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Poisons Standard June 2017

Authoritative Version
Standards/Other as made
This standard substitutes the Poisons Standard February 2017 and consists of the standard for the Uniform Scheduling of Medicines and Poisons No. 17 (the SUSMP 17).
Administered by: Health
Made 18 May 2017
Registered 29 May 2017
Tabled HR 31 May 2017
Tabled Senate 13 Jun 2017
Table of contents.

 

Therapeutic Goods Administration

 

 

 

POISONS STANDARD JUNE 2017

 

I, ANTHONY GILL, a delegate of the Secretary to the Department of Health for the purposes of paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, prepare this new Poisons Standard, in substitution for the current Poisons Standard.

 

 

(Signed by)

 

ANTHONY GILL

Delegate of the Secretary to the Department of Health

 

Dated this  18th  May 2017

 

 

 

 

 

 

 

 

 

1.         Citation

This instrument is the Poisons Standard June 2017.

 

2.         The New Poisons Standard

The Poisons Standard June 2017 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 17 (the SUSMP 17), as set out in Schedule 1.

 

3.         Commencement

The Poisons Standard June 2017 commences on 1 June 2017.

 

 

 

 


 

 

 

 

 

 

 

 

 

 

 

Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 17

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS

No. 17

June 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reasons for scheduling delegates’ final decisions can be accessed from the TGA website, at https://www.tga.gov.au/reasons-scheduling-delegates-final-decisions  

Further inquiries in relation to this document should be directed to:


The Secretary
Chemicals Scheduling Secretariat (MD122)
Scheduling and Committee Governance
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

or by email to Chemicals.Scheduling@health.gov.au 

 

The Secretary
Medicines Scheduling Secretariat (MD122)
Scheduling and Committee Governance
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

or by email to Medicines.Scheduling@health.gov.au 

 


Media Liaison Unit
Australian Government Department of Health


Table of Contents

Table of Contents  i

INTRODUCTION  iv

CLASSIFICATION   v

PRINCIPLES OF SCHEDULING   vi

READING THE SCHEDULES  vi

AVAILABILITY OF POISONS  viii

PREPARATIONS CONTAINING POISONS LISTED IN TWO OR MORE SCHEDULES  viii

PART 1  1

INTERPRETATION_ 1

PART 2  10

CONTROL ON MEDICINES AND POISONS_ 10

SECTION ONE     LABELS_ 10

SECTION TWO    CONTAINERS_ 21

SECTION THREE    STORAGE_ 26

SECTION FOUR DISPOSAL_ 27

SECTION FIVE    RECORD KEEPING_ 27

SECTION SIX    SALE, SUPPLY, POSSESSION, or USE_ 27

SECTION SEVEN/Appendix I   PAINT OR TINTERS_ 28

PART 3  30

MISCELLANEOUS REGULATIONS_ 30

SECTION ONE    ADVERTISING_ 30

SECTION TWO    SALE OR SUPPLY_ 30

SECTION THREE    STORAGE_ 31

PART 4  32

THE SCHEDULES_ 32

SCHEDULE 1_ 32

SCHEDULE 2_ 32

SCHEDULE 3_ 50

SCHEDULE 4_ 57

SCHEDULE 5_ 143

SCHEDULE 6_ 174

SCHEDULE 7_ 220

SCHEDULE 8_ 232

SCHEDULE 9_ 236

SCHEDULE 10_ 243

PART 5  248

THE APPENDICES_ 248

APPENDIX A – GENERAL EXEMPTIONS_ 248

APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING   251

APPENDIX C (see SCHEDULE 10) 269

APPENDIX D – ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY OF POISONS INCLUDED IN SCHEDULE 4 OR 8_ 270

APPENDIX E – FIRST AID INSTRUCTIONS FOR POISONS_ 275

APPENDIX F – WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS  299

APPENDIX G – DILUTE PREPARATIONS_ 333

APPENDIX H – SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED_ 336

APPENDIX I 337

APPENDIX J – CONDITIONS FOR AVAILABILITY AND USE OF SCHEDULE 7 POISONS  338

APPENDIX K – DRUGS REQUIRED TO BE LABELLED WITH A SEDATION WARNING   344

APPENDIX L – REQUIREMENTS FOR DISPENSING LABELS FOR HUMAN AND VETERINARY MEDICINES_ 353

INDEX  358

 


 

INTRODUCTION

The Poisons Standard November 2016, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of decisions made under section 52D of the same Act.  The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the Australian Health Ministers' Advisory Council.  Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au.  Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).

The SUSMP serves two key purposes.

Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories.  The scheduling classification sets the level of control on the availability of poisons.  The scheduling of poisons is implemented through relevant State and Territory legislation.  Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.

Secondly, the SUSMP includes provisions for labelling, containers, storage, disposal, record-keeping, sale, supply and possession of poisons in general which are intended to be adopted for use in each jurisdiction of Australia.  Other government agencies may also impose controls on certain products, for example cosmetics.

The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers.  Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation. 

Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time.  Note, however that this exemption does not extend to controls on supply of these poisons.

The SUSMP is presented with a view to promoting uniform:

·      scheduling of poisons throughout Australia;

·      signal headings on labels for poisons throughout Australia;

·      labelling and packaging requirements for poisons throughout Australia;

·      additional controls on the availability and use of poisons in Australia.

The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:

·      the Agricultural and Veterinary Chemicals Code Act 1994

·      the Agricultural and Veterinary Chemicals Code Regulations 1995

·      the Therapeutic Goods Act 1989

·      Therapeutic Goods Order 69 – General requirements for labels for medicines

·      Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines

·      Therapeutic Goods Order 90 – Standard for labels of prescription and related medicines

·      Therapeutic Goods Order 91 – Standard for labels of non-prescription medicines

·      the Required Advisory Statements for Medicine Labels (RASML).

CLASSIFICATION

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 each 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.

Schedule 10 (previously Appendix C).

Substances of such danger to health as to warrant prohibition of sale, supply and use - Substances which are prohibited for the purpose or purposes listed for each poison.

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 lists poisons in ten Schedules according to the degree of control recommended to be exercised over their availability to the public.

Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 with progression through these Schedules signifying increasingly restrictive regulatory controls.

For some medicines and agricultural, domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly stricter container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7.  Products for domestic use must not include poisons listed in Schedule 7.

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

Schedule 10 (previously 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. 

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).

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 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 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 Schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.

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 Part 1, Interpretation, subparagraph 1(2)).

It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria.  Classification of a substance as a derivative of a scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, and toxicologically) to a scheduled poison or is readily converted (either physically or chemically) to a scheduled poison.  However, a substance is only considered a derivative of a scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry.  Additionally, some entries specifically exclude derivatives.  Once a substance is determined to be a derivative of a scheduled poison, the same scheduling requirements as the scheduled poison, including limits on access, supply and availability, will apply.

Finally, when using this 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 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 toxicological or pharmacological activity

“hydrocarbons, liquid” to find kerosene

a pharmacological group

“anabolic steroidal agents” to find “androsterone”

AVAILABILITY OF POISONS

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

These Schedules have been developed over a long period and contain 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 poison in a Schedule indicates the degree of control required if it is marketed.  It does not indicate:

·      that the poison is available; nor

·      that is 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 agricultural or veterinary chemical product containing that 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 on access and availability are 9, 10, 8, 4, 7, 3, 2, 6, 5.

Schedule 1 is not currently in use.

Some substances in certain circumstances are also subject to exemptions or additional restrictions as described in the Appendices of this Standard.  The table below summarises the purpose of each of the Appendices and the controls imposed on substances included in them.

 

Appendix

Title

Purpose/ controls imposed

Appendix A

General exemptions

List of classes of products or uses exempted from this Standard.

Appendix B

Substances considered not to require control by scheduling

List of poisons exempted from scheduling.

Appendix C

Appendix is intentionally left blank

See Schedule 10.

Appendix D

Additional controls on possession or supply of poisons included in Schedule 4 or 8           

List of poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply.

Appendix E

First aid instructions for poisons

First aid instructions for poisons (other than agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).

Appendix F

Warning statements and general safety directions for poisons

Warning statements and general safety directions for poisons (other than human medicines, agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).

Appendix G

Dilute preparations

Concentration cut-offs for specified poisons, below which the requirements of the Standard do not apply

Appendix H

Schedule 3 medicines permitted to be advertised

List of medicines included in Schedule 3 that are permitted to be advertised to the public.

Appendix I

Appendix is intentionally left blank

 

Appendix J

Conditions for availability and use of Schedule 7 poisons

List of poisons included in Schedule 7 where additional specified conditions apply to their availability and use.

Appendix K

Human medicines required to be labelled with a sedation warning           

List of human medicines required to be labelled with a warning regarding their sedation potential.

Appendix L

Requirements for dispensing labels for medicines       

Requirements applying to labels attached to medicines at the time of dispensing.


PART 1

INTERPRETATION

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

Agricultural chemical” means a substance that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:

a)      destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing;

b)      destroying a plant;

c)      modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity;

d)      modifying an effect of another agricultural chemical;

e)      attracting a pest for the purpose of destroying it; or

f)       any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an agricultural chemical product;

but does not include:

g)      a veterinary chemical.

Agricultural chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.

Animal” means any animal (other than a human being), whether vertebrate or not, and whether a food producing species or not, and includes mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs.

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 Government Health Directorate;

b)      for the purpose of providing an exemption from all or part of Section 1.1 to Section 1.5.3 in Part 2 of this Standard by the Australian Pesticides and Veterinary Medicines Authority, the Chief Executive Officer or their delegate;

c)      in New South Wales, the Director-General of the NSW Ministry of Health;

d)      in the Northern Territory, the Chief Health Officer of the Department of Health;

e)      in Queensland, the Chief Executive of Queensland Health;

f)       in South Australia, the Chief Executive of the Department for Health and Ageing;

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

h)      for the purpose of providing an exemption from all or part of Section 1.1 to Section 1.5.3 of this Standard by the Therapeutic Goods Administration, the National Manager or their delegate;

i)        in Victoria, the Secretary to the Department of Health;

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

Approved name” means:

a)      in relation to a poison that is for human therapeutic use, the name approved for use by the Therapeutic Goods Administration;

b)      in relation to a poison that is for animal or agricultural use, the name approved for use by the Australian Pesticides and Veterinary Medicines Authority;

c)      in relation to all other poisons:

i)        the name used in an entry in these Schedules; or, if no such name is given,

ii)      the English name recommended by Standards Australia as the common name for the poison; or, if no such name is given,

iii)    the English name given to the poison by the International Organization for Standardization; or, if no such name is given,

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

v)      the name that would comply with the requirements of part (a) or (b) of this definition, or, if no such name is given,

vi)    the English name given to the poison by the European Committee for Standardization (CEN); or, if no such name is given,

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

viii)     the International Nomenclature Cosmetic Ingredient name for the poison listed in the International Cosmetic Ingredient Dictionary & Handbook published by the Personal Care Products Council of America; or, if no such name is given,

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

Australian Code for the Transport of Dangerous Goods by Road and Rail” means the seventh edition of the document of that name.

Authorised prescriber” means a registered medical, dental or veterinary practitioner or such other person authorised by the appropriate authority.

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 AS 1928-2007 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);

b)      a closure approved by an order made under subsection 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”.

See also "Non-access packaging”.

Child-resistant packaging” means packaging that:

a)      complies with the requirements of the Australian Standard AS 1928-2007 entitled Child resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);

b)      is reclosable and complies with the requirements of at least one of the following Standards:

i)        the International Organization for Standardization Standard ISO 8317:2003 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages;

ii)      the British Standards Institution Standard BS EN ISO 8317:2004 entitled Child-resistant packaging.  Requirements and testing procedures for reclosable packages;

iii)    the Canadian Standards Association Standard CSA Z76.1-06 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 subsection 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 entitled Child-resistant packages.

See also "Non-access packaging".

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.

Cosmetic” means:

a)      a substance or preparation intended for placement in contact with any external part of the human body, including:

i)        the mucous membranes of the oral cavity; and

ii)      the teeth;

with a view to:

iii)    altering the odours of the body; or

iv)    changing its appearance; or

v)      cleansing it; or

vi)    maintaining it in good condition; or

vii)  perfuming it; or

viii)     protecting it.

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

"Dispensing label” means the label attached to the immediate container of a substance for therapeutic use at the time of dispensing.

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 Group Paint” means a paint containing the specified proportion of any substance in the First Group to Part 2 Section 7 of this Standard.

Free formaldehyde” includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol and formaldehyde released from formaldehyde donors.

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.

Hawking” means to sell or supply (including peddle or distribute or cause to be distributed) in a public place.

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)      a written statement on a container of a poison; and

b)      in relation to a therapeutic good, includes a display of printed information about the product:

i)        on, or attached to, the good;

ii)      on, or attached to, a container or primary pack in which the good is supplied; or

iii)    supplied with such a container or pack.

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

a)      the part of a label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and

b)      where there are two or more labels or two or more portions of a single label – that label or portion of the label where the product name is more or most conspicuously shown; or

c)      where the product name is equally conspicuous on two or more labels or portions of a label – each such label or portion.

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.

Medicine” means any poison for therapeutic use.
Note: To be preceded by “human” or “veterinary” where restriction of the “medicine” to human or animal use is intended.

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.

       See also "Child-resistant closure" and "Child-resistant packaging”.

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 1580-301.1-2005 entitled Paints and related materials – Methods of test – Non-volatile content by mass.

Oromucosal use” means administration to the oral mucosa, specifically the oral cavity and/or the pharynx.

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 or paints for therapeutic use.

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.

Product sample” means a packed poison supplied directly to the consumer free of charge or a nominal charge as a mechanism to promote the sale of the product and may be small packs produced specifically for the purposes of promotion or normal commercial packs which in other circumstances a consumer would need to purchase.

Public Place” means any place where members of the public are lawfully entitled, invited or permitted to be present in their capacity as members of the public. For example a street, road, footway, court, alley or through-fare that the public are allowed to use, in any residential premises, door to door, place to place or house to house.

Required Advisory Statements for Medicine Labels” means the document made under subsection 3(5A) of the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration.

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 Group Paint” means a paint containing the specified proportion of any substance in the Second Group to Part 2 Section 7 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 good” has the meaning defined in the Commonwealth Therapeutic Goods Act 1989.

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;

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

d)      influencing, controlling or preventing conception in human beings or animals;

e)      testing for pregnancy in human beings or animals; or

f)       the replacement or modification of parts of the anatomy in human beings or animals.

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 14 years.

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

Veterinary chemical” means a substance that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:

a)      preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest;

b)      curing or alleviating an injury suffered by the animal;

c)      modifying the physiology of the animal:

i)        so as to alter its natural development, productivity, quality or reproductive capacity; or

ii)      so as to make it more manageable;

d)      modifying the effect of another veterinary chemical

e)      any vitamin, mineral substance, or additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (a), (b), (c) or (d); or

f)       any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an veterinary chemical product;

but does not include:

g)      an agricultural chemical.

Veterinary chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.

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)      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 Standards for Active Constituents, 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, semi-solid or pressurised spray aerosol 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

CONTROL ON MEDICINES AND POISONS

SECTION ONE LABELS

1.1       General requirements

(1) A person must not sell or supply a poison unless it is labelled in accordance with Part 2 Section 1 of this Standard.

(2) Any word, expression or statement required by this Standard to be written on a label or container must be written:

a)      on the outside face of the label or container; and

b)      in the English language; and

c)      in durable characters; and

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

e)      in letters at least 1.5 millimetres in height.

(3) Section 1.1(2)(e) 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:

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

b)      the letters are at least 1 millimetre in height.

(4) The label must be printed on, or securely attached to:

a)      the outside of the immediate container; and

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

1.2       Immediate wrapper

(1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with Section 1.3 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 Section 1.4 of this Standard.

1.3       Primary packs and immediate containers

(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 sans serif 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 Section1.3(1)(a); and

ii)      in bold-face sans serif 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 Section 1.3(1)(a); or

B)       where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by Section 1.3(1)(b), on the line immediately below that statement; and

ii)      in bold-face sans serif 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, Division 5.1: Oxidising substances, as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, 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 Section 1.3(1)(c); and

ii)      in bold-face sans serif 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 Section 1.3(1)(c); and

ii)      in bold-face sans serif 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 Section1.3(1)(c); and

ii)      in bold-face sans serif 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)      for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if safety directions are required on the label by Section 1.3(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 Section (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 sans serif 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 and Rail, with the cautionary statement –

FLAMMABLE

written on the main label in bold-face sans serif 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 and 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 sans serif 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 sans serif 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 Section 1.4:

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

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

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 agents for epoxy resins (unless separately specified in the Schedules)

Aliphatic amines or aromatic amines

Epoxy resins, liquid

Liquid epoxy resins

Hydrocarbons, liquid

Liquid hydrocarbons

Quaternary ammonium compounds

Quaternary ammonium 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 Section 1.3(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)    for any poison other than a poison for human therapeutic use labelled in accordance with Therapeutic Goods Order 69 General requirements for labels for medicines or Therapeutic Goods Order 90 Standard for labels of prescription and related medicines or Therapeutic Goods Order 91 Standard for labels of non-prescription medicines or in an agricultural or veterinary chemical product labelled in compliance with the Agricultural and Veterinary Chemicals Code Act 1994, 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)      for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, 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)      for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, 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 Section 1.3(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 Section 1.3(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.

1.4       Statements of quantity, proportion or strength

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

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

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

i)        if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;

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

iii)    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;

iv)    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;

v)      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;

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

vii)  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;

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

c)      if the poison is a solution of a mineral acid, the proportion of the acid (un-neutralised by any bases present in the preparation) in a preparation may be expressed as the un-neutralised mass of the acid per stated mass of the preparation;

d)      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 of (insert name of the metal);       or

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

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

e)      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;

f)       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;

g)      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.

h)      for the purposes of Section 1.4(1)(g) “derivative” includes alkaloid.

1.5       Exemptions
1.5.1    Selected containers and measure packs

(1) The requirements of Section 1.3 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 Section 1.5.2 (1) and (2) apply) when:

a)      the immediate container is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or

b)      the immediate container is:

i)        packed in a primary pack labelled in accordance with Section 1.3; and

ii)      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 Section 1.3(1)(a); and

B)       the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; 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 sans serif capital letters.

1.5.2    Ampoules, pre-filled syringes and injection vials

(1) The requirements of Section 1.3 do not apply to a selected container, or an ampoule (other than an ampoule to which Section 1.5.2(2) applies) when:

a)      the selected container or ampoule is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or

b)      the selected container or ampoule is:

i)        packed in a primary pack labelled in accordance with Section 1.3; and

ii)      labelled with:

A)      the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; 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 sans serif capital letters.

(2) The requirements of Section 1.3 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:

a)      the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or

b)      the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is:

i)        packed in a primary pack labelled in accordance with Section 1.3; and

ii)      the strip is labelled in accordance with Section 1.5.2; and

iii)    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 Section 1.4.

1.5.3    Transport containers and wrappings

(1) 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.

1.5.4    Dispensary, industrial, laboratory and manufacturing poisons

(1) The labelling requirements of this Standard do not apply to a poison that:

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

b)      is labelled in accordance with requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time.

1.5.5    Exemptions from label requirements in certain circumstances

(1) the labelling requirements of Sections 1.3 to 1.5.3 do not apply to a poison where an appropriate authority has granted a labelling exemption in whole or in part for these sections for a specified product; and

(2) the labelling exemption from an appropriate authority referred to in Section 1.5.5(1) is limited to no more than 12 months from the effective date of the decision for retail supply of the product; and

(3) for the avoidance of doubt this paragraph does not apply to exemptions issued under Section 1.3(1)(m)(ii)(B) of this Standard.

1.5.6    Dispensed medicines

(1) Unless otherwise specified by regulation:

a)      The labelling requirements of this Standard do not apply to a medicine that:

i)        is supplied by an authorised prescriber or other person authorised to supply and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or

ii)      is supplied on and in accordance with a prescription written by an authorised prescriber and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or

iii)    is prepared and supplied by a pharmacist for an individual patient and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard.

b)      A person must not supply a dispensed medicine for human use containing:

i)        a poison listed in column 1 of the table at Appendix L Part 2 of this Standard unless it is clearly labelled with the warning statement(s) specified in column 2 of that table; or

ii)      a poison listed in Appendix K unless it is clearly labelled with a sedation warning (being statement 39, 40 or 90 as specified in Appendix F Part 1 of this Standard).

1.5.7    Gas cylinders

(1) The requirements of Sections 1.3(1)(a)(iv), 1.3(1)(c)(iv), and 1.3(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.

1.5.8    Paints

(1) The requirements of Section 1.3 do not apply to:

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

i)        contains only Schedule 5 poisons; or

ii)      is a First Group or Second Group paint that is labelled with:

A)      the word “WARNING”, written in bold-face sans serif 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 sans serif 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 appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and

D)      the name and proportion of the First Group or Second Group 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; or

b)      a tinter which contains:

i)        only Schedule 5 poisons; or

ii)      a poison included in the First Group or Second Group in Part 2 Section 7, provided that it is labelled with 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”.

1.5.9    Camphor and naphthalene

(1) The labelling requirements of Section1.1(2)(d) and Section 1.3 do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:

a)      complies with Section 2.7; and

b)      is sold or supplied in a primary pack labelled in accordance with Section 1.1 and Section 1.3.

1.6       Prohibitions

(1) A label used in connection with any poison must not include:

a)      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

b)      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

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

d)      any trade name or description that:

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

ii)      misrepresents the composition or any property or quality of the poison; or

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

(2) 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:

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

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

SECTION TWO CONTAINERS

2.1       Containers for poisons other than Schedule 5 poisons

(1)  A person must not sell or supply a poison unless the immediate container complies with the requirements of Sections 2.1 and 2.3 to 2.7 of this Standard.

(2) 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, entitled Packaging for poisonous substances.

(3) Notwithstanding Section 2.1(2), 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 Australian Standard AS 2216-1997, entitled Packaging for poisonous substances, if:

a)      the other safety factors are not diminished; and

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

(4) 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:

a)      comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances; and

b)      have the word “POISON”:

i)        in sans serif 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:

A)      embossed; or

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

ii)      on the side or shoulder of the container.

2.2       Containers for Schedule 5 poisons

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

a)      comply with the container requirements of Sections 2.1(2) or 2.1(4); or

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

i)        comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances, 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 Section 2.2(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 Section 2.1(2).

2.3       Approved containers

(1) Notwithstanding section 2.1(2), 2.1(4) and 2.2 a poison may be packed in a container that does not comply with the tactile identification requirements of Australian Standard AS2216-1997 entitled Packaging for poisonous substances or the requirements of Section 2.1(4)(b) or Section 2.2(1)(b)(iii) if:

a)      the other safety factors are not diminished;

b)      the container is for a specific purpose; and

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

2.4       Child-resistant closures

(1) If a poison, other than a poison included in a therapeutic good packaged in a manner compliant with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989, 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.

Column 1
Name of the poison

Column 2
Nominal capacity

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

All sizes

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

5 litres /kilograms or less

Alkaline salts included in Schedule 5, when packed and labelled as a food additive.

2.5 litres or less

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 in Schedule 5.

200 millilitres or less

Cinnamon leaf oil when included in Schedule 6.

200 millilitres or less

Clove oil when included in Schedule 6.

200 millilitres or less

Essential oils when included in Schedule 6 because of their natural camphor component.

200 millilitres or less

Ethylene glycol when included in
Schedule 6.

5 litres or less

Ethylene glycol when included in Schedule 5 in preparations containing more than 50 per cent of ethylene glycol.

5 litres or less

Eucalyptus oil when included in Schedule 6.

2 litres or less

Eugenol when included in Schedule 6.

200 millilitres or less

Fennel oil when included in Schedule 5.

200 millilitres or less

Hydrocarbons, liquid, when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid.

5 litres or less

Hydrochloric acid when included in Schedule 6.

5 litres or less

Leptospermum scoparium oil (manuka oil) when included in Schedule 6

200 millilitres or less

Marjoram oil when included in Schedule 5.

200 millilitres or less

Melaleuca oil (tea-tree oil) when included in Schedule 6.

200 millilitres or less

Methylated spirit excluding preparations or admixtures.

5 litres or less  

Methyl salicylate and preparations containing more than 50 per cent of methyl salicylate.

200 millilitres or less

Nutmeg oil when included in Schedule 5.

200 millilitres or less

Oil of turpentine.

5 litres or less

Pennyroyal oil when included in Schedule 6.

200 millilitres or less

Potassium hydroxide as such.

2.5 litres or less

Potassium hydroxide in oven, hot plate or drain cleaners when included in Schedule 6 except when in pressurised spray packs.

5 litres or less

d-Pulegone when included in Schedule 6.

200 millilitres or less

Sage oil (Dalmatian) when included in Schedule 6.

200 millilitres or less

Sodium hydroxide as such.

2.5 litres or less

Sodium hydroxide in oven, hot plate or drain cleaners when included in Schedule 6 except when in pressurised spray packs.

5 litres or less

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.

2.5       Schedule 8 poisons

(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 an:

a)      authorised prescriber or other authorised supplier;

b)      pharmacist on the prescription of an authorised prescriber;

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

d)      nurse or midwife on the direction in writing of an authorised prescriber.

2.6       Exemptions

(1) Section 2.1(2), Section 2.1(4) and Section 2.2 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) Section 2.4 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.

(3) The tactile identification or embossing required by Section 2.1(2), Section 2.1(4) and Section (2.2) of this Standard or Australian Standard AS 2216-1997 entitled Packaging for poisonous substances do not apply to a container that is an aerosol container, a collapsible tube, or a measure pack which is a flexible sachet.

2.7       Camphor and naphthalene

(1) The container requirements of Section 2.1(2) do not apply to a device that contains only camphor or naphthalene in block, ball, disc, pellet or flake form for domestic use, if the device:

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

b)      is incapable of reacting with the poison; and

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

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

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

2.8       Prohibitions

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

(2) A person must not sell any poison which is for internal use or any food, drink or condiment in a container prescribed by Sections 2.1(2), 2.1(4) and Section 2.2 of this Standard.

(3) A person must not sell any poison in a container that is not readily distinguishable from a container in which food, alcohol, other beverage or condiment is sold.

SECTION THREE      STORAGE

3.1       General requirements

(1) A person who sells or supplies Schedule 6 poisons by way of retail sale must keep those poisons in such a way as to prevent access by children.

(2) A person who sells or supplies Schedule 7 poisons must not keep those poisons for retail sale in any areas or in any area or in any manner that allows physical access by any person unless they are:

a)      the owner of the retail establishment; or

b)      an employee of the owner; or

c)      legally permitted to purchase the substance and are under the supervision of the owner or an employee of the owner.

(3) Controls on storage of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.

SECTION FOUR DISPOSAL

4.1       General requirements 

(1) A person must not dispose of or cause to be disposed of a Schedule 5, Schedule 6 or Schedule 7 poison in any place or manner that constitutes or is likely to constitute a risk to public health or safety.

(2) Controls on disposal of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.

SECTION FIVE RECORD KEEPING

5.1       General Requirements

(1) A person who sells or supplies Schedule 7 poisons must keep a record of:

a)      Name and address of seller or supplier and purchaser; and

b)      Date of order and supply; and

c)      Approved name or trade name that identifies the poison to be supplied or sold; and

d)      Quantity supplied or sold; and

e)      Proof of purchaser authorisation must be recorded in jurisdictions where an authorisation is required for purchase.

(2) Records for sale or supply of Schedule 7 poisons must be kept for a minimum period of five years.

(3) Controls on record keeping for sale or supply of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.

SECTION SIX    SALE, SUPPLY, POSSESSION, or USE

6.1       General Requirements for Schedule 5 and Schedule 6 Product samples

(1) A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in any manner unless the recipient has the opportunity to refuse at the time of sale or supply.

(2) A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in an unsolicited manner for example via the post / mailbox or attached to any other product.

(3) A person must not sell or supply a Schedule 5 or Schedule 6 poison product sample in a manner that does not promote disposal in accordance with section four.

6.2       Schedule 7 Poisons

(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 purchase, possess or use is required by the appropriate authority unless the purchaser produces his or her authorisation. 

(3) A person must not sell, supply or distribute free product samples containing Schedule 7 poisons.

6.3       Schedule 10 (previously Appendix C) poisons

(1) A person must not knowingly have in his or her possession or sell, supply or use a poison listed in Schedule 10 of this Standard for the purpose or purposes indicated in relation to that poison in Schedule 10.

6.4       Hawking

(1) A person must not sell by way of hawking a Schedule 7 poison.

(2) Controls on sale or supply or sale by way of hawking of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.

SECTION SEVEN/Appendix I       PAINT OR TINTERS

7.1       General Requirements

(1) A person must not manufacture, sell, supply or use a First Group Paint for application to:

a)      a roof or any surface to be used for the collection or storage of potable water; or

b)      furniture; or

c)      any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or

d)      any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.

(2) A person must not manufacture, sell, supply or use a paint or tinter containing more than 0.1% Lead (the proportion of Lead for the purposes of this section is calculated as a percentage of the element present in the non-volatile content of the paint).

(3) A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD).

(4) A person must not manufacture, sell, supply, or use a paint or tinter containing a pesticide except a fungicide, algaecide, bactericide or antifouling agent.

The First Group

The proportion of a substance for the purposes of this Group is calculated as a percentage of the element present in the non-volatile content of the paint.

Substance

Proportion

ANTIMONY or antimony compounds other than antimony titanate pigments

more than 5 per cent

BARIUM salts except barium sulfate or barium metaborate

more than 5 per cent

CADMIUM or cadmium compounds

more than 0.1 per cent

CHROMIUM as chromates of ammonia, barium, potassium sodium, strontium or zinc

more than 5 per cent

SELENIUM or selenium compounds

more than 0.1 per cent

The Second Group

Substance

Proportion

DICHLOROMETHANE (methylene chloride)

more than 5 per cent by wt

ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates

more than 10 per cent by vol

HEXYLOXYETHANOL

more than 10 per cent by vol

TOLUENE

more than 50 per cent by vol

XYLENE

more than 50 per cent by vol


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.)

SECTION ONE  ADVERTISING

3.1       General requirements

(1) 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.

(2) A person must not include any reference to a poison included in Schedule 9 or Schedule 10 (previously Appendix C) of this Standard in any advertisement.

SECTION TWO SALE OR SUPPLY

3.2       Schedule 2 poisons

(1) 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.

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

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

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

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

3.3       Schedule 3 poisons

(1) 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.

(2) The person who sells or supplies a Schedule 3 poison must:

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

b)      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

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

3.4       Schedule 4 poisons

(1) 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.

(2) Section 3.4(1) 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:

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

b)      the quantity sold or supplied does not exceed 3 days' medication; and

c)      the pharmacist is satisfied that an emergency exists.

(3) Section 3.2(1), Sections 3.3(1) and (2) and Section 3.4(1) 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.

3.5       Prohibitions on sale, prescribing and possession

(1) A person must not:

a)      sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3, 4, 6 and 7 except in accordance with the provisions indicated for that poison in Appendix D; or

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

SECTION THREE      STORAGE

(1) 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.

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


PART 4

THE SCHEDULES

SCHEDULE 1

 

This Schedule is intentionally blank.

 

SCHEDULE 2

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.

ALIMEMAZINE 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 alimemazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

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

ALOXIPRIN.

AMOROLFINE in preparations for topical use 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;

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) 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.

AZELAIC ACID in dermal preparations.

AZELASTINE:

a)      in preparations for nasal use; or

b)      in topical eye preparations containing 0.05 per cent or less of azelastine.

BECLOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of beclometasone 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, except:

a)      in preparations for dermal use;

b)      in divided topical oral preparations containing 3 mg or less of benzydamine; or

c)      in undivided topical oral preparations containing 0.3 per cent or less of benzydamine in a primary pack containing not more than 50 mL.

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.

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 where the day and night doses are in the same immediate container or immediate wrapper,

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 except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

a)      in a primary pack containing not more than 10 days’ supply; and

b)      labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

CHLOPHEDIANOL.

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

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.

CHLORPHENAMINE 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 chlorphenamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

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

CICLOPIROX:

a)      in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis; or

b)      in preparations for application to the nails containing 8 per cent or less of ciclopirox.

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 in preparations for the treatment of coughs and colds when:

a)      not combined with any other opiate substance;

b)      compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance:

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

ii)      in undivided preparations containing 0.25 per cent or less of codeine;

c)      labelled with a recommended daily dose not exceeding 60 mg of codeine; and

d)      in packs containing not more than 6 days' supply at the maximum dose recommended on the label.

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

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.

DEXCHLORPHENAMINE 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 dexchlorphenamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

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

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

DIBROMOPROPAMIDINE for ophthalmic use.

DICLOFENAC when:

a)      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;

b)      in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 1 per cent or less of diclofenac or for the treatment of solar keratosis; or

c)      in transdermal preparations for topical use containing 140 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 10 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 where the day and night doses are in the same immediate container or immediate wrapper,

       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

b)      in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

       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.

ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days supply.

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;

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

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 except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

a)      in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and

b)      labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

FLUORIDES for human use:

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

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

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

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

A)                  Do not swallow; and

B)                   Do not use (this product/insert name of product) in children 6 years of age or less,

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

A)    Do not swallow; and

B)     Do not use (this product/insert name of product) in children 6 years of age or less,

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

FLURBIPROFEN in preparations for topical oral use when:

a)      in divided preparations containing 10 mg or less of flurbiprofen per dosage unit; or

b)      in undivided preparations containing 0.25 per cent or less, or 10 mg or less per dose, of flurbiprofen.

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:

a)      in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or

b)      in other preparations containing 0.2 per cent or less of free formaldehyde.

GELSEMIUM SEMPERVIRENS.

GLUTARAL for human therapeutic use.

GUAIFENESIN in a modified release dosage form of 1200 mg or less of guaifenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.

HEXACHLOROPHENE in preparations for human use containing 3 per cent or less of hexachlorophene except:

a)      in preparations for use on infants, as specified in Schedule 4; or

b)      in preparations for cosmetic use, as specified in Schedule 6; or

c)      in other preparations containing 0.75 per cent or less of hexachlorophene.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use:

a)      for dermal use in preparations containing 0.5 per cent or less of hydrocortisone, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or

b)      for dermal use in preparations containing 1 per cent or less of hydrocortisone, in packs containing 15 g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent:

i)        for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and

ii)      not labelled for the treatment of children under 12 years of age; or

c)      for rectal use in preparations containing 0.5 per cent or less of hydrocortisone, when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

i)        in undivided preparations in packs of 35 g or less; or

ii)      in packs containing 12 or less suppositories.

HYDROQUINONE (excluding monobenzone and 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:

a)      in hair preparations containing 0.3 per cent or less of hydroquinone; or

b)      in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.

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.

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 8 g 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 phenylephrine or when combined with 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)    compliant with the requirements of the Required Advisory Statements for Medicine Labels;

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

vi)    not labelled for the treatment of children under 12 years of age when combined with phenylephrine.

INDANAZOLINE.

INDOMETACIN in preparations for external use containing 1 per cent or less of indometacin.

IODINE:

a)      in preparations for human internal therapeutic use containing 300 micrograms or more of iodine 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),

       except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

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.

KETOTIFEN for ophthalmic use in preparations containing 0.025 per cent or less of ketotifen.

LANSOPRAZOLE in oral preparations 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply.

LEVOCABASTINE in topical eye or nasal preparations.

LEVOCETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

a)      in a primary pack containing not more than 5 days’ supply; and

b)      labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

LIDOCAINE 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, 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.

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 divided preparations for oral use in packs of 20 dosage units or less except in preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.

LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

a)      in a primary pack containing 10 dosage units or less; and

b)      labelled with a recommended daily dose not exceeding 10 mg of loratadine.

MACROGOLS in preparations for oral use as a liquid concentrate for laxative 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.

MERCUROCHROME in preparations for external use containing 2 per cent or less of mercurochrome except when included in Schedule 6.

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

METHOXAMINE in preparations for external use except in preparations 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.

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.

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

NOSCAPINE.

NYSTATIN in dermal preparations.

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply.

OXETACAINE (oxethazaine) in preparations for internal use.

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

OXYMETAZOLINE.

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

PAPAVERINE except when included in Schedule 4.

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7days’ supply.

PARACETAMOL for therapeutic use:

a)      when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or

b)      in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or

c)      in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or

d)      in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or

e)      in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’; or

f)       in other preparations except:

i)        when included in Schedule 3 or 4; or

ii)      in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

(A)              enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,

(B)              compliant with the requirements of the Required Advisory Statements for Medicine Labels,

(C)              not labelled for the treatment of children 6 years of age or less, and

(D)              not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or

iii)    in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

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

(B)              in a primary pack containing not more than 20 tablets or capsules,

(C)              compliant with the requirements of the Required Advisory Statements for Medicine Labels,

(D)              not labelled for the treatment of children 6 years of age or less, and

(E)               not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

a)      in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or

b)      in other preparations containing 0.2 per cent or less of free 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 where the day and night doses are in the same immediate container or immediate wrapper,

       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 1 per cent or less of phenol and in preparations for external use containing 3 per cent or less of cresols and xylenols and other homologues of phenol.

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

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 where the day and night doses are in the same immediate container or immediate wrapper,

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

PROPAMIDINE for ophthalmic use.

PYRANTEL for human therapeutic use.

PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10 per cent of such substances.

PYRITHIONE ZINC for human therapeutic use, except in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply.

RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days' supply except:

a)      in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units; or

b)      in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.

SALICYLAMIDE except when included in Schedule 4.

SELENIUM in preparations for human therapeutic use except:

a)      for topical use containing 3.5 per cent or less of selenium sulfide;

b)      when included in Schedule 4; or

c)      for oral use with a recommended daily dose of 150 micrograms or less.

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.

TETRACAINE 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.

TETRACHLOROETHYLENE for human therapeutic use.

TETRYZOLINE.

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.

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 where the day and night doses are in the same immediate container or immediate wrapper,

       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 unless packed and labelled for injection.

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.

ALIMEMAZINE:

a)      in solid oral preparations except when included in Schedule 2; or

b)      in liquid oral preparations containing 10 mg or less of alimemazine per 5 mL,

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

AMINOPHYLLINE in liquid oral preparations containing 2 per cent or less of aminophylline.

AZATADINE in oral preparations.

BROMPHENIRAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

BUCLIZINE in oral preparations.

BUTOCONAZOLE in preparations for vaginal use.

CHLORAMPHENICOL for ophthalmic use only.

CHLORBUTANOL in preparations for human use except:

a)      when included in Schedule 2; or

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

CHLORPHENAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

CICLOPIROX in preparations for dermal use and for application to the nails except:

a)      when included in Schedule 2; or

b)      in preparations for the treatment of tinea pedis.

CIMETIDINE in a primary pack containing not more than 14 days' supply.

CLEMASTINE in preparations for oral use.

CLOBETASONE (clobetasone-17-butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05 per cent or less of clobetasone in packs containing 30 g or less of the preparation.

CLOTRIMAZOLE in preparations for vaginal use.

CODEINE when:

a)      not combined with any other opiate substance;

b)      compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance:

i)        in divided preparations containing 12 mg or less of codeine per dosage unit; or

ii)      in undivided preparations containing 0.25 per cent or less of codeine;

c)      labelled with a recommended daily dose not exceeding 100 mg of codeine; and

d)      in packs containing not more than 5 days' of supply at the maximum dose recommended on the label,

       except when included in Schedule 2.

CYCLIZINE in divided preparations for oral use in primary packs containing 6 dosage units or less.

CYPROHEPTADINE in oral preparations.

DEXCHLORPHENAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

DICLOFENAC in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2.

DIHYDROCODEINE when compounded with one or more other therapeutically active substances:

a)      in divided preparations containing 10 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or

b)      in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine,

       except when included in Schedule 2.

DIIODOHYDROXYQUINOLINE (iodoquinol) for vaginal use.

DIMENHYDRINATE in oral preparations except when included in Schedule 2.

DIMETHINDENE in oral preparations.

DIPHENHYDRAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate.

DITHRANOL for therapeutic use.

DOXYLAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

ECONAZOLE in preparations for vaginal use.

ERYTHRITYL TETRANITRATE for therapeutic use.

ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply except when in Schedule 2.

FAMCICLOVIR for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).

FLAVOXATE.

FLUCONAZOLE in single-dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis.

FLUORIDES for human topical use:

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

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

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

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

A)      Do not swallow; and

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

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

GLUCAGON.

GLYCERYL TRINITRATE:

a)      in preparations for oral use; or

b)      in preparations for rectal use.

GLYCOPYRRONIUM except when included in Schedule 4.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1 per cent or less of hydrocortisone:

a)      for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or

b)      for dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older); or

c)      for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

i)        in undivided preparations, in packs of 35 g or less; or

ii)      in packs containing 12 or less suppositories;

       except when included in Schedule 2.

IBUPROFEN in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units when labelled:

a)      with a recommended daily dose of 1200 mg or less of ibuprofen; and

b)      not for the treatment of children under 12 years of age;

       except when included in or expressly excluded from Schedule 2.

INOSITOL NICOTINATE.

ISOCONAZOLE in preparations for vaginal use.

ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.

KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

LEVONORGESTREL for emergency post-coital contraception.

MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.

MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.

MALATHION in preparations for human external use except in preparations containing 2 per cent or less of malathion.

MANNITYL HEXANITRATE for therapeutic use.

MEPYRAMINE in oral preparations.

METHDILAZINE in oral preparations.

METOCLOPRAMIDE when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units.

MICONAZOLE for human use in topical preparations:

a)      for the treatment of oral candidiasis; or

b)      for vaginal use.

NALOXONE when used for the treatment of opioid overdose.

NAPROXEN in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except:

a)      in preparations containing 100 mg or less of nicotinic acid per dosage unit; or

b)      nicotinamide.

NICOTINYL ALCOHOL except in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit.

NYSTATIN in preparations for topical use except when included in Schedule 2.

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

ORLISTAT in oral preparations for weight-control purposes containing 120 mg or less of orlistat per dosage unit.

OXICONAZOLE in preparations for vaginal use.

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.

PHENIRAMINE in oral preparations except:

a)      when included in Schedule 2; or

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

PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PODOPHYLLUM EMODI (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PROCHLORPERAZINE in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.

PROMETHAZINE in oral preparations except:

a)      when included in Schedule 2; or

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

PSEUDOEPHEDRINE (other than preparations for stimulant, appetite suppression or weight-control purposes) when supplied in a primary pack:

a)      in liquid preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its equivalent); or

b)      in other preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its equivalent).

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.

SALBUTAMOL as the only therapeutically active substance:

a)      in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or

b)      in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose.

SALICYLIC ACID in preparations for dermal use except in preparations containing 40 per cent or less of salicylic acid.

SANTONIN.

SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.

SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical or surgical procedures.

SULFACETAMIDE in preparations for ophthalmic use containing 10 per cent or less of sulfacetamide.

TERBUTALINE as the only therapeutically active substance:

a)      in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose; or

b)      in dry powders for inhalation delivering 500 micrograms or less of terbutaline per dose.

THEOPHYLLINE in liquid oral preparations containing 2 per cent or less of theophylline.

TIOCONAZOLE in preparations for vaginal use.

TRIAMCINOLONE for buccal use in preparations containing 0.1 per cent or less of triamcinolone in a pack of 5 g or less.

TRIPROLIDINE in oral preparations except:

a)      when included in Schedule 2; or

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

ULIPRISTAL for emergency post-coital contraception.

VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose. 


SCHEDULE 4

ABACAVIR.

ABATACEPT.

ABIRATERONE ACETATE.

ABCIXIMAB.

ACAMPROSATE CALCIUM.

ACARBOSE.

ACEBUTOLOL.

ACEPROMAZINE.

ACETANILIDE and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.

ACETARSOL.

ACETAZOLAMIDE.

ACETOHEXAMIDE.

ACETYL ISOVALERYLTYLOSIN.

ACETYLCARBROMAL.

ACETYLCHOLINE.

ACETYLCYSTEINE except:

a)      when included in Schedule 2; or

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

ACETYLDIGITOXIN.

ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE.

ACETYLSTROPHANTHIDIN.

ACICLOVIR except in preparations containing 5 per cent or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less.

ACIPIMOX.

# ACITRETIN.

ACLIDINIUM BROMIDE.

ACOKANTHERA OUABAIO.

ACOKANTHERA SCHIMPERI.

ACONITUM spp. except:

a)      when included in Schedule 2;

b)      in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or

c)      in preparations for dermal use in adults containing 0.02 per cent or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids.

ACRIVASTINE.

ADALIMUMAB.

ADAPALENE.

ADEFOVIR.

ADENOSINE for human therapeutic use in preparations for injection.

ADIPHENINE.

ADONIS VERNALIS.

ADRAFINIL.

ADRENALINE except:

a)      when included in Schedule 3; or

b)      in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.

ADRENOCORTICAL HORMONES except when separately specified in these Schedules.

AFAMELANOTIDE.

AFATINIB DIMALEATE.

AFLIBERCEPT.

AGALSIDASE.

AGLEPRISTONE.

AGOMELATINE.

ALATROFLOXACIN MESILATE.

ALBENDAZOLE except:

a)      when included in Schedule 5 or 6; or

b)      in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals.

ALCLOFENAC.

ALCLOMETASONE except when included in Schedule 3.

ALCURONIUM.

ALDESLEUKIN.

ALDOSTERONE.

# ALEFACEPT.

ALEMTUZUMAB.

ALENDRONIC ACID.

ALFACALCIDOL.

ALFUZOSIN.

ALGLUCERASE.

ALGLUCOSIDASE.

ALIMEMAZINE except when included in Schedule 2 or 3.

ALIROCUMAB.

ALISKIREN.

ALLERGENS for therapeutic use.

ALLOPURINOL.

ALLYLESTRENOL.

ALOGLIPTIN.

ALOSETRON.

ALPHA1-PROTEINASE INHIBITOR (HUMAN).

ALPHADOLONE.

ALPHAXALONE.

ALPRENOLOL.

ALPROSTADIL.

ALSEROXYLON.

ALTEPLASE.

ALTRENOGEST.

ALTRETAMINE (hexamethylmelamine).

AMANTADINE.

AMBENONIUM CHLORIDE.

# AMBRISENTAN.

AMBUCETAMIDE.

AMBUTONIUM BROMIDE.

AMCINONIDE.

AMIFOSTINE.

AMIKACIN.

AMILORIDE.

AMINOCAPROIC ACID.

AMINOGLUTETHIMIDE.

5-AMINOLEVULINIC ACID.

AMINOMETRADINE.

AMINOPHENAZONE (amidopyrine) and derivatives for the treatment of animals.

AMINOPHYLLINE except when included in Schedule 3.

AMINOPTERIN.

4-AMINOPYRIDINE for therapeutic use.

AMINOREX.

AMINOSALICYLIC ACID.

AMIODARONE.

AMIPHENAZOLE.

AMISOMETRADINE.

AMISULPRIDE.

AMITRIPTYLINE.

AMLODIPINE.

AMMI VISNAGA.

AMMONIUM BROMIDE for therapeutic use.

AMOBARBITAL when packed and labelled for injection.

AMODIAQUINE.

AMOROLFINE except:

a)      when included in Schedule 2; or

b)      in preparations for the treatment of tinea pedis.

AMOXAPINE.

AMOXICILLIN

AMPHOMYCIN.

AMPHOTERICIN B

AMPICILLIN.

AMPRENAVIR.

AMRINONE.

AMSACRINE.

AMYL NITRITE.

AMYLOCAINE.

# ANABOLIC STEROIDAL AGENTS.

ANAGRELIDE.

ANAKINRA.

ANASTROZOLE.

ANCESTIM.

ANCROD and its immunoglobulin antidote.

ANECORTAVE.

# ANDROGENIC STEROIDAL AGENTS.

# ANDROISOXAZOLE.

# ANDROSTANOLONE.

# ANDROSTENEDIOL.

# ANDROSTENEDIONE.

ANGIOTENSIN AMIDE.

ANIDULAFUNGIN.

ANISTREPLASE.

ANTAZOLINE except when included in Schedule 2.

ANTIBIOTIC SUBSTANCES except:

a)      when separately specified in these Schedules; or

b)      nisin.

ANTIGENS for human therapeutic use except when separately specified in this Schedule.

ANTIHISTAMINES except:

a)      when included in Schedule 2 or 3; or

b)      when separately specified in this Schedule.

ANTIMONY for therapeutic use except when separately specified in these Schedules.

ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules.

# AOD-9604 (CAS No. 221231-10-3).

APIXABAN.

APOCYNUM spp.

APOMORPHINE.

APRACLONIDINE.

APRAMYCIN.

APREMILAST.

APREPITANT.

APRONAL.

APROTININ.

ARECOLINE.

ARIPIPRAZOLE.

ARMODAFINIL.

ARSENIC for human therapeutic use except when separately specified in these Schedules.

ARTEMETHER.

ARTICAINE.

ASENAPINE.

ASFOTASE ALFA.

ASPARAGINASE.

ASPIRIN:

a)      when combined with caffeine, paracetamol or salicylamide or any derivative of these substances; or

b)      for injection.

ASTEMIZOLE.

ASUNAPREVIR.

# ATAMESTANE.

ATAZANAVIR.

ATENOLOL.

ATIPAMEZOLE.

ATOMOXETINE.

ATORVASTATIN.

ATOSIBAN.

ATOVAQUONE.

ATRACURIUM BESILATE.

ATROPA BELLADONNA (belladonna) except when included in Schedule 2.

ATROPINE except when included in Schedule 2.

ATROPINE METHONITRATE.

AURANOFIN.

AUROTHIOMALATE SODIUM.

AVILAMYCIN except:

a)      in animal feed premixes containing 15 per cent or less of avilamycin activity; or

b)      in animal feeds containing 50 mg/kg or less of avilamycin activity.

AVIPTADIL.

AXITINIB.

AVOPARCIN.

AZACITIDINE.

AZACYCLONOL.

AZAPERONE.

AZAPROPAZONE.

AZARIBINE.

AZATADINE except when included in Schedule 3.

AZATHIOPRINE.

AZELAIC ACID except:

a)      when included in Schedule 2; or

b)      in preparations containing 1 per cent or less of azelaic acid for non-human use.

AZELASTINE except when included in Schedule 2.

AZITHROMYCIN.

AZLOCILLIN.

AZTREONAM.

BACAMPICILLIN.

BACITRACIN.

BACLOFEN.

BALSALAZIDE.

BAMBERMYCIN (flavophospholipol) except:

a)      when included in Schedule 6; or

b)      in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

BAMBUTEROL.

BAMETHAN.

BAMIPINE.

BARBITURATES except when separately specified in these Schedules.

BASILIXIMAB.

BAZEDOXIFENE.

BECAPLERMIN.

BECLAMIDE.

BECLOMETASONE except when included in Schedule 2.

BELATACEPT.

BELIMUMAB.

BEMEGRIDE.

BENACTYZINE.

BENAZEPRIL.

BENDAMUSTINE.

BENDROFLUAZIDE.

BENETHAMINE PENICILLIN.

BENORYLATE.

BENOXAPROFEN.

BENPERIDOL.

BENSERAZIDE.

BENZATHINE PENICILLIN.

BENZILONIUM.

BENZOCAINE except:

a)      when included in Schedule 2;

b)      in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

c)      in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

# BENZODIAZEPINE derivatives except when separately specified in these Schedules.

BENZOYL PEROXIDE in preparations for human therapeutic use except:

a)      when included in Schedule 2; or

b)      in preparations for external use containing 5 per cent or less of benzoyl peroxide.

BENZPHETAMINE.

BENZTHIAZIDE.

BENZATROPINE.

BENZYDAMINE except:

a)      when included in Schedule 2;

b)      in preparations for dermal use;

c)      in divided topical oral preparations containing 3 mg or less of benzydamine; or

d)      in undivided topical oral preparations containing 0.3 per cent or less of benzydamine in a primary pack containing not more than 50 mL.

BENZYLPENICILLIN.

BEPRIDIL.

BERACTANT.

BESIFLOXACIN.

BETAHISTINE.

BETAMETHASONE.

BETAXOLOL.

BETHANECHOL CHLORIDE.

BETHANIDINE.

BEVACIZUMAB.

BEVANTOLOL.

# BEXAROTENE.

BEZAFIBRATE.

BICALUTAMIDE.

BIFONAZOLE except:

a)      when included in Schedule 2;

b)      in preparations for dermal use containing 1 per cent or less of bifonazole for the treatment of the scalp; or

c)      in preparations for dermal use for the treatment of tinea pedis.

BIMATOPROST.

BIPERIDEN.

BISMUTH COMPOUNDS for cosmetic use, except:

a)      bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per or less; or

b)      bismuth oxychloride.

BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.

BISOPROLOL.

BIVALIRUDIN.

BLEOMYCIN.

BOCEPREVIR.

# BOLANDIOL.

# BOLASTERONE.

# BOLAZINE.

# BOLDENONE (dehydrotestosterone).

# BOLENOL.

# BOLMANTALATE.

BORON, including boric acid and borax, for human therapeutic use except:

a)      in preparations for internal use containing 6 mg or less of boron per recommended daily dose;

b)      in preparations for dermal use containing 0.35 per cent or less of boron, which are not for paediatric or antifungal use; or

c)      when present as an excipient.

BORTEZOMIB.

# BOSENTAN.

BOSUTINIB.

BOTULINUM TOXINS for human use except when separately specified in these Schedules.

BRENTUXIMAB VEDOTIN.

BRETYLIUM TOSILATE.

BREXPIPRAZOLE.

BRIMONIDINE.

BRINZOLAMIDE.

BRIVARACETAM.

# BROMAZEPAM.

BROMIDES, inorganic, for therapeutic use except when separately specified in these Schedules.

BROMOCRIPTINE.

BROMOFORM for therapeutic use.

BROMPHENIRAMINE except when included in Schedule 2 or 3.

BROMVALETONE.

BRUGMANSIA spp.

BUCLIZINE except when included in Schedule 3.

BUDESONIDE except when included in Schedule 2.

BUFEXAMAC except:

a)      in preparations for dermal use containing 5 per cent or less of bufexamac; or

b)      in suppositories.

BUMETANIDE.

BUPHENINE.

BUPIVACAINE except when included in Schedule 5.

BUPROPION.

BUSERELIN.

BUSPIRONE.

BUSULPHAN.

BUTACAINE.

BUTAMBEN except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

BUTOCONAZOLE except when included in Schedule 3.

BUTRACONAZOLE.

BUTYLCHLORAL HYDRATE.

BUTYL NITRITE.

CABAZITAXEL.

CABERGOLINE.

CADMIUM COMPOUNDS for human therapeutic use.

CALCIPOTRIOL.

CALCITONIN.

CALCITONIN SALMON.

CALCITRIOL.

CALCIUM CARBIMIDE for therapeutic use.

CALCIUM HYDROXYAPATITE in preparations for injection or implantation:

a)      for tissue augmentation; or

b)      for cosmetic use.

CALCIUM POLYSTYRENE SULPHONATE.

CALOTROPIS GIGANTEA.

CALOTROPIS PROCERA.

# CALUSTERONE.

CAMPHORATED OIL for therapeutic use.

CAMPHOTAMIDE.

CANAGLIFLOZIN.

CANAKINUMAB.

CANDESARTAN CILEXETIL.

CANDICIDIN.

CANINE TICK ANTI-SERUM.

CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis.

CANTHARIDIN.

CAPECITABINE.

CAPREOMYCIN.

CAPTODIAME.

CAPTOPRIL.

CAPURIDE.

CARAMIPHEN.

CARBACHOL.

CARBAMAZEPINE.

CARBARYL for human therapeutic use.

CARBAZOCHROME.

CARBENICILLIN.

CARBENOXOLONE for internal use.

CARBETOCIN.

CARBIDOPA.

CARBIMAZOLE.

CARBOCROMEN.

CARBOPLATIN.

CARBOPROST.

CARBROMAL.

CARBUTAMIDE.

CARBUTEROL.

CARFILZOMIB.

CARGLUMIC ACID (N-carbamoyl-L-glutamic acid)

CARINDACILLIN.

CARISOPRODOL.

CARMUSTINE.

CARNIDAZOLE.

CARPROFEN.

CARVEDILOL.

CASPOFUNGIN.

CATHINE.

CATUMAXOMAB.

CEFACETRILE.

CEFACLOR.

CEFADROXIL.

CEFALEXIN.

CEFALORIDINE.

CEFALOTIN.

CEFAMANDOLE.

CEFAPIRIN.

CEFAZOLIN.

CEFEPIME.

CEFETAMET.

CEFIXIME.

CEFODIZIME.

CEFONICID.

CEFOPERAZONE.

CEFOTAXIME.

CEFOTETAN.

CEFOTIAM.

CEFOVECIN for veterinary use.

CEFOXITIN.

CEFPIROME.

CEFPODOXIME.

CEFQUINOME.

CEFTAROLINE FOSAMIL.

CEFSULODIN.

CEFTAZIDIME.

CEFTIBUTEN.

CEFTIOFUR.

CEFTRIAXONE.

CEFUROXIME.

CELECOXIB.

CELIPROLOL.

CEPHAELIS ACUMINATA (ipecacuanha) except in preparations containing 0.2 per cent or less of emetine.

CEPHAELIS IPECACUANHA except in preparations containing 0.2 per cent or less of emetine.

CEPHALONIUM.

CEPHRADINE.

CERITINIB.

CERIVASTATIN.

CERTOLIZUMAB PEGOL.

CERULETIDE.

CETIRIZINE except

a)      when included in Schedule 2; or

b)      in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

i)        in a primary pack containing not more than 10 days’ supply; and

ii)      labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

CETRORELIX.

CETUXIMAB.

CHENODEOXYCHOLIC ACID.

CHLORAL FORMAMIDE.

CHLORAL HYDRATE except in preparations for topical use containing 2 per cent or less of chloral hydrate.

CHLORALOSE except when included in Schedule 6.

CHLORAMBUCIL.

CHLORAMPHENICOL except when included in Schedule 3.

# CHLORANDROSTENOLONE.

CHLORAZANIL.

CHLORCYCLIZINE.

# CHLORDIAZEPOXIDE.

CHLORMERODRIN.

CHLORMETHIAZOLE.

CHLORMEZANONE.

CHLOROFORM for use in anaesthesia.

# 4-CHLOROMETHANDIENONE.

2-(4-CHLOROPHENYL)-(1,2,4)TRIAZOLO[5,1-A]ISOQUINOLINE.

CHLOROQUINE.

CHLOROTHIAZIDE.

CHLOROTRIANISENE.

# CHLOROXYDIENONE.

CHLORPHENAMINE except when included in Schedule 2 or 3.

CHLORPHENTERMINE.

CHLORPROMAZINE.

CHLORPROPAMIDE.

CHLORPROTHIXENE.

CHLORQUINALDOL for human topical use.

CHLORTALIDONE

CHLORTETRACYCLINE except when included in Schedule 5.

CHLORZOXAZONE.

CHOLERA VACCINE.

CHOLIC ACID.

CHYMOPAPAIN for human therapeutic use.

CICLACILLIN.

CICLESONIDE.

CICLOPIROX except:

a)      when included in Schedule 2 or 3; or

b)      in preparations for the treatment of tinea pedis.

CICLOSPORIN.

CIDOFOVIR.

CILASTATIN.

CILAZAPRIL.

CILOSTAZOL.

CIMETIDINE except when included in Schedule 3.

CINACALCET.

CINCHOCAINE except when included in Schedule 2.

CINOXACIN.

CIPROFLOXACIN.

CISAPRIDE.

CISATRACURIUM BESILATE.

CISPLATIN.

CITALOPRAM.

# CJC-1295 (CAS No. 863288-34-0).

CLADRIBINE.

CLANOBUTIN.

CLARITHROMYCIN.

CLAVULANIC ACID.

CLEMASTINE except when included in Schedule 3.

CLEMIZOLE.

CLENBUTEROL.

CLEVIDIPINE.

CLIDINIUM BROMIDE.

CLINDAMYCIN.

CLIOQUINOL and other halogenated derivatives of oxyquinoline for human topical use except when separately specified in this Schedule.

CLOBAZAM.

CLOBETASOL.

CLOBETASONE (clobetasone-17-butyrate) except when included in Schedule 3.

CLOCORTOLONE.

CLODRONIC ACID (includes sodium clodronate).

CLOFARABINE.

CLOFAZIMINE.

CLOFENAMIDE.

CLOFIBRATE.

# CLOMIFENE.

CLOMIPRAMINE.

CLOMOCYCLINE.

# CLONAZEPAM.

CLONIDINE.

CLOPAMIDE.

CLOPIDOGREL.

CLOPROSTENOL.

# CLORAZEPATE.

CLOREXOLONE.

CLORPRENALINE.

# CLOSTEBOL (4-chlorotestosterone).

CLOTRIMAZOLE except:

a)      when included in Schedule 2, 3 or 6; or

b)      in preparations for dermal use for the treatment of tinea pedis.

CLOXACILLIN.

# CLOZAPINE.

COBALT for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.

COBICISTAT.

COBIMETINIB.

CODEINE when compounded with one or more other therapeutically active substances:

a)      in divided preparations containing 30 mg or less of codeine per dosage unit; or

b)      in undivided preparations containing 1 per cent or less of codeine,

       except when included in Schedule 2 or 3.

CO-DERGOCRINE.

COLCHICINE.

COLCHICUM AUTUMNALE.

COLESTIPOL.

COLESTYRAMINE for human therapeutic use.

COLFOSCERIL PALMITATE for human therapeutic use.

COLISTIN.

COLLAGEN in preparations for injection or implantation:

a)      for tissue augmentation; or

b)      for cosmetic use.

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.

CONVALLARIA KEISKI.

CONVALLARIA MAJALIS.

COPPER COMPOUNDS for human use except:

a)      when separately specified in these Schedules;

b)      in preparations for human internal use containing 5 mg or less of copper per recommended daily dose; or

c)      in other preparations containing 5 per cent or less of copper compounds.

# CORIFOLLITROPIN ALFA.

CORONILLA spp.

CORTICOSTERONE.

CORTICOTROPHIN.

CORTISONE.

CO-TRIMOXAZOLE.

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

CRIZOTINIB.

CROFELEMER.

CUPRIMYXIN.

CURARE.

CYCLANDELATE.

CYCLIZINE except when included in Schedule 3.

CYCLOBENZAPRINE.

# CYCLOFENIL.

CYCLOHEXIMIDE.

CYCLOPENTHIAZIDE.

CYCLOPENTOLATE.

CYCLOPHOSPHAMIDE.

CYCLOPROPANE for therapeutic use.

CYCLOSERINE.

CYCLOTHIAZIDE.

CYCRIMINE.

CYMARIN.

CYPROHEPTADINE except when included in Schedule 3.

CYPROTERONE.

CYTARABINE.

DABRAFENIB MESILATE.

DABIGATRAN.

DACARBAZINE.

DACLATASVIR.

DACLIZUMAB.

DACTINOMYCIN.

DALFOPRISTIN.

DALTEPARIN (includes dalteparin sodium).

DANAPAROID (includes danaparoid sodium).

# DANAZOL.

DANTHRON for human use.

DANTROLENE.

DAPAGLIFLOZIN.

DAPOXETINE.

DAPSONE.

DAPTOMYCIN.

# DARBEPOETIN.

DARIFENACIN.

DARUNAVIR.

DATURA spp. except:

a)      when included in Schedule 2; or

b)      when separately specified in this Schedule.

DASABUVIR.

DASATINIB.

DATURA STRAMONIUM (stramonium) except:

a)      when included in Schedule 2; or

b)      for smoking or burning.

DATURA TATULA (stramonium) except:

a)      when included in Schedule 2; or

b)      for smoking or burning.

DAUNORUBICIN.

DEANOL for therapeutic use.

DEBRISOQUINE.

DECAMETHONIUM.

DEFERASIROX.

DEFERIPRONE.

DEFLAZACORT.

DEGARELIX.

# DEHYDROCHLOROMETHYLTESTOSTERONE.

DEHYDROCORTICOSTERONE.

DELAVIRDINE MESILATE.

DEMBREXINE except when included in Schedule 5.

DEMECARIUM.

DEMECLOCYCLINE.

DENGUE VACCINE.

DENOSUMAB.

DEOXYCHOLIC ACID.

DEOXYCORTONE.

DEOXYRIBONUCLEASE except:

a)      when separately specified in this Schedule; or

b)      for external use.

DERACOXIB.

DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES FARINAE EXTRACT.

DESFERRIOXAMINE.

DESFLURANE.

DESIPRAMINE.

DESIRUDIN.

DESLANOSIDE.

DESLORATADINE except when included in Schedule 2.

DESLORELIN.

DESMOPRESSIN (D.D.A.V.P.).

DESOGESTREL.

DESONIDE.

DESOXYMETHASONE.

DESVENLAFAXINE.

DETOMIDINE.

DEXAMETHASONE.

DEXCHLORPHENAMINE except when included in Schedule 2 or 3.

DEXFENFLURAMINE.

DEXMEDETOMIDINE.

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

# DEXTROPROPOXYPHENE:

a)      in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit; or

b)      liquid preparations containing 2.5 per cent or less of dextropropoxyphene.

DEXTRORPHAN (excluding its stereoisomers).

DIAMTHAZOLE.

DIAVERIDINE.

# DIAZEPAM.

DIAZOXIDE.

DIBENZEPIN.

DIBOTERMIN.

DIBROMOPROPAMIDINE for therapeutic use except when included in Schedule 2.

DICHLORALPHENAZONE.

DICHLOROPHEN for human therapeutic use.

DICHLORPHENAMIDE.

DICLOFENAC except:

a)      when included in Schedule 2 or 3; or

b)      in preparations for dermal use unless:

i)        for the treatment of solar keratosis; or

ii)      containing more than 4 per cent of diclofenac.

DICLOXACILLIN.

DICYCLOMINE.

DIDANOSINE.

DIENESTROL.

DIENOGEST.

DIETHAZINE.

DIETHYLCARBAMAZINE for human therapeutic use.

DIETHYLPROPION.

DIFENOXIN in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulfate equivalent to at least 5 per cent of the dose of difenoxin.

DIFLORASONE.

DIFLOXACIN.

DIFLUCORTOLONE.

DIFLUNISAL.

DIGITALIS LANATA.

DIGITALIS PURPUREA.

DIGITOXIN.

DIGOXIN.

DIGOXIN-SPECIFIC ANTIBODY FRAGMENT F (Ab).

DIHYDRALAZINE.

DIHYDROCODEINE when compounded with one or more other therapeutically active substances:

a)      in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or

b)      in undivided preparations with a concentration of not more than 2.5 per cent of dihydrocodeine,

       except when included in Schedule 2 or 3.

DIHYDROERGOTOXINE.

# DIHYDROLONE.

DIHYDROSTREPTOMYCIN.

DIHYDROTACHYSTEROL.

DIIODOHYDROXYQUINOLINE (iodoquinol) except:

a)      when included in Schedule 3; or

b)      for human internal use.

DIISOPROPYLAMINE DICHLOROACETATE.

DILTIAZEM.

DIMENHYDRINATE except when included in Schedule 2 or 3.

DIMERCAPROL.

# DIMETHANDROSTANOLONE.

# DIMETHAZINE.

DIMETHINDENE except when included in Schedule 3.

DIMETHOTHIAZINE.

DIMETHOXANATE.

DIMETHYL FUMARATE.

DIMETHYL SULFOXIDE (excluding dimethyl sulfone) for therapeutic use except:

a)      when included in Schedule 6; or

b)      in in vitro test kits.

DIMETRIDAZOLE.

2,4-DINITROCHLOROBENZENE for therapeutic use.

DINITROCRESOLS for therapeutic use except when separately specified in these Schedules.

DINITRONAPHTHOLS for therapeutic use except when separately specified in these Schedules.

DINITROPHENOLS for therapeutic use.

DINITROTHYMOLS for therapeutic use except when separately specified in these Schedules.

# DINOPROST.

# DINOPROSTONE.

DIPERODON.

DIPHEMANIL except in preparations for dermal use.

DIPHENHYDRAMINE except when included in Schedule 2 or 3.

DIPHENIDOL.

DIPHENOXYLATE in preparations containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate except when included in Schedule 3.

DIPHENYLPYRALINE.

DIPHTHERIA TOXOID.

DIPIVEFRIN.

DIPYRIDAMOLE.

DIRITHROMYCIN.

DIRLOTAPIDE.

DISOPHENOL.

DISOPYRAMIDE.

DISTIGMINE.

DISULFIRAM for therapeutic use.

DISULPHAMIDE.

DITHIAZANINE except when included in Schedule 6.

DITIOCARB.

DOBUTAMINE.

DOCETAXEL.

DOFETILIDE.

DOLASETRON.

DOLUTEGRAVIR.

DOMPERIDONE.

DONEPEZIL.

DOPAMINE.

DOPEXAMINE.

DORIPENEM.

DORNASE.

DORZOLAMIDE.

DOSULEPIN.

DOXANTRAZOLE.

DOXAPRAM.

DOXAZOSIN.

DOXEPIN.

DOXORUBICIN.

DOXYCYCLINE.

DOXYLAMINE except when included in Schedule 2 or 3.

DRONEDARONE.

DROPERIDOL.

DROSPIRENONE.

# DROSTANOLONE.

DROTRECOGIN.

DUBOISIA LEICHHARDTII except when included in Schedule 2.

DUBOISIA MYOPOROIDES except when included in Schedule 2.

DULOXETINE.

DUTASTERIDE.

DYDROGESTERONE.

ECONAZOLE except:

a)      when included in Schedule 2, 3 or 6; or

b)      in preparations for dermal use for the treatment of tinea pedis.

ECOTHIOPATE (includes ecothiopate iodide).

ECTYLUREA.

ECULIZUMAB.

EDETIC ACID for human therapeutic use except:

a)      in preparations containing 0.25 per cent or less of edetic acid;

b)      as dicobalt edetate in preparations for the treatment of cyanide poisoning; or

c)      in contact lens preparations.

EDOXUDINE.

EDROPHONIUM.

EFALIZUMAB.

EFAVIRENZ.

EFLORNITHINE.

ELBASVIR.

ELETRIPTAN.

ELOSULFASE ALFA.

ELOTUZUMAB.

ELTENAC.

ELTROMBOPAG.

ELUXADOLINE.

ELVITEGRAVIR.

EMEPRONIUM.

EMETINE except in preparations containing 0.2 per cent or less of emetine.

EMPAGLIFLOZIN.

EMTRICITABINE.

ENALAPRIL.

# ENESTEBOL.

ENFLURANE for therapeutic use.

ENFUVIRTIDE.

# ENOBOSARM.

ENOXACIN.

ENOXAPARIN.

ENOXIMONE.

ENPROSTIL.

ENROFLOXACIN.

ENTACAPONE.

ENTECAVIR.

ENZALUTAMIDE.

EPHEDRA spp. except in preparations containing 0.001 per cent or less of ephedrine.

# EPHEDRINE.

EPICILLIN.

EPINASTINE.

EPIRUBICIN.

# EPITIOSTANOL.

EPLERENONE.

# EPOETINS.

EPOPROSTENOL.

EPROSARTAN.

EPTIFIBATIDE.

ERGOMETRINE.

ERGOT.

ERGOTAMINE.

ERGOTOXINE.

ERIBULIN MESILATE.

ERLOTINIB.

ERTAPENEM.

ERYSIMUM spp.

ERYTHROMYCIN.

# ERYTHROPOIETIN.

# ERYTHROPOIETINS except when separately specified in these Schedules.

ESCITALOPRAM.

ESMOLOL.

ESOMEPRAZOLE except when included in Schedule 2 or 3.

ESTRADIOL except when included in Schedule 5.

ESTRIOL.

ESTRAMUSTINE.

ESTROGENS except when separately specified in these Schedules.

ESTRONE.

ESTROPIPATE (piperazine estrone sulfate).

ETACRYNIC ACID.

ETANERCEPT.

ETHAMBUTOL.

ETHAMIVAN.

ETHCHLORVYNOL.

ETHER for use in anaesthesia.

ETHINAMATE.

ETHINYLESTRADIOL.

ETHIONAMIDE.

# ETHISTERONE.

ETHOGLUCID.

ETHOHEPTAZINE.

ETHOPROPAZINE.

ETHOSUXIMIDE.

ETHOTOIN.

ETHOXZOLAMIDE.

ETHYL CHLORIDE for human therapeutic use.

# ETHYLDIENOLONE.

ETHYLHEXANEDIOL for animal use.

ETHYLMORPHINE when compounded with one or more other therapeutically active substances:

a)      in divided preparations containing not more than 100 mg of ethylmorphine per dosage unit; or

b)      in undivided preparations with a concentration of not more than 2.5 per cent of ethylmorphine;

       except when included in Schedule 2.

# ETHYLESTRENOL.

ETIDOCAINE.

ETIDRONIC ACID (includes etidronate disodium):

a)      for internal use; or

b)      in topical preparations except in preparations containing 1 per cent or less of etidronic acid.

ETILEFRIN.

ETIPROSTON.

ETODOLAC.

ETOFENAMATE except when included in Schedule 2.

ETONOGESTREL.

ETOPOSIDE.

ETORICOXIB.

ETRAVIRINE.

# ETRETINATE.

ETYNODIOL.

EVEROLIMUS.

EXEMESTANE.

EXENATIDE.

EZETIMIBE.

FAMCICLOVIR except when included in Schedule 3.

FAMOTIDINE except when included in Schedule 2.

FEBUXOSTAT.

FELBINAC except when included in Schedule 2.

FELODIPINE.

FELYPRESSIN.

FENBUFEN.

FENCAMFAMIN.

FENCLOFENAC.

FENFLURAMINE.

FENOFIBRATE.

FENOLDOPAM.

FENOPROFEN.

FENOTEROL.

FENPIPRAMIDE.

FENPIPRANE.

FENPROPOREX.

FENPROSTALENE.

FEXOFENADINE except:

a)      when included in Schedule 2; or

b)      in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

i)        in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and

ii)      labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

FIBRINOLYSIN except for external use.

FIBROBLAST GROWTH FACTORS

FIDAXOMICIN.

FILGRASTIM.

FINASTERIDE.

FINGOLIMOD.

FIROCOXIB.

FLECAINIDE.

FLEROXACIN.

FLOCTAFENINE.

FLORFENICOL.

FLUANISONE.

FLUCLOROLONE.

FLUCLOXACILLIN.

FLUCONAZOLE except when included in Schedule 3.

FLUCYTOSINE.

FLUDARABINE.

FLUDROCORTISONE.

FLUFENAMIC ACID.

FLUMAZENIL.

FLUMETASONE.

FLUMETHIAZIDE.

FLUNISOLIDE.

FLUNIXIN MEGLUMINE.

FLUOCINOLONE.

FLUOCINONIDE.

FLUOCORTIN.

FLUOCORTOLONE.

FLUORESCEIN in preparations for injection.

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

FLUOROMETHOLONE.

FLUOROURACIL.

FLUOXETINE.

# FLUOXYMESTERONE.

FLUPENTIXOL.

FLUPHENAZINE.

FLUPROSTENOL.

FLURANDRENOLONE.

# FLURAZEPAM.

FLURBIPROFEN except when included in Schedule 2.

FLUROXENE for human therapeutic use.

FLUSPIRILENE.

FLUTAMIDE.

FLUTICASONE except when included in Schedule 2.

FLUVASTATIN.

FLUVOXAMINE.

FOLIC ACID in preparations for human use for injection.

FOLINIC ACID in preparations for human use for injection.

FOLLICLE-STIMULATING HORMONE except when separately specified in this Schedule.

# FOLLISTATIN.

# FOLLITROPIN ALFA.

# FOLLITROPIN BETA.

# FOLLITROPIN DELTA.

FOMEPIZOLE.

FOMIVIRSEN.

FONDAPARINUX.

# FORMEBOLONE.

FORMESTANE.

FORMOTEROL

FOSAMPRENAVIR.

FOSAPREPITANT.

FOSCARNET.

FOSFESTROL (diethylstilbestrol diphosphate).

FOSINOPRIL.

FOSPHENYTOIN.

FOTEMUSTINE.

FRAMYCETIN.

FULVESTRANT.

FURALTADONE.

# FURAZABOL.

FURAZOLIDONE.

FUROSEMIDE (frusemide).

FUSIDIC ACID.

GABAPENTIN.

GALANTAMINE.

GALANTHUS spp.

GALLAMINE.

GALSULFASE.

GANCICLOVIR.

GANIRELIX.

GATIFLOXACIN.

GRAZOPREVIR.

GEFITINIB.

GEMCITABINE.

GEMEPROST.

GEMFIBROZIL.

GEMIFLOXACIN.

GEMTUZUMAB OZOGAMICIN.

GENTAMICIN.

GESTODENE.

GESTONORONE.

# GESTRINONE.

GHRH INJECTABLE PLASMID.

GITALIN.

GLATIRAMER ACETATE.

GLIBENCLAMIDE.

GLIBORNURIDE.

GLICLAZIDE.

GLIMEPIRIDE.

GLIPIZIDE.

GLISOXEPIDE.

GLUTATHIONE for parenteral use.

# GLUTETHIMIDE.

GLYCERYL TRINITRATE except when included in Schedule 3.

GLYCOPYRRONIUM in preparations for injection.

GLYMIDINE.

GnRH VACCINE.

GOLIMUMAB.

GONADORELIN.

GONADOTROPHIC HORMONES except when separately specified in this Schedule.

GOSERELIN.

GRAMICIDIN.

GRANISETRON.

GREPAFLOXACIN.

GRISEOFULVIN.

# GROWTH HORMONE RELEASING HORMONES* (GHRHs).

# GROWTH HORMONE RELEASING PEPTIDES (GHRPs).

# GROWTH HORMONE RELEASING PEPTIDE-6 (GHRP-6).

# GROWTH HORMONE SECRETAGOGUES* (GHSs).

GUAIFENESIN for human therapeutic use except:

a)      when included in Schedule 2;

b)      in oral liquid preparations containing 2 per cent or less of guaifenesin; or

c)      in divided preparations containing 200 mg or less of guaifenesin per dosage unit.

GUANABENZ.

GUANACLINE.

GUANETHIDINE.

GUANFACINE.

GUANIDINE for therapeutic use.

HACHIMYCIN.

HAEMATIN.

HAEMOPHILUS INFLUENZAE VACCINE.

HALCINONIDE.

HALOFANTRINE.

HALOFENATE.

HALOFUGINONE in preparations containing 0.1 per cent or less of halofuginone for the treatment of animals.

HALOPERIDOL.

HALOTHANE for therapeutic use.

HEMEROCALLIS (Hemerocallis flava).

HEPARINS for internal use except when separately specified in this Schedule.

HEPATITIS A VACCINE.

HEPATITIS B VACCINE.

HETACILLIN.

HEXACHLOROPHENE:

a)      in preparations for use on infants; or

b)      in other preparations except:

i)        when included in Schedule 2 or 6; or

ii)      in preparations containing 0.75 per cent or less of hexachlorophene.

HEXAMETHONIUM.

# HEXARELIN.

HEXETIDINE for human internal use.

HEXOBENDINE.

HEXOCYCLIUM.

HEXOPRENALINE.

HEXYL AMINOLEVULINATE (AS HYDROCHLORIDE)

HISTAMINE for therapeutic use except in preparations containing 0.5 per cent or less of histamine.

HMG-CoA REDUCTASE INHIBITORS (including "statins") except when separately specified in these Schedules.

HOMATROPINE.

HUMAN CHORIONIC GONADATROPHIN except in pregnancy test kits.

HUMAN PAPILLOMAVIRUS VACCINE.

HYALURONIC ACID AND ITS POLYMERS in preparations for injection or implantation:

a)      for tissue augmentation;

b)      for cosmetic use; or

c)      for the treatment of animals.

HYDRALAZINE.

HYDRARGAPHEN.

HYDROCHLOROTHIAZIDE.

HYDROCORTISONE:

a)      for human use except when included in Schedule 2 or 3; or

b)      for the treatment of animals.

HYDROCYANIC ACID for therapeutic use.

HYDROFLUMETHIAZIDE.

HYDROQUINONE (other than its alkyl ethers separately specified in this Schedule) in preparations for human therapeutic or cosmetic use except:

a)      when included in Schedule 2; or

b)      in hair preparations containing 0.3 per cent or less of hydroquinone; or

c)      in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.

HYDROXYCARBAMIDE.

HYDROXYCHLOROQUINE.

HYDROXYEPHEDRINE.

HYDROXYPHENAMATE.

HYDROXYPROGESTERONE.

# HYDROXYSTENOZOL.

HYDROXYZINE.

HYGROMYCIN.

HYOSCINE except when included in Schedule 2.

HYOSCYAMINE except when included in Schedule 2.

HYOSCYAMUS NIGER except:

a)      when included in Schedule 2; or

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

HYPOTHALAMIC RELEASING FACTORS except when separately specified in this Schedule.

HYPROMELLOSE in preparations for injection.

IBAFLOXACIN for veterinary use.

IBANDRONIC ACID.

IBOGAINE.

IBRITUMOMAB.

IBRUTINIB.

IBUFENAC.

IBUPROFEN except:

a)      when included in or expressly excluded from Schedule 2 or 3; or

b)      in preparations for dermal use.

IBUTEROL.

IBUTILIDE.

ICATIBANT.

IDARUBICIN.

IDARUCIZUMAB

IDOXURIDINE except in preparations containing 0.5 per cent or less of idoxuridine for dermal use.

IDURSULFASE.

IFOSFAMIDE.

ILOPROST.

IMATINIB.

IMEPITOIN.

IMIDAPRIL.

IMIGLUCERASE.

IMIPENIM.

IMIPRAMINE.

IMIQUIMOD.

IMMUNOGLOBULINS for human parenteral use except when separately specified in these Schedules.

INDACATEROL.

INDAPAMIDE.

INDINAVIR.

INDOMETACIN except when included in Schedule 2.

INDOPROFEN.

INDORAMIN.

INFLIXIMAB.

INFLUENZA AND CORYZA VACCINES:

a)      for parenteral use; or

b)      for nasal administration.

INGENOL MEBUTATE.

INSULIN GLARGINE.

# INSULIN-LIKE GROWTH FACTOR I.

# INSULIN-LIKE GROWTH FACTORS except when separately specified in this Schedule.

INSULINS.

INTERFERONS.

INTERLEUKINS except when separately specified in these Schedules.

IODOTHIOURACIL.

# IPAMORELIN.

IPILIMUMAB.

IPRATROPIUM except when included in Schedule 2.

IPRIFLAVONE.

IPRINDOLE.

IPRONIAZID.

IRBESARTAN.

IRINOTECAN.

IRON COMPOUNDS in injectable preparations for human use.

ISOAMINILE.

ISOAMYL NITRITE.

ISOBUTYL NITRITE.

ISOCARBOXAZID.

ISOCONAZOLE except when included in Schedule 2, 3 or 6.

ISOETARINE.

ISOFLURANE for therapeutic use.

ISOMETHEPTENE.

ISONIAZID.

ISOPRENALINE.

ISOPRINOSINE.

ISOPROPAMIDE except when included in Schedule 2.

ISOSORBIDE DINITRATE except when included in Schedule 3.

ISOSORBIDE MONONITRATE.

# ISOTRETINOIN.

ISOXICAM.

ISOXSUPRINE.

ISRADIPINE.

ITRACONAZOLE.

IVABRADINE.

IVACAFTOR.

IVERMECTIN:

a)      for human use; or

b)      for the treatment of mange in dogs.

IXABEPILONE.

IXAZOMIB.

IXEKIZUMAB.

JAPANESE ENCEPHALITIS VACCINE.

KANAMYCIN.

KETANSERIN except in topical veterinary preparations containing 0.5 per cent or less of ketanserin.

# KETAZOLAM.

KETOCONAZOLE except:

a)      when included in Schedule 2;

b)      in preparations for dermal use containing 1 per cent or less of ketoconazole for the treatment of the scalp; or

c)      in preparations for dermal use for the treatment of tinea pedis.

KETOPROFEN except:

a)      in preparations for dermal use; or

b)      when included in Schedule 3.

KETOROLAC (includes ketoralac trometamol).

KETOTIFEN except when included in Schedule 2.

KHELLIN.

KITASAMYCIN except:

a)      when included in Schedule 5 ; or

b)      in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic substances.

LABETALOL.

LACIDIPINE.

LACOSAMIDE.

LAMIVUDINE.

LAMOTRIGINE.

LANATOSIDES.

LANREOTIDE.

LANSOPRAZOLE except when included in Schedule 2 or 3.

LANTHANUM for therapeutic use.

LAPATINIB.

LARONIDASE.

LAROPIPRANT.

LATAMOXEF.

LATANOPROST.

LAUDEXIUM.

LAUROMACROGOLS in preparations for injection except:

a)      when present as an excipient; or

b)      when separately specified in these Schedules.

LEAD for human therapeutic use.

LEDIPASVIR.

LEFETAMINE.

LEFLUNOMIDE.

# LENALIDOMIDE.

LENOGRASTIM.

LENVATINIB.

LEPIRUDIN.

LEPTAZOL.

LERCANIDIPINE.

LESINURAD

LETROZOLE.

LEUPRORELIN.

LEVALLORPHAN.

LEVAMISOLE:

a)      for human therapeutic use; or

b)      in preparations for the prevention or treatment of heartworm in dogs.

LEVETIRACETAM.

LEVOBUNOLOL.

LEVOBUPIVACAINE.

LEVOCABASTINE except when included in Schedule 2.

LEVOCETIRIZINE except:

a)      when included in Schedule 2; or

b)      in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

i)        in a primary pack containing not more than 5 days’ supply; and

ii)      labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

LEVODOPA.

LEVOMEPROMAZINE.

LEVOMILNACIPRAN.

LEVONORGESTREL except when included in Schedule 3.

LEVOSIMENDAN.

LIDOCAINE except:

a)      when included in Schedules 2 or 5;

b)      in dermal preparations containing 2 per cent or less of total local anaesthetic substances per dosage unit; or

c)      in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.

LIDOFLAZINE.

LINAGLIPTIN.

LINCOMYCIN.

LINDANE for human therapeutic use except when included in Schedule 2.

LINEZOLID.

LIOTHYRONINE.

LIPEGFILGRASTIM.

LIRAGLUTIDE.

LISINOPRIL.

LISURIDE.

LITHIUM for therapeutic use except:

a)      when included in Schedule 2;

b)      when present as an excipient in preparations for dermal use containing 0.25 per cent or less of lithium; or

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

LIXISENATIDE.

LODOXAMIDE except when included in Schedule 2.

LOFEXIDINE.

LOGIPARIN for internal use.

LOMEFLOXACIN.

LOMUSTINE.

LOPERAMIDE except:

a)      when included in Schedule 2; or

b)      in divided oral preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.

LOPINAVIR.

# LOPRAZOLAM.

LORACARBEF.

LORATADINE except:

a)      when included in Schedule 2; or

b)      in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

i)        in a primary pack containing 10 dosage units or less; and

ii)      labelled with a recommended daily dose not exceeding 10 mg of loratadine.

# LORAZEPAM.

# LORMETAZEPAM.

LOSARTAN.

LOTEPREDNOL.

LOXAPINE.

LUMACAFTOR.

LUMEFANTRINE.

LUMIRACOXIB.

LURASIDONE.

# LUTEINISING HORMONE except in ovulation test kits.

LYMECYCLINE.

MACITENTAN for human use.

MAFENIDE except when included in Schedule 6.

MANDRAGORA OFFICINARUM.

MANNOMUSTINE.

MAPROTILINE.

MARAVIROC.

MARBOFLOXACIN.

MAROPITANT.

MAVACOXIB.

MAZINDOL.

MEASLES VACCINE.

MEBANAZINE.

MEBEVERINE.

MEBHYDROLIN.

# MEBOLAZINE.

MEBUTAMATE.

MECAMYLAMINE.

MECASERMIN.

MECILLINAM.

MECLOCYCLINE.

MECLOFENAMATE.

MECLOFENOXATE.

MECLOZINE except when included in Schedule 2.

# MEDAZEPAM.

MEDETOMIDINE.

MEDIGOXIN (methyldigoxin).

MEDROXYPROGESTERONE.

MEDRYSONE.

MEFENAMIC ACID except when included in Schedule 2.

MEFENOREX.

MEFLOQUINE.

MEFRUSIDE.

MEGESTROL.

MELAGATRAN.

MELATONIN for human use.

MELENGESTROL except when included in Schedule 6.

MELOXICAM.

MELPHALAN.

MEMANTINE.

MENINGOCOCCAL VACCINE.

MENINGOCOCCAL GROUP B VACCINE.

MENOTROPHIN.

MEPACRINE.

MEPENZOLATE.

MEPHENESIN.

MEPHENTERMINE.

MEPINDOLOL.

# MEPITIOSTANE.

MEPIVACAINE.

MEPROBAMATE.

MEPTAZINOL.

MEPYRAMINE except when included in Schedule 2 or 3.

MEQUITAZINE.

MERCAPTAMINE for human therapeutic use.

MERCAPTOMERIN.

MERCAPTOPURINE.

MERCUROCHROME except when included in Schedule 2 or 6.

MERCURY for cosmetic or therapeutic use except:

a)      when separately specified in these Schedules; or

b)      in a sealed device which prevents access to the mercury.

MEROPENEM.

MERSALYL.

# MESABOLONE.

MESALAZINE.

MESNA.

# MESTANOLONE (androstalone).

# MESTEROLONE.

MESTRANOL.

# METANDIENONE.

METARAMINOL.

# METENOLONE.

METERGOLINE.

METFORMIN.

METHACHOLINE.

METHACYCLINE.

METHALLENESTRIL.

# METHANDRIOL.

METHANTHELINIUM.

METHAZOLAMIDE.

METHDILAZINE except when included in Schedule 3.

# METHENOLONE.

METHICILLIN.

METHIMAZOLE.

METHISAZONE.

METHIXENE.

METHOCARBAMOL.

METHOHEXITONE.

METHOIN.

METHOTREXATE.

METHOXAMINE except:

a)      when included in Schedule 2; or

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

METHOXSALEN.

METHOXYFLURANE.

METHSUXIMIDE.

METHYCLOTHIAZIDE.

METHYL AMINOLEVULINATE.

#METHYLANDROSTANOLONE.

# METHYLCLOSTEBOL.

METHYLDOPA.

METHYLENE BLUE in preparations for injection.

METHYLERGOMETRINE.

METHYLMERCURY for therapeutic use.

METHYLNALTREXONE.

METHYLPENTYNOL.

METHYLPHENOBARBITAL.

METHYLPREDNISOLONE.

METHYLROSANILINIUM CHLORIDE for human use except when used as a dermal marker.

METHYL SALICYLATE in preparations for internal therapeutic use.

# METHYLTESTOSTERONE.

METHYLTHIOURACIL.

# METHYLTRIENOLONE.

METHYPRYLONE.

METHYSERGIDE.

METOCLOPRAMIDE except when included in Schedule 3.

METOLAZONE.

METOPROLOL.

# METRIBOLONE.

METRIFONATE (trichlorfon) for human therapeutic use.

METRONIDAZOLE.

METYRAPONE.

MEXILETINE.

MEZLOCILLIN.

MIANSERIN.

MIBEFRADIL.

# MIBOLERONE.

MICAFUNGIN.

MICONAZOLE except:

a)      when included in Schedule 2, 3 or 6; or

b)      in preparations for dermal use for the treatment of tinea pedis.

# MIDAZOLAM.

MIDODRINE.

MIFEPRISTONE.

MIGLITOL.

MIGLUSTAT.

MILBEMYCIN OXIME except when included in Schedule 5.

MILNACIPRAN.

MILRINONE.

MINOCYCLINE.

MINOXIDIL except when included in Schedule 2.

MIRABEGRON.

MIRTAZAPINE.

MISOPROSTOL.

MITOBRONITOL.

MITOMYCIN.

MITOTANE.

MITOXANTRONE.

MITRATAPIDE.

MIVACURIUM CHLORIDE.

MOCLOBEMIDE.

MODAFINIL.

MOLGRAMOSTIM.

MOLINDONE.

MOMETASONE except when included in Schedule 2.

MONENSIN except:

a)      when included in Schedule 5 or 6; or

b)      in animal feeds containing 360 mg/kg or less of antibiotic substances.

MONOBENZONE and alkyl ethers of hydroquinone for human therapeutic use or cosmetic use except in cosmetic nail preparations containing 0.02 per cent or less of monobenzone or alkyl ethers of hydroquinone.

MONOCLONAL ANTIBODIES for therapeutic use except:

a)      in diagnostic test kits; or

b)      when separately specified in these Schedules.

MONOETHANOLAMINE in preparations for injection.

MONTELUKAST.

MOPERONE.

MORAZONE.

MORICIZINE.

MOTRAZEPAM.

MOTRETINIDE.

MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin except when included in Schedule 5.

MOXIFLOXACIN.

MOXONIDINE.

MUMPS VACCINE.

MUPIROCIN.

MURAGLITAZAR.

MUROMONAB.

MUSTINE (nitrogen mustard).

MYCOPHENOLIC ACID (includes mycophenolate mofetil).

NABUMETONE.

NADOLOL.

NADROPARIN.

NAFARELIN.

NAFTIDROFURYL.

NALBUPHINE.

NALIDIXIC ACID.

NALMEFENE.

NALORPHINE.

NALOXEGOL.

NALOXONE except when in Schedule 3.

NALTREXONE.

# NANDROLONE.

NAPROXEN except when included in Schedule 2 or 3.

NARASIN except:

a)      when included in Schedule 6; or

b)      in animal feeds containing 100 mg/kg or less of antibiotic substances.

NARATRIPTAN.

NATALIZUMAB.

NATAMYCIN except for use as a food additive.

NATEGLINIDE.

NEBACUMAB.

NEBIVOLOL.

NEDOCROMIL.

NEFAZODONE.

NEFOPAM.

NELFINAVIR (includes nelfinavir mesilate).

NEOMYCIN.

NEOSTIGMINE.

NEPAFENAC.

NERIUM OLEANDER.

NESIRITIDE.

NETILMICIN.

NETUPITANT.

NEVIRAPINE.

NIALAMIDE.

NICARDIPINE.

NICERGOLINE.

NICOFURANOSE.

NICORANDIL.

NICOTINE in preparations for human therapeutic use except for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal or transdermal use.

NICOTINIC ACID for human therapeutic use except:

a)      when separately specified in these Schedules;

b)      in preparations containing 100 mg or less of nicotinic acid per dosage unit; or

c)      nicotinamide.

NICOUMALONE.

NIFEDIPINE.

NIFENAZONE.

NIKETHAMIDE.

NILOTINIB.

NILUTAMIDE.

NIMESULIDE.

NIMODIPINE.

NIMORAZOLE.

NINTEDANIB.

NIRIDAZOLE.

NISOLDIPINE.

NITISINONE.

# NITRAZEPAM.

NITRENDIPINE.

NITRIC OXIDE for human therapeutic use.

NITROFURANTOIN.

NITROFURAZONE.

NITROUS OXIDE for therapeutic use.

NITROXOLINE.

NIZATIDINE except when included in Schedule 2.

NOMEGESTROL.

NOMIFENSINE.

NORADRENALINE.

# 19-NORANDROSTENEDIOL.

# 19-NORANDROSTENEDIONE.

# NORANDROSTENOLONE.

# NORBOLETHONE.

# NORCLOSTEBOL.

NORELGESTROMIN.

# NORETHANDROLONE.

NORETHISTERONE.

NORFLOXACIN.

NORGESTREL.

NORIBOGAINE.

NORMAL HUMAN IMMUNOGLOBULIN.

# NORMETHANDRONE.

NORTRIPTYLINE.

NOVOBIOCIN.

NOXIPTYLINE.

NYSTATIN except when included in Schedule 2 or 3.

OCLACITINIB.

OCRELIZUMAB.

OCRIPLASMIN.

OCTAMYLAMINE.

OCTATROPINE.

OCTREOTIDE.

OCTYL NITRITE.

OFATUMUMAB.

OFLOXACIN.

OLANZAPINE.

OLAPARIB.

OLEANDOMYCIN except:

a)      when included in Schedule 5; or

b)      in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

OLEANDRIN.

OLMESARTAN.

OLODATEROL.

OLOPATADINE.

OLSALAZINE.

OMALIZUMAB.

OMBITASVIR.

OMEGA-3-ACID ETHYL ESTERS (excluding salts and derivatives) for human therapeutic use, for the treatment of post-myocardial infarction and/or hypertriglyceridaemia.

OMEPRAZOLE except when included in Schedule 2 or 3.

ONDANSETRON.

OPIPRAMOL.

ORBIFLOXACIN.

ORCIPRENALINE.

ORGANOPHOSPHORUS COMPOUNDS with anticholinesterase activity for human therapeutic use except:

a)      when separately specified in these Schedules; or

b)      in preparations containing 2 per cent or less of malathion for external use.

ORLISTAT except when included in Schedule 3.

ORNIDAZOLE.

ORNIPRESSIN.

ORPHENADRINE.

ORTHOPTERIN.

OSELTAMIVIR.

OSIMERTINIB.

OUABAIN.

# OVANDROTONE.

# OXABOLONE.

OXACILLIN.

OXALIPLATIN.

# OXANDROLONE.

OXAPROZIN.

# OXAZEPAM.

OXCARBAZEPINE.

OXEDRINE for human internal use except in preparations labelled with a recommended daily dose of 30 mg or less of oxedrine.

OXETACAINE (oxethazaine) except when included in Schedule 2.

OXICONAZOLE except:

a)      when included in Schedule 2 or 3; or

b)      in preparations for the treatment of tinea pedis.

OXITROPIUM.

OXOLAMINE.

OXOLINIC ACID.

OXPRENOLOL.

OXYBUPROCAINE.

OXYBUTYNIN.

# OXYMESTERONE.

# OXYMETHOLONE.

OXYPHENBUTAZONE.

OXYPHENCYCLIMINE.

OXYPHENONIUM.

OXYTETRACYCLINE except when included in Schedule 5.

OXYTOCIN.

PACLITAXEL.

PALIFERMIN.

PALIPERIDONE.

PALIVIZUMAB.

PALONOSETRON.

PAMAQUIN.

PAMIDRONIC ACID (includes pamidronate disodium)

PANCREATIC ENZYMES except:

a)      in preparations containing 20,000 BP units or less of lipase activity per dosage unit; or

b)      when separately specified in these Schedules.

PANCURONIUM.

PANITUMUMAB.

PANOBINOSTAT.

PANTOPRAZOLE except when included in Schedule 2 or 3.

PAPAVERINE in preparations for injection.

PARACETAMOL:

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

b)      when combined with ibuprofen in a primary pack containing more than 30 dosage units;

c)      in slow release tablets or capsules containing more than 665 mg paracetamol;

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

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

f)       in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;

g)      in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;

h)      for injection.

PARALDEHYDE.

PARAMETHADIONE.

PARAMETHASONE.

PARECOXIB.

PARICALCITOL.

PARITAPREVIR.

PAROMOMYCIN.

PAROXETINE.

PASIREOTIDE.

PAZOPANIB.

PECAZINE.

PEFLOXACIN.

PEGAPTANIB.

PEGFILGRASTIM.

PEGINTERFERON.

PEGVISOMANT.

PEMBROLIZUMAB.

PEMETREXED.

PEMOLINE.

PEMPIDINE.

PENBUTOLOL.

PENCICLOVIR except when included in Schedule 2.

PENETHAMATE.

PENICILLAMINE.

PENTAERYTHRITYL TETRANITRATE.

PENTAGASTRIN.

PENTAMETHONIUM.

PENTAMIDINE (includes pentamidine isetionate).

PENTHIENATE.

PENTOBARBITAL when packed and labelled for injection.

PENTOLINIUM.

PENTOSAN POLYSULFATE SODIUM.

PENTOXIFYLLINE.

# PERAMPANEL.

PERGOLIDE.

PERHEXILINE.

PERICIAZINE.

PERINDOPRIL.

PERMETHRIN for human therapeutic use except in preparations containing 5 per cent or less of permethrin.

PERPHENAZINE.

PERTUSSIS ANTIGEN.

PERTUZUMAB.

PHENACEMIDE.

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

PHENAGLYCODOL.

PHENAZONE except when included in Schedule 2 or 5.

PHENAZOPYRIDINE.

PHENELZINE.

PHENETICILLIN.

PHENFORMIN.

PHENGLUTARIMIDE.

PHENINDIONE.

PHENIRAMINE except when included in Schedule 2 or 3.

PHENISATIN.

PHENOBARBITAL.

PHENOL in preparations for injection.

PHENOLPHTHALEIN for human therapeutic use.

PHENOXYBENZAMINE.

PHENOXYMETHYLPENICILLIN.

PHENSUXIMIDE.

# PHENTERMINE.

PHENTHIMENTONIUM.

PHENTOLAMINE.

PHENYLBUTAZONE.

PHENYLEPHRINE:

a)      in preparations for injection; or

b)      in preparations for human ophthalmic use containing 5 per cent or more of phenylephrine.

PHENYLPROPANOLAMINE.

PHENYLTOLOXAMINE.

PHENYTOIN.

PHLEUM PRATENSE POLLEN EXTRACT (Timothy-grass pollen extract).

PHOLCODINE:

a)      in divided preparations containing 100 mg or less of pholcodine per dosage unit; or

b)      in undivided preparations containing 2.5 per cent or less of pholcodine,

except when included in Schedule 2.

PHOSPHODIESTERASE TYPE 5 INHIBITORS except:

a)      when separately specified in these Schedules; or

b)      when present as an unmodified, naturally occurring substance.

PHTHALYLSULFATHIAZOLE.

PHYSOSTIGMINE.

PICROTOXIN.

PILOCARPINE except in preparations containing 0.025 per cent or less of pilocarpine.

PIMECROLIMUS.

PIMOBENDAN.

PIMOZIDE.

PINACIDIL.

PINDOLOL.

PIOGLITAZONE.

PIPECURONIUM.

PIPEMIDIC ACID.

PIPENZOLATE.

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

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

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

ii)      the amount of dried whole or peeled rhizome and/or root in the teabag does not exceed 3 g;

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

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

c)      in dermal preparations.

PIPERACILLIN.

PIPERIDINE.

PIPERIDOLATE.

PIPOBROMAN.

PIPOTHIAZINE.

PIPRADROL.

PIRACETAM.

PIRBUTEROL.

PIRENOXINE (catalin).

PIRENZEPINE.

PIRETANIDE.

PIRFENIDONE.

PIROXICAM except in preparations for dermal use.

PIRPROFEN.

PITAVASTATIN.

PITUITARY HORMONES except when separately specified in these Schedules.

PIVAMPICILLIN.

PIZOTIFEN.

PLICAMYCIN.

PLERIXAFOR.

PNEUMOCOCCAL VACCINE.

PODOPHYLLOTOXIN for human use:

a)      internally;

b)      in preparations for the treatment of anogenital warts; or

c)      in other preparations except when included in Schedule 2 or 3.

PODOPHYLLUM EMODI (podophyllin) for human use:

a)      internally;

b)      in preparations for the treatment of anogenital warts; or

c)      in other preparations except when included in Schedule 2 or 3.

PODOPHYLLUM PELTATUM (podophyllin) for human use:

a)      internally;

b)      in preparations for the treatment of anogenital warts; or

c)      in other preparations except when included in Schedule 2 or 3.

POLIDEXIDE.

POLIOMYELITIS VACCINE.

POLYACRYLAMIDE in preparations for injection or implantation:

a)      for tissue augmentation; or

b)      for cosmetic use.

POLYCAPROLACTONE in preparations for injection or implantation:

a)      for tissue augmentation; or

b)      for cosmetic use.

POLYESTRADIOL.

POLYLACTIC ACID in preparations for injection or implantation:

a)      for tissue augmentation; or

b)      for cosmetic use.

POLYMYXIN.

POLYSULFATED GLYCOSAMINOGLYCANS in preparations for injection, except when separately specified in these Schedules.

POLYTHIAZIDE.

POMALIDOMIDE.

PORACTANT.

POSACONAZOLE.

POTASSIUM BROMIDE for therapeutic use.

POTASSIUM CHLORIDE in oral preparations for human therapeutic use except:

a)      when containing less than 550 mg of potassium chloride per dosage unit;

b)      in preparations for oral rehydration therapy;

c)      in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or

d)      in preparations for enteral feeding.

POTASSIUM PERCHLORATE for therapeutic use.

PRACTOLOL.

PRADOFLOXACIN.

PRALATREXATE.

PRALIDOXIME.

PRAMIPEXOLE.

PRAMOCAINE.

# PRALMORELIN (GROWTH HORMONE RELEASING PEPTIDE-2 (GHRP-2)).

PRAMPINE.

# PRASTERONE (dehydroepiandrosterone, dehydroisoandrosterone).

PRASUGREL.

PRAVASTATIN.

# PRAZEPAM.

PRAZIQUANTEL for human therapeutic use.

PRAZOSIN.

PREDNISOLONE.

PREDNISONE.

PREGABALIN.

PREGNENOLONE.

PRENALTEROL.

PRENYLAMINE.

PRILOCAINE except when included in Schedule 2.

PRIMAQUINE.

PRIMIDONE.

PROBENECID.

PROBUCOL.

PROCAINAMIDE.

PROCAINE.

PROCAINE BENZYLPENICILLIN.

PROCARBAZINE.

PROCHLORPERAZINE except when included in Schedule 3.

PROCYCLIDINE except when included in Schedule 2.

PROGESTERONE except when included in Schedule 5.

PROGESTOGENS except when separately specified in these Schedules.

PROGLUMIDE.

PROGUANIL.

PROLINTANE.

PROMAZINE.

PROMETHAZINE except when included in Schedule 2 or 3.

PROMOXOLANE.

PROPAFENONE.

PROPAMIDINE for therapeutic use except when included in Schedule 2.

PROPANIDID.

PROPANTHELINE.

PROPENTOFYLLINE.

# PROPETANDROL.

PROPIONIBACTERIUM ACNES for therapeutic use.

PROPOFOL.

PROPRANOLOL.

PROPYLHEXEDRINE.

PROPYLTHIOURACIL.

PROPYPHENAZONE.

PROQUAZONE.

PROSCILLARIDIN.

PROSTAGLANDINS except when separately specified in this Schedule.

PROSTIANOL.

PROTAMINE.

PROTHIONAMIDE.

PROTHIPENDYL.

PROTIRELIN.

PROTOVERATRINES.

PROTRIPTYLINE.

PROXYMETACAINE.

PRUCALOPRIDE.

PSEUDOEPHEDRINE except when included in Schedule 3.

PYRAZINAMIDE.

PYRIDINOLCARBAMATE.

PYRIDOSTIGMINE.

PYRIDOXINE, PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use except:

a)      in oral preparations containing 200 mg or less but more than 50 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

b)      in oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.

PYRIMETHAMINE.

PYROVALERONE.

PYRVINIUM.

# QUAZEPAM.

QUETIAPINE.

QUINAGOLIDE.

QUINAPRIL.

# QUINBOLONE.

QUINETHAZONE.

QUINIDINE.

QUININE for human therapeutic use except when the maximum recommended daily dose is 50 mg or less of quinine.

QUINISOCAINE (dimethisoquin).

QUINUPRISTIN.

RABEPRAZOLE except when included in Schedule 2 or 3.

RABIES VACCINE.

RACTOPAMINE except when included in Schedule 5.

RALOXIFENE.

RALTEGRAVIR.

RALTITREXED.

RAMIPRIL.

RANIBIZUMAB.

RANITIDINE except:

a)      when included in Schedule 2;

b)      in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit when supplied in the manufacturer’s original pack containing not more than 14 dosage units;

c)      in divided preparations for oral use containing 300mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.

RANOLAZINE

RAPACURONIUM.

RASAGILINE.

RASBURICASE.

RAUWOLFIA SERPENTINA.

RAUWOLFIA VOMITORIA.

RAZOXANE.

REBOXETINE.

RED YEAST RICE for human therapeutic use.

REGORAFENIB.

REMOXIPRIDE.

REPAGLINIDE.

RESERPINE.

RETAPAMULIN.

RETEPLASE.

RETIGABINE.

RIBAVIRIN.

RIDAFOROLIMUS.

RIFABUTIN.

RIFAMPICIN.

RIFAMYCIN.

RIFAPENTINE.

RIFAXIMIN.

RILPIVIRINE.

RILUZOLE.

RIMEXOLONE.

RIMITEROL.

RIMONABANT.

RIOCIGUAT.

RISEDRONIC ACID.

RISPERIDONE.

RITODRINE.

RITONAVIR.

RITUXIMAB.

RIVAROXABAN.

RIVASTIGMINE.

RIZATRIPTAN.

ROBENACOXIB.

ROCURONIUM.

ROFECOXIB.

ROFLUMILAST.

ROLITETRACYCLINE.

ROMIDEPSIN.

ROMIFIDINE.

ROMIPLOSTIM.

RONIDAZOLE.

ROPINIROLE.

ROPIVACAINE.

ROSIGLITAZONE.

ROSOXACIN.

ROSUVASTATIN.

ROTIGOTINE.

# ROXIBOLONE.

ROXITHROMYCIN.

RUBELLA VACCINE.

RUBOXISTAURIN.

RUPATADINE.

RUXOLITINIB.

SACUBITRIL.

SALBUTAMOL except when included in Schedule 3.

SALICYLAMIDE when combined with aspirin, caffeine or paracetamol or any derivative of these substances.

SALINOMYCIN except:

a)      when included in Schedule 6; or

b)      in animal feeds containing 60 mg/kg or less of antibiotic substances.

SALMETEROL.

SAPROPTERIN.

SAQUINAVIR.

SARILUMAB.

SAXAGLIPTIN.

SCHOENOCAULON OFFICINALE (sabadilla) except in preparations containing 10 mg/kg or 10 mg/L or less of total alkaloids of Schoenocaulon officinale.

SCOPOLIA CARNIOLICA for therapeutic use.

SEBELIPASE ALFA.

# SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM).

SELEGILINE.

SELENIUM:

a)      for human oral use with a recommended daily dose of more than 300 micrograms; or

b)      for the treatment of animals except:

i)        when included in Schedule 6 or 7;

ii)      in solid, slow release bolus preparations each weighing 100 g or more and containing 300 mg or less of selenium per dosage unit;

iii)    in other divided preparations containing 30 micrograms or less of selenium per dosage unit;

iv)    as elemental selenium, in pellets containing 100 g/kg or less of selenium; or

v)      in feeds containing 1 g/tonne or less of selenium.

SERELAXIN.

SELEXIPAG.

SERMORELIN.

SERTINDOLE.

SERTRALINE.

SEVELAMER.

SEVOFLURANE.

SEX HORMONES and all substances having sex hormonal activity except when separately specified in these Schedules.

SIBUTRAMINE.

# SILANDRONE.

SILDENAFIL.

SILICONES for intra-ocular use. 

SILODOSIN.

SILVER SULFADIAZINE.

SIMEPREVIR.

SIMVASTATIN.

SIROLIMUS.

SISOMICIN (sisomycin).

SITAGLIPTIN.

# SITAXENTAN.

SODIUM BROMIDE for therapeutic use.

SODIUM CELLULOSE PHOSPHATE for human internal use.

SODIUM CROMOGLYCATE except when included in Schedule 2.

SODIUM MORRHUATE in preparations for injection.

SODIUM NITROPRUSSIDE for human therapeutic use.

SODIUM PHENYLBUTYRATE.

SODIUM PHOSPHATE in preparations for oral laxative use.

SODIUM POLYSTYRENE SULPHONATE for human therapeutic use.

SODIUM SALICYLATE in preparations for injection for the treatment of animals.

SODIUM TETRADECYLSULFATE in preparations for injection.

SODIUM ZIRCONIUM CYCLOSILICATE.

SOFOSBUVIR.

SOLASODINE.

SOLIFENACIN.

SOMATOSTATIN.

SOMATOTROPIN EQUINE.

# SOMATROPIN (human growth hormone).

SONIDEGIB.

SONTOQUINE.

SORAFENIB.

SOTALOL.

SPARFLOXACIN.

SPARTEINE.

SPECTINOMYCIN.

SPIRAMYCIN.

SPIRAPRIL.

SPIRONOLACTONE.

# STANOLONE.

# STANOZOLOL.

STAVUDINE.

# STENBOLONE.

STEROID HORMONES except when separately specified in these Schedules.

STILBESTROL (diethylstilbestrol).

STREPTODORNASE.

STREPTOKINASE.

STREPTOMYCIN.

STRONTIUM RANELATE.

STROPHANTHINS.

STROPHANTHUS spp.

STRYCHNINE in preparations containing 1.5 per cent or less of strychnine for the treatment of animals.

STRYCHNOS spp. except in preparations containing 1 mg or less per litre or per kilogram of strychnine.

STYRAMATE.

SUCCIMER.

SUGAMMADEX.

SULBACTAM.

SULCONAZOLE except when included in Schedule 2.

SULFACETAMIDE except when included in Schedule 3 or 5.

SULFADIAZINE except when included in Schedule 5.

SULFADIMETHOXINE.

SULFADIMIDINE except when included in Schedule 5.

SULFADOXINE.

SULFAFURAZOLE.

SULFAGUANIDINE.

SULFAMERAZINE except when included in Schedule 5.

SULFAMETHIZOLE.

SULFAMETHOXAZOLE.

SULFAMETHOXYDIAZINE.

SULFAMETHOXYPYRIDAZINE.

SULFAMETROLE.

SULFAMONOMETHOXINE.

SULFAMOXOLE.

SULFAPHENAZOLE.

SULFAPYRIDINE.

SULFAQUINOXALINE.

SULFASALAZINE.

SULFATHIAZOLE except when included in Schedule 5.

SULFATROXAZOLE.

SULFINPYRAZONE.

SULFOMYXIN.

SULFONAMIDES except:

a)      when separately specified in this Schedule;

b)      when included in Schedule 3, 5 or 6; or

c)      when packed and labelled solely for use as a herbicide.

SULFONMETHANE (sulfonal) and alkyl sulfonals.

SULINDAC.

SULTAMICILLIN.

SULTHIAME.

SUMATRIPTAN.

SUNITINIB.

SUPROFEN.

SUTILAINS.

SUXAMETHONIUM.

SUXETHONIUM.

SUVOREXANT.

TACRINE.

TACROLIMUS.

TADALAFIL.

TAFLUPROST.

TALIGLUCERASE ALFA.

TALIMOGENE LAHERPAREPVEC.

TAMOXIFEN.

TAMSULOSIN.

TANACETUM VULGARE except in preparations containing 0.8 per cent or less of oil of tansy.

TASONERMIN.

TAZAROTENE.

TAZOBACTAM.

TB-500.

T-CELL RECEPTOR ANTIBODY.

TEGAFUR.

TEGASEROD.

TELAPREVIR.

TELITHROMYCIN.

TEICOPLANIN.

TELBIVUDINE.

TELMISARTAN.

# TEMAZEPAM.

TEMOZOLOMIDE.

TEMSIROLIMUS.

TENECTEPLASE.

TENIPOSIDE.

TENOFOVIR.

TENOXICAM.

TEPOXALIN.

TERAZOSIN.

TERBINAFINE except:

a)      when included in Schedule 2; or

b)      in preparations for dermal use for the treatment of tinea pedis.

TERBUTALINE except when included in Schedule 3.

TERFENADINE.

TERIFLUNOMIDE.

# TERIPARATIDE.

TERLIPRESSIN.

TERODILINE.

TEROPTERIN.

# TESTOLACTONE.

# TESTOSTERONE except when included in Schedule 6.

TETANUS ANTITOXIN except when used for short-term protection or treatment of tetanus in animals.

TETANUS TOXOID for human use.

TETRABENAZINE.

TETRACAINE except:

a)      when included in Schedule 2; or

b)      in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

TETRACOSACTIDE.

TETRACYCLINE except when included in Schedule 5.

TETRAETHYLAMMONIUM.

TETROXOPRIM.

# THALIDOMIDE.

THENYLDIAMINE.

THEOPHYLLINE except when included in Schedule 3.

THEVETIA PERUVIANA.

THEVETIN.

THIACETARSAMIDE in preparations for the prevention or treatment of heartworm in dogs.

THIAMBUTOSINE.

THIAZOSULFONE.

THIETHYLPERAZINE.

THIOACETAZONE.

THIOCARLIDE.

# THIOMESTERONE (tiomesterone).

THIOPENTAL.

THIOPROPAZATE.

THIOPROPERAZINE.

THIORIDAZINE.

THIOSTREPTON.

THIOTEPA.

THIOTHIXENE.

THIOURACIL.

THIOUREA for therapeutic use except in preparations containing 0.1 per cent or less of thiourea.

THYMOSIN BETA 4 (THYMOSIN β4)

THYMOXAMINE (includes thymoxamine hydrochloride).

THYROID except when separately specified in this Schedule.

THYROTROPHIN.

THYROXINE (includes thyroxine sodium).

TIAGABINE.

TIAMULIN.

# TIANEPTINE.

TIAPROFENIC ACID.

TIARAMIDE.

TIBOLONE.

TICAGRELOR.

TICARCILLIN.

TICLOPIDINE.

TIEMONIUM.

TIENILIC ACID.

TIGECYCLINE.

TIGLOIDINE.

TILDIPIROSIN.

TILETAMINE.

TILMICOSIN.

TILUDRONIC ACID (includes disodium tiludronate).

TIMOLOL.

TINIDAZOLE.

TINZAPARIN (includes tinzaparin sodium).

TIOCONAZOLE except:

a)      when included in Schedule 2 or 3; or

b)      in preparations for dermal use for the treatment of tinea pedis.

TIOGUANINE.

TIOTROPIUM.

TIPEPIDINE.

TIPRANAVIR.

TIRILAZAD.

TIROFIBAN.

TOBRAMYCIN.

TOCAINIDE.

TOCERANIB.

TOCILIZUMAB.

TOFACITINIB.

TOLAZAMIDE.

TOLAZOLINE.

TOLBUTAMIDE.

TOLCAPONE.

TOLFENAMIC ACID.

TOLMETIN.

TOLONIUM.

TOLPROPAMINE.

TOLRESTAT.

TOLTERODINE.

TOLVAPTAN.

TOPIRAMATE.

TOPOTECAN.

TORASEMIDE.

TOREMIFENE.

TOXOIDS for human parenteral use except when separately specified in these Schedules.

TRAMADOL.

TRANDOLAPRIL.

TRAMETINIB DIMETHYL SULFOXIDE.

TRANEXAMIC ACID except in preparations containing 3 per cent or less of cetyl tranexamate hydrochloride for dermal cosmetic use. 

TRANYLCYPROMINE.

TRASTUZUMAB.

TRASTUZUMAB EMTANSINE.

TRAVOPROST.

TRAZODONE.

# TRENBOLONE (trienbolone, trienolone) except when included in Schedule 5.

TREOSULPHAN.

TREPROSTINIL.

# TRESTOLONE.

TRETAMINE.                           

# TRETINOIN.

TRIACETYLOLEANDOMYCIN.

TRIAMCINOLONE except when included in Schedule 2 or 3.

TRIAMTERENE.

TRIAZIQUONE.

# TRIAZOLAM.

TRICHLORMETHIAZIDE.

TRICHLOROACETIC ACID for human dermal use except when in preparations containing 12.5 per cent or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

TRICHLOROETHYLENE for therapeutic use.

TRICLOFOS.

TRICYCLAMOL.

TRIDIHEXETHYL.

TRIFLUOPERAZINE.

TRIFLUPERIDOL.

TRIFLUPROMAZINE.

TRIHEXYPHENIDYL

TRILOSTANE.

TRIMETAPHAN.

TRIMETHOPRIM.

TRIMIPRAMINE.

TRIMUSTINE.

TRINITROPHENOL (excluding its derivatives) in preparations for human therapeutic use.

TRIOXYSALEN.

TRIPELENNAMINE.

TRIPLE ANTIGEN VACCINE.

TRIPROLIDINE except when included in Schedule 2 or 3.

TRIPTORELIN.

TROGLITAZONE.

TROLAMINE when in preparations for tattoo removal.

TROMETAMOL in preparations for injection except in preparations containing 3 per cent or less of trometamol.

TROPICAMIDE.

TROPISETRON.

TROVAFLOXACIN.

TROXIDONE.

TRYPTOPHAN for human therapeutic use except in preparations labelled with a recommended daily dose of 100 mg or less of tryptophan.

TUBERCULIN.

TUBOCURARINE.

TULATHROMYCIN.

TULOBUTEROL.

TYLOSIN.

TYPHOID VACCINE.

ULIPRISTAL except when included in Schedule 3.

UMECLIDINIUM.

UNOPROSTONE.

URACIL.

URAPIDIL.

URETHANE (excluding its derivatives) for therapeutic use.

# UROFOLLITROPIN.

UROKINASE.

URSODEOXYCHOLIC ACID.

USTEKINUMAB.

VACCINES for human therapeutic use except when separately specified in this Schedule.

VACCINES, veterinary live virus except:

a)      poultry vaccines;

b)      pigeon pox vaccine; or

c)      scabby mouth vaccine.

VACCINIA VIRUS VACCINE.

VALACICLOVIR.

VALDECOXIB.

VALGANCICLOVIR.

VALNOCTAMIDE.

VALPROIC ACID.

VALSARTAN.

VANCOMYCIN.

VANDETANIB.

VARDENAFIL.

VARENICLINE.

VARICELLA VACCINE.

VASOPRESSIN.

VECURONIUM.

VEDAPROFEN.

VEDOLIZUMAB.

VELAGLUCERASE ALFA.

VELPATASVIR.

VEMURAFENIB.

VENETOCLAX.

VENLAFAXINE.

VERAPAMIL.

VERATRUM spp. except when separately specified in this Schedule.

VERNAKALANT.

VERTEPORFIN.

VIDARABINE.

VIGABATRIN.

VILANTEROL.

VILDAGLIPTIN.

VILOXAZINE.

VINBLASTINE.

VINCAMINE.

VINCRISTINE.

VINDESINE.

VINFLUNINE.

VINORELBINE.

VINYL ETHER for therapeutic use.

VIRGINIAMYCIN except when included in Schedule 5.

VISMODEGIB.

VISNADINE.

VITAMIN A for human therapeutic or cosmetic use except:

a)      in preparations for topical use containing 1 per cent or less of Vitamin A;

b)      in preparations for internal use containing 3000 micrograms retinol equivalents or less of Vitamin A per daily dose; or

c)      in preparations for parenteral nutrition replacement.

VITAMIN D for human internal therapeutic use except:

a)      in preparations containing 25 micrograms or less of vitamin D per recommended daily dose ; or

b)      when included in Schedule 3.

VORAPAXAR.

VORICONAZOLE.

VORINOSTAT.

VORTIOXETINE.

WARFARIN for therapeutic use.

XAMOTEROL.

XANTHINOL NICOTINATE.

XIMELAGATRAN.

XIPAMIDE.

XYLAZINE.

YOHIMBINE.

ZAFIRLUKAST.

ZALCITABINE.

ZALEPLON.

ZANAMIVIR.

ZERANOL except when included in Schedule 6.

ZIDOVUDINE.

ZILPATEROL.

ZIMELDINE.

ZINC COMPOUNDS for human internal use except:

a)      in preparations with a recommended daily dose of 25 mg or less of zinc; or

b)      in preparations with a recommended daily dose of more than 25 mg but not more than 50 mg of zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.

ZIPRASIDONE.

ZOLAZEPAM.

ZOLEDRONIC ACID.

ZOLMITRIPTAN.

ZOLPIDEM.

ZONISAMIDE.

ZOPICLONE.

ZOXAZOLAMINE.

ZUCLOPENTHIXOL.


SCHEDULE 5

ABAMECTIN

a)      in preparations, for internal use for the treatment of animals, containing 1 per cent or less of abamectin; or

b)      in gel formulations containing 0.05 per cent or less of abamectin in applicators containing 50 mg or less of abamectin.

ABSCISIC ACID.

ACETIC ACID (excluding its salts and derivatives) in preparations containing more than 30 per cent of acetic acid (CH3COOH) except:

a)      when included in Schedule 2 or 6; or

b)      for therapeutic use.

ACETONE except in preparations containing 25 per cent or less of designated solvents.

ACRIFLAVINIUM CHLORIDE in preparations for veterinary use containing 2.5 per cent or less of acriflavinium chloride.

AFOXOLANER in oral divided preparations each containing 150 mg or less of afoxolaner per dosage unit

a)      for the treatment and prevention of flea infestations and control of ticks in dogs; or

b)      for the treatment and prevention of flea infestations, control of ticks, gastrointestinal nematodes and heartworm in dogs, when combined with milbemycin oxime.

AKLOMIDE.

ALBENDAZOLE for the treatment of animals, in preparations containing 12.5 per cent or less of albendazole except in intraruminal implants each containing 3.85 g or less of albendazole.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination:

a)      in solid orthodontic device cleaning preparations, the pH of which as an “in-use” aqueous solution is more than 11.5;

b)      in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 11.5 but less than or equal to 12.5;

c)      in other solid preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5; or

d)      in liquid or semi-solid preparations, the pH of which is more than 11.5, unless:

i)        in food additive preparations for domestic use; or

ii)      in automatic dish washing preparations for domestic use with a pH of more than 12.5,

       except when separately specified in these Schedules.

ALKOXYLATED FATTY ALKYLAMINE POLYMER in preparations containing 50 per cent or less of alkoxylated fatty alkylamine polymer except in preparations containing 20 per cent or less of alkoxylated fatty alkylamine polymer.

ALLETHRIN in preparations containing 10 per cent or less of allethrin except:

a)      in insecticidal mats; or

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

ALLOXYDIM.

ALPHA-CYPERMETHRIN:

a)      in aqueous preparations containing 3 per cent or less of alpha-cypermethrin; or

b)      in other preparations containing 1.5 per cent or less of alpha-cypermethrin.

AMETRYN.

AMINES for use as curing agents for epoxy resins except when separately specified in these Schedules.

AMINOACRIDINE in preparations for veterinary use containing 2.5 per cent or less of aminoacridine.

AMINOPYRALID in preparations containing 22 per cent or less of aminopyralid.

AMITROLE.

AMINOCYCLOPYRACHLOR.

AMISULBROM

AMMONIA (excluding its salts and derivatives other than ammonium hydroxide) in preparations containing 5 per cent or less of ammonia except:

a)      in preparations for human internal therapeutic use;

b)      in preparations for inhalation when absorbed in an inert solid material; or

c)      in preparations containing 0.5 per cent or less of free ammonia.

AMMONIUM THIOCYANATE except in preparations containing 10 per cent or less of ammonium thiocyanate.

ANHYDRIDES, ORGANIC ACID for use as curing agents for epoxy resins except when separately specified in these Schedules.

ANISE OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

                        KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 50 per cent or less of anise oil.

ASPIRIN for the treatment of animals, in divided preparations when packed in blister or strip packaging or in a container with a child-resistant closure.

ATRAZINE.

AZADIRACHTA INDICA EXTRACTS (neem extracts), extracted from neem seed kernels using water, methanol or ethanol, in preparations containing 5 per cent or less of total limonoids, for agricultural use.

AZOXYSTROBIN.

BACILLUS THURINGIENSIS DELTA ENDOTOXIN encapsulated in killed Pseudomonas fluorescens.

BARIUM SILICOFLUORIDE when coated on paper in an amount not exceeding 8 mg of barium silicofluoride per sq. cm.

BASIL OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

                        KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 5 per cent or less of methyl chavicol.

BEAUVERIA BASSIANA in preparations containing 1 x 108 Colony Forming Units (CFU)/mL or less of Beauveria bassiana.

BENALAXYL.

BENDIOCARB in preparations containing 2 per cent or less of bendiocarb.

BENTAZONE.

BENZALKONIUM CHLORIDE in preparations containing 10 per cent or less of benzalkonium chloride except in preparations containing 5 per cent or less of benzalkonium chloride.

BENZOFENAP.

BENZOYL PEROXIDE except:

a)      when included in Schedule 2 or 4; or

b)      in preparations containing 5 per cent or less of benzoyl peroxide.

BERGAMOT OIL except:

a)      when steam distilled or rectified;

b)      in preparations for internal use;

c)      in preparations containing 0.4 per cent or less of bergamot oil;

d)      in soaps or bath or shower gels that are washed off the skin;

e)      in medicines for human therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

f)       in other preparations when packed in containers labelled with the statement:

                        Application to the skin may increase sensitivity to sunlight.

BETACYFLUTHRIN:

a)      in aqueous preparations containing 2.5 per cent or less of betacyfluthrin; or

b)      in solid preparations containing 8 per cent or less of betacyfluthrin in a plastic matrix.

BICYCLOPYRONE in preparations containing 20 per cent or less of bicyclopyrone.

BIFLUORIDES (including ammonium, potassium and sodium salts), in preparations containing 0.3 per cent or less of total bifluorides.

BIOALLETHRIN in preparations containing 10 per cent or less of bioallethrin except in preparations containing 1 per cent or less of bioallethrin.

BIORESMETHRIN except in preparations containing 10 per cent or less of bioresmethrin.

BISPYRIBAC except in preparations containing 10 per cent or less of bispyribac.

BIXAFEN.

BORIC ACID (excluding its salts) and BORAX except:

a)      when included in Schedule 4;

b)      in preparations, other than insect baits, containing 1 per cent or less of boron; or

c)      in hand cleaning preparations.

BORON TRIFLUORIDE in preparations containing 0.1 per cent or less of boron trifluoride (BF3).

BROMUCONAZOLE in preparations containing 20 per cent or less of bromuconazole.

BUPIVACAINE in aqueous gel preparations containing 0.5 per cent or less of bupivacaine, for the dermal spray-on treatment of wounds associated with 'mulesing' of sheep.

BUPROFEZIN except in preparations containing 40 per cent or less of buprofezin.

BUTHIDAZOLE.

BUTOXYCARBOXIM in solid preparations containing 10 per cent or less of butoxycarboxim.

BUTRALIN.

BUTROXYDIM.

n-BUTYL ALCOHOL in preparations containing 10 per cent or less of n-butyl alcohol except:

a)      in preparations containing 5 per cent or less of n-butyl alcohol; or

b)      in preparations for cosmetic or therapeutic use other than spray form.

CAMPHOR as a natural component in essential oils containing 10 per cent or less of camphor except:

a)      in medicines for human therapeutic use, in essential oils when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, in essential oils when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and

                        NOT TO BE TAKEN;

c)      in rosemary oil, sage oil (Spanish), or lavandin oils; or

d)      in preparations containing 2.5 per cent or less of camphor.

CARBAMIDE PEROXIDE in preparations containing 18 per cent or less of carbamide peroxide except in preparations containing 9 per cent or less of carbamide peroxide.

CARBARYL:

a)      in preparations containing 10 per cent or less of carbaryl except when included in Schedule 4; or

b)      when impregnated into plastic resin material containing 20 per cent or less of carbaryl.

CASSIA OIL except:

a)      in food additives;

b)      in preparations for dermal use as a rubefacient containing 5 per cent or less of cassia oil; or

c)      in other preparations containing 2 per cent or less of cassia oil.

CHLORFENAC.

CHLORFENAPYR. in preparations containing 0.5 per cent or less of chlorfenapyr.

CHLORFENSON.

CHLORHEXIDINE in preparations containing 3 per cent or less of chlorhexidine except:

a)      in preparations containing 1 per cent or less of chlorhexidine; or

b)      when in solid preparations.

CHLORINATING COMPOUNDS containing 20 per cent or less of available chlorine, except:

a)      when separately specified in these Schedules;

b)      sodium hypochlorite preparations with a pH of less than 11.5;

c)      liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using.  Vapour may be harmful.  May give off dangerous gas if mixed with other products;

d)      liquid preparations containing less than 2 per cent of available chlorine; or

e)      other preparations containing 4 per cent or less of available chlorine.

CHLORNIDINE.

CHLOROCRESOL except in preparations containing 3 per cent or less of chlorocresol.

CHLORPROPHAM.

CHLORPYRIFOS:

a)      in aqueous preparations containing 20 per cent or less of microencapsulated chlorpyrifos;

b)      in controlled release granular preparations containing 10 per cent or less of chlorpyrifos; or

c)      in other preparations containing 5 per cent or less of chlorpyrifos,

       except in prepared potting or soil mixes containing 100 g or less of chlorpyrifos per cubic         metre.

CHLORSULFURON.

CHLORTETRACYCLINE in preparations:

a)      for topical application to animals for ocular use only; or

b)      containing 40 per cent or less of chlortetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

CHLORTHAL-DIMETHYL.

CINMETHYLIN.

CINNAMON BARK OIL except:

a)      in food additives; or

b)      in preparations containing 2 per cent or less of cinnamon bark oil.

CLETHODIM.

CLIMBAZOLE in preparations containing 40 per cent or less of climbazole except in preparations containing 2 per cent or less of climbazole.

CLOFENTEZINE.

CLOPYRALID.

CLOQUINTOCET.

CLORSULON.

CLOTHIANIDIN in preparations containing 20 per cent or less of clothianidin except in gel preparations dispensed in sealed cartridges containing 1 per cent or less of clothianidin.

CLOVE OIL for topical use in the mouth in a pack containing 5 mL or less of clove oil except in preparations containing 25 per cent or less of clove oil.

COPPER ACETATE in preparations containing 20 per cent or less of copper acetate except in preparations containing 5 per cent or less of copper acetate.

COPPER COMPOUNDS in animal feed additives containing 5 per cent or less of copper except in preparations containing 1 per cent or less of copper.

COPPER HYDROXIDE in preparations containing 50 per cent or less of copper hydroxide except in preparations containing 12.5 per cent or less of copper hydroxide.

COPPER OXIDES in preparations containing 25 per cent or less of copper oxides except:

a)      in preparations for internal use;

b)      in marine paints; or

c)      in other preparations containing 5 per cent or less of copper oxides.

COPPER OXYCHLORIDE in preparations containing 50 per cent or less of copper oxychloride except in preparations containing 12.5 per cent or less of copper oxychloride.

COPPER SULFATE in preparations containing 15 per cent or less of copper sulfate except:

a)      in preparations for internal use; or

b)      in other preparations containing 5 per cent or less of copper sulfate.

COUMATETRALYL in rodenticides containing 0.05 per cent or less of coumatetralyl.

4-CPA.

CYANATRYN.

CYANOACRYLATE ESTERS in contact adhesives except:

a)      when labelled with the warning:

KEEP OUT OF REACH OF CHILDREN.  Avoid contact with skin and eyes and avoid breathing vapour.  Bonds on contact.  Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water.  Do not use solvents near eyes or open wounds.  In case of eye contact immediately flush with water; or

b)      when packed in sealed measure packs each containing 0.5 g or less of cyanoacrylate esters:

i)        labelled with the approved name or trade name of the poison, the quantity and the warning:

Can cause eye injury.  Instantly bonds skin; and

ii)      enclosed in a primary pack labelled with the warning:

KEEP OUT OF REACH OF CHILDREN.  Avoid contact with skin and eyes and avoid breathing vapour.  Bonds on contact.  Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water.  Do not use solvents near eyes or open wounds.  In case of eye contact immediately flush with water.

CYANTRANILIPROLE.

CYANURIC ACID (excluding its salts and derivatives).

CYAZOFAMID.

CYCLOHEXANONE PEROXIDE.

CYCLOPROTHRIN except in preparations containing 10 per cent or less of cycloprothrin.

CYCLOXYDIM.

CYFLUFENAMID.

CYFLUTHRIN:

a)      in wettable powders containing 10 per cent or less of cyfluthrin;

b)      in emulsifiable concentrates containing 2 per cent or less of cyfluthrin; or

c)      in emulsions containing 5 per cent or less of cyfluthrin.

CYHALOFOP-BUTYL.

CYMIAZOLE.

CYPERMETHRIN in preparations containing 10 per cent or less of cypermethrin.

CYPHENOTHRIN in preparations containing 10 per cent or less of cyphenothrin.

CYPROCONAZOLE except in preparations containing 10 per cent or less of cyproconazole.

CYPRODINIL.

CYTHIOATE for the treatment of animals:

a)      in divided preparations containing 30 mg or less of cythioate per dosage unit when packed in blister or strip packaging or in a container with a child-resistant closure; or

b)      in undivided preparations containing 5 per cent or less of cythioate.

2,4-D in preparations containing 20 per cent or less of 2,4-D.

DAMINOZIDE.

2,4-DB.

DECOQUINATE:

DELTAMETHRIN:

a)      when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin;

b)      in aqueous preparations containing 5 per cent or less of deltamethrin when no organic solvent other than a glycol is present;

c)      in wettable granular preparations containing 25 per cent or less of deltamethrin when packed in child-resistant packaging each containing 3 g or less of the formulation;

d)      in water-dispersible tablets each containing 500 mg or less of deltamethrin in child-resistant packaging; or

e)      in other preparations containing 0.5 per cent or less of deltamethrin,

except:

a)      in factory prepared mosquito nets containing 1 per cent or less deltamethrin; or

b)      in preparations containing 0.1 per cent or less of deltamethrin.

DEMBREXINE in oral preparations for the treatment of animals.

2,4-DES.

DIAFENTHIURON.

N,N-DIALLYLDICHLOROACETAMIDE except in preparations containing 10 per cent or less of N,N-diallyldichloroacetamide.

DIAZINON in dust preparations containing 2 per cent or less of diazinon.

DICAMBA (including its salts and derivatives) in preparations containing 20 per cent or less of dicamba.

DICHLONE.

p-DICHLOROBENZENE.

DICHLOROISOCYANURIC ACID containing 40 per cent or less of available chlorine, except in:

a)      liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using.  Vapour may be harmful.  May give off dangerous gas if mixed with other products;

b)      liquid preparations containing less than 2 per cent of available chlorine; or

c)      other preparations containing 4 per cent or less of available chlorine.

DICHLOROMETHANE (methylene chloride) except:

a)      in preparations in pressurised spray packs labelled as degreasers, decarbonisers or paint strippers and containing 10 per cent or less of dichloromethane; 

b)      in other preparations in pressurised spray packs; or

c)      in paints and tinters containing 5 per cent or less of dichloromethane.

DICHLOROPHEN for the treatment of animals.

DICHLORVOS:

a)      when impregnated in plastic resin strip material containing 20 per cent or less of dichlorvos;

b)      in sustained release resin pellets containing 20 per cent or less of dichlorvos for the treatment of animals; or

c)      in pressurised spray packs containing 10 grams or less of dichlorvos.

DICLOBUTRAZOL.

DICLORAN.

DICOFOL.

DIETHANOLAMINE (excluding its salts and derivatives) in preparations containing 20 per cent or less of diethanolamine except in preparations containing 5 per cent or less of diethanolamine.

DIETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:

a)      in paints or paint tinters;

b)      in toothpastes or mouthwashes containing more than 0.25 per cent of diethylene glycol; or

c)      in other preparations containing 2.5 per cent or less of diethylene glycol.

DIETHYLENE GLYCOL MONOBUTYL ETHER except in preparations containing 10 per cent or less of diethylene glycol monobutyl ether.

DIETHYLTOLUAMIDE (DEET) except:

a)      in medicines for human therapeutic use containing 20 per cent or less of diethyltoluamide, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; 

b)      in preparations for human use, other than medicines, containing 20 per cent or less of diethyltoluamide, when labelled with the warning statement:

WARNING: May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time; or

c)      in preparations other than for human use containing 20 per cent or less of diethyltoluamide.

DIFENOCONAZOLE.

DIFLUBENZURON.

DIMETHICODIETHYLBENZALMALONATE except when included in preparations containing 10 per cent or less of dimethicodiethylbenzalmalonate.

DIMETHIRIMOL.

DIMETHOMORPH except in preparations containing 10 per cent or less of dimethomorph.

DIMETHYLACETAMIDE in preparations containing 20 per cent or less of dimethylacetamide.

DIMETHYLFORMAMIDE in preparations containing 10 per cent or less of dimethylformamide except in silicone rubber mastic containing 2 per cent or less of dimethylformamide.

3,7-DIMETHYL-2,6-OCTADIENAL and its isomers in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-dimethyl-2,6,-octadienal isomers.

DINICONAZOLE.

DINOTEFURAN.

DI-n-PROPYL ISOCINCHOMERONATE except in preparations containing 25 per cent or less of di-n-propyl isocinchomeronate.

DIPHENAMID.

DIRECT RED 254 in preparations containing 30 per cent or less of Direct Red 254.

DITHIOPYR.

N-(N-DODECYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-dodecyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-dodecyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or N-(N-octyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

DORAMECTIN for internal use for the treatment of animals, in preparations containing 2 per cent or less of doramectin.

EMAMECTIN in preparations containing 2 per cent or less of emamectin.

EMODEPSIDE in preparations:

a)      containing 2.5 per cent or less of emodepside for the external treatment of animals; or

b)      containing 30 mg or less of emodepside per dosage unit for the oral treatment of animals.

EPOXICONAZOLE.

EPOXY RESINS, LIQUID.

EPRINOMECTIN in preparations containing 0.5 per cent or less of eprinomectin.

ESBIOTHRIN in preparations containing 10 per cent or less of esbiothrin except in pressurised spray packs containing 1 per cent or less of esbiothrin.

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

ESTRADIOL in implant preparations for growth promotion in animals.

1,2-ETHANEDIAMINE POLYMERWITH (CHLOROMETHYL) OXIRANE AND N-METHYLMETHANAMINE.

ETHER in preparations containing more than 10 per cent of ether for use in internal combustion engines.

ETHOFUMESATE.

ETHOXYQUIN except in preparations containing 10 per cent or less of ethoxyquin.

ETHOXYSULFURON.

ETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:

a)      in paints or paint tinters;

b)      in toothpastes or mouthwashes containing more than 0.25 per cent of ethylene glycol; or

c)      in other preparations containing 2.5 per cent or less of ethylene glycol.

ETHYL METHACRYLATE (excluding its derivatives) for cosmetic use except in preparations containing 1 per cent or less of ethyl methacrylate as residual monomer in a polymer.

ETRIDIAZOLE.

EUGENOL for topical use in the mouth in a pack containing 5 mL or less of eugenol except in preparations containing 25 per cent or less of eugenol.

EXTRACT OF LEMON EUCALYPTUS, being acid modified oil of lemon eucalyptus (Corymbia citriodora) , except in preparations containing 40 per cent or less of extract of lemon eucalyptus.

FENARIMOL.

FENBENDAZOLE for the treatment of animals.

FENBUCONAZOLE.

FENCHLORAZOLE-ETHYL.

FENNEL OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 5 per cent or less of methyl chavicol.

FENOPROP.

FENOXAPROP-ETHYL.

FENOXAPROP-p-ETHYL.

FENPYRAZAMINE except in preparations containing 40 per cent or less of fenpyrazamine

FENSON.

FENTHION:

a)      in preparations containing 25 per cent or less of fenthion when packed in single-use containers having a capacity of 2 mL or less; or

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

FIPRONIL in preparations containing 10 per cent or less of fipronil except in preparations containing 0.05 per cent or less of fipronil.

FLAMPROP-METHYL.

FLAMPROP-M-METHYL.

FLAZASULFURON.

FLORASULAM.

FLUAZURON.

FLUBENDAZOLE for the treatment of animals.

FLUBENDIAMIDE.

FLUCHLORALIN.

FLUDIOXONIL except in preparations containing 10 per cent or less of fludioxonil.

FLUMETHRIN:

a)      when impregnated in plastic resin strip material containing 3 per cent or less of flumethrin; or

b)      in oil based preparations containing 1 per cent or less of flumethrin.

FLUMICLORAC PENTYL.

FLUOPYRAM except in preparations containing 50 per cent or less of fluopyram.

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

a)      in preparations for human use; or

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

FLURALANER for the treatment and prevention of flea infestations and control of ticks in dogs in oral divided preparations each containing 1400 mg or less of fluralaner per dosage unit.

FLUVALINATE in aqueous preparations containing 25 per cent or less of fluvalinate.

FLUXAPYROXAD.

FORAMSULFURON.

FORMIC ACID (excluding its salts and derivatives) except in preparations containing 0.5 per cent or less of formic acid.

FOSPIRATE when impregnated in plastic resin strip material containing 20 per cent or less of fospirate.

FURALAXYL.

FURATHIOCARB in microencapsulated suspensions containing 50 per cent or less of furathiocarb.

GAMMA-CYHALOTHRIN in aqueous preparations containing 15 per cent or less of microencapsulated gamma-cyhalothrin.

GLUFOSINATE-AMMONIUM.

GLUTARAL in preparations containing 5 per cent or less of glutaral except:

a)      when included in Schedule 2; or

b)      in preparations containing 0.5 per cent or less of glutaral when labelled with the statements:

                        IRRITANT; and

                        Avoid contact with eyes.

GLYPHOSATE.

HALOSULFURON-METHYL.

HEXACONAZOLE except in preparations containing 5 per cent or less of hexaconazole.

HEXAZINONE in preparations containing 25 per cent or less of hexazinone.

HYDRAMETHYLNON in solid baits containing 2 per cent or less of hydramethylnon in welded plastic labyrinths.

HYDROCARBONS, LIQUID, including kerosene, diesel (distillate), mineral turpentine, white petroleum spirit, toluene, xylene and light mineral  and paraffin oils (but excluding their derivatives), except:

a)      toluene and xylene when included in Schedule 6;

b)      benzene and liquid aromatic hydrocarbons when included in Schedule 7;

c)      food grade and pharmaceutical grade white mineral oils;

d)      in solid or semi-solid preparations;

e)      in preparations containing 25 per cent or less of designated solvents;

f)       in preparations packed in pressurised spray packs;

g)      in adhesives packed in containers each containing 50 grams or less of adhesive;

h)      in writing correction fluids and thinners for writing correction fluids packed in containers having a capacity of 20 mL or less; or

i)        in other preparations when packed in containers with a capacity of 2 mL or less.

HYDROCHLORIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of hydrochloric acid (HCl) except:

a)      in preparations containing 0.5 per cent or less of hydrochloric acid (HCl); or

b)      for therapeutic use.

HYDROFLUORIC ACID (excluding its salts and derivatives) and admixtures that generate hydrofluoric acid, in preparations containing 0.1 per cent or less of hydrogen fluoride.

HYDROGEN PEROXIDE (excluding its salts and derivatives):

a)      in hair dye preparations containing 12 per cent or less of hydrogen peroxide except in hair dyes containing 6 per cent or less of hydrogen peroxide; or

b)      in other preparations containing 6 per cent (20 volume) or less of hydrogen peroxide except in preparations containing 3 per cent (10 volume) or less of hydrogen peroxide.

HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) in preparations containing 0.1 per cent or less of hydrosilicofluoric acid (H2SiF6).

2-HYDROXYETHYL METHACRYLATE except when included in dental restorative preparations for therapeutic use or in nail preparations when labelled “Avoid contact with skin”.

2-HYDROXYPROPYL METHACRYLATE in nail preparations except when labelled 'avoid contact with skin'.

IMAZALIL.

IMAZAMOX except in preparations containing 25 per cent or less of imazamox.

IMAZAPIC except in preparations containing 25 per cent or less of imazapic.

IMAZAPYR except in preparations containing 25 per cent or less of imazapyr.

IMAZETHAPYR except in preparations containing 25 per cent or less of imazethapyr.

IMIDACLOPRID in preparations containing 20 per cent or less of imidacloprid except in preparations containing 5 per cent or less of imidacloprid.

IMIPROTHRIN in preparations containing 50 per cent or less of imiprothrin except in preparations containing 10 per cent or less of imiprothrin.

INDOXACARB (includes the R and S enantiomers) in preparations containing 1 per cent or less of indoxacarb.

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) ) in preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate except:

a)      in aqueous preparations not for cosmetic use containing 10 per cent or less 3-iodo-2-propynyl butyl carbamate; or

b)      in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate.

IODOSULFURON-METHYL-SODIUM.

IPCONAZOLE in preparations containing 2 per cent or less of ipconazole.

IRON COMPOUNDS:

a)      for the treatment of animals (excluding up to 1 per cent of iron oxides when present as an excipient):

i)        in preparations for injection containing 20 per cent or less of iron except in preparations containing 0.1 per cent or less of iron; or

ii)      in other preparations containing 4 per cent or less of iron except:

A)      in liquid or gel preparations containing 0.1 per cent or less of iron; or

B)       in animal feeds or feed premixes; or

b)      in garden preparations except in preparations containing 4 per cent or less of iron.

ISOEUGENOL in preparations containing 25 per cent or less of isoeugenol except in preparations containing 10 per cent or less of isoeugenol.

ISOPHORONE.

ISOXABEN.

ISOXAFLUTOLE.

IVERMECTIN for use in animals:

a)      in preparations for the prophylaxis of heartworm in cats and dogs;

b)      in intraruminal implants containing 160 mg or less of ivermectin;

c)      in preparations containing 3.5 per cent or less of ivermectin when packed in child-resistant packaging or in packaging approved by the relevant registration authority; or

d)      in other preparations containing 2 per cent or less of ivermectin.

KITASAMYCIN in animal feed premixes for growth promotion containing 2 per cent or less of antibiotic substances.

LAMBDA-CYHALOTHRIN:

a)      in aqueous preparations containing 1 per cent or less of lambda- cyhalothrin; or

b)      in aqueous preparations containing 2.5 per cent or less of microencapsulated lambda-cyhalothrin.

LASIODIPLODIA PSEUDOTHEOBROMAE except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

LEAD COMPOUNDS in preparations for use as hair cosmetics.

LEMON OIL except:

a)      when steam distilled or rectified;

b)      in preparations for internal use;

c)      in preparations containing 0.05 per cent or less of lemon oil;

d)      in soaps or bath or shower gels that are washed off the skin;

e)      in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

f)       in other preparations when packed in containers labelled with the statement:

                        Application to the skin may increase sensitivity to sunlight.

LEMONGRASS OIL in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-dimethyl-2,6-octadienal.

LEVAMISOLE in preparations containing 15 per cent or less of levamisole for the treatment of animals except:

a)      when included in Schedule 4; or

b)      in preparations for the treatment of ornamental birds or ornamental fish, in packs containing 10 mg or less of levamisole.

LIDOCAINE in aqueous gel preparations containing 4.5 per cent or less of lidocaine, for the dermal spray-on treatment of wounds associated with 'mulesing' of sheep.

LIME OIL except:

a)      when steam distilled or rectified;

b)      in preparations for internal use;

c)      in preparations containing 0.5 per cent or less of lime oil;

d)      in soaps or bath or shower gels that are washed off the skin;

e)      in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

f)       in other preparations when packed in containers labelled with the statement:

                        Application to the skin may increase sensitivity to sunlight.

LINDANE in preparations containing 10 per cent or less of lindane except when included in Schedule 2 or 4.

LUFENURON except:

a)      in divided preparations each containing 500 mg or less of lufenuron for the treatment of animals; or

b)      in single use syringes each containing 500 mg or less of lufenuron for the treatment of animals.

MACROPHOMINA PHASEOLINA except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

MADURAMICIN in animal feed premixes containing 1 per cent or less of antibiotic substances.

MAGNESIUM CHLORATE except in preparations containing 10 per cent or less of magnesium chlorate.

MALACHITE GREEN in preparations for veterinary use containing 10 per cent or less of malachite green.

MALATHION in preparations containing 10 per cent or less of malathion except:

a)      for human therapeutic use; or

b)      in dust preparations containing 2 per cent or less of malathion.

MANCOZEB.

MANDESTROBIN except in preparations containing 25 per cent or less of mandestrobin.

MANDIPROPAMID.

MARJORAM OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

                        KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 50 per cent or less of marjoram oil.

MCPA:

a)      in preparations containing 25 per cent or less of MCPA (acid); or

b)      in preparations containing 50 per cent or less of the salts and esters of MCPA.

MCPB.

MEBENDAZOLE for the treatment of animals:

a)      in divided preparations each containing 300 mg or less of mebendazole per dosage unit; or

b)      in undivided preparations containing 25 per cent or less of mebendazole.

MECLOFENAMIC ACID for the treatment of animals.

MECOPROP in preparations containing 2 per cent or less of mecoprop.

MEFENPYR-DIETHYL.

MEPIQUAT.

MERCAPTAMINE in cosmetic preparations containing 6 per cent or less of mercaptamine except in preparations containing 1 per cent or less of mercaptamine.

MERCAPTOACETIC ACID and its salts, but excluding its derivatives, in cosmetic preparations containing 20 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid), except in preparations containing 5 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid)

MESOTRIONE.

METAFLUMIZONE.

METALAXYL in preparations containing 35 per cent or less of metalaxyl.

METALDEHYDE in preparations containing 2 per cent or less of metaldehyde.

METAZACHLOR.

METHABENZTHIAZURON.

METHANOL (excluding its derivatives) in preparations containing 10 per cent or less of methanol except in preparations containing 2 per cent or less of methanol.

METHENAMINE in cosmetic preparations, except in preparations containing 0.15 per cent or less of methenamine.

METHIOCARB in pelleted preparations containing 2 per cent or less of methiocarb.

METHOXYCHLOR.

METHYLATED SPIRIT(S) (being ethanol denatured with denatonium benzoate, methyl isobutyl ketone and fluorescein) except:

a)      when included in preparations or admixtures; or

b)      when packed in containers having a capacity of more than 5 litres.

METHYLATED SPIRIT(S) when packed and labelled as a 'biofuel' suitable for use in 'spirit burners'

METHYLENE BLUE in preparations for veterinary use containing 50 per cent or less of methylene blue.

METHYL ETHYL KETONE except in preparations containing 25 per cent or less of designated solvents.

METHYL ETHYL KETONE PEROXIDE.

METHYL ISOAMYL KETONE except in preparations containing 25 per cent or less of designated solvents.

METHYL ISOBUTYL KETONE except in preparations containing 25 per cent or less of designated solvents.

N-METHYL-2-PYRROLIDONE:

a)      when packed in single use containers having a capacity of 2 mL or less; or

b)      in preparations containing 50 per cent or less of N-methyl-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-methyl-2-pyrrolidone, N-(N-octyl)-2-pyrrolidone or N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

METHYL SALICYLATE in preparations containing 25 per cent or less of methyl salicylate except:

a)      in preparations for therapeutic use; or

b)      in preparations containing 5 per cent or less of methyl salicylate.

2-METHYLTHIO-4-(2-METHYLPROP-2-YL) AMINO-6-CYCLOPROPYLAMINO-5- TRIAZINE.

METIRAM.

METOFLUTHRIN:

a)      in impregnated fabric mosquito repellent preparations for use in a vaporiser containing 15 mg or less of metofluthrin per disk; or

b)      when impregnated into a polyethylene slow release matrix containing 250 mg or less of metofluthrin for use as a mosquito repellent.

METOLACHLOR.

METRAFENONE in preparations containing 50 per cent or less of metrafenone.

MILBEMECTIN in preparations containing 1 per cent or less of milbemectin.

MILBEMYCIN OXIME

a)      for the prophylaxis of heartworm in dogs and cats; or

b)      for the treatment and prevention of flea infestations, control of ticks, gastrointestinal nematodes and heartworm in dogs, when combined with afoxolaner, in oral divided preparations each containing 150 mg or less of afoxolaner per dosage unit.

MONENSIN in intraruminal implants for cattle, each containing 35 g or less of monensin.

MONEPANTEL.

MONOETHANOLAMINE (excluding its salts and derivatives) in preparations containing 20 per cent or less of monoethanolamine except:

a)      when included in Schedule 4; or

b)      in preparations containing 5 per cent or less of monoethanolamine.

MORANTEL in preparations containing 25 per cent or less of morantel except in preparations containing 10 per cent or less of morantel.

MOXIDECTIN:

a)      in preparations for external use for the treatment of animals other than cats and dogs, containing 0.5 per cent or less of moxidectin;

b)      in preparations for external use for the treatment of cats and dogs, containing 2.5 per cent or less of moxidectin packed in single dose tubes with a volume of 1 mL or less; or

c)      for internal use for the treatment of animals:

i)        in divided preparations for dogs, containing 250 micrograms or less of moxidectin per dosage unit in a pack containing six or less dosage units; or

ii)      in other preparations containing 2 per cent or less of moxidectin.

MYCLOBUTANIL.

NAA except in preparations containing 25 per cent or less of NAA.

NALED when impregnated in plastic resin strip material containing 20 per cent or less of naled.

NAPTALAM.

NEOSCYTALIDIUM NOVAEHOLLANDIAE except when used as a herbicide in capsule preparations at a concentration of 16 CFU or less per capsule.

NETOBIMIN for the treatment of animals, in preparations containing 12.5 per cent or less of netobimin.

NITRIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of nitric acid (HNO3) except in preparations containing 0.5 per cent or less of nitric acid.

NITROSCANATE for the treatment of animals.

NONANOIC ACID except in preparations containing 10 per cent or less of nonanoic acid.

NONOXINOL 9 in preparations containing 25 per cent or less of nonoxinol 9 except:

a)      when labelled with the statements:

                        IRRITANT; and

                        Avoid contact with eyes;

b)      in preparations containing 12.5 per cent or less of nonoxinol 9; or

c)      in preparations for human use.

NORBORMIDE.

NUTMEG OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

                        KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 50 per cent or less of nutmeg oil.

N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE except in preparations containing 10 per cent or less of N-octyl bicycloheptene dicarboximide.

N-(N-OCTYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of:

a)      N-(N-octyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-octyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or

b)      N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

OLEANDOMYCIN in animal feed premixes for growth promotion.

OMETHOATE in pressurised spray packs containing 0.2 per cent or less of omethoate.

ORANGE OIL (BITTER) except:

a)      when steam distilled or rectified;

b)      in preparations for internal use;

c)      in preparations containing 1.4 per cent or less of orange oil (bitter);

d)      in soaps or bath or shower gels that are washed off the skin;

e)      in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

f)       in other preparations when packed in containers labelled with the statement:

Application to the skin may increase sensitivity to sunlight.

OXADIARGYL.

OXADIXYL.

OXANTEL EMBONATE for the treatment of animals.

OXFENDAZOLE for the treatment of animals.

OXIBENDAZOLE for the treatment of animals.

OXYCARBOXIN.

OXYTETRACYCLINE in preparations:

a)      for topical application to animals for ocular use only; or

b)      containing 40 per cent or less of oxytetracycline per dose, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

OXYTHIOQUINOX.

PACLOBUTRAZOL.

PENCONAZOLE.

PENDIMETHALIN.

PENFLUFEN.

PENTHIOPYRAD except in preparations containing 20 per cent or less of penthiopyrad.

PERACETIC ACID in concentrations of 10 per cent or less of peracetic acid.

PERMETHRIN (excluding preparations for human therapeutic use):

a)      in preparations containing 25 per cent or less of permethrin; or

b)      in preparations for external use, for the treatment of dogs, containing 50 per cent or less of permethrin when packed in single use containers having a capacity of 4 mL or less,

       except in preparations containing 2 per cent or less of permethrin.

PETROL except preparations containing 25 per cent or less of petrol.

PHENAZONE for the external treatment of animals.

PHENISOPHAM.

PHENOL, including cresols and xylenols and any other homologue of phenol boiling below 220°C, when in animal feed additives containing 15 per cent or less of such substances, except in preparations containing 1 per cent or less of phenol and in preparations containing 3 per cent or less of cresols and xylenols and other homologues of phenol.

PHENYL METHYL KETONE except in preparations containing 25 per cent or less of designated solvents.

o-PHENYLPHENOL except in preparations containing 5 per cent or less of o-phenylphenol.

PHOSPHONIC ACID (excluding its salts and derivatives) except in preparations containing 10 per cent or less of phosphonic acid (H3PO3).

PHOSPHORIC ACID (excluding its salts and derivatives) in preparations containing 35 per cent or less of phosphoric acid (H3PO4) except:

a)      in preparations containing 15 per cent or less of phosphoric acid (H3PO4);

b)      in solid or semi-solid preparations; or

c)      in professional dental kits.

o-PHTHALALDEHYDE in preparations containing 1 per cent or less of o-phthalaldehyde.

PICARIDIN except in preparations containing 20 per cent or less of picaridin.

PINE OILS in preparations containing 25 per cent or less of pine oils when packed and labelled as a herbicide.

PINOXADEN in preparations containing 10 per cent or less of pinoxaden.

PIPERAZINE for animal use.

PIRIMICARB in preparations containing 0.5 per cent or less of pirimicarb.

POLIXETONIUM SALTS in preparations containing 60 per cent or less of polixetonium salts except in preparations containing 1 per cent or less of polixetonium salts.

POLYETHANOXY (15) TALLOW AMINE.

POLY(OXY-1,2-ETHANEDIYL), α -[2-[(2-HYDROXYETHYL)AMINO]-2-OXOETHYL]- α -HYDROXY-,MONO-C13-15-ALKYL ETHERS.

POTASSIUM CHLORATE except:

a)      when included in Schedule 2; or

b)      in preparations containing 10 per cent or less of potassium chlorate.

POTASSIUM HYDROXIDE (excluding its salts and derivatives) in preparations containing 5 per cent or less of potassium hydroxide being:

a)      solid preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5; or

b)      liquid or semi-solid preparations, the pH of which is more than 11.5 except in food additive preparations for domestic use.

POTASSIUM METABISULPHITE when packed for domestic use except in preparations containing 10 per cent or less of potassium metabisulphite.

POTASSIUM NITRITE in preparations containing 1 per cent or less of potassium nitrite except:

a)      in preparations containing 0.5 per cent or less of potassium nitrite;

b)      when present as an excipient in preparations for therapeutic use; or

c)      in aerosols.

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT in preparations containing 5 per cent or less of potassium peroxomonosulfate triple salt being:

a)      solid preparations, the pH of which in a 10 g/L aqueous solution is less than 2.5; or

b)      liquid or semi-solid preparations, the pH of which is less than 2.5.

POTASSIUM SULFIDE in preparations for metal treatment in containers each containing 50 g or less of potassium sulfide.

PRALLETHRIN (cis:trans=20:80) in preparations containing 10 per cent or less of prallethrin except in insecticidal mats containing 1 per cent or less of prallethrin.

PROFOXYDIM except in preparations containing 20 per cent or less of profoxydim.

PROGESTERONE:

a)      in implant preparations or controlled release pessaries for synchronisation of oestrus in cattle, sheep or goats; or

b)      in implant preparations for growth promotion in cattle.

PROHEXADIONE CALCIUM.

PROMETRYN.

PROPAMOCARB.

PROPANIL.

PROPAQUIZAFOP.

PROPICONAZOLE in preparations containing 20 per cent or less of propiconazole.

PROPIONIC ACID (excluding its salts and derivatives) in preparations containing 80 per cent or less of propionic acid, except:

a)      in preparations containing 30 per cent or less of propionic acid; or

b)      for therapeutic use.

PROPOXUR:

a)      when impregnated in plastic resin strip material containing 10 per cent or less of propoxur;

b)      in dust preparations containing 3 per cent or less of propoxur;

c)      in granular sugar-based fly baits containing 1 per cent or less of propoxur, a dark colouring agent and a separate bittering agent;

d)      in pressurised spray packs containing 2 per cent or less of propoxur; or

e)      in printed paper sheets for pest control containing 0.5 per cent or less of propoxur and in any case not more than 100 mg of propoxur per sheet.

n-PROPYL ALCOHOL in preparations containing 10 per cent or less of n-propyl alcohol except:

a)      in preparations containing 5 per cent or less of n-propyl alcohol; or

b)      in preparations for cosmetic or therapeutic use other than in spray form.

PROPYZAMIDE.

PROTHIOCONAZOLE-DESCHLORO except in preparations containing 0.5 per cent or less of prothioconazole-deschloro.

PROTHIOCONAZOLE-TRIAZOLIDINETHIONE except in preparations containing 0.5 per cent or less of prothioconazole-triazolidinethione.

PYMETROZINE.

PYRACLOSTROBIN.

PYRAFLUFEN-ETHYL.

PYRASULFOTOLE.

PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids except:

a)      in preparations for human therapeutic use; or

b)      in preparations containing 10 per cent or less of such substances.

PYRIDABEN in preparations containing 25 per cent or less of pyridaben.

PYRIFENOX.

PYRITHIOBAC SODIUM.

PYRITHIONE ZINC in paints containing 0.5 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint except in paints containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint.

PYRIOFENONE in preparations containing 30 per cent or less of pyriofenone.

QUATERNARY AMMONIUM COMPOUNDS in preparations containing 20 per cent or less of quaternary ammonium compounds except:

a)      when separately specified in these Schedules;

b)      dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or

c)      in preparations containing 5 per cent or less of such quaternary ammonium compounds.

QUINCLORAC.

QUININE in preparations for veterinary use containing 1 per cent or less of quinine.

QUINTOZENE.

QUIZALOFOP-p-ETHYL in aqueous preparations containing 40 per cent or less of
quizalofop-p-ethyl.

RACTOPAMINE in animal feed premixes containing 10 per cent or less of ractopamine.

RESMETHRIN in preparations containing 10 per cent or less of resmethrin.

RIMSULFURON.

ROBENIDINE except in preparations containing 20 per cent or less of robenidine.

ROSIN when packaged for use as a soldering flux or in flux-cored solder.

SAFLUFENACIL in water dispersible granule preparations.

SALICYLANILIDE.

SAROLANER for the treatment, prevention and control of fleas and ticks in dogs in oral divided preparations each containing 120 mg or less of sarolaner per dosage unit.

SEDAXANE.

SELAMECTIN except in preparations containing 12 per cent or less of selamectin.

SETHOXYDIM.

SIDURON.

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

a)      barium silicofluoride when separately specified in this Schedule; or

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

SINBIOALLETHRIN in preparations containing 10 per cent or less of sinbioallethrin except in preparations containing 1 per cent or less of sinbioallethrin.

SODIUM CHLORATE except in preparations containing 10 per cent or less of sodium chlorate.

SODIUM DIACETATE except in preparations containing 60 per cent or less of sodium diacetate.

SODIUM DODECYLBENZENE SULFONATE except in preparations containing 30 per cent or less of sodium dodecylbenzene sulfonate.

SODIUM HYDROGEN SULFATE except in preparations containing 10 per cent or less of sodium hydrogen sulfate.

SODIUM HYDROSULFITE when packed for domestic use except in preparations containing 10 per cent or less of sodium hydrosulfite.

SODIUM HYDROXIDE (excluding its salts and derivatives) in preparations containing 5 per cent or less of sodium hydroxide being:

a)      solid preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5; or

b)      liquid or semi-solid preparations, the pH of which is more than 11.5 except in food additive preparations for domestic use.

SODIUM LAURETH-6 CARBOXYLATE except in preparations containing 1 per cent or less of sodium laureth-6 carboxylate.

SODIUM METABISULPHITE when packed for domestic use except in preparations containing 10 per cent or less of sodium metabisulphite.

SODIUM NITRITE in preparations containing 1 per cent or less of sodium nitrite except:

a)      in preparations containing 0.5 per cent or less of sodium nitrite;

b)      when present as an excipient in preparations for therapeutic use; or

c)      in aerosols.

SODIUM PERCARBONATE (CAS No. 15630-89-4) in preparations containing 35 per cent or less of sodium percarbonate except in preparations containing 15 per cent or less of sodium percarbonate.

SODIUM POLYSTYRENE SULPHONATE in preparations for cosmetic use except in preparations containing 10 per cent or less of sodium polystyrene sulphonate.

SODIUM STANNATE except in preparations for cosmetic use containing 1 per cent or less of sodium stannate.

SODIUM SULFIDE in preparations for metal treatment in containers each containing 50 g or less of sodium sulfide.

SPINETORAM.

SPINOSAD except in aqueous suspensions containing 25 per cent or less of spinosad.

STAR ANISE OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 50 per cent or less of star anise oil.

STYRENE (excluding its derivatives).

SULFACETAMIDE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFADIAZINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFADIMIDINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFAMERAZINE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFAMIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of sulfamic acid (H3NO3S).

SULFATHIAZOLE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFOMETURON-METHYL.

SULFOXAFLOR in preparations containing 25 per cent or less of sulfoxaflor.

SYMPHYTUM spp. (Comfrey) for dermal therapeutic or dermal cosmetic use.

2,3,6-TBA.

TDE (1,1-dichloro-2,2-bis[4-chlorophenyl]ethane) in preparations containing 10 per cent or less of TDE.

TEBUCONAZOLE.

TEBUFENOZIDE.

TEFLUTHRIN in preparations containing 2 per cent or less of tefluthrin.

TEMEPHOS:

a)      in liquid preparations containing 10 per cent or less of temephos;

b)      in powders containing 2 per cent or less of temephos; or

c)      in preparations containing 40 per cent or less of temephos when packed in single use containers having a capacity of 2 mL or less.

TEPRALOXYDIM.

TERBUTRYN.

TETRACHLOROETHYLENE in preparations containing 5 per cent or less of tetrachloroethylene except:

a)      when included in Schedule 2;

b)      in preparations for the treatment of animals; or

c)      when absorbed into an inert solid.

TETRACHLORVINPHOS except in animal feeds containing 0.2 per cent or less of tetrachlorvinphos.

TETRACONAZOLE in preparations containing 20 per cent or less of tetraconazole.

TETRACYCLINE in preparations:

a)      for topical application to animals for ocular use only; or

b)      containing 40 per cent or less of tetracycline when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

TETRAMETHRIN [(R, cis): (R, trans) = 20:80] except in pressurised spray packs.

THIABENDAZOLE:

a)      for the treatment of animals; or

b)      when packed and labelled for use as a fungicide except in preparations containing 50 per cent or less of thiabendazole.

THIAMETHOXAM in preparations containing 60 per cent or less of thiamethoxam.

THIAZOPYR.

THIFENSULFURON.

THIOBENCARB.

THIODICARB in pelleted preparations containing 1.5 per cent or less of thiodicarb.

THIOPHANATE-METHYL in preparations containing 25 per cent or less of thiophanate-methyl.

THYME OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

                        KEEP OUT OF REACH OF CHILDREN; or

c)      in preparations containing 50 per cent or less of thyme oil.

TIOCARBAZIL.

TOLCLOFOS-METHYL.

TOLTRAZURIL.

TOPRAMEZONE

TRALKOXYDIM.

TRENBOLONE in implant preparations for growth promotion in animals.

TRIADIMEFON in wettable powders containing 25 per cent or less of triadimefon.

TRIADIMENOL.

TRI-ALLATE.

TRIBENURON-METHYL.

TRICHLOROACETIC ACID, alkali salts of.

1,1,1-TRICHLOROETHANE except:

a)      in preparations packed in pressurised spray packs;

b)      in preparations containing 25 per cent or less of designated solvents;

c)      in preparations, other than writing correction fluids or thinners for writing correction fluidsin containers having a capacity of 50 mL or less; or

d)      in writing correction fluids or thinners for writing correction fluids, in containers having a capacity of 50 mL or less labelled with:

i)        the word “Trichloroethane” written in letters not less than 1 mm in height and in distinct contrast to the background; and

ii)      the expression:

WARNING – DO NOT DELIBERATELY SNIFF THIS PRODUCT. SNIFFING MIGHT HARM OR KILL YOU;

written in bold face sans serif capital letters not less than 1 mm in height and in distinct contrast to the background.

TRIDIPHANE.

TRIETAZINE.

TRIFLOXYSTROBIN.

TRIFLUMIZOLE.

TRIFLUMURON.

TRIISOPROPANOLAMINE LAURYL ETHER SULFATE except in preparations containing 30 per cent or less of triisopropanolamine lauryl ether sulfate when labelled with the statements:

                        Avoid contact with eyes and skin; and

                        Wash hands after handling.

TRINEXAPAC-ETHYL except:

a)      when packed in a sealed water-soluble measure pack; or

b)      in solid preparations containing 25 per cent or less of trinexapac-ethyl in packs of 50 g or less.

3,6,9-TRIOXAUNDECANEDIOIC ACID except in preparations containing 5 per cent or less of 3,6,9-trioxaundecanedioic acid, the pH of which is 3.5 or greater.

TRITICONAZOLE.

TROLAMINE (excluding its salts and derivatives) except:

a)      when in Schedule 4;or

b)      in preparations containing 5 per cent or less of trolamine.

TURPENTINE OIL except in preparations containing 25 per cent or less of turpentine oil.

VIRGINIAMYCIN in animal feed additives containing 1 per cent or less of virginiamycin for the prevention of laminitis in horses when in a pack of 5 kg or less.

VERNOLATE.

WARFARIN in rodent baits containing 0.1 per cent or less of warfarin.

ZINEB.


SCHEDULE 6

ABAMECTIN:

a)      in preparations for pesticidal use containing 4 per cent or less of abamectin except when included in Schedule 5; or

b)      in slow-release plastic matrix ear tags for livestock use containing 1 g or less of abamectin.

ACEPHATE.

ACETAMIPRID except in preparations containing 1 per cent or less of acetamiprid.

ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH3COOH) except when included in Schedule 2.

ACETIC ANHYDRIDE excluding its derivatives.

ACIFLUORFEN.

ACINITRAZOLE except in preparations containing 20 per cent or less of acinitrazole.

ALBENDAZOLE for the treatment of animals except:

a)      when included in Schedule 5; or

b)      in intraruminal implants each containing 3.85 g or less of albendazole.

ALDRIN.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for non-domestic use:

a)      in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or

b)      in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

ALKOXYLATED FATTY ALKYLAMINE POLYMER except:

a)      when included in Schedule 5; or

b)      in preparations containing 20 per cent or less of alkoxylated fatty alkylamine polymer.

ALLETHRIN except:

a)      when included in Schedule 5;

b)      in insecticidal mats containing 20 per cent or less of allethrin; or

c)      in other preparations containing 1 per cent or less of allethrin.

ALPHA-CYPERMETHRIN:

a)      in aqueous preparations containing 25 per cent or less of alpha-cypermethrin; or

b)      in other preparations containing 10 per cent or less of alpha-cypermethrin,

       except when included in Schedule 5.

AMICARBAZONE.

AMIDITHION.

AMIDOPROPYL BETAINES except:

a)      in cosmetic wash-off preparations containing 30 per cent or less of amidopropyl betaines and, if containing more than 5 per cent of amidopropyl betaines when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

b)      in cosmetic leave-on preparations containing 1.5 per cent or less of amidopropyl betaines; or

c)      in other preparations containing 30 per cent or less of amidopropyl betaines and, if containing more than 5 per cent of amidopropyl betaines, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER

2-AMINO-6-CHLORO-4-NITROPHENOL in hair dye and eyebrow/eyelash colouring preparations, except:

a)      in preparations containing 2 per cent or less of 2-amino-6-chloro-4-nitrophenol when applied directly to the hair, or containing 2 per cent or less of 2-amino-6-chloro-4-nitrophenol after mixing and when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN; and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

b)      in eyelash and eyebrow tinting products containing 1.5 per cent or less of 2-amino-6-chloro-4-nitrophenol after mixing for use when the immediate container and primary pack are labelled with the following statement:

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals, and when used for eyelash or eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5mm in height.

4-AMINO-m-CRESOL in hair dyes and eyebrow/eyelash colouring preparations except:

a)      in hair dye preparations containing 1.5 per cent or less of 4-amino-m-cresol after mixing for use when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5mm in height; or

b)      in eyelash and eyebrow tinting products containing 1.5 per cent or less of 4-amino-m-cresol after mixing for use when the immediate container and primary pack are labelled with the following statement:

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals, and when used for eyelash or eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5mm in height.

2-AMINO-5-ETHYLPHENOL in hair dye preparations except in preparations containing 1 per cent or less of 2-amino-5-ethylphenol when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN; and

WARNING – This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes and eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5 mm in height.

4-AMINO-2-HYDROXYTOLUENE in hair dyes and eyebrow/eyelash colouring products except:

a)      in hair dye preparations containing 1.5 per cent or less of 4-amino-2-hydroxytoluene after mixing for use when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5mm in height; or

b)      in eyelash and eyebrow tinting products containing 1.5 per cent or less of 4-amino-2-hydroxytoluene after mixing for use when the immediate container and primary pack are labelled with the following statement:

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals, and when used for eyelash or eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5mm in height.

AMINOCARB in preparations containing 25 per cent or less of aminocarb.

AMINOETHOXYVINYLGLYCINE except in preparations containing 15 per cent or less of aminoethoxyvinylglycine.

1-AMINOMETHANAMIDE DIHYDROGEN TETRAOXOSULFATE.

4-AMINO-3-NITROPHENOL except:

a)      in non-oxidative hair dye preparations and eyebrow/eyelash colouring products containing 1 per cent or less of 4-amino-3-nitrophenol when the immediate container and primary pack are labelled with the following statements:

 

KEEP OUT OF REACH OF CHILDREN, and

 

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use, and

 

Written in letters not less than 1.5 mm in height; or

 

b)      in oxidative hair dye preparations and eyebrow/eyelash colouring products containing 1 per cent or less of 4-amino-3-nitrophenol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

 

KEEP OUT OF REACH OF CHILDREN, and

 

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use, and

 

Written in letters not less than 1.5 mm in height.

 

p- AMINOPHENOL except when used in hair dye and eyebrow/eyelash colouring products at a concentration of 1 per cent or less of p-aminophenol after mixing for use when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

       WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use, and

            Written in letters not less than 1.5 mm in height.

AMINOPYRALID except when included in Schedule 5.

AMITRAZ.

AMMONIA (excluding its salts and derivatives other than ammonium hydroxide) except:

a)      when included in Schedule 5;

b)      in preparations for human internal therapeutic use;

c)      in preparations for inhalation when absorbed in an inert solid material; or

d)      in preparations containing 0.5 per cent or less of ammonia.

AMMONIUM COCOYL ISETHIONATE, except in cosmetic rinse-off preparations containing 30 per cent or less of ammonium cocoyl isethionate and, if containing more than 5 per cent of ammonium cocoyl isethionate, when labelled with a warning to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER

AMMONIUM PERSULFATE in hair preparations.

ANILINE (excluding its salts and derivatives) except in preparations containing 1 per cent or less of aniline.

ANTIMONY COMPOUNDS except:

a)      when included in Schedule 4;

b)      antimony chloride in polishes;

c)      antimony titanate pigments in paint; or

d)      in paints or tinters containing 5 per cent or less of antimony calculated on the non-volatile content of the paint or tinter.

ARSENIC:

a)      in ant poisons containing 0.4 per cent or less of arsenic;

b)      in animal feed premixes containing 4 per cent or less of arsenic; or

c)      in preparations for the treatment of animals except thiacetarsamide when included in Schedule 4,

       except when separately specified in this Schedule.

ASPIRIN for the treatment of animals except when included in Schedule 4 or 5.

AZACONAZOLE except in preparations containing 1 per cent or less of azaconazole.

AZADIRACHTA INDICA (Neem) including its extracts and derivatives except:

a)      when included in Schedule 5;

b)      in preparations for human internal use;

c)      debitterised neem seed oil;

d)      in preparations for human dermal therapeutic use containing cold pressed neem seed oil, when in a container fitted with a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

e)      in preparations for dermal use containing 1 per cent or less of cold pressed neem seed oil.

AZAMETHIPHOS.

AZOBENZENE.

BAMBERMYCIN (flavophospholipol) in animal feed premixes for growth promotion containing 2 per cent or less of antibiotic substances.

BARIUM SALTS except:

a)      when included in Schedule 5;

b)      barium sulfate; or

c)      in paints or tinters containing 5 per cent or less of barium calculated on the non-volatile content of the paint or tinter.

BASIC BLUE 26 (CAS No. 2580-56-5) except when used as a colourant in cosmetics not intended to be in contact with mucous membranes.

BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) except:

a)      in preparations for skin colouration and dyeing of eyelashes or eyebrows; or

b)      in hair dye preparations containing 1 per cent or less of Basic Orange 31 when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN;

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

WARNING – This product contains ingredients which may cause skin irritation to certain individuals.  A preliminary test according to the accompanying directions should be made before use.  This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5 mm in height.

BAY OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

KEEP OUT OF REACH OF CHILDREN; and

NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

KEEP OUT OF REACH OF CHILDREN; and

NOT TO BE TAKEN; or

e)      in preparations containing 25 per cent or less of bay oil.

BEAUVERIA BASSIANA except when included in Schedule 5.

BENDIOCARB:

a)      in wettable powders containing 80 per cent or less of bendiocarb when packed in containers or primary packs containing not less than 100 g of bendiocarb;

b)      in wettable powders containing 20 per cent or less of bendiocarb and not less than 0.002 per cent of denatonium benzoate when packed in containers or primary packs containing not less than 48 g of bendiocarb and labelled for use as a fly control preparation;

c)      in insoluble granular preparations containing 5 per cent or less of bendiocarb; or

d)      when impregnated in plastic resin strip material containing 10 per cent or less of bendiocarb,

       except when included in Schedule 5.

BENQUINOX.

BENSULIDE.

BENZALKONIUM CHLORIDE except:

a)      when included in Schedule 5; or

b)      in preparations containing 5 per cent or less of benzalkonium chloride.

1,2-BENZENEDIOL.

6-BENZYLADENINE except in preparations containing 2 per cent or less of 6-benzyladenine.

BERYLLIUM.

BETACYFLUTHRIN in preparations containing 12.5 per cent or less of betacyfluthrin except when included in Schedule 5.

BETA-CYPERMETHRIN.

BHC (excluding lindane).

BICYCLOPYRONE except when included in Schedule 5.

BIFENTHRIN in preparations containing 25 per cent or less of bifenthrin except in preparations containing 0.5 per cent or less of bifenthrin.

BIFLUORIDES (including ammonium, potassium and sodium salts) in preparations containing 3 per cent or less of total bifluorides except when included in Schedule 5.

BIOALLETHRIN except:

            (a)        when included in Schedule 5; or

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

BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETICONE COPOLYMER except in rinse-off cosmetic products containing 1 per cent or less of bis-isobutyl PEG/PPG-20/35/amodimeticone copolymer when labelled with a warning to the following effect:

            IF IN EYES, WASH OUT IMMEDIATELY WITH WATER.

N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,5-DIMETHANAMINE except in preparations containing 1 per cent or less of N,N-bis(phenylmethylene)-bicyclo- (2.2.1)heptane-2,5-dimethanamine, or a combination of N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,5-dimethanamine and N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine, when labelled with statements to the effect of:

            IRRITANT;

            REPEATED EXPOSURE MAY CAUSE SENSITISATION;

            Avoid contact with eyes;

            Avoid contact with skin;

            Wear protective gloves when mixing or using; and

            Ensure adequate ventilation when using.

N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,6-DIMETHANAMINE except in preparations containing 1 per cent or less of N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine, or a combination of N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,5-dimethanamine and N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine, when labelled with statements to the effect of:

            IRRITANT;

            REPEATED EXPOSURE MAY CAUSE SENSITISATION;

            Avoid contact with eyes;

            Avoid contact with skin;

            Wear protective gloves when mixing or using; and

            Ensure adequate ventilation when using.

BITHIONOL for the treatment of animals.

BORON TRIFLUORIDE in preparations containing 1 per cent or less of boron trifluoride (BF3) except when included in Schedule 5.

BRODIFACOUM in preparations containing 0.25 per cent or less of brodifacoum.

BROMADIOLONE in preparations containing 0.25 per cent or less of bromadiolone.

BROMETHALIN in rodent baits containing 0.01 per cent or less of bromethalin.

BROMOFORM except when included in Schedule 4.

BROMOPHOS.

BROMOPHOS-ETHYL.

BROMOXYNIL.

BROMUCONAZOLE except when included in Schedule 5.

BROTIANIDE.

BUNAMIDINE.

BUTACARB.

BUTOXYCARBOXIM except when included in Schedule 5.

2-BUTOXYETHANOL and its ACETATES except in preparations containing 10 per cent or less of such substances.

2-BUTOXY-2’-THIOCYANODIETHYL ETHER.

n-BUTYL ALCOHOL except:

a)      when included in Schedule 5;

b)      in preparations containing 5 per cent or less of n-butyl alcohol; or

c)      in preparations for cosmetic or therapeutic use other than in spray form.

BUTYRIC ACID in preparations for use as insect lures.

CACODYLIC ACID:

a)      in animal feed premixes containing 4 per cent or less of arsenic; or

b)      in herbicide or defoliant preparations containing 10 per cent or less of cacodylic acid.

CADMIUM COMPOUNDS except:

a)      when included in Schedule 4; or

b)      in paints or tinters containing 0.1 per cent or less of cadmium calculated on the non-volatile content of the paint or tinter.

CADUSAFOS in aqueous preparations containing 20 per cent or less of microencapsulated cadusafos.

CAJUPUT OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and

                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and

                        NOT TO BE TAKEN;

e)      in preparations containing 25 per cent or less of cajuput oil; or

f)       in oils containing 25 per cent or less of cajuput oil.

CALCIFEROL in rodent baits containing 0.1 per cent or less of calciferol.

CAMBENDAZOLE.

CAMPHOR except:

a)      when included in Schedule 4 or 5;

b)      when enclosed in an inhaler device which prevents ingestion of its contents;

c)      in solid or semi-solid preparations containing 12.5 per cent or less of camphor;

d)      in liquid preparations containing 2.5 per cent or less of camphor;

e)      in essential oils when the camphor is present as a natural component of the oil:

i)        in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

ii)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

iii)    in essential oils other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN; or

iv)    in essential oils other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN; or

f)       in rosemary oil, sage oil (Spanish), or lavandin oil as such.

CAPTAN.

CARBARYL except when included in Schedule 4 or 5.

CARBON DISULFIDE.

CARBAMIDE PEROXIDE except:

a)      when included in Schedule 5; or

b)      in other preparations containing 9 per cent or less of carbamide peroxide.

CASTOR OIL, MONOMALEATE (excluding its salts and derivatives) in preparations for cosmetic use except in wash-off preparations containing 1 per cent or less of castor oil, monomaleate.

CHLORALOSE (alpha-CHLORALOSE) when packed and labelled for use as a pesticide.

CHLORDANE.

CHLORFENAPYR in preparations containing 36 per cent or less of chlorfenapyr except when included in Schedule 5.

CHLORFENETHOL.

CHLORHEXIDINE in preparations containing 7 per cent or less of chlorhexidine except:

a)      when included in Schedule 5;

b)      in preparations containing 1 per cent or less of chlorhexidine; or

c)      when in solid preparations.

CHLORINATING COMPOUNDS except:

a)      when included in Schedule 5;

b)      when separately specified in these Schedules;

c)      sodium hypochlorite preparations with a pH of less than 11.5;

d)      in liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using.  Vapour may be harmful.  May give off dangerous gas if mixed with other products;

e)      in liquid preparations containing less than 2 per cent of available chlorine; or

f)       in other preparations containing 4 per cent or less of available chlorine.

CHLORMEQUAT.

CHLOROFORM except:

a)      when included in Schedule 2 or 4; or

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

ALPHA-CHLOROHYDRIN.

CHLOROPHACINONE.

(E)-(S)-1-(4-CHLOROPHENYL)-4,4-DIMETHYL-2-(1H-1,2,4-TRIAZOL-1-YL)PENT-1-EN-3-OL (uniconazole-p) except in preparations containing 5 per cent or less of (E)-(S)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pent-1-en-3-ol.

CHLOROPICRIN in preparations containing 5 per cent or less of chloropicrin.

CHLOROTHALONIL except in water-based paint containing 0.5 per cent or less of chlorothalonil.

2-CHLORO-6-(TRICHLOROMETHYL)-PYRIDINE.

CHLORPYRIFOS except:

a)      when included in Schedule 5; or

b)      in prepared potting or soil mixes containing 100 g or less of chlorpyrifos per cubic metre.

CHLORPYRIFOS-METHYL.

CHLORTHIAMID.

CHROMATES (including dichromates) except in paints or tinters containing 5 per cent or less of chromium as the ammonium, barium, calcium, iron, potassium, sodium, strontium or zinc chromate calculated on the non-volatile content of the paint or tinter.

CHROMIUM TRIOXIDE (excluding its salts and derivatives).

CHRYSOIDINE BASE except when in Schedule 10.

CINEOLE except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

e)      in preparations containing 25 per cent or less of cineole;

f)       in oils containing 25 per cent or less of cineole; or

g)      in rosemary oil or camphor oil (white).

CINNAMON LEAF OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and

                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

e)      in preparations containing 25 per cent or less of cinnamon leaf oil.

CLIMBAZOLE except:

a)      when included in Schedule 5; or

b)      in preparations containing 2 per cent or less of climbazole.

CLODINAFOP-PROPARGYL.

CLOMAZONE.

CLOSANTEL.

CLOTHIANIDIN except

a)      When included in Schedule 5; or

b)      When in gel preparations dispensed in sealed cartridges containing 1 per cent or less of clothianidin.

CLOTRIMAZOLE for the external treatment of animals.

CLOVE OIL except:

a)      when included in Schedule 5;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

e)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and

                        NOT TO BE TAKEN; or

f)       in preparations containing 25 per cent or less of clove oil.

N-COCO-1,3-DIAMINOPROPANE.

COCOYL GLYCINATE in cosmetic preparations except:

a)      in leave-on preparations containing 5 per cent or less of cocoyl glycinate; or

b)      in wash-off preparations containing 30 per cent or less of cocoyl glycinate and, when containing more than 5 per cent of cocoyl glycinate labelled with a warning to the following effect:

                        IF IN EYES WASH OUT IMMEDIATELY WITH WATER.

COPPER ACETATE except:

a)      when included in Schedule 5; or

b)      in preparations containing 5 per cent or less of copper acetate.

COPPER COMPOUNDS except:

a)      when separately specified in these Schedules;

b)      in preparations for human internal use containing 5 mg or less of copper per recommended daily dose;

c)      pigments where the solubility of the copper compound(s) in water is 1 gram per litre or less;

d)      in feed additives containing 1 per cent or less of copper; or

e)      in other preparations containing 5 per cent or less of copper compounds.

COPPER HYDROXIDE except:

a)      when included in Schedule 5; or

b)      in preparations containing 12.5 per cent or less of copper hydroxide.

COPPER NITRATE in preparations containing copper chloride for the treatment of footrot in sheep.

COPPER OXIDES except:

a)      when included in Schedule 5;

b)      in preparations for internal use;

c)      in marine paints; or

d)      in other preparations containing 5 per cent or less of copper oxides.

COPPER OXYCHLORIDE except:

a)      when included in Schedule 5; or

b)      in preparations containing 12.5 per cent of less of copper oxychloride.

COPPER SULFATE except:

a)      when included in Schedule 5;

b)      in preparations for internal use; or

c)      in other preparations containing 5 per cent or less of copper sulfate.

COUMAPHOS:

a)      in slow-release plastic matrix ear tags for livestock use containing 6 g or less of coumaphos; or

b)      in other preparations containing 5 per cent or less of coumaphos.

COUMATETRALYL in rodenticides containing 1 per cent or less of coumatetralyl except when included in Schedule 5.

CREOSOTE derived from wood other than beechwood except:

a)      when included in Schedule 2;

b)      in preparations for human therapeutic use containing 10 per cent or less of creosote derived from wood other than beechwood; or

c)      in other preparations containing 3 per cent or less of phenols and homologues of phenol boiling below 220°C.

CROTOXYPHOS.

CRUFOMATE.

CYANAMIDE.

CYANAZINE.

CYCLANILIDE.

N-CYCLOHEXYLDIAZENIUMDIOXY-POTASSIUM.

CYFLUTHRIN except:

a)      when included in Schedule 5; or

b)      in pressurised spray packs containing 1 per cent or less of cyfluthrin.

CYOMETRINIL.

CYPERMETHRIN except when included in Schedule 5.

CYPHENOTHRIN except when included in Schedule 5.

CYTHIOATE except when included in Schedule 5.

2,4-D except when included in Schedule 5.

DAZOMET.

DELTAMETHRIN:

a)      in aqueous preparations containing 25 per cent or less of deltamethrin, when no organic solvent, other than 10 per cent or less of a glycol, is present;

b)      in wettable granular preparations containing 25 per cent or less of deltamethrin;

c)      in water-dispersible tablets each containing 500 mg or less of deltamethrin;

d)      in emulsifiable concentrates containing 11 per cent or less of deltamethrin in a solvent containing 40 per cent or less of acetophenone and 45 per cent or less of liquid hydrocarbons; or

e)      in other preparations containing 3 per cent or less of deltamethrin,

       except:

a)      when included in Schedule 5;

b)      in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or

c)      in preparations containing 0.1 per cent or less of deltamethrin.

DERQUANTEL.

2,4-DIAMINOPHENOXYETHANOL in hair dye preparations except in preparations containing 4 per cent or less of 2,4-diaminophenoxyethanol when the immediate container and primary pack are labelled with the following:

            KEEP OUT OF REACH OF CHILDREN

            WARNING – this product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dying eyelashes and eyebrow; to do so may be injurious to the eye.

            Written in letters not less than 1.5 mm in height.

DIAZINON except when included in Schedule 5.

DICAMBA (including its salts and derivatives) except when included in Schedule 5.

DICHLOBENIL.

DICHLOFENTHION.

DICHLOFLUANID.

o-DICHLOROBENZENE.

DICHLOROETHYL ETHER.

DICHLOROISOCYANURIC ACID except:

a)      when included in Schedule 5;

b)      in liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using.  Vapour may be harmful.  May give off dangerous gas if mixed with other products;

c)      in liquid preparations containing less than 2 per cent of available chlorine; or

d)      in other preparations containing 4 per cent or less of available chlorine.

4,5-DICHLORO-2-N-OCTYL-3(2H)-ISOTHIAZOLONE.

DICHLOROPHEN except:

a)      when included in Schedule 4 or 5; or

b)      in fabrics other than when:

i)        for human therapeutic use; or

ii)      as part of a registered pesticidal product.

1,2-DICHLOROPROPANE.

2,4-DICHLORPROP (including the R and S enantiomers).

DICHLORVOS in preparations containing 50 per cent or less of dichlorvos except when included in Schedule 5.

DICLOFOP-METHYL.

DICYCLANIL except in preparations containing 5 per cent or less of dicyclanil.

DIDECYLDIMETHYLAMMONIUM SALTS except in preparations containing 1 per cent or less of didecyldimethylammonium salts labelled with the statement:

            Avoid contact with eyes.

DIELDRIN.

DIETHANOLAMINE (excluding its salts and derivatives) except:

a)      when included in Schedule 5; or

b)      in preparations containing 5 per cent or less of diethanolamine.

DIETHYLENE GLYCOL (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in paints or paint tinters;

c)      in toothpastes or mouthwashes containing more than 0.25 per cent of diethylene glycol; or

d)      in other preparations containing 2.5 per cent or less of diethylene glycol.

DIETHYLENE GLYCOL MONOMETHYL ETHER.

DIFENACOUM in preparations containing 0.25 per cent or less of difenacoum.

DIFENZOQUAT.

DIFETHIALONE in rodent baits containing 0.0025 per cent or less of difethialone.

5,6-DIHYDROXYINDOLINE.

DIMETHENAMID-P.

DIMETHIPIN.

DIMETHOATE.

2,6-DIMETHOXY-3,5-PYRIDINEDIAMINE except when used in hair dye and eyebrow/eyelash colouring products at a concentration of 0.25 per cent or less of 2,6-dimethoxy-3,5-pyridinediamine after mixing for use when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use, and

Written in letters not less than 1.5 mm in height.

DIMETHYLACETAMIDE except when included in Schedule 5.

DIMETHYLFORMAMIDE except:

a)      when included in Schedule 5; or

b)      in silicone rubber mastic containing 2 per cent or less of dimethylformamide.

4,4-DIMETHYL-1-CYCLOHEXENE-1-PROPANAL except:

a)      in leave-on cosmetic preparations containing 0.1 per cent or less of 4,4-dimethyl-1-cyclohexene-1-propanal;

b)      in rinse-off cosmetic preparations containing 0.5 per cent or less of 4,4-dimethyl-1-cyclohexene-1-propanal; or

c)      in other preparations containing 1 per cent or less of 4,4-dimethyl-1-cyclohexene-1-propanal.

DIMETHYL SULFOXIDE (excluding dimethyl sulfone):

a)      when not for therapeutic use; or

b)      for the treatment of animals:

i)        when combined with no other therapeutic substance(s);

ii)      in liquid preparations containing copper salicylate and 1 per cent or less of methyl salicylate as the only other therapeutic substances; or

iii)    in clay poultices containing 2 per cent or less of dimethyl sulfoxide.

DINITROCRESOLS and their homologues in preparations containing 5 per cent or less of such compounds except:

a)      when included in Schedule 4; or

b)      when separately specified in this Schedule.

DINITROPHENOLS and their homologues in preparations containing 5 per cent or less of such compounds except:

a)      when included in Schedule 4; or

b)      when separately specified in this Schedule.

DIOXACARB.

DIOXANE.

DIPHACINONE.

DIQUAT in preparations containing 20 per cent or less of diquat.

DIRECT RED 254 except when included in Schedule 5.

DISPERSE YELLOW 3 except when in Schedule 10.

DISULFIRAM except when included in Schedule 4.

DISULFOTON in granular preparations containing 5 per cent or less of disulfoton.

DITHIANON.

DITHIAZANINE in preparations containing 2 per cent or less of dithiazanine for the treatment of animals.

DIUREDOSAN.

N-(N-DODECYL)-2-PYRROLIDONE except:

a)      when included in Schedule 5; or

b)      in preparations containing 25 per cent or less of designated solvents.

DODINE.

DORAMECTIN for external use for the treatment of animals, in preparations containing 2 per cent or less of doramectin.

DSMA in herbicide or defoliant preparations containing 10 per cent or less of DSMA.

ECONAZOLE for the external treatment of animals.

EMAMECTIN in preparations containing 5 per cent or less of emamectin except when included in Schedule 5.

EMODEPSIDE for the treatment of animals except when included in Schedule 5.

ENDOSULFAN in aqueous preparations containing 33 per cent or less of microencapsulated endosulfan.

ENDOTHAL in preparations containing 20 per cent or less of endothal.

EPTC.

ESBIOTHRIN except:

a)      when included in Schedule 5; or

b)      in pressurised spray packs containing 1 per cent or less of esbiothrin.

ESFENVALERATE except when included in Schedule 5.

ETHEPHON (excluding its salts and derivatives).

ETHER except:

a)      when included in Schedule 2, 4 or 5; or

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

ETHIOFENCARB.

ETHOATE-METHYL.

ETHOPROPHOS in granular formulations containing 10 per cent or less of ethoprophos and 2 per cent of linseed oil.

ETHYL BROMIDE.

2-ETHYLHEXANOIC ACID and its alkyl esters except in preparations containing 5 per cent or less calculated as 2-ethylhexanoic acid.

ETHYL FORMATE when packed and labelled for use as a fumigant.

ETHYLENE CHLOROHYDRIN.

ETHYLENE DICHLORIDE.

ETHYLENE GLYCOL (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in paints or paint tinters;

c)      in toothpastes or mouthwashes containing more than 0.25 per cent of ethylene glycol; or

d)      in other preparations containing 2.5 per cent or less of ethylene glycol.

ETHYLENE GLYCOL MONOALKYL ETHERS and their ACETATES, except:

a)      when separately specified in these Schedules; or

b)      in preparations containing 10 per cent or less of such substances.

ETRIMFOS.

EUCALYPTUS OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

e)      in preparations containing 25 per cent or less of eucalyptus oil.

EUGENOL except:

a)      when included in Schedule 5;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

e)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

f)       in preparations containing 25 per cent or less of eugenol.

FAMPHUR in preparations containing 20 per cent or less of famphur.

FEBANTEL except:

a)      in divided preparations containing 1000 mg or less of febantel per dosage unit; or

b)      in undivided preparations containing 10 per cent or less of febantel.

FENAMIPHOS in granular preparations containing 5 per cent or less of fenamiphos.

FENAZAFLOR.

FENBUTATIN OXIDE.

FENCHLORPHOS.

FENITROTHION.

FENOXACRIM in preparations for the treatment of carpets during manufacture.

FENPYROXIMATE.

FENTHION in preparations containing 60 per cent or less of fenthion except when included in Schedule 5.

FENVALERATE.

FIPRONIL except:

a)      when included in Schedule 5; or

b)      in preparations containing 0.05 per cent or less of fipronil.

FLOCOUMAFEN in preparations containing 0.005 per cent or less of flocoumafen.

FLONICAMID.

FLUAZIFOP-BUTYL.

FLUAZIFOP-p-BUTYL.

FLUAZINAM.

FLUCOFURON in preparations for the treatment of carpets during manufacture.

FLUENSULFONE.

FLUMETHRIN except when included in Schedule 5.

FLUMIOXAZIN when contained in water soluble bags individually packed in sealed sachets.

FLUORIDES except:

a)      when included in Schedule 5;

b)      in preparations for human use; or

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

FLUPROPANATE.

FLUPYRADIFURONE.

FLUQUINCONAZOLE.

FLUSILAZOL.

FLUTRIAFOL except in fertilisers containing 0.5 per cent or less of flutriafol.

FLUVALINATE except when included in Schedule 5.

FORMALDEHYDE (excluding its derivatives) in preparations containing 0.05 per cent or more of free formaldehyde except:

a)      for human therapeutic use;

b)      in oral hygiene preparations;

c)      in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde;

d)      in nail hardener cosmetic preparations containing 0.2 per cent or less of free formaldehyde when labelled with the statement:

                        PROTECT CUTICLES WITH GREASE OR OIL;

e)      in all other cosmetic preparations; or

f)       in other preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:

                        CONTAINS FORMALDEHYDE.

FORMOTHION.

FOSPIRATE except when included in Schedule 5.

FUMAGILLIN.

FURFURAL except in preparations containing 0.1 per cent or less of furfural.

GLUTARAL except:

a)      when included in Schedule 2 or 5; or

b)      in preparations containing 0.5 per cent or less of glutaral when labelled with the statements:

IRRITANT; and
Avoid contact with eyes.

GLYCERYL THIOGLYCOLLATE in hair waving preparations except when labelled with directions for use that include the statement:

            Wear protective gloves when using.  Keep out of eyes.

GLYCOLIC ACID (including its salts and esters) in cosmetic products or when packed and labelled for use as an agricultural chemical except:

a)      in cosmetic preparations for salon use only, when labelled in accordance with requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time;

b)      in preparations containing 5 per cent or less of glycolic acid; or

c)      in preparations containing 20 per cent or less of glycolic acid with a pH of 3.5 or greater.

GUANIDINE except:

a)      when included in Schedule 4; or

b)      in preparations containing 1 per cent or less of guanidine.

GUAZATINE.

HALOXON.

HALOXYFOP.

HEPTACHLOR.

HEXACHLOROPHENE:

a)      in preparations for the treatment of animals; or

b)      for cosmetic use.

HEXAZINONE except when included in Schedule 5.

HEXYLOXYETHANOL except in preparations containing 10 per cent or less of hexyloxyethanol.

HYDRAMETHYLNON except when included in Schedule 5.

HYDRAZINE.

HYDROCHLORIC ACID (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in preparations for therapeutic use; or

c)      in preparations containing 0.5 per cent or less of hydrochloric acid (HCl).

HYDROFLUORIC ACID (excluding its salts and derivatives) and admixtures that generate hydrofluoric acid, in preparations containing 1 per cent or less of hydrogen fluoride except when included in Schedule 5.

HYDROGEN PEROXIDE (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in hair dye preparations containing 6 per cent (20 volume) or less of hydrogen peroxide; or

c)      in other preparations containing 3 per cent (10 volume) or less of hydrogen peroxide.

HYDROQUINONE except:

a)      when included in Schedule 2 or 4; or

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

HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) in preparations containing 1 per cent or less of hydrosilicofluoric acid (H2SiF6) except when included in Schedule 5.

IMIDACLOPRID except:

a)      when included in Schedule 5; or

b)      in preparations containing 5 per cent or less of imidacloprid.

IMIDOCARB.

IMINOCTADINE TRIALBESILATE.

IMIPROTHRIN except:

a)      when included in Schedule 5; or

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

INDAZIFLAM.

INDOXACARB (includes the R and S enantiomers) except when included in Schedule 5.

IODINE (excluding its salts, derivatives and iodophors) except:

a)      when included in Schedule 2; or

b)      in solid or semi-solid preparations containing 2.5 per cent or less of available iodine.

IODOPHORS except in preparations containing 1.5 per cent or less of available iodine.

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) except:

a)      when included in Schedule 5;

b)      in aqueous preparations not for cosmetic use containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate (Iodocarb); or

c)      in cosmetic preparations (other than aerosolised preparations) containing 0.1 per cent or less of 3-iodo-2-propynyl butyl carbamate. 

IOXYNIL.

IPCONAZOLE except when included in Schedule 5.

IRON COMPOUNDS (excluding up to 1 per cent of iron oxides when present as an excipient) for the treatment of animals except:

a)      when included in Schedule 5;

b)      in liquid or gel preparations containing 0.1 per cent or less of iron; or

c)      in animal feeds or feed premixes.

ISOCONAZOLE for the external treatment of animals.

ISOCYANATES, free organic, boiling below 300° C, except in:

a)      viscous polyurethane adhesives; or

b)      viscous polyurethane sealants;

       containing not more than 0.7 per cent of free organic isocyanates boiling below 300°C.

ISOEUGENOL except:

a)      when included in Schedule 5; or

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

ISOPYRAZAM.

LAMBDA-CYHALOTHRIN:

a)      in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or

b)      in other preparations containing 1.6 per cent or less of lambda-cyhalothrin

       except when included in Schedule 5

LASALOCID except in animal feeds containing 100 mg/kg or less of antibiotic substances.

LAURETH CARBOXYLIC ACIDS (excluding their salts and derivatives) except:

a)      in leave-on preparations containing 1.5 per cent or less of laureth carboxylic acids;

b)      in wash-off preparations containing 30 per cent or less of laureth carboxylic acids and, if containing more than 5 per cent of laureth carboxylic acids, when labelled with a warning to the following effect:

                        IF IN EYES WASH OUT IMMEDIATELY WITH WATER; or

c)      in other preparations containing 30 per cent or less of laureth carboxylic acids and, if containing more than 5 per cent of laureth carboxylic acids, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and
IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

LAURYL ISOQUINOLINIUM BROMIDE.

LAURYL SULFATE SALTS (excluding their derivatives) except:

a)      in wash-off preparations containing 30 per cent or less of lauryl sulfates and, if containing more than 5 per cent of lauryl sulfates, when labelled with a warning to the following effect:

                        IF IN EYES WASH OUT IMMEDIATELY WITH WATER;

b)      in leave-on preparations containing 1.5 per cent or less of lauryl sulfates;

c)      in toothpaste and oral hygiene preparations containing 5 per cent or less of lauryl sulfates;

d)      in other preparations for animal use containing 2 per cent or less of lauryl sulfates; or

e)      in other preparations containing 30 per cent or less of lauryl sulfates and, if containing more than 5 per cent of lauryl sulfates, when labelled with warnings to the following effect:

IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and

IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN AND HAIR WITH RUNNING WATER.

LEAD COMPOUNDS except:

a)      when included in Schedule 4 or 5;

b)      in paints, tinters, inks or ink additives;

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

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

e)      in ceramic glazes when labelled with the warning statement:

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

written in letters not less than 1.5 mm in height.

LEPTOSPERMUM SCOPARIUM OIL (manuka oil) except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings;

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

e)      in preparations containing 25 per cent or less of Leptospermum scoparium oil.

LEVAMISOLE for the treatment of animals except:

a)      when included in Schedule 4 or 5; or

b)      in preparations for the treatment of ornamental birds or ornamental fish, in packs containing 10 mg or less of levamisole.

LINDANE except when included in Schedule 2, 4 or 5.

MAFENIDE when packed and labelled for the treatment of ornamental fish only.

MALATHION except:

a)      when included in Schedule 5;

b)      for human therapeutic use; or

c)      in dust preparations containing 2 per cent or less of malathion.

MCPA except when included in Schedule 5.

MEBENDAZOLE for the treatment of animals except when included in Schedule 5.

MECOPROP except when included in Schedule 5.

MECOPROP-P.

MEFLUIDIDE.

MELALEUCA OIL (tea tree oil) except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

c)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN;

d)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

e)      in preparations containing 25 per cent or less of melaleuca oil.

MELENGESTROL ACETATE when used as an animal feed additive.

MENAZON.

MERCAPTAMINE for cosmetic use except:

a)      when included in Schedule 5; or

b)      in preparations containing 1 per cent or less of mercaptamine.

MERCAPTOACETIC ACID and its salts, but excluding its derivatives, in cosmetic preparations except:

a)      when included in Schedule 5

b)      in preparations containing 5 per cent or less of mercaptoacetic acid or its salts (as mercapturic acid).

2-MERCAPTOETHANOL in preparations for use as insect lures.

MERCURIC OXIDE for the treatment of animals, in preparations for ocular use.

MERCUROCHROME for the treatment of animals, in preparations for topical use.

METACRESOLSULPHONIC ACID AND FORMALDEHYDE CONDENSATION PRODUCT for the treatment of animals.

METALAXYL except when included in Schedule 5.

METALDEHYDE except when included in Schedule 5.

METHACRIFOS in preparations containing 60 per cent or less of methacrifos.

METHAM.

METHANOL (excluding its derivatives) except:

a)      when included in Schedule 5; or

b)      in preparations containing 2 per cent or less of methanol.

METHIOCARB in preparations containing 20 per cent or less of methiocarb except when included in Schedule 5.

METHOMYL in fly-baits containing 1 per cent or less of methomyl and not less than 0.002 per cent of denatonium benzoate as a bittering agent.

2-METHOXY-5-NITROPHENOL.

METHYLCHLOROISOTHIAZOLINONE in leave-on cosmetic products or therapeutic goods intended for leave-on topical application, except in preparations containing 0.0015 per cent or less of methylchloroisothiazolinone and methylisothiazolinone in total.

METHYLCYCLOPENTADIENYL MANGANESE TRICARBONYL in preparations containing 10 per cent or less of methylcyclopentadienyl manganese tricarbonyl when fitted with a child-resistant closure.

METHYLDIBROMO GLUTARONITRILE except when in Schedule 10.

METHYLENE BISTHIOCYANATE except in preparations containing 1 per cent or less of methylene bisthiocyanate.

METHYLEUGENOL except in preparations containing 1 per cent or less of methyleugenol.

METHYL ETHYL KETONE OXIME except:

a)      in viscous silicone adhesives or viscous silicone sealants containing 2.5 per cent or less of methyl ethyl ketone oxime; or

b)      in other preparations conting 1 per cent or less of methyl ethyl ketone oxime.

p-METHYLAMINOPHENOL except when used in hair dye and eyebrow/eyelash colouring products at a concentration of 1 per cent or less of p-methylaminophenol after mixing for use when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use, and

Written in letters not less than 1.5 mm in height.

METHYL ISOTHIOCYANATE.

METHYL METHACRYLATE (excluding its derivatives) except:

a)      for cosmetic use; or

b)      in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.

METHYL NEODECANAMIDE except in liquid preparations containing 2 per cent or less of methyl neodecanamide.

METHYLISOTHIAZOLINONE in leave-on cosmetic products or therapeutic goods intended for leave-on topical application, except in preparations containing 0.01 per cent or less of methylisothiazolinone.

METHYLNORBORNYLPYRIDINE.

N-METHYL-2-PYRROLIDONE except:

a)      when included in Schedule 5; or

b)      in preparations containing 25 per cent or less of designated solvents.

2-METHYLRESORCINOL except:

a)      in non-oxidative hair dye preparations containing 1.8 per cent or less of 2‑methylresorcinol when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

Written in letters not less than 1.5 mm in height; or

b)      in oxidative hair dye preparations containing 1.8 per cent or less of 2-methylresorcinol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

Written in letter not less than 1.5 mm in height.

METHYLROSANILINIUM CHLORIDE (formerly known as crystal violet CAS No. 548-62-9) and the following TRIARYLMETHANE DYES:

- Acid Violet 49 (CAS No. 1694-09-3),

- Ethyl Violet (CAS No. 2390-59-2),

- Basic Blue 7 (CAS No. 2390-60-5),

- Methylium, 4-(dimethylamino)phenylbis4-(ethylamino)-3-methylphenyl-, acetate (CAS No. 72102-55-7),

except when included in Schedule 4 or Schedule 10.

METHYL SALICYLATE except:

a)      when included in Schedule 5;

b)      in preparations for therapeutic use; or

c)      in preparations containing 5 per cent or less of methyl salicylate.

METOFLUTHRIN except when included in Schedule 5.

METOSULAM.

METRAFENONE except when included in Schedule 5.

METRIBUZIN.

MICONAZOLE for the external treatment of animals.

MILBEMECTIN except when included in Schedule 5.

MOMFLUOROTHRIN.

MONENSIN:

a)      in animal feed premixes containing 12.5 per cent or less of antibiotic substances; or

b)      in stockfeed supplements, blocks or licks containing 0.75 per cent or less of antibiotic substances.

MONOETHANOLAMINE (excluding its salts and derivatives) except:

a)      when included in Schedule 4 or 5; or

b)      in preparations containing 5 per cent or less of monoethanolamine.

MORANTEL except:

a)      when included in Schedule 5; or

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

MOXIDECTIN for external use:

a)      in preparations containing 2.5 per cent or less of moxidectin when packed in single dose tubes for the treatment of cats and dogs; or

b)      in preparations containing 2 per cent or less of moxidectin for the treatment of animals,

       except when included in Schedule 5.

MSMA in herbicide or defoliant preparations containing 10 per cent or less of MSMA.

NALED except when included in Schedule 5.

NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.

1,5-NAPHTHALENEDIOL except:

a)      in non-oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye, and

Written in letters not less than 1.5 mm in height; or

b)   in oxidative hair dye preparations containing 1 per cent or less of 1,5-naphthalenediol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye, and

Written in letters not less than 1.5 mm in height.

2,7-NAPHTHALENEDIOL except:

a)      in non-oxidative hair dye preparations containing 1 per cent or less of 2,7-naphthalenediol when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye, and

Written in letters not less than 1.5 mm in height; or

b)      in oxidative hair dye preparations containing 1 per cent or less of 2,7-naphthalenediol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye, and

Written in letters not less than 1.5 mm in height.

1-NAPHTHOL except in hair dye preparations containing 1 per cent or less of 1-naphthol after mixing under oxidative conditions when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye, and

Written in letters not less than 1.5 mm in height.

NAPHTHALOPHOS in preparations containing 80 per cent or less of naphthalophos.

NARASIN in animal feed premixes containing 12 per cent or less of narasin.

NETOBIMIN for the treatment of animals except when included in Schedule 5.

NICKEL SULFATE.

NICOTINE in preparations containing 3 per cent or less of nicotine when labelled and packed for the treatment of animals.

NIMIDANE in preparations containing 25 per cent or less of nimidane.

NITENPYRAM except in divided preparations containing 100 mg or less of nitenpyram.

NITRIC ACID (excluding its salts and derivatives) except:

a)      when included in Schedule 5; or

b)      in preparations containing 0.5 per cent or less of nitric acid (HNO3).

NITROBENZENE except:

a)      in solid or semi-solid polishes;

b)      in soaps containing 1 per cent or less of nitrobenzene; or

c)      in other preparations containing 0.1 per cent or less of nitrobenzene.

NITROPHENOLS, ortho, meta and para, except when separately specified in these Schedules.

NITROPRUSSIDES in preparations containing 2.5 per cent or less of nitroprussides except when included in Schedule 4.

NITROXYNIL.

NONOXINOL 9 except:

a)      when included in Schedule 5;

b)      in preparations containing 25 per cent or less of nonoxinol 9 when labelled with the statements:

                        IRRITANT; and
                        Avoid contact with eyes;

c)      in preparations containing 12.5 per cent or less of nonoxinol 9; or

d)      in preparations for human use.

1-OCTEN-3-OL except in preparations containing 5 per cent or less of 1-octen-3-ol.

OCTHILINONE except in paints, jointing compounds and sealants containing 1 per cent or less of octhilinone calculated on the non-volatile content.

N-(N-OCTYL)-2-PYRROLIDONE except:

a)      when included in Schedule 5; or

b)      in preparations containing 25 per cent or less of designated solvents.

OLAQUINDOX except in preparations containing 10 per cent or less of olaquindox.

N-OLEYL-1,3-DIAMINOPROPANE.

OMETHOATE in preparations containing 30 per cent or less of omethoate except when included in Schedule 5.

OXADIAZON.

OXALIC ACID except

a)      in dental care preparations, including mouthwashes, containing 3 per cent or less of soluble salts of oxalic acid; or

b)      its insoluble salts.

OXYCLOZANIDE.

PAECILOMYCES LILACINUS STRAIN 251.

PARAFORMALDEHYDE (excluding its derivatives) in preparations containing 0.05 per cent or more of free formaldehyde except:

a)      for human therapeutic use;

b)      in oral hygiene preparations;

c)      in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde;

d)      in nail hardener cosmetic preparations containing 0.2 per cent or less of free formaldehyde when labelled with the statement:

                        PROTECT CUTICLES WITH GREASE OR OIL;

e)      in all other cosmetic preparations; or

f)       in other preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:

                        CONTAINS FORMALDEHYDE.

PARATHION-METHYL in aqueous preparations containing 45 per cent or less of microencapsulated parathion-methyl.

PARBENDAZOLE.

PEBULATE.

PENNYROYAL OIL except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

c)      in preparations containing 4 per cent or less of d-pulegone.

PENTACHLOROPHENOL in preparations containing 1.5 per cent or less of pentachlorophenol.

PERACETIC ACID except when included in Schedule 5.

PERFLUIDONE.

PERMANGANATES except potassium permanganate in aqueous solutions containing 1 per cent or less of potassium permanganate.

PERMETHRIN except:

a)      when included in Schedule 4 or 5;

b)      in preparations for human therapeutic use containing 5 per cent or less of permethrin; or

c)      in preparations containing 2 per cent or less of permethrin.

2-PHENOXYETHANOL except:

a)      in cosmetic preparations containing 1 per cent or less of 2-phenoxyethanol; or

b)      in other preparations containing 15 per cent or less of 2-phenoxyethanol.

PHENOL, including cresols and xylenols and any other homologue of phenol boiling below 220°C, except:

a)      when separately specified in these Schedules; or

b)      in preparations containing 1 per cent or less of phenols, and in preparations containing 3 per cent or less of cresols and xylenols and other homologues of phenol.

PHENOTHIAZINE (excluding its derivatives) except in preparations containing 10 per cent or less of phenothiazine.

PHENOXYMETHYL OXIRANE.

†PHENYLENEDIAMINES including alkylated, arylated and nitro derivatives not elsewhere specified in these Schedules:

a)      in preparations packed and labelled for photographic purposes;

b)      in preparations packed and labelled for testing water except tablets containing 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for use include the statement, “Do not discard testing solutions into the pool”;

c)      in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING ‒ This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5 mm in height; or

d)      in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:

WARNING ‒ This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5 mm in height.

PHOSALONE.

PHOSMET.

PHOSPHORIC ACID (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in preparations containing 15 per cent or less of phosphoric acid (H3PO4);

c)      in solid or semi-solid preparations; or

d)      in professional dental kits.

PHOXIM.

o-PHTHALALDEHYDE except when included in Schedule 5.

PINDONE.

PINE OILs when packed and labelled as a herbicide except when included in Schedule 5.

PINOXADEN except when included in Schedule 5.

PIPEROPHOS.

PIRIMICARB except when included in Schedule 5.

PIRIMIPHOS-ETHYL.

PIRIMIPHOS-METHYL.

POLIHEXANIDE except:

a)      in preparations containing 5 per cent or less of polihexanide; or

b)      when packed and labelled for therapeutic use.

POLIXETONIUM SALTS except:

a)      when included in Schedule 5; or

b)      in preparations containing 1 per cent or less of polixetonium salts.

POTASSIUM AZELOYL DIGLYCINATE except in preparations for cosmetic use containing 1 per cent or less of potassium azeloyl diglycinate.

POTASSIUM BROMATE except in preparations containing 0.5 per cent or less of potassium bromate.

POTASSIUM CYANATE.

POTASSIUM HYDROXIDE (excluding its salts and derivatives) except:

a)      when included in Schedule 5 or Schedule 10;

b)      in preparations containing 5 per cent or less of potassium hydroxide being:

i)        solid preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or

ii)      liquid or semi-solid preparations, the pH of which is 11.5 or less.

POTASSIUM NITRITE in preparations containing 40 per cent or less of potassium nitrite except:

a)      when included in Schedule 5;

b)      in preparations containing 0.5 per cent or less of potassium nitrite;

c)      when present as an excipient in preparations for therapeutic use; or

d)      in aerosols containing 2 per cent or less of potassium nitrite.

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT except:

a)      when included in Schedule 5;

b)      in solid orthodontic device cleaning preparations, the pH of which as an “in-use” aqueous solution is 2.5 or more, but not more than 11.5; or

c)      in preparations containing 5 per cent or less of potassium peroxomonosulfate triple salt being:

i)        solid preparations, the pH of which in a 10 g/L aqueous solution is 2.5 or more; or

ii)      liquid or semi-solid preparations, the pH of which is 2.5 or more.

POTASSIUM PERSULFATE in hair preparations.

PRALLETHRIN (cis:trans=20:80) except:

a)      when included in Schedule 5; or

b)      in insecticidal mats containing 1 per cent or less of prallethrin.

PROCHLORAZ.

PROFENOFOS.

PROMACYL.

PROPACHLOR.

PROPARGITE.

PROPETAMPHOS.

PROPICONAZOLE except when included in Schedule 5.

PROPINEB.

PROPIONIC ACID (excluding its salts and derivatives) except:

a)      when included in Schedule 5;

b)      in preparations containing 30 per cent or less of propionic acid; or

c)      for therapeutic use.

PROPOXUR except when included in Schedule 5.

n-PROPYL ALCOHOL except:

a)      when included in Schedule 5;

b)      in preparations containing 5 per cent or less of n-propyl alcohol; or

c)      in preparations for cosmetic or therapeutic use other than in spray form.

PROQUINAZID.

PROSULFOCARB.

PROSULFURON.

PROTHIOFOS.

d-PULEGONE except in preparations containing 4 per cent or less of d- pulegone.

PYRACLOFOS.

PYRAZOPHOS.

PYRIDABEN except when included in Schedule 5.

PYRIDALYL.

PYRIDATE.

PYRIPROLE.

PYRITHIONE COPPER.

PYRITHIONE ZINC except:

a)      when included in Schedule 2 or 5;

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

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

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

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

f)       in paints, jointing materials or sealants containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content.

PYRIOFENONE except when included in Schedule 5.

PYROXASULFONE.

PYROXSULAM.

QUATERNARY AMMONIUM COMPOUNDS except:

a)      when separately specified in these Schedules;

b)      when included in Schedule 5;

c)      dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or

d)      in preparations containing 5 per cent or less of such quaternary ammonium compounds.

QUINOLINE and its salts (excluding other derivatives).

QUIZALOFOP ETHYL.

QUIZALOFOP-p-ETHYL except when included in Schedule 5.

QUIZALOFOP-p-TEFURYL.

RESMETHRIN except when included in Schedule 5.

ROTENONE except in solid or semi-solid preparations containing 2 per cent or less of rotenone.

SAFROLE except:

a)      for internal use; or

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

SAGE OIL (Dalmatian) except:

a)      in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

b)      in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15 mL or less fitted with a restricted flow insert and a child-resistant closure and labelled with the warnings:

                        KEEP OUT OF REACH OF CHILDREN; and
                        NOT TO BE TAKEN; or

c)      in preparations containing 4 per cent or less of thujone.

SALINOMYCIN in animal feed premixes containing 12 per cent or less of antibiotic substances.

SAROLANER except when included in Schedule 5.

SASSAFRAS OIL except:

a)      for internal use; or

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

SELENIUM:

a)      in preparations containing 2.5 per cent or less of selenium when packed and labelled:

i)        for the blueing of gun barrels;

ii)      for photographic purposes; or

iii)    for the colouring of lead or lead alloys;

b)      in coated granules containing 1 per cent or less of selenium for application to pasture except in fertilisers containing 200 g/tonne or less of selenium; or

c)      for the treatment of animals:

i)        in a drench, injection, paste, stocklick, vaccine or horse feed supplement containing 0.5 per cent or less of selenium;

ii)      in animal feed premixes containing 2 per cent or less of selenium for the preparation of feeds containing 1 g/tonne or less of selenium;

iii)    in controlled release bolus preparations containing 25 mg or less of selenium with a release rate not greater than 0.25 mg/day; or

iv)    as barium selenate in preparations for injection containing 5 per cent or less of selenium.

SEMDURAMICIN in animal feed premixes for coccidiosis prevention containing 5 per cent or less of antibiotic substances.

SILICOFLUORIDES except:

a)      when included in Schedule 5; or

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

SILVER NITRATE except:

a)      when included in or expressly excluded from Schedule 2; or

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

SINBIOALLETHRIN except:

a)      when included in Schedule 5; or

b)      in preparations containing 1 per cent or less of sinbioallethrin.

SODIUM ALUMINATE (excluding its salts and derivatives) except:

a)      in solid preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or

b)      in liquid preparations, the pH of which is 11.5 or less.

SODIUM BROMATE except in preparations containing 0.5 per cent or less of sodium bromate.

SODIUM HYDROXIDE (excluding its salts and derivatives) except:

a)      when included in Schedule 5 or Schedule 10;

b)      in preparations containing 5 per cent or less of sodium hydroxide being:

i)        solid preparations, the pH of which in a 10 g/L aqueous solution is 11.5 or less; or

ii)      liquid or semi-solid preparations, the pH of which is 11.5 or less.

SODIUM NITRITE in preparations containing 40 per cent or less of sodium nitrite except:

a)      when included in Schedule 2 or 5;

b)      in preparations containing 0.5 per cent or less of sodium nitrite;

c)      when present as an excipient in preparations for therapeutic use; or

d)      in aerosols containing 2 per cent or less of sodium nitrite.

SODIUM PERCARBONATE (CAS No. 15630-89-4) except:

a)      when included in Schedule 5; or

b)      in preparations containing 15 per cent or less of sodium percarbonate.

SODIUM PERSULFATE:

a)      in hair preparations; or

b)      in products for the treatment of water for swimming pools and spas.

SODIUM SULFIDE in preparations for use as insect lures.

SPIROTETRAMAT.

SPIROXAMINE.

SULCOFURON in preparations for the treatment of carpets during manufacture.

SULFAMIC ACID (excluding its salts and derivatives) except when included in Schedule 5.

SULFLURAMID.

SULFOXAFLOR except when included in Schedule 5.

SULFURIC ACID (excluding its salts and derivatives) except:

a)      in fire extinguishers; or

b)      in preparations containing 0.5 per cent or less of sulfuric acid (H2SO4).

SULFURYL FLUORIDE.

SULPROFOS.

2,4,5-T.

N-TALLOW ALKYL-1,3-PROPANEDIAMINE DIACETATE and TALLOW ALKYLAMINE ACETATES.

TAR ACIDS distilling within the range 230-290°C inclusive.

TCMTB (2-[thiocyanomethylthio]benzothiazole).

TDE (1,1-dichloro-2,2-bis[4-chlorophenyl]ethane) except when included in Schedule 5.

TEBUFENPYRAD.

TEBUTHIURON.

TEMEPHOS except when in Schedule 5.

TERBUTHYLAZINE except in preparations containing 5 per cent or less of terbuthylazine.

TERPENES, CHLORINATED.

TESTOSTERONE in implant preparations for use in animals.

TETRACHLOROETHYLENE except:

a)      when included in Schedule 2 or 5;

b)      in preparations containing 6 per cent or less of tetrachloroethylene when absorbed into an inert solid; or

c)      in preparations for the treatment of animals.

TETRACONAZOLE except when included in Schedule 5.

TETRADIFON.

2,2’,6,6’-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE in amitraz formulations containing 2 per cent or less of 2,2’,6,6’-tetraisopropyl-diphenyl-carbodiimide.

TETRAMISOLE in preparations for the treatment of animals.

THIACLOPRID.

THIAMETHOXAM except when included in Schedule 5.

THIAZAFLURON.

THIODICARB except when included in Schedule 5.

THIOMETON.

THIOPHANATE-METHYL except when included in Schedule 5.

THIOUREA AND ALKYL THIOUREAS except:

a)      when separately specified in these Schedules; or

b)      for therapeutic use.

THIRAM except in paint containing 0.5 per cent or less of thiram.

THUJONE except in preparations containing 4 per cent or less of thujone.

THYMOL when packed and labelled for the control of Varroa mites in bee hives.

TOLUENE (excluding its derivatives) except in preparations containing 50 per cent or less of toluene or toluene and xylene.

TOLUENEDIAMINE not elsewhere specified in these Schedules:

a)      in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:

KEEP OUT OF REACH OF CHILDREN, and

WARNING – This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.

written in letters not less than 1.5 mm in height; or

b)      in eyelash and eyebrow tinting products when the immediate container and primary pack are labelled with the following statement:

WARNING – This product contains ingredients which may cause skin irritation to certain individuals, and when used for eyelash and eyebrow tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5 mm in height.

c)      in nail polish preparations containing 2,5-toluenediamine except when labelled ‘avoid contact with skin’

TOLYLFLUANID.

TRANSFLUTHRIN except:

a)      in preparations containing 1 per cent or less of transfluthrin; or

b)      in a cartridge for vaporiser use containing 600 mg or less of transfluthrin per cartridge.

TRIADIMEFON except:

a)      when included in Schedule 5; or

b)      in fertilisers containing 5 g/kg or less of triadimefon.

TRICHLORFON except metrifonate included in Schedule 4.

TRICHLOROACETIC ACID except:

a)      when included in Schedule 4 or 5; or

b)      in human dermal preparations containing 12.5 per cent or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

TRICHLOROETHYLENE except when included in Schedule 4.

TRICHLOROPHENOL.

TRICLABENDAZOLE except in preparations containing 20 per cent or less of triclabendazole.

TRICLOPYR.

TRICLOSAN in cosmetic preparations for human use containing more than 0.3 per cent of triclosan.

TRIDEMORPH.

TRIETHYL PHOSPHATE.

TRIFLUOROMETHANESULFONIC ACID.

TRINITROPHENOL (excluding its derivatives) except:

            (a)        in preparations for human therapeutic use; or

            (b)        in preparations containing 5 per cent or less of trinitrophenol.

TRISODIUM NITRILOTRIACETATE except in preparations containing 20 per cent or less of trisodium nitrilotriacetate.

VAMIDOTHION.

WARFARIN except when included in Schedule 4 or 5.

XYLENE (excluding its derivatives) except in preparations containing 50 per cent or less of xylene or xylene and toluene.

ZERANOL in ear implants for use as a growth promotant in steer cattle.

ZETA-CYPERMETHRIN in preparations containing 10 per cent or less of zeta-cypermethrin.

ZINC BORATE (excluding its derivatives) for use as an agricultural chemical.

ZINC CHLORIDE except:

a)      when included in Schedule 2; or

b)      in preparations containing 5 per cent or less of zinc chloride.

ZINC para-PHENOLSULFONATE except in preparations containing 5 per cent or less of zinc para-phenolsulfonate.

ZINC LACTATE in toothpaste except in toothpaste preparations containing 2.5 per cent or less of zinc lactate and labelled with the statement :

Not recommended for children under twelve years of age.

ZINC SULFATE except:

a)      when included in or expressly excluded from Schedule 4; or

b)      in other preparations containing 5 per cent or less of zinc sulfate.

ZIRAM in granular preparations.


SCHEDULE 7

ABAMECTIN except when included in Schedule 5 or 6.

ACIBENZOLAR-S-METHYL.

ACRIFLAVINIUM CHLORIDE for veterinary use except when in Schedule 5.

ACROLEIN.

ACRYLONITRILE.

ALACHLOR.

ALDICARB.

ALDOXYCARB.

ALLYL ALCOHOL.

ALPHA-CYPERMETHRIN except when included in Schedule 5 or 6.

AMINOACRIDINE for veterinary use except when included in Schedule 5.

AMINOCARB except when included in Schedule 6.

4-AMINOPROPIOPHENONE.

4-AMINOPYRIDINE except when included in Schedule 4.

AMITON.

ARPRINOCID.

ARSENIC except:

a)      when separately specified in this Schedule;

b)      when included in Schedule 4 or 6;

c)      as selenium arsenide in photocopier drums;

d)      as 10,10’-oxydiphenoxarsine in silicone rubber mastic containing 120 mg/kg or less of arsenic;

e)      as 10,10’-oxydiphenoxarsine contained in polyvinyl chloride and polyurethane extruded and moulded articles containing 160 mg/kg or less of arsenic other than when included in articles:

i)        in contact with food stuffs, animal feeds or potable water;

ii)      of clothing and footwear in contact with the skin;

iii)    used as infant wear; or

iv)    intended for use as packaging materials;

f)       in animal feeds containing 75 g/tonne or less of arsenic; or

g)      in paints containing 0.1 per cent or less of arsenic calculated on the non-volatile content of the paint.

AZAFENIDIN.

AZINPHOS-ETHYL.

AZINPHOS-METHYL.

AZOCYCLOTIN.

AZO DYES that are derivatives by diazotisation of any of the following substances:

p-aminoazobenzene (CAS No. 60-09-3)

o-aminoazotoluene (CAS No. 97-56-3)

o-anisidine (CAS No. 90-04-0)

p-chloroaniline (CAS No. 106-47-8)

4-chloro-o-toluidine (CAS No. 95-69-2)

6-methoxy-m-toluidine (p-cresidine) (CAS No. 120-71-8)

2-naphthylamine (CAS No. 91-59-8)

5-nitro-o-toluidine (CAS No. 99-55-8)

2,4-toluenediamine (CAS No. 95-80-7)

o-toluidine (CAS No. 95-53-4)

2,4,5-trimethylaniline (CAS No. 137-17-7)

BENDIOCARB except when included in Schedule 5 or 6.

BENOMYL except in paints containing 0.5 per cent or less of benomyl.

BENZENE (excluding its derivatives) except:

a)      preparations containing 15 mL/L or less of benzene; or

b)      petrol containing 50 mL/L or less of benzene.

BENZIDINE-BASED AZO DYES being:

2,2'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[N-(4-chlorophenyl)-3-oxobutanamide]
(CAS No. 94249-03-3)

Acid Red 85 (Acid Fast Red A)

1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-, disodium salt
(CAS No. 3567-65-5)

C.I Acid Black 29
(CAS No. 12217-14-0)

C.I. Direct Orange 1
(CAS No. 54579-28-1)

Direct Black 38

2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt
(CAS No. 1937-37-7)

Direct Blue 2

2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt
(CAS No. 2429-73-4)

Direct Blue 6

2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium salt
(CAS No. 2602-46-2)

Direct Brown 2

5-[[4'-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl)azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxy- benzoic acid disodium salt
(CAS No. 2429-82-5)

Direct Brown 95

Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt
(CAS No. 16071-86-6)

Direct Green 1

2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt
(CAS No. 3626-28-6)

Direct Green 6

2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt
(CAS No. 4335-09-5)

Direct Red 28 (Congo Red)

1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[4-amino-, disodium salt
(CAS No. 573-58-0)

Direct Red 37

1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-ethoxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-7-hydroxy-, disodium salt
(CAS No. 3530-19-6)

BENZIDINE-CONGENER (3,3’-disubstituted) AZO DYES.

BETACYFLUTHRIN except when included in Schedule 5 or 6.

BIFENTHRIN except:

            (a)        when included in Schedule 6; or

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

BIFLUORIDES (including ammonium, potassium and sodium salts) except when included in Schedule 5 or 6.

BORON TRIFLUORIDE except when included in Schedule 5 or 6.

BRODIFACOUM except when included in Schedule 6.

BROMADIOLONE except when included in Schedule 6.

BROMETHALIN except when included in Schedule 6.

BROMINE (excluding its salts and derivatives).

BRUCINE except in alcohol containing 0.02 per cent or less of brucine as a denaturant.

CACODYLIC ACID except:

a)      when included in Schedule 6; or

b)      in animal feeds containing 75 g/tonne or less of arsenic.

CADUSAFOS except when included in Schedule 6.

CALCIFEROL for use as a rodenticide except when included in Schedule 6.

CAPTAFOL.

CARBADOX.

CARBENDAZIM except in paints, jointing compounds and sealants containing 0.1 per cent or less of carbendazim.

CARBOFURAN.

CARBON TETRACHLORIDE except in chlorinated rubber based paint containing 1 per cent or less of carbon tetrachloride.

CARBONYL SULFIDE when packed and labelled for use as a fumigant.

CARBOPHENOTHION.

CARBOSULFAN.

CHLORDECONE.

CHLORDIMEFORM.

CHLORFENAPYR except when included in Schedule 5 or 6.

CHLORFENVINPHOS.

CHLORINE (excluding its salts and derivatives).

CHLORHEXIDINE except:

a)      when included in Schedule 5 or 6;

b)      in preparations containing 1 per cent or less of chlorhexidine; or

c)      in solid preparations.

CHLOROMETHIURON.

5-CHLORO-3-METHYL-4-NITROPYRAZOLE.

4-CHLORO-o-TOLUIDINE.

CHLOROPICRIN except when included in Schedule 6.

CHLORTHIOPHOS.

COLECALCIFEROL for use as a rodenticide.

COUMAPHOS except when included in Schedule 6.

COUMATETRALYL except when included in Schedule 5 or 6.

CREOSOTE derived from coal.

CREOSOTE derived from beechwood.

CYANIDES, metallic except:

a)      ferricyanides;

b)      ferrocyanides; or

c)      when separately specified in these Schedules.

CYANOGEN.

CYHALOTHRIN (aRS,1R,cis,Z):(aRS,1S,cis,Z) = 50:50.

CYHEXATIN.

DELTAMETHRIN except:

a)      when included in Schedule 5 or 6; or

b)      in factory prepared mosquito nets containing 1 per cent or less of deltamethrin; or

c)      in preparations containing 0.1 per cent or less of deltamethrin.

DEMETON.

DEMETON-O-METHYL.

DEMETON-S-METHYL.

DIALIFOS.

4,4-DIAMINODIPHENYLMETHANE (Methylene dianiline).

1,2-DIBROMO-3-CHLOROPROPANE.

1,3-DICHLOROPROPENE except in biocidal preparations containing 0.3 per cent or less of 1,3-dichloropropene.

DICHLORVOS except when included in Schedule 5 or 6.

DICROTOPHOS.

DIFENACOUM except when included in Schedule 6.

DIFETHIALONE except when included in Schedule 6.

DIMEFOX.

4-DIMETHYLAMINOAZOBENZENE (N,N-dimethyl-4-[phenylazo]-benzenamine).

DIMETHYL SULFATE.

DIMETILAN.

DINITROCRESOLS except when included in Schedule 4 or 6.

DINITROPHENOLS except when included in Schedule 4, 6 or 10.

DINOCAP.

DINOSEB.

DIQUAT except when included in Schedule 6.

DISULFOTON except when included in Schedule 6.

DORAMECTIN except when included in Schedule 5 or 6.

DSMA except when included in Schedule 6.

EMAMECTIN except when included in Schedule 5 or 6.

ENDOSULFAN except when included in Schedule 6.

ENDOTHAL except when included in Schedule 6.

ENDRIN.

EPICHLOROHYDRIN.

EPIDERMAL GROWTH FACTOR except in preparations for human therapeutic use.

EPRINOMECTIN except when included in Schedule 5.

ETACONAZOLE.

ETHION.

ETHOPROPHOS except when included in Schedule 6.

2-ETHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or less of 2-ethoxyethanol.

ETHYLENE DIBROMIDE.

ETHYLENE OXIDE.

FAMPHUR except when included in Schedule 6.

FENAMIPHOS except when included in Schedule 6.

FENOXACRIM except:

a)      when included in Schedule 6; or

b)      in treated carpets.

FENSULFOTHION.

FENTHION except when included in Schedule 5 or 6.

FENTHION-ETHYL.

FLOCOUMAFEN except when included in Schedule 6.

FLUCOFURON except:

a)      when included in Schedule 6; or

b)      in treated carpets.

FLUCYTHRINATE.

FLUMIOXAZIN except when included in Schedule 6.

FLUOROACETAMIDE.

FLUOROACETIC ACID.

FOLPET.

FORMETANATE.

FOSTHIAZATE.

FURATHIOCARB except when included in Schedule 5.

GAMMA-CYHALOTHRIN except when included in Schedule 5.

HALOFUGINONE except when included in Schedule 4.

HALOGENATED DIBENZODIOXINS AND DIBENZOFURANS.

HCB.

HYDROCARBONS LIQUID AROMATIC (including aromatic extract oils), any fraction of which boils above 350°C except:

a)      when in solid polymers;

b)      when containing 1 per cent or less of total polycyclic aromatic compounds as measured by IP 346; or

c)      when having a Mutagenicity Index of zero as measured by ASTM E1687-95.

HYDROCYANIC ACID except:

a)      when included in Schedule 4; or

b)      its salts and derivatives other than cyanides separately specified in this Schedule.

HYDROFLUORIC ACID (excluding its salts and derivatives) except when included in Schedule 5 or 6.

HYDROGEN SULFIDE.

HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) except when included in Schedule 5 or 6.

IODOMETHANE.

ISOCARBOPHOS.

ISOFENPHOS.

ISOPROTURON.

IVERMECTIN except when included in Schedule 4 or 5.

LAMBDA-CYHALOTHRIN except when included in Schedule 5 or 6.

LEPTOPHOS.

LITHIUM PERFLUOROOCTANE SULFONATE except in sealed bait stations containing 1 per cent or less of lithium perfluorooctane sulfonate.

MADURAMICIN except:

a)      when included in Schedule 5; or

b)      in animal feeds containing 5 mg/kg or less of antibiotic substances.

MALACHITE GREEN for veterinary use except when included in Schedule 5.

MAZIDOX.

MECARBAM.

2-METHOXYETHANOL and its acetates except in preparations containing 0.5 per cent or les of 2-methoxyethanol.

MERCURIC CHLORIDE when prepared for use for agricultural, industrial, pastoral or horticultural purposes.

MERCURY except:

a)      when separately specified in this Schedule;

b)      when included in Schedule 2, 4 or 6;

c)      in preparations containing 0.01 per cent or less of mercury in organic form as a preservative;

d)      mercury (metallic) in scientific instruments;

e)      dental amalgams; or

f)       in a sealed device, for therapeutic use, which prevents access to the mercury.

METHACRIFOS except when included in Schedule 6.

METHAMIDOPHOS.

METHAPYRILENE.

METHAZOLE.

METHIDATHION.

METHIOCARB except when included in Schedule 5 or 6.

METHOMYL except when included in Schedule 6.

METHOXYETHYLMERCURIC ACETATE.

METHOXYETHYLMERCURIC CHLORIDE.

METHYL BROMIDE.

METHYLCYCLOPENTADIENYL MANGANESE TRICARBONYL except:

a)      when included in Schedule 6;

b)      when used in laboratory analysis; or

c)      when packed for industrial use in containers with a nominal capacity of 100 L or more.

4,4’-METHYLENEBIS[2-CHLOROANILINE] (MOCA).

METHYLENE BLUE for veterinary use except when included in Schedules 4 or 5.

MEVINPHOS.

MIPAFOX.

MIREX.

MOLINATE.

MONOCROTOPHOS.

MOXIDECTIN except when included in Schedule 4, 5 or 6.

MSMA except when included in Schedule 6.

NAPHTHALOPHOS except when included in Schedule 6.

NICOTINE except:

a)      when included in Schedule 6;

b)      in preparations for human therapeutic use; or

c)      in tobacco prepared and packed for smoking.

NIMIDANE except when included in Schedule 6.

NITROFEN.

NITROPRUSSIDES except when included in Schedule 4 or 6.

2-NITROTOLUENE.

OMETHOATE except when included in Schedule 5 or 6.

OXAMYL.

OXYDEMETON METHYL.

PARAQUAT.

PARATHION.

PARATHION-METHYL except when included in Schedule 6.

PENTACHLOROPHENOL except when included in Schedule 6.

PHENYLMERCURIC ACETATE except in preparations containing 0.01 per cent or less of mercury as a preservative.

PHORATE.

PHOSFOLAN.

PHOSPHIDES, METALLIC.

PHOSPHINE.

PHOSPHORUS, YELLOW (excluding its salts and derivatives).

POTASSIUM NITRITE except:

a)      when included in Schedule 5 or 6;

b)      in preparations containing 0.5 per cent or less of potassium nitrite;

c)      when present as an excipient in preparations for therapeutic use; or

d)      in aerosols containing 2 per cent or less of potassium nitrite.

PROCYMIDONE.

PROPYLENE OXIDE.

PYRINURON.

QUININE for veterinary use except when included in Schedule 5.

SAFLUFENACIL except when included in Schedule 5.

SCHRADAN.

SELENIUM except:

a)      when included in Schedule 6;

b)      as selenium arsenide in photocopier drums;

c)      in preparations for therapeutic use other than:

i)        drench concentrates containing 2.5 per cent or less of selenium; or

ii)      pour-on preparations containing 0.5 per cent or less of selenium;

d)      in paints or tinters containing 0.1 per cent or less of selenium calculated on the non-volatile content of the paint or tinter; or

e)      in fertilisers containing 200 g/tonne or less of selenium.

SEMDURAMICIN except:

a)      when included in Schedule 6; or

b)      in animal feeds containing 25 mg/kg or less of antibiotic substances.

SODIUM NITRITE except:

a)      when included in Schedule 2, 5 or 6;

b)      in preparations containing 0.5 per cent or less of sodium nitrite;

c)      when present as an excipient in preparations for therapeutic use; or

d)      in aerosols containing 2 per cent or less of sodium nitrite.

STRYCHNINE except when included in Schedule 4.

SULCOFURON except:

a)      when included in Schedule 6; or

b)      in treated carpets.

SULFENTRAZONE.

SULFOTEP.

TEFLUTHRIN except when included in Schedule 5.

TEPP.

TERBUFOS.

TETRACHLOROETHANE.

2,2’,6,6’-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE except when included in Schedule 6.

THALLIUM.

THIOFANOX.

TIN ORGANIC COMPOUNDS, being dialkyl, trialkyl and triphenyl tin compounds where the alkyl group is methyl, ethyl, propyl or butyl except:

a)      when separately specified in this Schedule;

b)      in plastics;

c)      in semi-solid sealants, adhesives or elastomers containing 1 per cent or less of the dialkyl, trialkyl or triphenyl tin component; or

d)      in paint containing 1 per cent or less of such compounds calculated as tin in the non-volatile content of the paint.

o-TOLIDINE except in solid-state diagnostic therapeutic reagents.

TRIAMIPHOS.

TRIAZBUTIL.

TRIBUFOS (S,S,S-tributylphosphorotrithioate).

VINCLOZOLIN.

VINYL CHLORIDE.

ZETA-CYPERMETHRIN except when included in Schedule 6.

ZIRAM except when included in Schedule 6.


SCHEDULE 8

ACETYLDIHYDROCODEINE.

ACETYLMETHADOL.

ACETYLMORPHINES.

ALFENTANIL.

ALPHACETYLMETHADOL.

ALPHAPRODINE.

# ALPRAZOLAM.

AMFETAMINE.

AMOBARBITAL except when included in Schedule 4.

ANILERIDINE.

BENZYLMORPHINE.

BEZITRAMIDE.

BUPRENORPHINE.

BUTOBARBITAL.

BUTORPHANOL.

# CANNABIS (including seeds, extracts, resins and the plant, and any part of the plant) when prepared or packed for human therapeutic use, when:

a)      cultivated or produced, or in products manufactured[1], in accordance with the Narcotic Drugs Act 1967; and/or

b)      for use in products manufactured in accordance with the Narcotic Drugs Act 1967; and/or

c)      imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or

d)      in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989,

except when:

i)        it is a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or

ii)      separately specified in Schedule 4; or

iii)    separately specified in the NABIXIMOLS entry in this Schedule; or

iv)    in hemp seed oil for purposes other than internal human therapeutic use containing 50 mg/kg or less of cannabinoids.

CARFENTANYL.

COCAINE.

CODEINE except when included in Schedule 2, 3 or 4.

CODEINE-N-OXIDE.

CONCENTRATE OF POPPY STRAW (the material arising when poppy straw has entered into a process for concentration of its alkaloids).

4-CYANO-1-METHYL-4-PHENYLPIPERIDINE (Pethidine intermediate A).

CYCLOBARBITAL.

DEXAMFETAMINE.

DEXTROMORAMIDE.

DEXTROPROPOXYPHENE except when included in Schedule 4.

DIFENOXIN except when included in Schedule 4.

DIHYDROCODEINE except when included in Schedule 2, 3 or 4.

DIHYDROMORPHINE.

DIPHENOXYLATE except when included in Schedule 3 or 4.

DIPIPANONE.

# DRONABINOL (delta-9-tetrahydrocannabinol) when prepared and packed for therapeutic use.

DROTEBANOL.

ETHYLAMFETAMINE.

ETHYLMORPHINE except when included in Schedule 2 or 4.

FENTANYL.

# FLUNITRAZEPAM.

HYDROCODONE.

HYDROMORPHINOL.

HYDROMORPHONE.

KETAMINE.

LEVAMFETAMINE.

LEVOMETHAMFETAMINE.

LEVOMORAMIDE.

LEVORPHANOL (excluding its stereoisomers).

LISDEXAMFETAMINE.

METHADONE.

METAMFETAMINE.

METHYLDIHYDROMORPHINE.

METHYLPHENIDATE.

1-METHYL-4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID (Pethidine intermediate C).

MORPHINE.

MORPHINE METHOBROMIDE.

MORPHINE-N-OXIDE.

NABILONE.

# NABIXIMOLS (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinols, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acids, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinols and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use.

NORCODEINE.

NORMETHADONE.

OPIUM except the alkaloids noscapine in Schedule 2 and papaverine when included in Schedule 2 or 4.

OXYCODONE.

OXYMORPHONE.

PENTAZOCINE.

PENTOBARBITAL except when included in Schedule 4.

PETHIDINE.

PHENDIMETRAZINE.

PHENMETRAZINE.

PHENOPERIDINE.

4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID ETHYL ESTER (Pethidine intermediate B).

PHOLCODINE except when included in Schedule 2 or 4.

PIRITRAMIDE.

PROPIRAM.

RACEMORAMIDE.

REMIFENTANIL.

SECBUTOBARBITAL.

SECOBARBITAL.

# SODIUM OXYBATE for human therapeutic use.

SUFENTANIL.

TAPENTADOL.

# TETRAHYDROCANNABINOLS when extracted from cannabis for human therapeutic use, when:

a)      included in products manufactured in accordance with the Narcotic Drugs Act 1967; and/or

b)       imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or

c)      in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989,

except when:

i)        it is in a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or

ii)      in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with either of the following warning statements:

(A)            Not for internal use; or

(B)             Not to be taken; or

iii)    in products for purposes other than for internal human use containing 50 mg/kg or less of tetrahydrocannabinols; or

iv)    separately specified in the NABIXIMOLS entry in this Schedule.

THEBACON.

THEBAINE.

TILIDINE.


SCHEDULE 9

ACETORPHINE.

ACETYL-ALPHA-METHYLFENTANYL.

ALKOXYAMFETAMINES and substituted alkoxyamfetamines except when separately specified in these Schedules.

ALKOXYPHENYLETHYLAMINES and substituted alkoxyphenylethylamines except when separately specified in these Schedules.

ALKYLTHIOAMFETAMINES and substituted alkylthioamfetamines except when separately specified in these Schedules.

ALLYLPRODINE.

ALPHAMEPRODINE.

ALPHA-METHYLFENTANYL.

ALPHA-METHYLTHIOFENTANYL.

ALPHAMETHADOL.

2-AMINO-1-(2,5-DIMETHOXY-4-METHYL)PHENYLPROPANE *(STP or DOM).

5-(2-AMINOPROPYL)INDAN and substituted 5-(2-aminopropyl)indans except when separately specified in these Schedules.

BENZETHIDINE.

BENZOYLINDOLES except when separately specified in these Schedules.

BENZYLPIPERAZINE            *(BZP).

BETACETYLMETHADOL.

BETA-HYDROXYFENTANYL.

BETA-HYDROXY-3-METHYLFENTANYL.

BETAMEPRODINE.

BETAMETHADOL.

BETAPRODINE.

1-(8-BROMOBENZO[1,2-B;4,5-B]DIFURAN-4-YL)-2-AMINOPROPANE *(Bromo-Dragonfly).

4-BROMO-2,5-DIMETHOXYPHENETHYLAMINE *(BDMPEA).

BUFOTENINE.

CANNABIS (including seeds, extracts, resins, and the plant and any part of the plant when packed or prepared), except:

a)      when separately specified in these Schedules; or

b)      processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinols and hemp fibre products manufactured from such fibre; or

c)      in hemp seed oil for purposes other than internal human use containing 50 mg/kg or less of cannabinoids.

CATHINONE.

CLONAZOLAM.

CLONITAZENE.

COCA LEAF.

CODOXIME.

4-CYANO-2-DIMETHYLAMINO-4,4’-DIPHENYLBUTANE.

CYCLOHEXYLPHENOLS except

a)      when separately specified in these Schedules; or

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

DESCHLOROETIZOLAM.

DESOMORPHINE.

DIAMPROMIDE.

DIBENZOPYRANS except when separately specified in these Schedules.

DICLAZEPAM.

3,4-DICHLORO-N-{[1- (DIMETHYLAMINO)CYCLOHEXYL]METHYL}BENZAMIDE *(AH-7921).

DIETHYLTHIAMBUTENE.

N,N-DIETHYLTRYPTAMINE            *(DET).

DIMENOXADOL.

DIMEPHEPTANOL.

2,5-DIMETHOXYAMFETAMINE *(DMA).

2,5-DIMETHOXY-4-BROMOAMFETAMINE *(DOB).

2,5-DIMETHOXY-4-ETHYL-a-AMFETAMINE *(DOET).

2,5-DIMETHOXY-4-ETHYLTHIOPHENETHYLAMINE *(2C-T-2).

2,5-DIMETHOXY-4-IODOPHENETHYLAMINE *(2C-I).

2,5-DIMETHOXY-4-(N)-PROPYLTHIOPHENETHYLAMINE           *(2C-T-7).

3-(2-DIMETHYLAMINOETHYL)-4-HYDROXYINDOLE *(PSILOCINE or PSILOTSIN).

3-(1,2-DIMETHYLHEPTYL)-1-HYDROXY-7,8,9,10-TETRAHYDRO-6,6,9- TRIMETHYL-6H-DIBENZO (b,d) PYRAN *(DMHP).

N, α -DIMETHYL-3,4-(METHYLENEDIOXY)PHENYLETHYLAMINE *(MDMA).

N,N-DIMETHYLAMFETAMINE (Dimetamfetamine).

DIMETHYLTHIAMBUTENE.

N,N-DIMETHYLTRYPTAMINE *(DMT).

DIOXAPHETYL BUTYRATE.

ECGONINE.

N-ETHYL-α-METHYL-3,4-(METHYLENEDIOXY)PHENETHYLAMINE *(N-ETHYL MDA).

ETHYLMETHYLTHIAMBUTENE.

ETICYCLIDINE *(PCE).

ETONITAZENE.

ETORPHINE.

ETOXERIDINE.

FENETYLLINE.

4-FLUORO-N-METHYLAMFETAMINE.

FLUBROMAZEPAM.

FLUBROMAZOLAM.

1-(5-FLUOROPENTYL)-3-(2-IODOBENZOYL)INDOLE *(AM-694).

FURETHIDINE.

HARMALA ALKALOIDS except in herbs, or preparations, for therapeutic use:

a)      containing 0.1 per cent or less of harmala alkaloids; or

b)      in divided preparations containing 2 mg or less of harmala alkaloids per recommended daily dose.

HEROIN.

3-HEXYL-1-HYDROXY-7,8,9,10-TETRAHYDRO-6,6,9-TRIMETHYL-6H-DIBENZO (b,d) PYRAN *(PARAHEXYL).

4-HYDROXYBUTANOIC ACID and its salts except for sodium oxybate when in Schedule 8. *(GAMMA HYDROXYBUTYRATE (GHB)).

2-[(1R,3S)-3-HYDROXYCYCLOHEXYL]-5-(2-METHYLNONAN-2-YL)PHENOL  *(Cannabicyclohexanol or CP 47,497 C8 homologue).

2-[(1R,3S)-3-HYDROXYCYCLOHEXYL]-5-(2-METHYLOCTAN-2-YL)PHENOL *(CP 47,497).

HYDROXYPETHIDINE.

ISOMETHADONE.

KETOBEMIDONE.

LEVOMETHORPHAN (excluding its stereoisomers).

LEVOPHENACYLMORPHAN.

LYSERGIC ACID.

LYSERGIDE.

MECLONAZEPAM.

MECLOQUALONE.

METAZOCINE.

METHAQUALONE.

METHCATHINONE.

5-METHOXY- α –METHYLTRYPTAMINE *(5-MeO-AMT).

5-METHOXY-3,4-METHYLENEDIOXYAMFETAMINE *(MMDA).

4-METHOXY- α –METHYLPHENYLETHYLAMINE *(PMA).

2-(2-METHOXYPHENYL)-1-(1-PENTYLINDOL-3-YL)ETHANONE *(JWH-250).

METHYL (2S, 4aR, 6aR, 7R, 9S, 10aS, 10bR)-9-ACETOXY-6a,10b-DIMETHYL-4,10-DIOXO-DODECAHYDRO-2-(3-FURYL)-2H-NAPHTHO[2,1-c]PYRAN-7-CARBOXYLATE         *(SALVINORIN A).

4-METHYLAMINOREX.

METHYLDESORPHINE.

3,4-METHYLENEDIOXYAMFETAMINE *(MDA).

3,4-METHYLENEDIOXYPYROVALERONE *(MDPV).

3-METHYLFENTANYL.

4-METHYLMETHCATHINONE *(MEPHEDRONE).

N- α -[METHYL-3,4-(METHYLENEDIOXY)PHENETHYL]HYDROXYLAMINE *(N-HYDROXY MDA).

N-METHYL-1-(3,4-METHYLENEDIOXYPHENYL)-2-BUTANAMINE *(MBDB).

2-METHYL-3-MORPHOLINO-1, 1-DIPHENYLPROPANE CARBOXYLIC ACID (Moramide intermediate).

1-METHYL-4-PHENYL-4-PIPERIDINOL PROPIONATE *(MPPP).

4-METHYLTHIOAMFETAMINE.

3-METHYLTHIOFENTANYL.

METOPON.

MITRAGYNA SPECIOSA.

MITRAGYNINE.

MORPHERIDINE.

(1-(2-MORPHOLIN-4-YLETHYL)INDOL-3-YL)-NAPTHALEN-1-YLMETHANONE          *(JWH-200).

MUSCIMOL.

MYROPHINE.

NAPHTHOYLINDOLES except when separately specified in these Schedules.

NAPHTHYLMETHYLINDOLES except when separately specified in these Schedules.

NAPHTHOYLPYRROLES except when separately specified in these Schedules.

NAPHTHYLMETHYLINDENES except when separately specified in these Schedules.

NAPHTHALEN-1-YL-(1-BUTYLINDOL-3-YL)METHANONE *(JWH-073).

NICOCODINE.

NICODICODINE.

NICOMORPHINE.

NIFOXIPAM.

NORACYMETHADOL.

NORLEVORPHANOL.

NORMORPHINE.

NORPIPANONE.

PARA-FLUOROFENTANYL.

1-PENTYL-3-(4-METHYL-1-NAPTHOYL)INDOLE. *(JWH-122).

1-PENTYL-3-(1-NAPHTHOYL)INDOLE *(JWH-018).

PHENADOXONE.

PHENAMPROMIDE.

PHENAZOCINE.

PHENCYCLIDINE *(PCP).

N-PHENETHYL-4-PIPERIDONE.

PHENOMORPHAN.

PHENYLACETYLINDOLES except when separately specified in these Schedules.

1-PHENYLETHYL-4-PHENYL-4-PIPERIDINOL ACETATE *(PEPAP).

PIMINODINE.

PROHEPTAZINE.

PROPERIDINE.

PSILOCYBINE.

PYRAZOLAM.

RACEMETHORPHAN.

RACEMORPHAN.

ROLICYCLIDINE *(PHP or PCPY).

SALVIA DIVINORUM.

SYNTHETIC CANNABINOMIMETICS except when separately specified in these Schedules.

TENOCYCLIDINE *(TCP).

TETRAHYDROCANNABINOLS and their alkyl homologues, except:

a)      when included in Schedule 4 or Schedule 8; or

b)      processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinols, and hemp fibre products manufactured from such fibre; or

c)      in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with either of the following warning statements:

i)        Not for internal use; or

ii)      Not to be taken; or

d)      in products for purposes other than internal human use containing 50 mg/kg or less of tetrahydrocannabinols.

THIOFENTANYL.

1-(3-TRIFLUOROMETHYLPHENYL)PIPERAZINE *(TFMPP).

TRIMEPERIDINE.

3,4,5-TRIMETHOXY- α –METHYLPHENYLETHYLAMINE *(TMA).

3,4,5-TRIMETHOXYPHENETHYLAMINE (mescaline) and other substances structurally derived from methoxy-phenylethylamine except:

a)      methoxyphenamine; or

b)      when separately specified in this Schedule.

1-(3,4,5-TRIMETHOXYPHENYL)-2-AMINOBUTANE.


SCHEDULE 10

SUBSTANCES OF SUCH DANGER TO HEALTH AS TO WARRANT PROHIBITION OF SALE, SUPPLY AND USE

ABRUS PRECATORIUS (Jequirity) seed or root for therapeutic use.

ACORUS CALAMUS (calamus) for human therapeutic use.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for domestic use:

a)      in liquid or semi-solid food additive preparations, the pH of which is more than 11.5;

b)      in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or

c)      in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

ALLYLISOPROPYLACETYLUREA for therapeutic use.

AMINOPHENAZONE (amidopyrine) and its derivatives for human therapeutic use.

AMYGDALIN for therapeutic use.

ANCHUSA OFFICINALIS for therapeutic use.

ARISTOLOCHIA spp. for therapeutic use.

ARISTOLOCHIC ACID(S) for human therapeutic use.

ASARUM spp. containing aristolochic acid(s) for human therapeutic use.

AZADIRACHTA INDICA (neem) including its extracts and derivatives, in preparations for human internal use except ‘debitterised neem seed oil’

BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.

1,2-BENZENEDIAMINE in preparations for cosmetic use and skin colouration (including tattooing).

1,3-BENZENEDIAMINE in preparations for cosmetic use and skin colouration (including tattooing).

BITHIONOL for human therapeutic use.

BORAGO OFFICINALIS (Borage) for therapeutic use except the fixed oil derived from the seeds of Borago officinalis.

BRAGANTIA spp. containing aristolochic acid(s) for human therapeutic use.

BUCLOSAMIDE for therapeutic use.

BUNIODYL SODIUM for therapeutic use.

1,4-BUTANEDIOL (excluding its derivatives) in non-polymerised form in preparations for domestic use.

CACALIA spp. for therapeutic use.

CARBAMIDE PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 18 per cent of carbamide peroxide except in preparations manufactured for, and supplied solely by, registered dental practitioners as part of their dental practice.

CHRYSOIDINE BASE in preparations for use in hair dyes.

CINCHOPHEN and its derivatives for therapeutic use.

CLIOQUINOL and other halogenated derivatives of oxyquinoline for human internal use except or when being used solely for experimental purposes in humans and where such use:

a)      is in accordance with:

i)        an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and

ii)      any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and

iii)    any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or

b)      is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.

COAL TAR for cosmetic use other than in therapeutic goods.

CONIUM MACULATUM (coniine) for therapeutic use.

COTARNINE for therapeutic use.

CROTALARIA spp. for therapeutic use.

CROTON TIGLIUM for therapeutic use.

CYNOGLOSSUM spp. for therapeutic use.

DIBUTYLPHTHALATE for cosmetic use.

DICOPHANE (DDT) for therapeutic use.

DIETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of diethylene glycol.

DIETHYLENE GLYCOL MONOMETHYL ETHER for cosmetic use.

DIETHYLHEXYL PHTHALATE for cosmetic use.

DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.

5,6-DIHYDROXYINDOLINE for cosmetic use in preparations containing more than 2 per cent of 5,6-dihydroxyindoline.

DIIODOHYDROXYQUINOLINE (iodoquinol) for human internal use.

DIISOBUTYL PHTHALATE for cosmetic use.

1,3-DIMETHYLAMYLAMINE (DMAA).

1-(1,1-DIMETHYLETHYL)-2-METHOXY-4-METHYL-3,5-DINITROBENZENE (musk ambrette)

DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.

DI(METHYLOXYETHYL) PHTHALATE for cosmetic use.

2,4-DINITROPHENOL for human use.

DISPERSE YELLOW 3 for use in hair dyes.

DULCIN for therapeutic use.

ETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of ethylene glycol.

ETHYLHEXANEDIOL for human use.

EUPATORIUM CANNABINUM (Hemp Agrimony) for therapeutic use.

FARFUGIUM JAPONICUM for therapeutic use.

FORMALDEHYDE (excluding its derivatives):

a)      in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

b)      in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

c)      in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde; or

d)      in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde except in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:

CONTAINS FORMALDEHYDE.

GAMMA BUTYROLACTONE (excluding its derivatives) in non-polymerised form in preparations for domestic and cosmetic use.

HELIOTROPIUM spp. for therapeutic use.

HYDROGEN PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 6 per cent (20 volume) of hydrogen peroxide except in preparations manufactured for, and supplied solely by, registered dental practitioners as part of their dental practice.

JUNIPERUS SABINE [savin(e)] for therapeutic use.

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

LIGULARIA DENTATA for therapeutic use.

MELIA AZEDARACH including its extracts and derivatives.

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use..

METHYL METHACRYLATE for cosmetic use except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer .

METHYLROSANILINIUM CHLORIDE (formerly known as crystal violet CAS No. 548-62-9) and the following TRIARYLMETHANE DYES – for use in hair dyes:

- Acid Violet 49 (CAS No. 1694-09-3),

- Ethyl Violet (CAS No. 2390-59-2),

- Basic Blue 7 (CAS No. 2390-60-5),

- Basic Blue 26 (CI 44045) (CAS No. 2580-56-5).

OXYPHENISATIN for therapeutic use.

PARAFORMALDEHYDE (excluding its derivatives):

a)      in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

b)      in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

c)      in nail hardener cosmetic preparations containing 5 per cent or more of free formaldehyde;

d)      in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde except in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:

                        CONTAINS FORMALDEHYDE.

PETASITES spp. for therapeutic use.

PHENYLENEDIAMINES, including alkylated, arylated and nitro derivatives, in preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except when included in Schedule 6.

POTASSIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

PTERIDIUM spp. for therapeutic use.

PULMONARIA spp. for therapeutic use.

SAFROLE for internal therapeutic use except in preparations containing 0.1 per cent or less of safrole.

SENECIO spp. for therapeutic use.

SILICONES for injection or implantation except when included in Schedule 4.

SODIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

SYMPHYTUM spp. (Comfrey) in preparations for human or animal use except when in Schedule 5.

2,4-TOLUENEDIAMINE in preparations for skin colouration (including tattooing) and dyeing of hair, eyelashes or eyebrows.

TOLUENEDIAMINES in preparations for skin colouration (including tattooing) and dyeing of eyelashes or eyebrows except when included in Schedule 6.

1,1,1-TRICHLOROETHANE in pressurised spray packs for therapeutic use.

TRICHODESMA AFRICANA for therapeutic use.

TRIPARANOL for therapeutic use.

TUSSILAGO FARFARA for therapeutic use.


PART 5

THE APPENDICES

APPENDIX A – GENERAL EXEMPTIONS

This Standard does not apply to a poison in any of the following products:

ALGICIDES, BACTERIOCIDES OR SLIMICIDES for industrial use that do not fit the definition of an agvet chemical product.

BACTERIAL CULTURE MEDIA containing antibiotics.

CERAMICS.

CHEMISTRY SETS for toy and educational use, when complying with the requirements of Australian Standard AS 8124.4-2003 Safety of toys entitled Part 4: Experimental sets for chemistry and related activities.

COPPER COMPOUNDS in paints.

DEXTRANS, GELATIN - SUCCINYLATED & ETHERIFIED STARCHES used as plasma substitutes/blood volume expanders.

ELECTRICAL ACCUMULATORS, BATTERIES, COMPONENTS or LAMPS.

ELECTRONIC COMPONENTS.

ENHANCING AGENTS for use in ultrasonic and magnetic resonance imaging.

EXPLOSIVES.

FOOD except:

a)      food additives before incorporation into food; or

b)      when used as a means of administering a poison for therapeutic use.

FRITTED GLAZING OR ENAMELLING PREPARATIONS in which the poison is confined as a non-migratory component of glassy solid flakes or granules.

GLASS (including CRYSTAL WARE).

GLAZED POTTERY.

HUMAN BLOOD PRODUCTS including:

a)      whole blood;

b)      blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and

c)      the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives:

i)        albumin;

ii)      anticoagulation complex;

iii)    C1 esterase inhibitors;

iv)    clotting factors;

v)      fibrinogen;

vi)    protein C;

vii)  prothrombin complex concentrate (PCC) ; and

viii)     thrombin.

IN VITRO DIAGNOSTIC AND ANALYTICAL PREPARATIONS containing 0.001 per cent or less of a poison included in Schedules 1 to 8.

INTRAOCULAR VISCOELASTIC PRODUCTS.

LUBRICANTS except soluble oils and solvent-deposited lubricating agents.

MATCHES.

MEDICAL AND VETERINARY ADHESIVES, GLUES AND CEMENTS.

MEDICAL DEVICES classified as Class III by the classification rules set out in Schedule 2 to the Therapeutic Goods (Medical Devices) Regulation 2002, except:

a)      injectable tissue reconstructive, augmentation and restoration materials, including collagen;

b)      medical devices which include anticoagulants;

c)      artificial tears;

d)      urinary catheters; or

e)      intra-articular fluids.

MOTOR, HEATING or FURNACE FUELS except:

a)      when the contrary intention appears in any Schedule;

b)      when containing methanol;

c)      toy or hobby fuels; or

d)      petrol or kerosene when packed in containers having a capacity of 20 litres or less.

NUTRITION REPLACEMENT PREPARATIONS FOR PARENTERAL ADMINISTRATION.

PAPER except:

a)      when prepared for pesticidal use; or

b)      when containing a poison included in Schedule 8 or 9.

PHOTOGRAPHIC PAPER or FILM.

PIGMENTS when immobilised in a polymer.

PORCELAIN.

PRINTING INKS or INK ADDITIVES except:

a)      when containing a pesticide; or

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

RADIOGRAPHIC CONTRAST MEDIA (radiopaques) for therapeutic use.

RADIOISOTOPES for therapeutic use.

SEEDS treated with seed protectants.

SINGLE-USE TUBES for the estimation of alcohol content of breath.

TERMITE BARRIERS consisting of an active ingredient, other than arsenic, approved by the relevant registration authority, and laminated between impervious sheeting.

TIMBER or WALLBOARD.

VITREOUS ENAMELS.

WRITING CORRECTION PENS which do not allow ingestion of the contents and which contain no scheduled poison other than designated solvents included in Schedule 5.


APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING

(This Appendix should be read in conjunction with Appendix A.)

INTRODUCTION

Substances for which the available information suggests that inclusion in the Poisons Schedules is not necessary, or not the most appropriate means of controlling the risk to public health, have been considered at various times.

Listing in Appendix B indicates that a decision has been taken not to list substances anywhere in the Schedules, either for a specific purpose, or generally.  It is an inclusive, but not an exhaustive, list i.e. there may be substances not included in the Schedules, and not included in Appendix B, which may be hazardous or non-hazardous, but have not been considered in relation to the need for scheduling.

Substances may be included in Appendix B because they have intrinsically low toxicity, or where other factors suggest that the potential public health risk would be minimal.  Factors which are considered when determining an Appendix B entry include:

·      the toxicology profile was adequately characterised and not consistent with inclusion in any of the Schedules;

·      the use, purpose or product presentation minimised any hazard to the public such as to not require scheduling; or

·      the public access was limited such that scheduling was inappropriate or unnecessary.

The list was developed from scheduling files and historical records.  For transparency, where the reason for entry and/or purpose or use for the substance was apparent in the consideration, this has been included in the columns “Reason for Entry” and “Area of Use”.

Inclusion in Appendix B will not prevent reconsideration of