendment to the Poisons Standard 2013
STANDARD
FOR THE
UNIFORM SCHEDULING
OF
MEDICINES AND POISONS
No. 4
AMENDMENT No. 3
Effective Date – 1 June 2014
© Commonwealth of Australia 2014
ISBN: 978-1-74186-129-7
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 Communication 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.
Publications approval number: 10747
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 April 2014. 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 June 2014.
PART 4 – THE SCHEDULES
SCHEDULE 2 – NEW ENTRY
MACROGOLS in preparations for oral use as a liquid concentrate for laxative use.
SCHEDULE 3 – NEW ENTRY
ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply.
SCHEDULE 4 – NEW ENTRIES
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.
EMPAGLIFLOZIN.
FEBUXOSTAT.
NORMAL HUMAN IMMUNOGLOBULIN.
SERELAXIN.
SIMEPREVIR.
SOFOSBUVIR.
UMECLIDINIUM.
SCHEDULE 4 – AMENDMENT
DEANOL for therapeutic use.
ESOMEPRAZOLE except when included in Schedule 3.
SCHEDULE 5 – NEW ENTRIES
AFOXOLANER for the treatment and prevention of flea infestations and control of ticks in dogs in oral divided preparations each containing 140 mg or less of afoxolaner per dosage unit.
AMINOPYRALID in water soluble gel formulations containing 0.5 per cent or less of aminopyralid.
SCHEDULE 6 – NEW ENTRIES
2-CHLORO-6-(TRICHLOROMETHYL)-PYRIDINE.
fluensulfone.
METHYL ETHYL KETONE OXIME except in preparations containing 1 per cent or less of methyl ethyl ketone oxime.
FURFURAL except in preparations containing 0.1 per cent or less of furfural.
SCHEDULE 6 – AMENDMENTS
AMINOPYRALID except when included in Schedule 5.
CHROMATES (including dichromates) except in paints or tinters containing 5 per cent or less of chromium as the ammonium, barium, calcium, iron, potassium, sodium, strontium or zinc chromate calculated on the non-volatile content of the paint or tinter.
SCHEDULE 7 – NEW ENTRIES
BENZIDINE-BASED AZO DYES being:
2,2'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[N-(4-chlorophenyl)-3-oxobutanamide]
CAS No. 94249-03-3
Acid Red 85 (Acid Fast Red A)
1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-, disodium salt
CAS No. 3567-65-5
Direct Black 38
2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt
CAS No. 1937-37-7
Direct Blue 2
2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt
CAS No. 2429-73-4
Direct Blue 6
2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt
CAS No. 2602-46-2
Direct Brown 2
5-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxy- benzoic acid disodium salt
CAS No. 2429-82-5
Direct Brown 95
Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt
CAS No. 16071-86-6
Direct Green 1
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt
CAS No. 3626-28-6
Direct Green 6
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt
CAS No. 4335-09-5
Direct Red 28 (Congo Red)
1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[4-amino-, disodium salt
CAS No. 573-58-0
Direct Red 37
1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-ethoxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt
CAS No. 3530-19-6
2-NITROTOLUENE.
SCHEDULE 9 – NEW ENTRY
3,4-DICHLORO-N-{[1- (DIMETHYLAMINO)CYCLOHEXYL]METHYL}BENZAMIDE
*AH-7921
PART 5 – THE APPENDICES
APPENDIX E, PART 2 – NEW ENTRIES
________________________________________________________________________
POISONS STANDARD STATEMENT
________________________________________________________________________
Methyl ethyl ketone oxime A,E1,S1
Furfural A,E1,S1
APPENDIX F, PART 3 – NEW ENTRIES
________________________________________________________________________
POISONS WARNING SAFETY
STATEMENT DIRECTION
________________________________________________________________________
Methyl ethyl ketone oxime 5,28 1,4
Furfural 5 1,4
APPENDIX I – NEW ENTRY
The Second Schedule
________________________________________________________________________
SUBSTANCE PROPORTION
________________________________________________________________________
CHROMIUM as chromates of ammonia, more than 5 per cent
barium, calcium, iron, potassium, sodium,
strontium or zinc
INDEX – NEW ENTRIES
2-FURANCARBOXALDEHYDE
See FURFURAL
DEANOL
See 2-(dimethylamino)ethanol, DMEA, DIMETHYL MEA
2-(dimethylamino)ethanol
See DMEA, DIMETHYL MEA, DEANOL
DMEA
See DIMETHYL MEA, DEANOL, 2-(dimethylamino)ethanol
DIMETHYL MEA
See DEANOL, 2-(dimethylamino)ethanol, DMEA
INTERPRETATION
PART 1 INTERPRETATION – NEW ENTRY
“Cosmetic” means:
(a) a substance or preparation intended for placement in contact with any external part of the human body, including:
(i) the mucous membranes of the oral cavity; and
(ii) the teeth;
with a view to:
(iii) altering the odours of the body; or
(iv) changing its appearance; or
(v) cleansing it; or
(vi) maintaining it in good condition; or
(vii) perfuming it; or
(viii) protecting it.
