POISONS STANDARD 2007

The National Drugs and Poisons Schedule Committee, acting in accordance with their power under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act), prepares this new Poisons Standard under the Act, in substitution for the current Poisons Standard.

Signed

DR ROHAN HAMMETT

CHAIR

NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE

Dated this     14th     day of December 2007

1. Citation

This instrument is the Poisons Standard 2007.

2.             The New Poisons Standard

(1) The Poisons Standard 2007 prepared by the National Drugs and Poisons Schedule Committee (the Committee) consists of the following:

(a) Part 1- Standard for the Uniform Scheduling of Drugs and Poisons No. 22, published by the Committee in 2007; and

(b) Part 2 – Standard for the Uniform Scheduling of Drugs and Poisons No. 22, Consolidated Amendment.

3.             Commencement

(1)          Subject to subsection (2), the Poisons Standard 2007 commences on 1 January 2008.

(2)          Part D of Part 2 – Standard for the Uniform Scheduling of Drugs and Poisons No. 22, Consolidated Amendment, commences on 1 January 2009.

Part 1- Standard for the Uniform Scheduling of Drugs and Poisons No. 22 published by the Committee in 2007

STANDARD FOR THE UNIFORM SCHEDULING OF

DRUGS AND POISONS

No. 22

Effective Date – 1 June 2007

© Commonwealth of Australia 2007

ISBN

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 Australian Government available from the Attorney-General’s Department.  Requests and inquiries concerning reproduction and rights should be addressed to the:

Commonwealth Copyright Administration
Copyright Law Branch
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:

This publication is a consolidation of the amendments resulting from decisions made at meetings of the National Drugs and Poisons Schedule Committee (NDPSC) up to and including the October 2006 meeting.  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

PO Box 100

WODEN   ACT  2606

Or by email:  NDPSC@health.gov.au

Media Liaison Unit

Australian Government Department of Health and Ageing

CONTENTS

PREFACE     v

INTRODUCTION   vii

 Classification   vii

 Principles of Scheduling ix

 Reading the Schedules ix

PART 1 INTERPRETATION 1

PART 2 LABELS AND CONTAINERS 10

LABELS      10

 General requirements 10

 Immediate wrapper  10

 Primary packs and immediate containers 11

 Statements of quantity, proportion or strength 18

 Exemptions    20

  Selected containers and measure packs 20

  Ampoules, pre-filled syringes and injection vials 20

  Transport containers and wrappings 21

  Dispensary, industrial, laboratory and manufacturing poisons 21

  Dispensed medicines 22

  Gas cylinders   22

  Paints     22

  Camphor and naphthalene 23

 Prohibitions    23

CONTAINERS    24

 Containers for poisons other than Schedule 5 poisons 24

 Containers for Schedule 5 poisons 25

 Approved containers 26

 Child-resistant closures 26

 Schedule 8 poisons  29

 Exemptions    29

 Camphor and naphthalene 30

 Prohibitions    30

PART 3  MISCELLANEOUS REGULATIONS 31

 Advertising    31

 Sale or supply   31

  Schedule 2 poisons 31

  Schedule 3 poisons 31

  Schedule 4 poisons 32

  Schedule 7 poisons 32

 Prohibitions on sale, prescribing and possession 33 Storage                                                                      33

 Dispensed medicines 33

PART 4 THE SCHEDULES 35

 • Schedule 1   36

 • Schedule 2   37

 • Schedule 3   56

 • Schedule 4   63

 • Schedule 5   152

 • Schedule 6   188

 • Schedule 7   233

 • Schedule 8   245

 • Schedule 9   249

PART 5 APPENDICES 255

 • Appendix A  -  General Exemptions 256

 • Appendix B  -  Substances considered not to require  259
control by scheduling 

 • Appendix C  -  Substances other than those included in Schedule 9,  269

       of such danger to health as to warrant prohibition of

       sale, supply and use 

 • Appendix D -  Additional controls on possession or supply 272
of poisons included in Schedule 4 or 8 

 • Appendix E -  First Aid Instructions 275

 • Appendix F -  Warning Statements and general safety directions  294

       for poisons

 • Appendix G -  Dilute Preparations 324

 • Appendix H -  Schedule 3 poisons permitted to be advertised 326

 • Appendix I -  Uniform Paint Standard 327

 • Appendix J -  Conditions for availability and use of Schedule 7  329
poisons 

 • Appendix K -  Drugs required to be labelled with a sedation warning 334

INDEX       337

PREFACE

The Standard for the Uniform Scheduling of Drugs and Poisons is the decisions of the National Drugs and Poisons Schedule Committee, regarding classification of drugs and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. It also includes model provisions about containers and labels, and recommendations about other controls on drugs and poisons.

This document is presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. It has no legal standing other than that given to it by relevant legislation.

INTRODUCTION                        

CLASSIFICATION

Drugs and poisons are classified according to the Schedules in which they are included.  The following is a general description of the Schedules.  For the legal definitions, however, it is necessary to check with the relevant State or Territory Authority.

 Schedule 1. [This Schedule is intentionally blank.]

 Schedule 2. Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

 Schedule 3. Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

 Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

 Schedule 5. Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.

 Schedule 6. Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.

 Schedule 7. Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use.  These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely.  Special regulations restricting their availability, possession, storage or use may apply.

 Schedule 8. Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

 Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.

Availability of drugs and poisons

The purpose of classification is to group drugs and poisons into Schedules that require similar regulatory controls over their availability.

These Schedules have been developed over a long period and contain drugs and poisons that may be obsolete for various reasons.  Also as part of the move to harmonise the Australian and New Zealand classifications many substances have been added to the Schedules for that purpose, irrespective of their availability in either country.

Inclusion of a drug or poison in a Schedule indicates the degree of control required if it is marketed.  It does not indicate:

 • that the drug or poison is available; nor

 • that it has been approved or is efficacious for any use that may be specified                 in a Schedule,

nor does it negate any obligation for registration of a therapeutic good or an agricultural or veterinary chemical containing that drug or poison.

Preparations containing poisons listed in two or more schedules.

If a preparation contains two or more poisons, the provisions relating to each of the Schedules in which those poisons are included apply.

Where it is not possible to comply both with a provision relating to one of those Schedules and with a provision relating to another of those Schedules, the provision of the more restrictive Schedule applies, unless a contrary intention is indicated in the Schedules or relevant legislation.

The Schedules listed in order of greatest to least restriction are 9, 8, 4, 7, 3, 2, 6, 5.
Schedule 1 is not currently in use.

PRINCIPLES OF SCHEDULING

PRINCIPLES OF SCHEDULING

Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.

This Standard now lists poisons in nine Schedules according to the degree of control recommended to be exercised over their availability to the public.

Poisons for therapeutic use (drugs) are included in Schedules 2, 3, 4 and 8 with progression through these schedules signifying increasingly strict controls.

For agricultural, domestic and industrial poisons Schedules 5, 6 and 7 represent increasingly strict container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7.

Schedule 9 contains substances that should be available only for medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State/Territory Health Authorities. Although appearing as a Schedule in this Standard the method by which it is implemented in the States/Territories may vary.

Substances in products which have been considered for scheduling but have been exempted from this standard may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).

Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. It is recommended that provisions of this appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.

READING THE SCHEDULES

Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.

Firstly, poisons are now scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are being revised and replaced by individual entries as time permits although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.

Secondly, schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.

Where exceptions are included in an entry these have been emphasised by printing the word “except” in bold type.

Where the schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation such as pesticide registration may apply.

Where a poison has been included in more than one Schedule the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.

It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Interpretation PART 1 [paragraph 1(2)]).

Finally, when using the Standard to determine the scheduling status of a poison it may be necessary to search each relevant Schedule as well as Appendices A, B and C and the Index. In this process if the poison is not found under its “approved name” it may be shown under a group term such as:

 Group  Example

 the parent acid of salts  “oxalic acid” to find sodium oxalate

 the radical of a salt  “chromates” to find potassium chromate

 the element   “arsenic” to find arsenic trioxide

 a chemical group with similar  “hydrocarbons, liquid” to find kerosene

 toxicological or pharmacological

 activity

 a pharmacological group “anabolic steroidal agents” to find

  “androsterone”

PART 1

INTERPRETATION

1. (1) In this Standard, unless the contrary intention appears —

  “Animal feed premix” means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.

  “Appropriate authority” means:

   (a) in the Australian Capital Territory, ACT Health;

   (b) in New South Wales, the Director-General of New South Wales Health;

   (c) in Northern Territory, the Chief Health Officer of the Department of Health and Community Services;

   (d) in Queensland, the Chief Executive of Queensland Health;

   (e) in South Australia, the Chief Executive of the Department of Health;

   (f) in Tasmania, the Secretary of the Department of Health and Human Services;

   (g) in Victoria, Secretary to the Department of Human Services;

   (h) in Western Australia, the Chief Executive Officer, Department
of Health.

  “Approved name” means:

   (a) in relation to a poison that is for therapeutic use -

    (i) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic Goods Administration Approved Terminology for Medicines”, July 1999, or its successor, published by the Therapeutic Goods Administration, Canberra; or, if the poison is not listed in that publication,

    (ii) the international non-proprietary name recommended for the poison by the World Health Organisation; or, if no such name
is recommended,

    (iii) the English name, not including synonyms, by which the poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical Formulary and Handbook or the British Pharmacopoeia (Veterinary); or, if the poison is not described in any of
those publications,

    (iv) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,

    (v)  the accepted scientific name or the name descriptive of the true nature and origin of the poison;

   (b) in relation to a poison that is not for therapeutic use

    (i) the English name recommended by the Standards Association of Australia as the common name for the poison; or, if no such name is recommended,

    (ii) the English name given to the poison by the International Organisation for Standardisation; or, if no such name is given,

    (iii) the English name given to the poison by the British Standards Institution; or, if no such name is given,

    (iv) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic Goods Administration Approved Terminology for Drugs”, January 1993 (ISBN 0 644 28628 8), or its successor, published by the Australian Government Publishing Service; or, if the poison is not listed in that publication,

    (v) the English name, not including synonyms, by which the poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical Formulary and Handbook or the British Pharmacopoeia (Veterinary); or, if the poison is not described in any of those publications,

    (vi) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,

    (vii) the international non-proprietary name recommended for the poison by the World Health Organisation; or, if no such name is recommended,

    (viii) the accepted scientific name or the name descriptive of the true nature and origin of the poison.

   “Blood” means whole blood extracted from human donors.

  “Blood components” means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except for products derived through fractionation of plasma.

  “Child-resistant closure” means:

   (a) a closure that complies with the requirements for a child-resistant closure in the Australian Standard AS1928-2001 entitled Child-resistant packages as specified or amended from time to time;

   (b) a closure approved by any order made under section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or

   (c) in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”.

   “Child-resistant packaging” means packaging that:

   (a) complies with the requirements of the Australian Standard AS1928‑2001 entitled Child-resistant packages as specified or amended from time to time;

   (b) is reclosable and complies with the requirements of at least one of the following standards as specified or amended from time to time.

    (i) the International Organization for Standardization Standard ISO 8317:1989 entitled Child-resistant packaging - Requirements and testing procedures for reclosable packages;

    (ii) the British Standards Institution Standard BS EN 28317:1993 entitled Child-resistant packaging - Requirements and testing procedures for reclosable packages;

    (iii) the Canadian Standards Association Standard CSA Z76.1-99 entitled Reclosable Child-Resistant Packages;

    (iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, entitled Poison prevention packaging standards and Section 1700.20, entitled Testing procedure for special packaging;

   (c) is approved as child-resistant by any order made under section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or

   (d) is in the form of blister or strip packaging in which a unit of use is individually protected until the time of release and that complies with Section 3 (Requirements for non-reclosable packages) of Australian Standard AS 1928-2001 Child-resistant packages.

  “Compounded” in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.

  “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.

  “Dermal use” means application to the skin primarily for localised effect.

  “Designated solvent” means the following:

   acetone

   dimethylformamide

   N-(N-dodecyl)-2-pyrrolidone

   hydrocarbons, liquid

   methanol when included in Schedule 5

   methyl ethyl ketone

   methyl isoamyl ketone

   methyl isobutyl ketone

   N-methyl-2-pyrrolidone

   N-(N-octyl)-2- pyrrolidone

   phenyl methyl ketone

   styrene

   tetrachloroethylene

   1,1,1-trichloroethane

  “Distributor” means a person who imports, sells or otherwise supplies a poison.

  “Divided preparation” means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.

  “Dosage unit” means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.

  “Drug” means a poison intended for human or animal therapeutic use.

  “Essential oils” means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation.  For scheduling purposes it also means:

   (a) oils of equivalent composition derived through synthetic means; or

   (b) prepared mixtures of oils of equivalent composition comprising a mixture of synthetic and natural components.

  “External” in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.

  “First Schedule Paint” means a paint containing the specified proportion of any substance in the First Schedule to Appendix I of this Standard.

  “Graphic material” means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.

  “Height” in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.

  “Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.

  “Immediate container” includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.

  “Immediate wrapper” means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.

  “Internal use” means administration:

   (a) orally, except for topical effect in the mouth; or

   (b) for absorption and the production of a systemic effect,

    (i) by way of a body orifice other than the mouth; or

    (ii)  parenterally, other than by application to unbroken skin.

  “Label” means a statement in writing on a container of a poison.

  “Main label” means, where there are two or more labels on a container or a label is divided into two or more portions:

   (a) that label or portion of the label on which the name of the product is most prominently shown and which is primarily designed to attract attention; or

   (b) where the name of the product is equally prominent on two or more labels or portions of a label, each of those labels or portions of the label on which the name of the product is equally prominent.

  “Manufacturer” means a person who manufactures, produces, or packs a poison.

  “Measure pack” means a sealed container which contains a measured quantity of poison for use on one occasion as a pesticide or domestic product and one or more of which is enclosed in a primary pack.

  “Name and address” means the name and address, in Australia, of the manufacturer or distributor of a poison but does not include a post office, cable, telegraphic or code address.  Where such manufacturer or distributor is a company incorporated in accordance with the appropriate law of any State or Territory of the Commonwealth of Australia or a firm registered under the Business Names Act of any State or Territory, the inclusion in the label of the registered name of the corporation or firm or its branch or its division and the city or town in which a registered office is situated shall be deemed to comply with the requirements.

  “Non-access packaging” is packaging that complies with the requirements of Australian Standard AS4710-2001 entitled Packages for chemicals not intended for access or contact with their contents by humans, in relation to products that are not intended for human therapeutic use.

  “Non-volatile content” in relation to a paint or tinter means that portion of a paint or tinter determined to be the non-volatile content by Method 301.1 of Australian Standard AS 1580.

  “Paint”, without limiting the ordinary meaning, includes any substance used or intended to be used for application as a colouring or protective coating to any surface but does not include graphic material.

  “Pesticide” means any substance or mixture of substances used or intended to be used:

   (a) for preventing, destroying, repelling, attracting, inhibiting or controlling any insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of plant or animal life or viruses, which are pests; or

   (b) as a plant regulator, promoter, defoliant or desiccant for food storage, household, industrial, commercial, agricultural and non-agricultural application, but does not include veterinary drugs, stock medicines, stock feeds, stock feed additives, drugs for human use, food additives or fertilisers.

  “Poison” means any substance or preparation included in a Schedule to this Standard.

  “Primary pack” means the pack in which a poison and its immediate container or immediate wrapper or measure pack are presented for sale or supply.

  “Required Advisory Statements for Medicine Labels” means the document of that name published by the Therapeutic Goods Administration on 1 July 2004, as in force from time to time.

  “Restricted flow insert” means a restriction fitted, or moulded, in the neck of a container which:

   (a) cannot readily be removed from the container by manual force; and

   (b) limits the delivery of the contents to drops each of which is not more than 200 microlitres.

  “Second Schedule Paint” means a paint containing the specified proportion of any substance in the Second Schedule to Appendix I of this Standard.

  “Selected container” means:

   (a) an injection vial having a nominal capacity of ten millilitres or less;

   (b) a single use syringe; or

   (c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.

  “Solid” is considered to include “powder” for the purposes of scheduling.

  “Therapeutic use” means use in or in connection with:

   (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals;

   (b) influencing, inhibiting or modifying a physiological process in human beings or animals; or

   (c) testing the susceptibility of human beings or animals to a disease or ailment.

  “Third Schedule Paint” means a paint containing the specified proportion of any substance in the Third Schedule to Appendix I of this Standard.

  “Tinter” means any pigment or admixture of pigment with other substances, in powder, semi-solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.

  “Topical use” means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.

  “Toy” means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of fourteen years.

  “Transdermal use” means application to the skin primarily for systemic effect.

  “Writing” includes the visible representation or reproduction of words or figures in any form, and “to write” and “written” have corresponding meanings.

 (2) Unless the contrary intention appears a reference to a substance in a schedule or an appendix to this Standard includes:

  (a) that substance prepared from natural sources or artificially; and

  (b) where the substance is a plant (other than a plant included in Schedule 8 or 9), that plant or any part of that plant when packed or prepared for therapeutic use; and

  (c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative; and

  (d) every alkaloid of the substance and every salt of such an alkaloid; and

  (e) except where the substance is levomethorphan or levorphanol, every stereoisomer of the substance and every salt of such a stereoisomer; and

  (f) every recombinant form of the substance; and 

  (g) a preparation or admixture containing any proportion of the substance,

  but does not include:

  (h) a preparation or product included in Appendix A, or a substance and the reason for its entry in Appendix B; or

  (i) a substance included in Appendix G at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of that substance; or

  (j) any other substance included in Schedules 1 to 6, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8; or

  (k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the current version of the Minimum Compositional Standards (MCS) for Active Constituents or its successor, as published by the Australian Pesticides and Veterinary Medicines Authority.

 (3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a schedule or an appendix to this Standard in respect of a substance:

  (a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and

  (b) the expression “one per cent” means:

   (i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or

   (ii) in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation; and

   (iii) any expression of greater or lesser percentages shall have a corresponding meaning; and

  (c) in the case of codeine such concentration, strength or quantity is calculated as anhydrous codeine.

 (4) A reference to a boiling or distillation temperature in the schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).

PART 2

LABELS AND CONTAINERS

LABELS

2. A person must not sell or supply a poison unless it is labelled in accordance with paragraphs 3 to 19 of this Standard.

General requirements

3. Any word, expression or statement required by this Standard to be written on a label or container must be written:

 (1) on the outside face of the label or container; and

 (2) in the English language; and

 (3) in durable characters; and

 (4) in a colour or colours to provide a distinct contrast to the background colour; and

 (5) in letters at least 1.5 millimetres in height.

4. Sub-paragraph 3(5) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:

 (1) an appropriate authority approves the use of smaller letters; and

 (2) the letters are at least 1 millimetre in height.

5. The label must be printed on, or securely attached to:

 (1) the outside of the immediate container; and

 (2) if the immediate container is enclosed in a primary pack, the outside of that primary pack.

Immediate wrapper

6. (1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with paragraph 7 of this Standard; and

 (2) the immediate wrapper must be conspicuously labelled with:

  (a) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and

  (b) the approved name of the poison; and

  (c) a statement of the quantity or strength of the poison in accordance with paragraph 8.

Primary packs and immediate containers

7. (1) The primary pack and immediate container of a poison must be labelled as follows:

  (a) with the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the following table:

 Schedule Purpose Signal words required

 2 for any purpose PHARMACY MEDICINE

 3 for any purpose PHARMACIST ONLY MEDICINE

 4 for human use PRESCRIPTION ONLY MEDICINE

 4 for animal use PRESCRIPTION ANIMAL REMEDY

 5 for any purpose CAUTION

 6 for any purpose POISON

 7 for any purpose DANGEROUS POISON

 8 for any purpose CONTROLLED DRUG

   written:

   (i) on the first line or lines of the main label; and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least half the height of the largest letter or numeral on the label but need not be larger than:

    (A) 6 millimetres on labels for packages having a nominal capacity of 2 litres or less; or

    (B) 15 millimetres on labels for packages having a nominal capacity of more than 2 litres; and 

   (iv) if the poison:

    (A) is a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail or a statement of the principal hazard of the poison, written on that line; or

    (B) is not a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on that line;

  (b) if the poison is a Schedule 8 poison, with the cautionary statement –

POSSESSION WITHOUT AUTHORITY ILLEGAL

   written:

   (i) on a separate line or lines immediately below the signal words required by sub-paragraph 7(1)(a); and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal words; and

   (iv) with no other statement written on the same line;

  (c) with the cautionary statement –

KEEP OUT OF REACH OF CHILDREN

   written:

   (i) on a separate line or lines:

    (A) immediately below the signal word or words required by sub-paragraph 7(1)(a); or

    (B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by sub-paragraph 7(1)(b), on the line immediately below that statement; and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal word or words; and

   (iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;

  (d) if the poison is a dry chlorinating compound containing more than 10 per cent of available chlorine, except for preparations certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5.1 (oxidising substances), with the cautionary statement –

FIRE AND EXPLOSION HAZARD

   written:

   (i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal word or words; and

   (iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;

  (e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –

BURNS SKIN AND THROAT

   written:

   (i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal word; and

   (iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line of the main label;

  (f) if the poison is an aqueous solution of paraquat, with the cautionary statements –

CAN KILL IF SWALLOWED

DO NOT PUT IN DRINK BOTTLES

KEEP LOCKED UP

   written:

   (i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal words; and

   (iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;

  (g) if safety directions are required on the label by sub-paragraph 7(1)(n), with the cautionary statement –

READ SAFETY DIRECTIONS BEFORE OPENING

OR USING

   or with the cautionary statement –

READ SAFETY DIRECTIONS

   written:

   (i) on a separate line or lines;

    (A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); or

    (B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and

   (ii) in bold-face sanserif capital letters of uniform thickness; and

   (iii) in letters at least four tenths the height of the letters used for the signal word or words; and

   (iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;

  (h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road or Rail, as in force at the commencement of this Standard and as amended from time to time, with the cautionary statement –

FLAMMABLE

   written on the main label in bold-face sanserif capital letters of uniform thickness, unless already present in accordance with the requirements of the Australian Code for the Transport of Dangerous Goods by Road or Rail;

  (i) if the poison is for the treatment of animals, with the cautionary statement –

FOR ANIMAL TREATMENT ONLY

   written on the main label in bold-face sanserif capital letters of uniform thickness;

  (j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –

DO NOT SWALLOW

   written in sanserif capital letters on the main label or as part of the directions for use;

  (k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with paragraph 8:

   (i) if the poison is for human therapeutic use, written in accordance with orders made under section 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or

   (ii) if the poison is not for human therapeutic use, written in bold-face sanserif capital letters on the main label, unless:

    (A) a list of approved names is required; and

    (B) it is impractical to include the list on the main label; and

    (C) an appropriate authority has authorised its inclusion on another part of the label; or

   (iii) if the poison is a Schedule 5 poison referred to in column 1 of the following table the appropriate name opposite thereto in column 2 may be used as the approved name:

TABLE

    Column 1  Column 2

    Alkaline salts Alkaline salts

    Amines for use as curing Aliphatic amines or

    agents for epoxy resins aromatic amines

    (unless separately specified

    in the Schedules) 

    Epoxy resins, liquid Liquid epoxy resins

    Hydrocarbons, liquid Liquid hydrocarbons

    Quaternary ammonium Quaternary ammonium

    compounds compound(s)

   (iv) if a poison contains a mixture of designated solvents in excess of 25 per cent of the total volume of the poison but the proportion of one or more individual designated solvents in the mixture is equal to or less than 25 per cent, the approved names of those solvents may be expressed as follows:

    (A) where the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or

    (B) where the designated solvent is a ketone as “ketones”; or

    (C) in any other case as “solvents” or “other solvents”;

  (l) if the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, with the following expression written immediately below the approved name or the list of declared contents –

AN ANTICHOLINESTERASE COMPOUND

   (i) the requirements of sub-paragraph 7(1)(l) do not apply to:

    (A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or

    (B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or

    (C) an organophosphorus compound or carbamate contained in a

     pressurised spray pack for household use;

  (m) if the poison is prepared, packed or sold for a specific purpose, with clear and adequate directions for use unless:

   (i) the poison is included in Schedule 4 or Schedule 8; or

   (ii) it is impractical to include such directions on the label and:

    (A) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”; and

    (B) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label; and

    (C) the insert is enclosed in the primary pack;

  (n) if use of the poison may be harmful to the user, with appropriate safety directions (see Appendix F), grouped together as a distinct section of the label and prefaced by the words –

SAFETY DIRECTIONS

   written in bold-face capital letters;

  (o) if any warning statement or statements are required for the poison (see Appendix F), with that warning statement or those statements grouped together:

   (i) if safety directions are included on the label, immediately after the words “SAFETY DIRECTIONS”; or

   (ii) if there are no safety directions, immediately preceding the directions for use;

  (p) if the poison is not for human internal use and is not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):

   (i) grouped together and prefaced by the words –

FIRST AID

    written in bold-face capital letters; or

   (ii) if a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:

    (A) written on each immediate container as specified in sub-paragraph 7(1)(p)(i); and

    (B) replaced on the primary pack with the statement –

FIRST AID: See inner packs;

  (q) with the name and address of the manufacturer or distributor.

 (2) For the purposes of sub-paragraph 7(1)(a)(iii) the term “largest letter or numeral” does not include:

  (a) a single letter or numeral which is larger than other lettering on the label; or

  (b) an affix forming part of the trade name; or

  (c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.

Statements of quantity, proportion or strength

8. The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:

 (1) if the poison is for human therapeutic use, in the manner prescribed by orders made under section 10(3) of the Commonwealth Therapeutic Goods Act, 1989;

 (2) if the poison is for a purpose or purposes other than human therapeutic use and:

  (a) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;

  (b) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;

  (c) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;

  (d) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;

  (e) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;

  (f) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;

  (g) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;

 (3) if the poison is a solution of a mineral acid, the proportion of the acid may be expressed as the mass of the acid per stated mass of the preparation;

 (4) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:

   contains not more than 10 per cent (name of the metal); or

   contains not more than 30 per cent (name of the metal); or

   contains more than 30 per cent of (name of the metal);

 (5) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;

 (6) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;

 (7) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.

 (8) For the purposes of sub-paragraph 8(7) “derivative” includes alkaloid.

Exemptions

Selected containers and measure packs

9. The requirements of paragraph 7 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which paragraphs 10 or 11 apply) when:

 (1) packed in a primary pack labelled in accordance with paragraph 7; and

 (2) labelled with:

  (a) the signal word or words, relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to sub-paragraph 7(1)(a); and

  (b) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and

  (c) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and

  (d) if the poison is for the treatment of animals, with the cautionary statement –

FOR ANIMAL TREATMENT ONLY

   written in sanserif capital letters.

Ampoules, pre-filled syringes and injection vials

10. The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:

 (1) packed in a primary pack labelled in accordance with paragraph 7; and

 (2) labelled with:

  (a) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and

  (b) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and

  (c) if the poison is for the treatment of animals, with the cautionary statement –

FOR ANIMAL TREATMENT ONLY

   written in sanserif capital letters.

11. The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:

 (1) packed in a primary pack labelled in accordance with paragraph 7; and

 (2) the strip is labelled in accordance with paragraph 10; and

 (3) the ampoule is labelled with:

  (a) the approved name of the poison or the trade name of the product; and

  (b) the quantity, proportion or strength of the poison in accordance with paragraph 8.

Transport containers and wrappings

12. The labelling requirements of this Standard do not apply to a transparent cover, or to any wrapper, hamper, packing case, crate or other cover used solely for the purposes of transport or delivery.

Dispensary, industrial, laboratory and manufacturing poisons

13. The labelling requirements of this Standard do not apply to a poison that:

 (1) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and

 (2) is labelled in accordance with the National Occupational Health and Safety Commission’s National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012 (1994)] or its successors.

Dispensed medicines

14. Unless otherwise specified by regulation, the labelling requirements of this Standard do not apply to a poison for therapeutic use that:

 (1) is supplied by a medical, dental or veterinary practitioner in the ordinary course of their professional practice; or

 (2) is supplied on and in accordance with a prescription written by a medical, dental or veterinary practitioner or any other person authorised to prescribe drugs and poisons; or

 (3) is prepared and supplied by a pharmacist for an individual patient.

Gas cylinders

15. The requirements of sub-paragraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.

Paints

16. The requirements of paragraph 7 do not apply to:

 (1) paint (other than a paint for therapeutic or cosmetic use) which:

  (a) contains only Schedule 5 poisons; or

  (b) is a First Schedule, Second Schedule or Third Schedule paint, that is labelled with:

   (i) the word “WARNING”, written in bold-face sanserif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line;  and

   (ii) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sanserif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and

   (iii) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and

   (vi) the name and proportion of the First Schedule, Second Schedule or Third Schedule poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint.

 (2) a tinter which contains:

  (a) only Schedule 5 poisons; or

  (b) a poison included in the First Schedule, Second Schedule or Third Schedule to Appendix I, provided that it is labelled with:

   (i) the name and proportion of that poison, and where the poison is a metal or metal salt, the proportion is expressed as the metallic element present as “calculated on the non-volatile content” or “in the dried film”; and

   (ii) if it contains more than 0.1 per cent of lead in the non-volatile content of the tinter, with:

    (A) the word “WARNING”, written in bold-face sanserif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line; and

    (B) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sanserif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and

    (C) the warnings specified for tinters in Appendix F (see paint), written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”.

Camphor and naphthalene

17. The labelling requirements of sub-paragraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc or pellet form if the device:

 (1) complies with paragraph 28; and

 (2) is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.

Prohibitions

18. A label used in connection with any poison must not include:

 (1) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or

 (2) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or

 (3) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or

 (4) any trade name or description that:

  (a) represents any single constituent of a compound preparation; or

  (b) misrepresents the composition or any property or quality of the poison; or

  (c) gives any false or misleading indication of origin or place of manufacture of the poison.

19. A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure:

 (1) any expression required by this Standard to be written or embossed on the container or pack; or

 (2) any of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as appropriate.

CONTAINERS

20. A person must not sell or supply a poison unless the immediate container complies with the requirements of paragraphs 21 to 28 of this Standard.

Containers for poisons other than Schedule 5 poisons

21. If a poison, other than a Schedule 5 poison, is sold or supplied in a container with
a nominal capacity of 2 litres or less, the container must comply with
Australian Standard AS 2216 – 1997, Packaging for Poisonous Substances
(ISBN 0 7337 1176 6) as published by Standards Australia.

21a. Notwithstanding subparagraph 21, a poison which is in Schedule 6 and is an essential oil may be packed in an amber glass container which does not comply with the tactile identification requirements of the Australian Standard if:

 (1) the other safety factors are not diminished; and

 (2) the container has a restricted flow insert and a child-resistant closure.

22. If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of more than 2 litres, the container must:

 (1) comply with sub-section 1.4 (General Requirements) of Australian Standard AS 2216 – 1997; and

 (2) have the word “POISON”:

  (a) in sanserif capital letters the height of which is at least one thirty second part of the length, height or width of the container, whichever is the greatest:

   (i) embossed; or

   (ii) indelibly written in a colour in distinct contrast to the background colour;

  (b) on the side or shoulder of the container.

Containers for Schedule 5 poisons

23. (1) The container in which any Schedule 5 poison is sold or supplied must:

  (a) comply with the container requirements of paragraph 21 or paragraph 22; or

  (b) be readily distinguishable from a container in which food, wine or other beverage is sold; and

   (i) comply with sub-section 1.4 (General Requirements) of Australian Standard AS 2216 – 1997 excluding paragraph 1.4.3;

   (ii) be securely closed and, except when containing a preparation for use on one occasion only, be capable of being re-closed to prevent spillage of its contents; and

   (iii) have the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” embossed or indelibly written thereon, or printed on a permanent adhesive label designed to adhere to a substrate without lifting and which cannot be removed without damaging either the label or the substrate.

 (2) Notwithstanding sub-paragraph 23(1), the following Schedule 5 poisons namely:

  (a) methylated spirit(s);

  (b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;

  (c) petrol;

  (d) toluene; or

  (e) xylene,

  must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in paragraph 21.

Approved containers

24.  Notwithstanding sub-paragraphs 21, 22 and 23 a poison may be packed in a container that does not comply with the tactile identification requirements of the Australian Standard or the requirements of paragraphs 22(2) or 23(1)(iii) if:

 (1) the other safety factors are not diminished;

 (2) the container is for a specific purpose; and

 (3) an appropriate authority has approved the use of the container for that purpose.

Child-resistant closures

25. (1) If a poison listed in column 1 of the following table is sold or supplied in a container having a nominal capacity specified for that poison in column 2 it must be closed with a child-resistant closure.

TABLE

  Column 1  Column 2

  Name of the poison Nominal capacity

  Alkaline salts included  All sizes
in Schedule 5, when packed and labelled
as dishwashing machine tablets.

  Alkaline salts included in Schedule 5, 5 litres / kilograms or less
when packed and labelled as 
dishwashing machine liquids,
solids or gels.

  Alkaline salts included in Schedule 5, 2.5 litres or less

  when packed and labelled as a food

  additive.

TABLE

  Column 1  Column 2

  Name of the poison Nominal capacity

  Anise oil when included in Schedule 5. 200 millilitres or less

  Basil oil when included in Schedule 5. 200 millilitres or less

  Bay oil when included in Schedule 6. 200 millilitres or less

  Cajuput oil when included in Schedule 6. 200 millilitres or less

  Cassia oil when included in Schedule 5. 200 millilitres or less

  Cineole when included in Schedule 6. 2 litres or less

  Cinnamon bark oil when included 200 millilitres or less

  in Schedule 5.

  Cinnamon leaf oil when included 200 millilitres or less

  in Schedule 6.

  Clove oil when included in Schedule 6. 200 millilitres or less

  Essential oils when included in  200 millilitres or less

  Schedule 6 because of their natural

  camphor component.

  Ethylene glycol when included in 5 litres or less

  Schedule 6.

  Ethylene glycol when included in 5 litres or less

  Schedule 5 in preparations containing

  more than 50 per cent of ethylene glycol.

  Eucalyptus oil when included 2 litres or less

  in Schedule 6.

  Eugenol when included in Schedule 6. 200 millilitres or less

  Hydrocarbons, liquid, when packed  5 litres or less

  as kerosene, lamp oil, mineral turpentine,

  thinners, reducers, white petroleum spirit

  or dry cleaning fluid.

  Hydrochloric acid when included 5 litres or less

  in Schedule 6.

TABLE

  Column 1  Column 2

  Name of the poison Nominal capacity

  Marjoram oil when included in Schedule 5. 200 millilitres or less

  Melaleuca oil (tea-tree oil) when 200 millilitres or less

  included in Schedule 6.

  Methylated spirit excluding 5 litres or less

  preparations or admixtures.

  Methyl salicylate and preparations 200 millilitres or less

  containing more than 50 per cent

  of methyl salicylate.

  Nutmeg oil when included in Schedule 5. 200 millilitres or less

  Oil of turpentine. 5 litres or less

  Pennyroyal oil when included 200 millilitres or less

  in Schedule 6.

  Potassium hydroxide as such. 2.5 litres or less

  Potassium hydroxide in oven, 5 litres or less

  hot plate or drain cleaners

  when included in Schedule 6

  except when in pressurised spray packs.

  d-Pulegone when included 200 millilitres or less

  in Schedule 6.

  Sage oil (Dalmatian) when 200 millilitres or less

  included in Schedule 6.

  Sodium hydroxide as such. 2.5 litres or less

  Sodium hydroxide in oven, 5 litres or less

  hot plate or drain cleaners

  when included in Schedule 6

  except when in pressurised spray packs.

  Thujone when included in Schedule 6. 200 millilitres or less

  Thyme oil when included in Schedule 5. 200 millilitres or less

 (2) The manufacturer or packer of a poison must ensure that the child-resistant closure is appropriate for the container and the poison and that it retains its child-resistant properties for the expected life of the poison.

Schedule 8 poisons

25A. (1) A person who supplies any Schedule 8 poison must ensure that the Schedule 8 poison is packaged in such a way that its primary pack is so sealed that, when the seal is broken, it is readily distinguishable from other sealed primary packs.

 (2) This paragraph does not apply to the supply of a Schedule 8 poison by a:

  (a) medical practitioner, dentist or veterinary surgeon in the practice of his or her profession;

  (b) pharmacist on the prescription of a medical practitioner, dentist or veterinary surgeon;

  (c) pharmacist employed at a hospital, on the written requisition of a medical practitioner, a dentist or the nurse in charge of the ward in which the Schedule 8 poison is to be used or stored; or

  (d) nurse on the direction in writing of a medical practitioner or dentist.

Exemptions

26. (1) Paragraphs 21, 22 and 23 do not apply to the immediate container of a poison prepared, packed and sold:

  (a) for human internal or animal internal use; or

  (b) as a solid or semi-solid preparation for human external or animal external use; or

  (c) as a paint, other than a paint for therapeutic or cosmetic use; or

  (d) in containers having a nominal capacity of 15 millilitres or less; or

  (e) for use in automatic photographic or photocopy processing machines if the container is specifically designed to fit into the machines; or

  (f) solely for dispensary, industrial, laboratory or manufacturing purposes.

 (2) Paragraph 25 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.

27. The tactile identification or embossing required by paragraphs 21, 22 or 23 of this Standard or Australian Standard AS 2216 – 1997 do not apply to a container that is an aerosol container, a collapsible tube, or a measure pack which is a flexible sachet.

Camphor and naphthalene

28. The container requirements of paragraph 21 do not apply to a device that contains only camphor or naphthalene in block, ball, disc or pellet form for domestic use, if the device:

 (1) in normal use, prevents removal or ingestion of its contents; and

 (2) is incapable of reacting with the poison; and

 (3) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and

 (4) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.

Prohibitions

29.  A person must not sell or supply camphor or naphthalene in ball, block, disc or pellet form for domestic use unless the balls, blocks, discs or pellets are enclosed in a device which prevents removal or ingestion of its contents.

30. A person must not sell or supply a poison in a container which has the name of another poison embossed or indelibly marked thereon.

31. A person must not sell any poison, drug or medicine which is for internal use or
any food, drink or condiment in a container prescribed by paragraphs 21, 22 or 23 of this Standard.

PART 3

MISCELLANEOUS REGULATIONS

(It is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)

ADVERTISING

32.  A person must not include any reference to a poison included in:

 (a) Schedule 3 unless included in Appendix H; or

 (b)  Schedule 4 or Schedule 8,

 of this Standard in any advertisement except in genuine professional or trade journals or other publications intended for circulation only within the medical, nursing, veterinary, dental or pharmaceutical professions or the wholesale drug industry.

33. A person must not include any reference to a substance included in Schedule 9 of this Standard in any advertisement.

SALE OR SUPPLY

Schedule 2 poisons

34. A person, other than a pharmacist (or an assistant under the direction of a pharmacist) or a medical, dental or veterinary practitioner in the lawful practice
of their professions, must not sell or supply a Schedule 2 poison unless licensed to do so.

35. A person is not eligible to be granted a licence to sell a Schedule 2 poison by way of retail sale unless:

 (1) he or she is carrying on the business of selling goods by retail; and

 (2) the premises from which the poison will be sold is more than 25 kilometres by the shortest practical route from the nearest pharmacy;  and

 (3) he or she produces such evidence, as may be required, that he or she is a fit and proper person to be so licensed.

Schedule 3 poisons

36. A person, other than a pharmacist, or a medical, dental or veterinary practitioner, in the lawful practice of his or her profession, must not sell or supply a Schedule 3 poison.

37. The person who sells or supplies a Schedule 3 poison must:

 (1) provide adequate instructions for use, either written or verbal, at the time of supply or sale;  and

 (2) label the container with his or her name or the name of the pharmacy and the address from which it was sold or supplied; and

 (3) if required by regulation, make a record of the transaction in a prescription book or other approved recording system.

Schedule 4 poisons

38. A person, other than a medical, dental or veterinary practitioner in the ordinary course of their professions or a pharmacist dispensing a legal prescription must not sell or supply a Schedule 4 poison.

39. Paragraph 38 does not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than a poison excepted by regulation from this provision, without a prescription if:

 (1) the patient is under medical treatment with the poison and continuation of medication is essential;  and

 (2) the quantity sold or supplied does not exceed 3 days medication;  and

 (3) the pharmacist is satisfied that an emergency exists.

40. Paragraphs 34, 36, 37 and 38 do not apply to sale by way of wholesale dealing to a pharmacist, medical practitioner, veterinary practitioner, dentist or a person licensed or otherwise authorised to possess, sell or supply such poisons.

Schedule 7 poisons

41.  (1) A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.

 (2) A person must not sell or supply:

  (a) a Schedule 7 poison for domestic or domestic garden purposes; or

  (b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or

  (c) a Schedule 7 poison for which an authorisation to possess or use is required by sub-paragraph (3) unless the purchaser produces his or her authorisation.

 (3) A person must not possess or use any of the following Schedule 7 poisons unless he or she is authorised to do so by the appropriate authority:

  Arsenic

  Cyanides

  Fluoroacetic acid

  Fluoroacetamide

  Hydrocyanic acid

  Strychnine

  Thallium.

 (4) The appropriate authority may exempt a person or a class of persons from the requirement to hold an authorisation under sub-paragraph (3) and may vary or revoke the exemption by notice in writing.

Prohibitions on sale, prescribing and possession

42. A person must not:

 (1) knowingly have in his or her possession or sell, supply or use a substance listed in Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Appendix C; or

 (2) sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions indicated for that poison in Appendix D; or

 (3) knowingly have in his or her possession a poison listed in Appendix D paragraph 5 without authority.

STORAGE

43. A person who sells or supplies Schedule 2 poisons must keep those poisons in such a way that public access to advice from a pharmacist is available if required.

44. A person who sells or supplies Schedule 3, Schedule 4 or Schedule 7 poisons must keep those poisons in a part of the premises to which the public does not have access.

DISPENSED MEDICINES

45. A person must not supply a dispensed medicine for human use containing:

 (1) a poison for internal use listed in Appendix K unless it is clearly labelled with warning statement 39, 40 or 90 as specified in Appendix F, Part 1; or

 (2) levocabastine, unless it is clearly labelled with warning statement 62 in Appendix F, Part 1; or

 (3) acitretin, adapalene, bexarotene, etretinate, isotretinoin, thalidomide or tretinoin:

  (i) for oral use unless it is clearly labelled with warning statements 7, 62 and 76 in Appendix F, Part 1;

  (ii) for topical use unless it is clearly labelled with warning statements 62 and 77 in Appendix F, Part 1; or

 (4) leflunomide unless it is clearly labelled with warning statements 7, 62 and 87 in Appendix F, Part 1; or

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

PART 4

THE SCHEDULES

SCHEDULE 1

This Schedule is intentionally blank.

SCHEDULE 2

(Substances marked † are listed in Appendix C)

ACETIC ACID (excluding its salts and derivatives) and preparations containing 

 more than 80 per cent of acetic acid (CH3COOH) for therapeutic use. 

ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.

ACONITUM spp. for therapeutic use in adults:

 (a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or

 (b) in preparations for dermal use containing 0.02 per cent or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.

ALOXIPRIN.

AMETHOCAINE in preparations for topical use other than eye drops, containing
10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

AMOROLFINE for topical use in preparations containing 0.25 per cent or less of amorolfine except in preparations for the treatment of tinea pedis.

ANTAZOLINE in eye drops.

ASPIRIN except:

 (a) when included in Schedule 4, 5 or 6;

 (b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when:

   (i) enclosed in a primary pack that contains 12 or less such powders or sachets of granules; and

   (ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

 (c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:

   (i) packed in blister or strip packaging or in a container with a child‑resistant closure;

SCHEDULE 2-continued

   (ii) in a primary pack of not more than 25 tablets or capsules, each containing 325 mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500 mg or less of aspirin; and

   (iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

 (d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:

   (i)  packed in blister or strip packaging or in a container with a child-resistant closure;

   (ii) in a primary pack containing 100 or less tablets or capsules, each containing 100 mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and

   (iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

ATROPA BELLADONNA (belladonna):

 (a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or

 (b) for oral use:

   (i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

   (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ATROPINE (excluding atropine methonitrate):

 (a) for oral use:

   (i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

SCHEDULE 2-continued

   (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in preparations containing atropine sulfate when packed and labelled for the treatment of organophosphorus poisoning:

   (i) in tablets each containing 0.6 mg or less of atropine sulfate in packs of 20 tablets; or

   (ii) in preparations for injection each containing 0.6 mg per mL or less of atropine sulfate in packs of 5.

AZELAIC ACID in dermal preparations.

AZELASTINE in preparations for nasal use.

BECLOMETHASONE in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing
200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

BENZOCAINE in preparations for topical use other than eye drops:

 (a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

 (b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10 per cent or less of benzoyl peroxide except in preparations containing
5 per cent or less of benzoyl peroxide.

BENZYDAMINE in preparations for topical use.

BEPHENIUM SALTS.

BIFONAZOLE in preparations for dermal use except:

 (a) in preparations containing 1 per cent or less of bifonazole for the treatment of the scalp; or

 (b) in preparations for the treatment of tinea pedis.

SCHEDULE 2-continued

BROMHEXINE.

BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 (b) in a day-night pack containing brompheniramine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

BUDESONIDE in aqueous nasal sprays delivering 50 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

CARBETAPENTANE except in preparations containing 0.5 per cent or less of carbetapentane.

CARBOCISTEINE.

CETIRIZINE in preparations for oral use.

CHLOPHEDIANOL.

CHLORBUTOL for human use in topical preparations containing 5 per cent or less of chlorbutol except in preparations containing 0.5 per cent or less of chlorbutol.

CHLOROFORM in preparations for therapeutic use except:

 (a) when included in Schedule 4; or

 (b) in preparations containing 0.5 per cent or less of chloroform.

CHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 (b) in a day-night pack containing chlorpheniramine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

CICLOPIROX in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for dermal use for the treatment of tinea pedis.

SCHEDULE 2-continued

CINCHOCAINE in preparations for topical use other than eye drops, containing 0.5 per cent or less of total local anaesthetic substances.

CINNAMEDRINE.

CLOTRIMAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

CODEINE when:

 (a) compounded:

   (i) with a single non-opiate analgesic substance in tablets or capsules each containing 10 mg or less of codeine when:

    (A) packed in blister or strip packaging or in a container with a child-resistant closure; and

    (B) in a primary package containing 25 or less dosage units; or

   (ii) with a single non-opiate analgesic substance in individually wrapped powders containing 10 mg or less of codeine when in a primary pack containing 25 or less dosage units; or

   (iii) with one or more other therapeutically active substances:

    (A) in divided preparations each containing 10 mg or less of codeine; or

    (B) in undivided preparations containing 0.25 per cent or less of codeine; and

 (b) labelled with a recommended daily dose not exceeding 60 mg of codeine.

CREOSOTE derived from wood other than beechwood for human therapeutic use, except in preparations containing 10 per cent or less of creosote derived from wood other than beechwood.

DATURA spp. for oral use:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids  and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids, or

SCHEDULE 2-continued

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

 except when separately specified in these Schedules.

DATURA STRAMONIUM (stramonium) for oral use when:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

 except for smoking or burning.

DATURA TATULA (stramonium) for oral use:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of  0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

except for smoking or burning.

DELPHINIUM STAPHISAGRIA except in preparations containing 0.2 per cent or less of Delphinium staphisagria.

DESLORATADINE in preparations for oral use.

DEXCHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 (b) in a day-night pack containing dexchlorpheniramine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

SCHEDULE 2-continued

DEXTROMETHORPHAN 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. 

DICLOFENAC in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac.

DIHYDROCODEINE when compounded with aspirin and no other therapeutically  active substance in divided preparations:

 (a) containing 5 mg or less of dihydrocodeine per dosage unit;

 (b) packed in blister or strip packaging or in a container with a child‑resistant closure;

 (c) enclosed in primary packs containing 25 or less dosage units; and

 (d) labelled with a recommended dose not exceeding 10 mg of dihydrocodeine.

DIMENHYDRINATE in primary packs of 10 doses or less, for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

DIPHENHYDRAMINE in oral preparations:

 (a) in a primary pack containing ten dosage units or less, for the prevention or treatment of motion sickness; or

 (b) when combined with one or more other therapeutically active substances when:

   (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

   (ii) in a day-night pack containing diphenhydramine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

SCHEDULE 2-continued

 (b) in a day-night pack containing doxylamine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

DUBOISIA LEICHHARDTII for oral use:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

DUBOISIA MYOPOROIDES for oral use:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ECONAZOLE for human use in dermal preparations except in preparations for the treatment of tinea pedis.

ETAFEDRINE.

ETHER for therapeutic use except:

 (a) when included in Schedule 4; or

 (b) in preparations containing 10 per cent or less of ether.

ETHYLMORPHINE when:

 (a) compounded with one or more other therapeutically active substances:

   (i) in divided preparations containing 10 mg or less of ethylmorphine per dosage unit; or

   (ii) in undivided preparations containing 0.25 per cent or less of ethylmorphine; and

 (b) labelled with a recommended dose not exceeding 15 mg of ethylmorphine.

SCHEDULE 2-continued

ETOFENAMATE in preparations for external use.

FAMOTIDINE when sold in the manufacturer’s original pack containing not more than 14 days supply.

FELBINAC in preparations for external use.

FEXOFENADINE in preparations for oral use.

FLUORIDES for human use (except in preparations containing 15 mg/kg or 15 mg/L or less of fluoride ion):

 (a)  as sodium fluoride, in preparations for ingestion containing 2.2 mg or less of sodium fluoride per dosage unit; or

 (b)  in preparations for topical use containing 2.5 per cent or less of fluoride ion except:

   (i)  when included in Schedule 3;

   (ii)  dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing
1000 mg/kg or less of fluoride ion;

   (iii)  other dental hygiene, whitening or bleaching products that are therapeutic goods, containing 220 mg/kg or 220 mg/L or less of fluoride ion, in packs containing not more than 120 mg total fluoride, fitted with a child-resistant closure, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

   (iv) other dental hygiene, whitening or bleaching products that are not therapeutic goods, containing 220 mg/kg or 220 mg/L or less of fluoride ion, in packs containing not more than 120 mg total fluoride, 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.

FLURBIPROFEN in divided preparations for topical oral use containing 10 mg or less of flurbiprofen per dosage unit.

SCHEDULE 2-continued

FLUTICASONE in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

FOLIC ACID for human therapeutic use except:

 (a) when included in Schedule 4; or

 (b) in preparations containing 500 micrograms or less of folic acid
per recommended daily dose.

FOLINIC ACID for human therapeutic use except:

 (a) when included in Schedule 4; or

 (b) in preparations containing 500 micrograms or less of folinic acid
per recommended daily dose.

FORMALDEHYDE (excluding its derivatives) for human therapeutic use except in preparations containing 5 per cent or less of formaldehyde.

GELSEMIUM SEMPERVIRENS.

GLUTARALDEHYDE for human therapeutic use.

GLYCERYL TRINITRATE except when included in Schedule 3 or 4.

HEXACHLOROPHANE in preparations for human use containing 3 per cent or less

 of hexachlorophane except:

 (a) in preparations containing 0.75 per cent or less of hexachlorophane; or

 (b) in preparations for use on infants, as specified in Schedule 4.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for dermal use containing 0.5 per cent or less of hydrocortisone in packs containing 30 g or less of such preparations containing:

 (a) no other therapeutically active substance; or

 (b) an antifungal as the only other therapeutically active substance.

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 hair preparations containing 1 per cent or less of hydroquinone.

SCHEDULE 2-continued

8-HYDROXYQUINOLINE and its non‑halogenated derivatives for human therapeutic use, except in preparations for external use containing 1 per cent or less of such substances.

HYOSCINE (excluding hyoscine butylbromide):

 (a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or

 (b) for oral use:

   (i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

   (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide
per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

HYOSCYAMINE:

 (a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or

 (b) for oral use:

   (i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

   (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less total solanaceous alkaloids.

SCHEDULE 2-continued

HYOSCYAMUS NIGER for oral use:

 (a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg of total solanaceous alkaloids
or less per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

 except in a pack containing 0.03 mg or less of total solanaceous alkaloids.

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

 (a) in liquid preparations when sold in the manufacturer’s original pack containing 4 grams or less of ibuprofen; or

 (b) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:

   (i) as the only therapeutically active constituent other than an effervescent agent;

   (ii) packed in blister or strip packaging or in a container with a child-resistant closure;

   (iii) in a primary pack containing not more than 25 dosage units;

   (iv) not labelled for the treatment of children 6 years of age or less; and

   (v) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

INDANAZOLINE.

INDOMETHACIN in preparations for external use containing 1 per cent or less of indomethacin.

IODINE:

 (a) in preparations for human internal therapeutic use containing
300 micrograms or more ofiodine per recommended daily dose; or

 (b) in preparations for human external therapeutic use containing more than 2.5 per cent of available iodine (excluding salts, derivatives or iodophors).

SCHEDULE 2-continued

IPRATROPIUM in preparations for nasal use.

IRON COMPOUNDS (excluding iron oxides when present as an excipient, in divided preparations containing 10 mg or less of total iron oxides per dosage unit or in undivided preparations containing 1 per cent or less of total iron oxides) for human internal use except:

 (a) when included in Schedule 4; or

 (b)  when labelled with a recommended daily dose of 24 mg or less of iron:

   (i)  in undivided preparations supplied in packs each containing 750 mg or less of iron; or

   (ii)  in divided preparations:

    (A)  containing more than 5 mg of iron per dosage unit in packs each containing 750 mg or less of iron; or

    (B) containing 5 mg or less of iron per dosage unit.

ISOCONAZOLE for human use in dermal preparations.

ISOPROPAMIDE in preparations for dermal use containing 2 per cent or less of isopropamide.

KETOCONAZOLE in preparations for dermal use except:

 (a) in preparations containing 1 per cent or less of ketoconazole for the treatment of the scalp; or

 (b) in preparations for the treatment of tinea pedis.

LEVOCABASTINE in topical eye or nasal preparations.

LIGNOCAINE in preparations for topical use other than eye drops:

 (a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

 (b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LINDANE in preparations for human external therapeutic use containing 2 per cent or less of lindane.

SCHEDULE 2-continued

LITHIUM in preparations for dermal use containing 1 per cent or less of lithium except:

 (a) when present as an excipient at 0.25 per cent or less of lithium; or

 (b) in preparations containing 0.01 per cent or less of lithium.

LOBELIA INFLATA except for smoking or burning.

LOBELINE except in preparations for smoking or burning.

LODOXAMIDE in preparations for ophthalmic use.

LOPERAMIDE in preparations for oral use in packs of 20 dosage units or less.

LORATADINE in preparations for oral use.

MEBENDAZOLE for human therapeutic use.

MECLOZINE in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

MEFENAMIC ACID in divided preparations for oral use in packs of 30 or less

 dosage units for the treatment of dysmenorrhoea.

MEPYRAMINE for dermal use.

MERCURY for external use in preparations containing 0.5 per cent or less of mercury.

METHOXAMINE except:

 (a) when included in Schedule 4; or

 (b) in preparations for external use containing 1 per cent or less of methoxamine.

METHOXYPHENAMINE.

METHYLEPHEDRINE.

MICONAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

MINOXIDIL in preparations for dermal use containing 5 per cent or less of minoxidil.

SCHEDULE 2-continued

MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

NAPHAZOLINE.

NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.

NICLOSAMIDE for human therapeutic use.

NICOTINE for use as an aid in withdrawal from tobacco smoking in preparations for inhalation.

NIZATIDINE when sold in the manufacturer’s original pack containing not more than 14 days supply.

NOSCAPINE.

NYSTATIN in dermal preparations.

OXETACAINE (oxethazaine) in preparations for internal use.

OXICONAZOLE for dermal use except in preparations for the treatment of tinea pedis.

OXYMETAZOLINE.

PAPAVERINE except when included in Schedule 4.

PARACETAMOL for therapeutic use except:

 (a) when included in Schedule 4;

 (b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents when:

   (i) enclosed in a primary pack that contains not more than
12 such powders or sachets of granules;

   (ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; and

   (iii) not labelled for the treatment of children 6 years of age or less; or

SCHEDULE 2-continued

 (c) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents when:

   (i) packed in blister or strip packaging or in a container with a child-resistant closure;

   (ii) in a primary pack containing not more than 25 tablets or capsules;

   (iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; and

   (iv) not labelled for the treatment of children 6 years of age or less.

PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except in preparations containing 5 per cent or less of formaldehyde.

PENCICLOVIR for external use for the treatment of Herpes labialis.

PHEDRAZINE.

PHENAZONE for human external use.

PHENIRAMINE:

 (a) in eye drops; or

 (b) when combined with one or more other therapeutically active substances in oral preparations when:

   (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

   (ii) in a day-night pack containing pheniramine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:

 (a) when included in Schedule 4; or

 (b) in preparations for external use containing 3 per cent or less of such substances.

SCHEDULE 2-continued

PHENYLEPHRINE except:

 (a) when included in Schedule 4;

 (b) in oral preparations containing 50 mg or less of phenylephrine per recommended daily dose in packs containing 250 mg or less of phenylephrine; or

 (c)  in topical eye or nasal preparations containing 1 per cent or less of phenylephrine.

PHOLCODINE:

 (a) in liquid preparations containing 0.5 per cent or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine; or

 (b) when compounded with one or more other therapeutically active substances, in divided preparations containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine.

PIPERAZINE for human therapeutic use.

PODOPHYLLOTOXIN in preparations containing 0.5 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM EMODI (podophyllin) in preparations containing 10 per cent or less of  podophyllin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts.

POTASSIUM CHLORATE for therapeutic use except in preparations containing
10 per cent or less of potassium chlorate.

PRILOCAINE in preparations for dermal use containing 10 per cent or less of total local anaesthetic substances.

PROCYCLIDINE in preparations containing 5 per cent or less of procyclidine for dermal use.

PROMETHAZINE in oral preparations:

 (a) in a primary pack containing 10 dosage units or less, for the prevention
or treatment of motion sickness; or

SCHEDULE 2-continued

 (b) when combined with one or more other therapeutically active substances when:

   (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

   (ii) in a day-night pack containing promethazine in the
bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

PYRANTEL for human therapeutic use.

PYRITHIONE ZINC for human therapeutic use, except:

 (a) in semi-solid hair preparations; or

 (b) in shampoos containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.

RANITIDINE when sold in the manufacturer’s original pack containing not more than 14 days supply.

SALICYLAMIDE except when included in Schedule 4.

SELENIUM in preparations for human topical therapeutic use except in preparations containing 3.5 per cent or less of selenium sulfide.

SILVER for therapeutic use except:

 (a) in solutions for human oral use containing 0.3 per cent or less of silver when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

 (b) in other preparations containing 1 per cent or less of silver.

SODIUM CROMOGLYCATE in preparations for nasal or ophthalmic use.

SODIUM NITRITE for therapeutic use (excluding when present as an excipient).

SQUILL except in preparations containing 1 per cent or less of squill.

SULCONAZOLE in preparations for dermal use.

TERBINAFINE for dermal use except in preparations for the treatment of tinea pedis.

SCHEDULE 2-continued

TETRACHLOROETHYLENE for human therapeutic use.

TETRAHYDROZOLINE.

THIABENDAZOLE for human therapeutic use.

TIOCONAZOLE in preparations for dermal use except in preparations for the treatment of tinea pedis.

TRAMAZOLINE.

TRIAMCINOLONE in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

TRIMEPRAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 (b) in a day-night pack containing trimeprazine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:

 (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

 (b) in a day-night pack containing triprolidine in the bed-time dose,

 except in preparations for the treatment of children under 2 years of age.

TUAMINOHEPTANE.

TYMAZOLINE.

XYLOMETAZOLINE.

ZINC CHLORIDE for human dermal use except in preparations containing 5 per cent or less of zinc chloride.

SCHEDULE 3

ADRENALINE in preparations containing 1 per cent or less of adrenaline except in  preparations containing 0.02 per cent or less of adrenaline.

ALCLOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.05 per cent or less of alclometasone in packs containing 30 g or less of the preparation.