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Poisons Standard Amendment No. 2 of 2014

Authoritative Version
  • - F2014L00566
  • No longer in force
No. 2 of 2014 Standards/Other as made
This instrument amends the Poisons Standard 2013.
Administered by: Health
Made 09 May 2014
Registered 19 May 2014
Tabled HR 26 May 2014
Tabled Senate 16 Jun 2014
Date of repeal 02 Jun 2014
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

Description: Therapeutic Goods Administration

 

 

 

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.