© Commonwealth of Australia 2009
ISBN 1-74186-909-9
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Published by the Australian Government under the Therapeutic Goods Act 1989.
Publication approval number: P3-5402
The amendments listed in this document were finalised at the February and June 2009 meetings of the National Drugs and Poisons Schedule Committee (NDPSC) except where separately specified. The basis of these amendments can be found in the ‘Record of the Reasons’, which can be accessed from the NDPSC website:
www.tga.gov.au/ndpsc
Further inquiries should be directed to:
The Secretary
National Drugs and Poisons Schedule Committee
GPO Box 9848
CANBERRA ACT 2601
Or by email: NDPSC@health.gov.au
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TABLE OF CONTENTS
Part 4 – The Schedules
Schedule 2 – New Entry
Schedule 2 – Amendment
Schedule 4 – New Entries
Schedule 4 – Amendments
Schedule 5 – New Entries
Schedule 5 – Amendment
Schedule 6 – New Entry
Schedule 6 – Amendment
Schedule 9 – New Entries
PART 5 – appendices
Appendix C – New Entry
Appendix D – Sub-paragraph 6 – New Entry
Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons
The National Drugs and Poisons Schedule Committee directs that the amendments below be applied to the Standard for the Uniform Scheduling of Drugs and Poisons No.24 and recommends that these amendments be adopted by the States and Territories with effect from 1 September 2009 unless otherwise stated. The amendments arise from decisions made by the Committee at its February 2009 meeting and confirmed at the June 2009 meeting except where separately specified.
(The following entry for guaiphenesin also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
GUAIPHENESIN in a modified release dosage form of 1200 mg or less of guaiphenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.
(The following entry for hydroquinone also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
HYDROQUINONE – Amend entry to read:
HYDROQUINONE (excluding monobenzone and other alkyl ethers of hydroquinone included in Schedule 4) in preparations for human external therapeutic or cosmetic use containing 2 per cent or less of hydroquinone except in hair preparations containing 0.3 per cent or less of hydroquinone.
ALPHA1-PROTEINASE INHIBITOR (HUMAN).
AMBRISENTAN.
BAZEDOXIFENE.
CILOSTAZOL.
DAPOXETINE.
ETRAVIRINE.
GEMTUZUMAB OZOGAMICIN.
METHYLNALTREXONE.
PHOSPHODIESTERASE TYPE 5 INHIBITORS except when separately specified in these Schedules.
RIVAROXABAN.
SUGAMADDEX.
TOCILIZUMAB.
(The following entry for guaiphenesin also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
GUAIPHENESIN – Amend entry to read:
GUAIPHENESIN for human therapeutic use except:
(a) when included in Schedule 2;
(b) in oral liquid preparations containing 2 per cent or less of guaiphenesin; or
(c) in divided preparations containing 200 mg or less of guaiphenesin per dosage unit.
HYDROQUINONE – Amend entry to read:
HYDROQUINONE (other than its alkyl ethers separately specified in this Schedule) in preparations for human therapeutic or cosmetic use except:
(a) when included in Schedule 2; or
(b) in hair preparations containing 0.3 per cent or less of hydroquinone.
(The following entry for diethylene glycol also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
† DIETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:
(a) in paints or paint tinters;
(b) in toothpastes or mouthwashes containing more than 0.25 per cent of diethylene glycol; or
(c) in other preparations containing 2.5 per cent or less of diethylene glycol.
PROTHIOCONAZOLE-DESCHLORO except in preparations containing 0.5 per cent or less of prothioconazole-deschloro.
PROTHIOCONAZOLE-TRIAZOLIDINETHIONE except in preparations containing 0.5 per cent or less of prothioconazole-triazolidinethione.
(The following entry for ethylene glycol also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
ETHYLENE GLYCOL – Amend entry to read:
† ETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:
(a) in paints or paint tinters;
(b) in toothpastes or mouthwashes containing more than 0.25 per cent of ethylene glycol; or
(c) in other preparations containing 2.5 per cent or less of ethylene glycol.
(The following entry for diethylene glycol also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
† DIETHYLENE GLYCOL (excluding its salts and derivatives) except:
(a) when included in Schedule 5;
(b) in paints or paint tinters;
(c) in toothpastes or mouthwashes containing more than 0.25 per cent of diethylene glycol; or
(d) in other preparations containing 2.5 per cent or less of diethylene glycol.
(The following entry for ethylene glycol also incorporates an editorial change identified at the June 2009 meeting under item 21.2)
ETHYLENE GLYCOL – Amend entry to read:
† ETHYLENE GLYCOL (excluding its salts and derivatives) except:
(a) when included in Schedule 5;
(b) in paints or paint tinters;
(c) in toothpastes or mouthwashes containing more than 0.25 per cent of ethylene glycol; or
(d) in other preparations containing 2.5 per cent or less of ethylene glycol.
1-(8-BROMOBENZO[1,2-B;4,5-B]DIFURAN-4-YL)-2-AMINOPROPANE *(Bromo-Dragonfly).
4-FLUORO-N-METHYLAMPHETAMINE.
N-PHENETHYL-4-PIPERIDONE.
ETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of ethylene glycol.
AMBRISENTAN for human use.
