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Poisons Standard Amendment No. 2 of 2008

Authoritative Version
  • - F2008L03261
  • No longer in force
No. 2 of 2008 Standards/Other as made
This instrument amends the Poisons Standard 2008 to provide for decisions made by the National Drugs and Poisons Schedule Committe.
Administered by: Health
Registered 29 Aug 2008
Tabling HistoryDate
Tabled HR01-Sep-2008
Tabled Senate01-Sep-2008
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

 

 

 

 

 

POISONS STANDARD AMENDMENT NO.2 OF  2008

 

 

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 2008 in the manner set out in Schedule 1.

 

The amendments  to the Poisons Standard 2008 as set out in Schedule 1 commence on 1 September 2008.

 

 

 

 

Signed

DR RUTH LOPERT

CHAIR

NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE

 

 

 

Dated this 28th day of August 2008


 

Schedule 1-Amendments  to the Poisons Standard 2008

 

 

 

 

 

 


STANDARD

FOR THE

UNIFORM SCHEDULING

OF

DRUGS AND POISONS

 

No. 23

 

 

 

AMENDMENT No. 1

 


 

Effective Date – 1 September 2008


© Commonwealth of Australia 2008

 

ISBN 1-74186-679-0

 

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 at http://www.ag.gov.au/cca

 

Published by the Australian Government under the Therapeutic Goods Act 1989.

 

Publication approval number: P3-4204

 

 

 

 

 

 

 

 

 


The amendments listed in this document were finalised at the February and June 2008 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

 

Media Liaison Unit

Australian Government Department of Health and Ageing


TABLE OF CONTENTS

 


Part 3 – mISCELLANEOUS rEGULATIONS                                                                                                        1

Dispensed Medicines – Amendment                                                                                                           1

Dispensed Medicines – New Entry                                                                                                               1

Part 4 – The Schedules                                                                                                                                         1

Schedule 2 – Amendment                                                                                                                                1

schedule 3 – Amendments                                                                                                                              2

Schedule 4 – New Entries                                                                                                                                 4

Schedule 4 – Amendments                                                                                                                              4

Schedule 5 – New Entries                                                                                                                                 6

Schedule 5 – Amendments                                                                                                                              6

Schedule 6 – New Entries                                                                                                                                 6

Schedule 6 – Amendments                                                                                                                              6

PART 5 – appendices                                                                                                                                                8

Appendix A – Amendment                                                                                                                               8

Appendix B, Part 3 – New Entry                                                                                                                    8

Appendix C – New Entry                                                                                                                                    8

Appendix F – Part 3 – New Entry                                                                                                                  8

Editorial Amendments and Errata                                                                                                            9

Schedule 2 – Amendments                                                                                                                              9

Schedule 4 – Amendments                                                                                                                              9

Schedule 7 – Amendment                                                                                                                                9

Appendix E, Part 2 - Amendment                                                                                                                 9

Appendix F, Part 1 - Amendment                                                                                                               10

Appendix F, Part 3 - Amendments                                                                                                             10

Appendix J, Part 2 – Amendment                                                                                                               10

 


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 Schedule 1 of the Poisons Standard 2008 (that schedule being titled the Standard for the Uniform Scheduling of Drugs and Poisons No.23) and recommends that these amendments be adopted by the States and Territories with effect from 1 September 2008 unless otherwise stated.  The amendments arise from decisions made by the Committee at its February 2008 meeting and confirmed at the June 2008 meeting except where separately specified.  While this instrument is titled “Poisons Standard Amendment No.2 of 2008” it is the first amendment of Poisons Standard 2008, as Poisons Standard Amendment No.1 of 2008 amended the Poisons Standard 2007.

 

Part 3 – mISCELLANEOUS rEGULATIONS

Dispensed Medicines – Amendment

Paragraph 45 – Amend subparagraph (5) to read:

(5)     misoprostol unless it is clearly labelled with warning statement 53 in Appendix F, Part 1; or

Dispensed Medicines – New Entry

Paragraph 45 – New subparagraph (6):

(6)     dienestrol unless it is clearly labelled with warning statement 67 in Appendix F,  Part 1.

Part 4 – The Schedules

Schedule 2 – Amendment

(The following entry for fluorides was varied at the June 2008 NDPSC meeting.)

FLUORIDES – Amend entry to read:

FLUORIDES for human use:

(a)     in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or

(b)     in liquid preparations for topical use containing 1000 mg/kg or less of fluoride ion, in a container with a child-resistant closure:

(i)           for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

(ii)          for non-therapeutic use when labelled with warnings to the following effect:

(A)       Do not swallow; and

(B)       Do not use [this product/name of product] in children six years of age or less,

              except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect:

(A)       Do not swallow; and

(B)       Do not use [this product/name of product] in children six years of age or less,

except in preparations containing 15 mg/kg or less of fluoride ion or preparations supplied to registered dental professionals or by approval of an appropriate authority.

schedule 3 – Amendments

(The following entries for brompheniramine, chlorpheniramine dexchlorpheniramine, diphenhydramine and doxylamine incorporate an editorial change identified at the June 2008 NDPSC Meeting under item 21.2)

BROMPHENIRAMINE – Amend entry to read:

BROMPHENIRAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

CHLORPHENIRAMINE – Amend entry to read:

CHLORPHENIRAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

DEXCHLORPHENIRAMINE – Amend entry to read:

DEXCHLORPHENIRAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

DIPHENHYDRAMINE – Amend entry to read:

DIPHENHYDRAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

DOXYLAMINE – Amend entry to read:

DOXYLAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

(The following entry for fluorides was varied at the June 2008 NDPSC meeting.)

FLUORIDES – Amend entry to read:

FLUORIDES for human topical use:

(a)     in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or

(b)     in non-liquid preparations containing 5500 mg/kg or less of fluoride ion except:

(i)           in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(ii)          in preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:

(A)       Do not swallow; and

(B)       Do not use [this product/name of product] in children six years of age or less; or

(iii)         in preparations supplied to registered dental professionals or by approval of an appropriate authority.

(The following entries for pheniramine and triprolidine incorporate an editorial change identified at the June 2008 NDPSC Meeting under item 21.2.)

PHENIRAMINE – Amend entry to read:

PHENIRAMINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

TRIPROLIDINE – Amend entry to read:

TRIPROLIDINE in oral preparations except:

(a)     when included in Schedule 2; or

(b)     for the treatment of children under 2 years of age.

Schedule 4 – New Entries

DIRLOTAPIDE.

PANITUMUMAB.

Schedule 4 – Amendments

FLUORIDES – Amend entry to read:

FLUORIDES in preparations for human use except when included in or expressly excluded from Schedule 2 or 3.

LEAD – Amend entry to read:

† LEAD for human therapeutic use.

(The following entry for paracetamol incorporates an editorial change identified at the June 2008 NDPSC Meeting under item 21.2.)

PARACETAMOL – Amend entry to read:

PARACETAMOL:

(a)     when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;

(b)     in slow release tablets or capsules containing more than 665 mg of paracetamol;

(c)     in non-slow release tablets or capsules containing more than 500 mg of paracetamol;

(d)     in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol; or

(e)     for injection.

(The following entry for piper methysticum incorporates an editorial change identified at the June 2008 NDPSC Meeting under item 21.2.)

PIPER METHYSTICUM (kava) – Amend entry to read:

PIPER METHYSTICUM (kava) in preparations for human use except when included on the Australian Register of Therapeutic Goods in preparations:

(a)     for oral use when present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250 mg or less of kavalactones, and:

(i)           the tablet or capsule form contains 125 mg or less of kavalactones per tablet or capsule; or

(ii)          the amount of dried whole or peeled rhizome in the teabag does not exceed 3 g,

          and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b)     in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole of peeled rhizome; or

(c)     in dermal preparations.

Schedule 5 – New Entries

ESFENVALERATE in preparations containing 0.1 per cent or less of esfenvalerate.

PYRITHIONE ZINC in paints containing 0.5 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint.

SPINETORAM.

Schedule 5 – Amendments

FLUORIDES – Amend entry to read:

FLUORIDES in preparations containing 3 per cent or less of fluoride ion except in preparations:

(a)     for human use; or

(b)     containing 15 mg/kg or less of fluoride ion.

LEAD COMPOUNDS – Amend entry to read:

† LEAD COMPOUNDS in preparations for use as hair cosmetics.

METRIBUZIN – Delete entry.

Schedule 6 – New Entries

METRIBUZIN.

PYROXSULAM.

Schedule 6 – Amendments

ESFENVALERATE – Amend entry to read:

ESFENVALERATE except when included in Schedule 5.

FLUORIDES – Amend entry to read:

FLUORIDES except:

(a)     when included in Schedule 5;

(b)     in preparations for human use; or

(c)     in preparations containing 15 mg/kg or less of fluoride ion.

LEAD COMPOUNDS – Amend entry to read:

† LEAD COMPOUNDS except:

(a)     when included in Schedule 4 or 5;

(b)     in zinc based paints or tinters containing 0.2 per cent or less of lead as an impurity in the zinc and calculated on the non-volatile content of the paint or tinter;

(c)     in other paints or tinters containing 0.1 per cent or less of lead calculated on the non-volatile content of the paint or tinter;

(d)     in preparations for cosmetic use containing 100 mg/kg or less of lead;

(e)     in pencil cores, finger colours, showcard colours, pastels, crayons, poster paints/colours or coloured chalks containing 100 mg/kg or less of lead; or

(f)      in ceramic glazes when labelled with the warning statement:

                      CAUTION - Harmful if swallowed. Do not use on surfaces which contact food or drink.

                      written in letters not less than 1.5 mm in height.

(The following entry for pyrithione zinc was varied at the June 2008 NDPSC meeting.)

PYRITHIONE ZINC – Amend entry to read:

PYRITHIONE ZINC except:

(a)     when included in Schedule 2 or 5;

(b)     for human use in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(c)     in semi-solid hair preparations for animal use;

(d)     in shampoos for animal use containing 2 per cent or less of pyrithione zinc when labelled with the statement “Keep out of eyes” and “If in eyes rinse well with water”; or

(e)     when immobilised in solid preparations containing 0.5 per cent or less of pyrithione zinc.

PART 5 – appendices

Appendix A – Amendment

PRINTING INKS OR INK ADDITIVES – Amend entry to read:

PRINTING INKS or INK ADDITIVES except:

(a)     when containing a pesticide; or

(b)     preparations containing more than 0.1 per cent of lead calculated on the non-volatile content of the ink or ink additive.

Appendix B, Part 3 – New Entry

SUBSTANCE                         DATE OF                   REASON        AREA

                                                            ENTRY                       FOR                OF

                                                                                                LISTING        USE

 

CHLORANTRANILIPROLE              Sep 2008                     a                      1.2

 

Appendix C – New Entry

LEAD COMPOUNDS in inks or ink additives except preparations containing 0.1 per cent or less of lead calculated on the non-volatile content of the ink or ink additive.

Appendix F – Part 3 – New Entry

POISON                                                                     WARNING          SAFETY

                                                                             STATEMENTS          DIRECTIONS

 

Dienestrol                                                             67

 


 

Editorial Amendments and Errata

Schedule 2 – Amendments

DEXTROMETHORPHAN – Amend entry to read:

 

DEXTROMETHORPHAN (excluding its stereoisomers) when supplied in a pack containing 600 mg or less of dextromethorphan and with a recommended daily dose of 120 mg or less of dextromethorphan.

 

METHOXAMINE – Amend entry to read:

METHOXAMINE in preparations for external use except containing 1 per cent or less of methoxamine.

Schedule 4 – Amendments

DEXTROMETHORPHAN – Amend entry to read:

 

DEXTROMETHORPHAN (excluding its stereoisomers) except when included in Schedule 2.

 

DEXTRORPHAN – Amend entry to read:

 

DEXTRORPHAN (excluding its stereoisomers).

 

FRUSEMIDE – Amend entry to read:

FUROSEMIDE (frusemide).

METHOTRIMEPRAZINE – Amend entry to read:

LEVOMEPROMAZINE.

Schedule 7 – Amendment

EPIDERMAL GROWTH FACTOR – Amend entry to read:

EPIDERMAL GROWTH FACTOR except in preparations for human therapeutic use.

Appendix E, Part 2 - Amendment

Maldison – Amend entry to read:

 

POISON                                                             STANDARD STATEMENTS

 

Malathion at 20 per cent or less                             A

 

Appendix F, Part 1 - Amendment

Warning Statement 102 Amend entry to read:

 

102.   Unless a doctor has told you to, don’t use [this product / name of the product]:
For more than a few days at a time

With other medicines containing aspirin or other anti-inflammatory medicines

If you have asthma

In children under 12 years of age

In children 12-16 years of age with or recovering from chicken pox, influenza or fever

If you are pregnant.

 

Appendix F, Part 3 - Amendments

Hydrocortisone – Amend entry to read:

 

POISON                                                                     WARNING              SAFETY

                                                                             STATEMENTS              DIRECTIONS

Hydrocortisone

 

            (a)   for dermal use when included                     38,72,73,74,75

                   in Schedule 2 or 3

 

            (b)   for topical rectal use when                                      38,75

                   included in Schedule 2 or 3

 

Tranexamic acid – Delete entry.

 

Appendix J, Part 2 – Amendment

CHOLECALCIFEROL – Amend entry to read:

POISON                                                         CONDITIONS

 

Colecalciferol                                                                1