POISONS STANDARD AMENDMENT No. 3 OF 2009
The National Drugs and Poisons Schedule Committee, acting in accordance with its power under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act), amends the Poisons Standard 2009 in the manner set out in Schedule 1.
The amendments to the Poisons Standard 2009 as set out in Schedule 1 commence on 1 January 2010.
(signed by)
Signed
DR RUTH LOPERT
CHAIR
NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE
Dated this 2nd day of December 2009
Schedule 1-Amendments to the Poisons Standard 2009
© Commonwealth of Australia 2009
ISBN: 978-1-74241-082-1
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the:
Commonwealth Copyright Administration
Attorney-General’s Department
Robert Garran Offices
National Circuit
BARTON ACT 2600
or posted at http://www.ag.gov.au/cca
Published by the Australian Government under the Therapeutic Goods Act 1989.
Publication approval number: 6229
The amendments listed in this document were finalised at the June and October 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:
http://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
Media Liaison Unit
Australian Government Department of Health and Ageing
TABLE OF CONTENTS
Part 4 – The Schedules
Schedule 2 – Amendment
Schedule 3 – New Entries
Schedule 4 – New Entries
Schedule 4 – Amendments
Schedule 5 – New Entry
Schedule 6 – New Entries
Schedule 7 – New Entry
PART 5 – appendices
Appendix C – New Entry
Appendix C – Amendment
Appendix E, Part 2 – New Entry
Appendix F, Part 3 – New Entry
Editorial Amendments and Errata
Schedule 4 – Amendment
Schedule 5 – Amendment
Appendix D – Amendment
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 January 2010 unless otherwise stated. The amendments arise from decisions made by the Committee at its June 2009 meeting and confirmed at the October 2009 meeting except where separately specified.
LOPERAMIDE – Amend entry to read:
LOPERAMIDE in divided preparations for oral use in packs of 20 dosage units or less.
MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.
RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.
DORIPENEM.
GOLIMUMAB.
HMG-CoA REDUCTASE INHIBITORS (including “statins”) except when separately specified in these Schedules.
HUMAN PAPILLOMAVIRUS VACCINE.
JAPANESE ENCEPHALITIS VACCINE.
LACOSAMIDE.
LIRAGLUTIDE.
PRASUGREL.
SUCCIMER.
GUANIDINE – Amend entry to read:
GUANIDINE for therapeutic use.
RABEPRAZOLE – Amend entry to read:
RABEPRAZOLE except when included in Schedule 3.
MONEPANTEL.
GUANIDINE except:
(a) when included in Schedule 4; or
(b) in preparations containing 1 per cent or less of guanidine.
(The following entry for methyldibromo glutaronitrile was a decision of the June 2008 meeting, varied at the October 2008 meeting for a delayed implementation date of 1 January 2010.)
† METHYLDIBROMO GLUTARONITRILE except in preparations intended to be in contact with the skin, including cosmetic use.
SAFLUFENACIL.
(The following entry for methyldibromo glutaronitrile was a decision of the June 2008 meeting, varied at the October 2008 meeting for a delayed implementation date of 1 January 2010.)
METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use.
DI-IODOHYDROXYQUINOLINE (iodoquinol) – delete entry.
POISON……………………………………………STANDARD STATEMENT
(The following entry for guanidine also incorporates an editorial change identified at the October 2009 meeting under item 21.2.)
Guanidine when included in Schedule 6………………….A,G3,E2,S1
(The following entry for methyldibromo glutaronitrile was a decision of the June 2008 meeting, varied at the October 2008 meeting for a delayed implementation date of 1 January 2010.)
POISON WARNING SAFETY
STATEMENT DIRECTIONS
Methyldibromo glutaronitrile 28 1,4,7
SUGAMADEX – Amend entry to read:
SUGAMMADEX.
ENILCONAZOLE – Delete entry.
Appendix D, Paragraph 3 – Amend entry to read:
3. Poisons available only from or on the prescription or order of a medical practitioner authorised or approved by the Secretary of the Commonwealth Department of Health and Ageing under section 19 of the Therapeutic Goods Act 1989.
