ISBN: 978-1-74186-129-7

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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.