POISONS STANDARD 2014
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 8th of October 2014
1. Citation
This instrument is the Poisons Standard 2014.
2. The New Poisons Standard
The Poisons Standard 2014 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 5 (the SUSMP5) as set out in Schedule 1.
3. Commencement
The Poisons Standard 2014 commences on the day after registration.
Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
No. 5
October 2014
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in July 2014. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further inquiries should be directed to:
The Secretary
Chemicals Scheduling Secretariat (MDP88)
Office of Chemical Safety
Department of Health
GPO Box 9848
CANBERRA ACT 2601
or by email to Chemicals.Scheduling@health.gov.au
The Secretary
Medicines Scheduling Secretariat (MD122)
Communications and Secretariat
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
or by email to Medicines.Scheduling@tga.gov.au
Media Liaison Unit
Australian Government Department of Health
Contents
INTRODUCTION.. iii
CLASSIFICATION.. iv
PRINCIPLES OF SCHEDULING.. iv
READING THE SCHEDULES. v
Availability of poisons. vi
Preparations containing poisons listed in two or more Schedules. vi
PART 1 - INTERPRETATION.. 2
PART 2 - LABELS AND CONTAINERS. 11
LABELS. 11
General requirements. 11
Immediate wrapper 11
Primary packs and immediate containers. 11
Statements of quantity, proportion or strength. 17
Exemptions. 18
Selected containers and measure packs. 18
Ampoules, pre-filled syringes and injection vials. 18
Transport containers and wrappings. 19
Dispensary, industrial, laboratory and manufacturing poisons. 19
Exemptions from label requirements in certain circumstances. 19
Dispensed medicines. 20
Gas cylinders. 20
Paints. 20
Camphor and naphthalene. 21
Prohibitions. 21
CONTAINERS. 21
Containers for poisons other than Schedule 5 poisons. 21
Containers for Schedule 5 poisons. 22
Approved containers. 22
Child-resistant closures. 23
Schedule 8 poisons. 25
Exemptions. 25
Camphor and naphthalene. 25
Prohibitions. 26
PART 3 - MISCELLANEOUS REGULATIONS. 27
ADVERTISING.. 27
SALE OR SUPPLY.. 27
Schedule 2 poisons. 27
Schedule 3 poisons. 27
Schedule 4 poisons. 28
Schedule 7 poisons. 28
PROHIBITIONS ON SALE, PRESCRIBING AND POSSESSION.. 28
STORAGE.. 29
PART 4 - THE SCHEDULES. 31
SCHEDULE 1. 32
SCHEDULE 2. 33
SCHEDULE 3. 49
SCHEDULE 4. 55
SCHEDULE 5. 136
SCHEDULE 6. 165
SCHEDULE 7. 204
SCHEDULE 8. 215
SCHEDULE 9. 218
PART 5 - THE APPENDICES. 224
APPENDIX A - General exemptions. 225
APPENDIX B - Substances considered not to require control by scheduling 228
APPENDIX C - Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use. 237
APPENDIX D - Additional controls on possession or supply of poisons included in Schedule 4 or 8. 241
APPENDIX E - First aid instructions for poisons. 243
APPENDIX F - Warning statements and general safety directions for poisons. 259
APPENDIX G - Dilute preparations. 283
APPENDIX H - Schedule 3 poisons permitted to be advertised. 284
APPENDIX I - Uniform Paint Standard. 285
APPENDIX J - Conditions for availability and use of Schedule 7 poisons. 287
APPENDIX K - Drugs required to be labelled with a sedation warning. 290
APPENDIX L - Requirements for dispensing labels for human and veterinary medicines. 293
INTRODUCTION
The Poisons Standard 2014, 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 the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. 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 model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. 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 Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. 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
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.
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 nine 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.
Substances in products which have been considered for scheduling, but have been exempted from this Standard, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. It is recommended that the provisions of this Appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.
READING THE SCHEDULES
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are 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, 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 C and the Index. In this process, if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium
chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find
toxicological or pharmacological kerosene
activity
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, 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
Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use
List of poisons prohibited from sale, supply or use because of their known potential for harm to human and/or animal health.
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
Uniform Paint Standard
Requirements applying to poisons included in paints or tinters.
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.
This page is intentionally blank.
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 paragraphs 2 to 12 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 paragraphs 2 to 12 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 Schedule Paint” means a paint containing the specified proportion of any substance in the First Schedule to Appendix I of this Standard.
“Free formaldehyde” includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol.
“Graphic material” means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.
“Height” in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.
“Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
“Immediate container” includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.
“Immediate wrapper” means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.
“Internal use” means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect;
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
“Label” means:
(a) 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.
“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 Schedule Paint” means a paint containing the specified proportion of any substance in the Second Schedule to Appendix I of this Standard.
“Selected container” means:
(a) an injection vial having a nominal capacity of ten millilitres or less;
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.
“Solid” is considered to include “powder” for the purposes of scheduling.
“Therapeutic 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 persons or animals;
(e) testing for pregnancy in persons or animals; or
(f) the replacement or modification of parts of the anatomy in persons or animals.
“Third Schedule Paint” means a paint containing the specified proportion of any substance in the Third Schedule to Appendix I of this Standard.
“Tinter” means any pigment or admixture of pigment with other substances, in powder, semi-solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.
“Topical use” means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
“Toy” means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of fourteen years.
“Transdermal use” means application to the skin primarily for systemic effect.
“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
LABELS AND CONTAINERS
LABELS
2. A person must not sell or supply a poison unless it is labelled in accordance with paragraphs 3 to 19 of this Standard.
General requirements
3. Any word, expression or statement required by this Standard to be written on a label or container must be written:
(1) on the outside face of the label or container; and
(2) in the English language; and
(3) in durable characters; and
(4) in a colour or colours to provide a distinct contrast to the background colour; and
(5) in letters at least 1.5 millimetres in height.
4. Subparagraph 3(5) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:
(1) an appropriate authority approves the use of smaller letters; and
(2) the letters are at least 1 millimetre in height.
5. The label must be printed on, or securely attached to:
(1) the outside of the immediate container; and
(2) if the immediate container is enclosed in a primary pack, the outside of that primary pack.
Immediate wrapper
6. (1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with paragraph 7 of this Standard; and
(2) the immediate wrapper must be conspicuously labelled with:
(a) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and
(b) the approved name of the poison; and
(c) a statement of the quantity or strength of the poison in accordance with
paragraph 8 of this Standard.
Primary packs and immediate containers
7. (1) The primary pack and immediate container of a poison must be labelled as follows:
(a) with the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the following table:
Schedule Purpose Signal words required
2 for any purpose PHARMACY MEDICINE
3 for any purpose PHARMACIST ONLY MEDICINE
4 for human use PRESCRIPTION ONLY MEDICINE
4 for animal use PRESCRIPTION ANIMAL REMEDY
5 for any purpose CAUTION
6 for any purpose POISON
7 for any purpose DANGEROUS POISON
8 for any purpose CONTROLLED DRUG
written:
(i) on the first line or lines of the main label; and
(ii) in bold-face 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 subparagraph 7(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 subparagraph 7(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by subparagraph 7(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 subparagraph 7(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 subparagraph 7(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 subparagraph 7(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 subparagraph 7(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(ii) in bold-face 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 paragraph 8:
(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) a list of approved names is required; and
(B) it is impractical to include the list on the main label; and
(C) an appropriate authority has authorised its inclusion on another part of the label; or
(iii) if the poison is a Schedule 5 poison referred to in column 1 of the following table the appropriate name opposite thereto in column 2 may be used as the approved name:
TABLE
Column 1 Column 2
Alkaline salts Alkaline salts
Amines for use as curing Aliphatic amines or
agents for epoxy resins aromatic amines
(unless separately specified
in the Schedules)
Epoxy resins, liquid Liquid epoxy resins
Hydrocarbons, liquid Liquid hydrocarbons
Quaternary ammonium Quaternary ammonium
compounds compound(s)
(iv) if a poison contains a mixture of designated solvents in excess of 25 per cent of the total volume of the poison but the proportion of one or more individual designated solvents in the mixture is equal to or less than 25 per cent, the approved names of those solvents may be expressed as follows:
(A) where the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or
(B) where the designated solvent is a ketone as “ketones”; or
(C) in any other case as “solvents” or “other solvents”;
(l) if the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, with the following expression written immediately below the approved name or the list of declared contents –
AN ANTICHOLINESTERASE COMPOUND
(i) the requirements of subparagraph 7(1)(l) do not apply to:
(A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or
(C) an organophosphorus compound or carbamate contained in a
pressurised spray pack for household use;
(m) 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 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 subparagraph 7(1)(p)(i); and
(B) replaced on the primary pack with the statement –
FIRST AID: See inner packs;
(q) with the name and address of the manufacturer or distributor.
(2) For the purposes of subparagraph 7(1)(a)(iii) the term “largest letter or numeral” does not include:
(a) a single letter or numeral which is larger than other lettering on the label; or
(b) an affix forming part of the trade name; or
(c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.
Statements of quantity, proportion or strength
8. The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(1) if the poison is for human therapeutic use, in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989;
(2) if the poison is for a purpose or purposes other than human therapeutic use and:
(a) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(b) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(c) 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;
(d) 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;
(e) 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;
(f) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(g) 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;
(h) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;
(3) if the poison is a solution of a mineral acid, the proportion of the acid (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;
(4) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:
contains not more than 10 per cent 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);
(5) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;
(6) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;
(7) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.
(8) For the purposes of subparagraph 8(7) “derivative” includes alkaloid.
Exemptions
Selected containers and measure packs
9. The requirements of paragraph 7 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which paragraph 10 or 11 apply) when:
(1) 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
(2) the immediate container is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) labelled with:
(i) 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 subparagraph 7(1)(a); and
(ii) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(iii) 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
(iv) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
Ampoules, pre-filled syringes and injection vials
10. The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:
(1) 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
(2) the selected container or ampoule is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) labelled with:
(i) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(ii) 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
(iii) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
11. The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(1) 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
(2) 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:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) the strip is labelled in accordance with paragraph 10; and
(c) the ampoule is labelled with:
(i) the approved name of the poison or the trade name of the product; and
(ii) the quantity, proportion or strength of the poison in accordance with paragraph 8.
Transport containers and wrappings
12. The labelling requirements of this Standard do not apply to a transparent cover, or to any wrapper, hamper, packing case, crate or other cover used solely for the purposes of transport or delivery.
Dispensary, industrial, laboratory and manufacturing poisons
13. The labelling requirements of this Standard do not apply to a poison that:
(1) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and
(2) is labelled in accordance with Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)].
Exemptions from label requirements in certain circumstances
13A. (1) The labelling requirements of paragraphs 7 to 12 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 subparagraph (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 subparagraph 7(1)(m)(ii)(B) of this Standard.
Dispensed medicines
14. Unless otherwise specified by regulation:
(1) The labelling requirements of this Standard do not apply to a medicine that:
(a) 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
(b) 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
(c) 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.
(2) A person must not supply a dispensed medicine for human use containing:
(a) 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
(b) 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).
Gas cylinders
15. The requirements of subparagraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.
Paints
16. The requirements of paragraph 7 do not apply to:
(1) paint (other than a paint for therapeutic or cosmetic use) which:
(a) contains only Schedule 5 poisons; or
(b) is a First Schedule or Second Schedule paint that is labelled with:
(i) 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
(ii) 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
(iii) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(iv) the name and proportion of the First Schedule or Second Schedule poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint; or
(2) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Schedule or Second Schedule to Appendix I, 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”.
Camphor and naphthalene
17. The labelling requirements of subparagraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:
(1) complies with paragraph 28; and
(2) is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.
Prohibitions
18. A label used in connection with any poison must not include:
(1) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or
(2) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or
(3) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or
(4) any trade name or description that:
(a) represents any single constituent of a compound preparation; or
(b) misrepresents the composition or any property or quality of the poison; or
(c) gives any false or misleading indication of origin or place of manufacture of the poison.
19. A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure:
(1) any expression required by this Standard to be written or embossed on the container or pack; or
(2) any of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as appropriate.
CONTAINERS
20. A person must not sell or supply a poison unless the immediate container complies with the requirements of paragraphs 21 to 28 of this Standard.
Containers for poisons other than Schedule 5 poisons
21. If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of 2 litres or less, the container must comply with Australian Standard AS 2216-1997, entitled Packaging for poisonous substances.
21a. Notwithstanding subparagraph 21, a poison which is in Schedule 6 and is an essential oil may be packed in an amber glass container which does not comply with the tactile identification requirements of Australian Standard AS 2216-1997, entitled Packaging for poisonous substances, if:
(1) the other safety factors are not diminished; and
(2) the container has a restricted flow insert and a child-resistant closure.
22. If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of more than 2 litres, the container must:
(1) comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances; and
(2) have the word “POISON”:
(a) 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:
(i) embossed; or
(ii) indelibly written in a colour in distinct contrast to the background colour;
(b) on the side or shoulder of the container.
Containers for Schedule 5 poisons
23. (1) The container in which any Schedule 5 poison is sold or supplied must:
(a) comply with the container requirements of paragraph 21 or paragraph 22; or
(b) be readily distinguishable from a container in which food, wine or other beverage is sold; and
(i) comply with 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 subparagraph 23(1), the following Schedule 5 poisons namely:
(a) methylated spirit(s);
(b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in paragraph 21.
Approved containers
24. Notwithstanding subparagraphs 21, 22 and 23 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 subparagraphs 22(2) or 23(1)(iii) if:
(1) the other safety factors are not diminished;
(2) the container is for a specific purpose; and
(3) an appropriate authority has approved the use of the container for that purpose.
Child-resistant closures
25. (1) If a poison, 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.
TABLE
______________________________________________________________________
Column 1 Column 2
Name of the poison Nominal capacity
______________________________________________________________________
Alkaline salts included in Schedule 5, All sizes
when packed and labelled as dishwashing
machine tablets.
Alkaline salts included in Schedule 5, 5 litres /kilograms or less
when packed and labelled as dishwashing
machine liquids, solids or gels.
Alkaline salts included in Schedule 5, when 2.5 litres or less
packed and labelled as a food additive.
Anise oil when included in Schedule 5. 200 millilitres or less
Basil oil when included in Schedule 5. 200 millilitres or less
Bay oil when included in Schedule 6. 200 millilitres or less
Cajuput oil when included in Schedule 6. 200 millilitres or less
Cassia oil when included in Schedule 5. 200 millilitres or less
Cineole when included in Schedule 6. 2 litres or less
Cinnamon bark oil when included 200 millilitres or less
in Schedule 5.
Cinnamon leaf oil when included in Schedule 6. 200 millilitres or less
Clove oil when included in Schedule 6. 200 millilitres or less
Essential oils when included in Schedule 6 200 millilitres or less
because of their natural camphor component.
Ethylene glycol when included in Schedule 6. 5 litres or less
Ethylene glycol when included in 5 litres or less
Schedule 5 in preparations containing
more than 50 per cent of ethylene glycol.
Eucalyptus oil when included in Schedule 6. 2 litres or less
Eugenol when included in Schedule 6. 200 millilitres or less
Hydrocarbons, liquid, when packed 5 litres or less
as kerosene, lamp oil, mineral turpentine,
thinners, reducers, white petroleum spirit
or dry cleaning fluid.
Hydrochloric acid when included in Schedule 6. 5 litres or less
Leptospermum scoparium oil (manuka oil) 200 millilitres or less
when included in Schedule 6
Marjoram oil when included in Schedule 5. 200 millilitres or less
Melaleuca oil (tea-tree oil) when included 200 millilitres or less
in Schedule 6.
Methylated spirit excluding preparations or 5 litres or less
admixtures.
Methyl salicylate and preparations containing 200 millilitres or less
more than 50 per cent of methyl salicylate.
Nutmeg oil when included in Schedule 5. 200 millilitres or less
Oil of turpentine. 5 litres or less
Pennyroyal oil when included in Schedule 6. 200 millilitres or less
Potassium hydroxide as such. 2.5 litres or less
Potassium hydroxide in oven, hot plate or 5 litres or less
drain cleaners when included in Schedule 6
except when in pressurised spray packs.
d-Pulegone when included in Schedule 6. 200 millilitres or less
Sage oil (Dalmatian) when included 200 millilitres or less
in Schedule 6.
Sodium hydroxide as such. 2.5 litres or less
Sodium hydroxide in oven, hot plate or 5 litres or less
drain cleaners when included in Schedule 6
except when in pressurised spray packs.
Thujone when included in Schedule 6. 200 millilitres or less
Thyme oil when included in Schedule 5. 200 millilitres or less
(2) The manufacturer or packer of a poison must ensure that the child-resistant closure is appropriate for the container and the poison and that it retains its child-resistant properties for the expected life of the poison.
Schedule 8 poisons
25A. (1) A person who supplies any Schedule 8 poison must ensure that the Schedule 8 poison is packaged in such a way that its primary pack is so sealed that, when the seal is broken, it is readily distinguishable from other sealed primary packs.
(2) This paragraph does not apply to the supply of a Schedule 8 poison by 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.
Exemptions
26. (1) Paragraphs 21, 22 and 23 do not apply to the immediate container of a poison prepared, packed and sold:
(a) for human internal or animal internal use; or
(b) as a solid or semi-solid preparation for human external or animal external use; or
(c) as a paint, other than a paint for therapeutic or cosmetic use; or
(d) in containers having a nominal capacity of 15 millilitres or less; or
(e) for use in automatic photographic or photocopy processing machines if the container is specifically designed to fit into the machines; or
(f) solely for dispensary, industrial, laboratory or manufacturing purposes.
(2) Paragraph 25 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.
27. The tactile identification or embossing required by paragraphs 21, 22 or 23 of this Standard or Australian Standard AS 2216-1997 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.
Camphor and naphthalene
28. The container requirements of paragraph 21 do not apply to a device that contains only camphor or naphthalene in block, ball, disc, pellet or flake form for domestic use, if the device:
(1) in normal use, prevents removal or ingestion of its contents; and
(2) is incapable of reacting with the poison; and
(3) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and
(4) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.
Prohibitions
29. A person must not sell or supply camphor or naphthalene in ball, block, disc, 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.
30. A person must not sell or supply a poison in a container which has the name of another poison embossed or indelibly marked thereon.
31. A person must not sell any poison which is for internal use or any food, drink or condiment in a container prescribed by paragraph 21, 22 or 23 of this Standard.
31A. A person must not sell any poison in a container used expressly for any food, drink or condiment.
PART 3
MISCELLANEOUS REGULATIONS
(It is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)
ADVERTISING
32. A person must not include any reference to a poison included in:
(a) Schedule 3 unless included in Appendix H; or
(b) Schedule 4 or Schedule 8,
of this Standard in any advertisement except in genuine professional or trade journals or other publications intended for circulation only within the medical, nursing, veterinary, dental or pharmaceutical professions or the wholesale drug industry.
33. A person must not include any reference to a poison included in Schedule 9 or Appendix C of this Standard in any advertisement.
SALE OR SUPPLY
Schedule 2 poisons
34. A person, other than a pharmacist (or an assistant under the direction of a pharmacist) or a medical, dental or veterinary practitioner in the lawful practice of their professions, must not sell or supply a Schedule 2 poison unless licensed to do so.
35. A person is not eligible to be granted a licence to sell a Schedule 2 poison by way of retail sale unless:
(1) he or she is carrying on the business of selling goods by retail; and
(2) the premises from which the poison will be sold is more than 25 kilometres by the shortest practical route from the nearest pharmacy; and
(3) he or she produces such evidence, as may be required, that he or she is a fit and proper person to be so licensed.
Schedule 3 poisons
36. A person, other than a pharmacist, or a medical, dental or veterinary practitioner, in the lawful practice of his or her profession, must not sell or supply a Schedule 3 poison.
37. The person who sells or supplies a Schedule 3 poison must:
(1) provide adequate instructions for use, either written or verbal, at the time of supply or sale; and
(2) label the container with his or her name or the name of the pharmacy and the address from which it was sold or supplied; and
(3) if required by regulation, make a record of the transaction in a prescription book or other approved recording system.
Schedule 4 poisons
38. A person, other than a medical, dental or veterinary practitioner in the ordinary course of their professions or a pharmacist dispensing a legal prescription must not sell or supply a Schedule 4 poison.
39. Paragraph 38 does not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than a poison excepted by regulation from this provision, without a prescription if:
(1) the patient is under medical treatment with the poison and continuation of medication is essential; and
(2) the quantity sold or supplied does not exceed 3 days' medication; and
(3) the pharmacist is satisfied that an emergency exists.
40. Paragraphs 34, 36, 37 and 38 do not apply to sale by way of wholesale dealing to a pharmacist, medical practitioner, veterinary practitioner, dentist or a person licensed or otherwise authorised to possess, sell or supply such poisons.
Schedule 7 poisons
41. (1) A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.
(2) A person must not sell or supply:
(a) a Schedule 7 poison for domestic or domestic garden purposes; or
(b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or
(c) a Schedule 7 poison for which an authorisation to possess or use is required by subparagraph (3) unless the purchaser produces his or her authorisation.
(3) A person must not possess or use any of the following Schedule 7 poisons unless he or she is authorised to do so by the appropriate authority:
Arsenic
Cyanides
Fluoroacetic acid
Fluoroacetamide
Hydrocyanic acid
Strychnine
Thallium.
(4) The appropriate authority may exempt a person or a class of persons from the requirement to hold an authorisation under subparagraph (3) and may vary or revoke the exemption by notice in writing.
Prohibitions on sale, prescribing and possession
42. A person must not:
(1) knowingly have in his or her possession or sell, supply or use a poison listed in Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Appendix C; or
(2) sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions indicated for that poison in Appendix D; or
(3) knowingly have in his or her possession a poison listed in Appendix D paragraph 5 without authority.
STORAGE
43. A person who sells or supplies Schedule 2 poisons must keep those poisons in such a way that public access to advice from a pharmacist is available if required.
44. A person who sells or supplies Schedule 3, Schedule 4 or Schedule 7 poisons must keep those poisons in a part of the premises to which the public does not have access.
This page is intentionally blank.
PART 4
THE SCHEDULES
SCHEDULE 1
This Schedule is intentionally blank.
SCHEDULE 2
(Substances marked † are listed in Appendix C)
ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH3COOH) for therapeutic use.
ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.
ACONITUM spp. for therapeutic use in adults:
(a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or
(b) in preparations for dermal use containing 0.02 per cent or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.
ALOXIPRIN.
AMETHOCAINE in preparations for topical use other than eye drops, containing 10 per cent or less of total local anaesthetic substances except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.
AMOROLFINE 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.
BECLOMETHASONE in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
BENZOCAINE in preparations for topical use other than eye drops:
(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10 per cent or less of benzoyl peroxide except in preparations containing 5 per cent or less of benzoyl peroxide.
BENZYDAMINE in preparations for topical use, except in preparations for dermal use.
BEPHENIUM SALTS.
BIFONAZOLE in preparations for dermal use except:
(a) in preparations containing 1 per cent or less of bifonazole for the treatment of the scalp; or
(b) in preparations for the treatment of tinea pedis.
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 5 days’ supply; and
(b) labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
CHLOPHEDIANOL.
CHLORBUTOL for human use in topical preparations containing 5 per cent or less of chlorbutol except in preparations containing 0.5 per cent or less of chlorbutol.
CHLOROFORM in preparations for therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations containing 0.5 per cent or less of chloroform.
CHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing chlorpheniramine in the bed-time dose 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.
DEXCHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose 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.
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 10 dosage units or less and not more than 5 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/name of product] in children six years of age or less,
except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect:
(A) Do not swallow; and
(B) Do not use [this product/name of product] in children six years of age or less,
except in preparations containing 15 mg/kg or less of fluoride ion or preparations 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.
GUAIPHENESIN in a modified release dosage form of 1200 mg or less of guaiphenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.
GELSEMIUM SEMPERVIRENS.
GLUTARALDEHYDE for human therapeutic use.
HEXACHLOROPHANE in preparations for human use containing 3 per cent or less of hexachlorophane except:
(a) in preparations containing 0.75 per cent or less of hexachlorophane; or
(b) in preparations for use on infants, as specified in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5 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 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.
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.
8-HYDROXYQUINOLINE and its non-halogenated derivatives for human therapeutic use, except in preparations for external use containing 1 per cent or less of such substances.
HYOSCINE (excluding hyoscine butylbromide):
(a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
(b) for oral use:
(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.
HYOSCYAMINE:
(a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or
(b) for oral use:
(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less total solanaceous alkaloids.
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 grams or less of ibuprofen; or
(b) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
(i) as the only therapeutically active constituent (other than 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.
INDOMETHACIN in preparations for external use containing 1 per cent or less of indomethacin.
IODINE:
(a) in preparations for human internal therapeutic use containing 300 micrograms or more 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.
LEVOCABASTINE in topical eye or nasal preparations.
LIGNOCAINE in preparations for topical use other than eye drops:
(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
LINDANE in preparations for human external therapeutic use containing 2 per cent or less of lindane.
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 5 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.
OXETACAINE (oxethazaine) in preparations for internal use.
OXICONAZOLE for dermal use except in preparations for the treatment of tinea pedis.
OXYMETAZOLINE.
PAPAVERINE except when included in Schedule 4.
PARACETAMOL for therapeutic use except:
(a) when included in Schedule 4;
(b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesinor when combined with effervescent agents) when:
(i) enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iii) not labelled for the treatment of children 6 years of age or less; and
(iv) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
(c) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin or when combined with effervescent agents) when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack containing not more than 20 tablets or capsules;
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iv) not labelled for the treatment of children 6 years of age or less; and
(v) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.
† 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 3 per cent or less of such substances.
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.
RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days' supply except 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.
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.
TETRACHLOROETHYLENE for human therapeutic use.
TETRAHYDROZOLINE.
THIABENDAZOLE for human therapeutic use.
TIOCONAZOLE in preparations for dermal use except in preparations for the treatment of tinea pedis.
TRAMAZOLINE.
TRIAMCINOLONE in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
TRIMEPRAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing trimeprazine in the bed-time dose 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.
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.
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.
CHLORBUTOL in preparations for human use except:
(a) when included in Schedule 2; or
(b) in preparations containing 0.5 per cent or less of chlorbutol.
CHLORPHENIRAMINE 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 preparations for oral use.
CYPROHEPTADINE in oral preparations.
DEXCHLORPHENIRAMINE 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 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.
DI-IODOHYDROXYQUINOLINE (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.
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 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.
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.
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 gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
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.
PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less.
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.
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.
TRIMEPRAZINE:
(a) in solid oral preparations except when included in Schedule 2; or
(b) in liquid oral preparations containing 10 mg or less of trimeprazine per 5 mL,
except in preparations for the treatment of children under 2 years of age.
TRIPROLIDINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
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
(Substances marked † are listed in Appendix C)
(Substances marked # are listed in Appendix D)
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 MESYLATE.
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.
ALISKIREN.
ALLERGENS.
ALLOPURINOL.
ALLYLOESTRENOL.
ALOGLIPTIN.
ALOSETRON.
ALPHA1-PROTEINASE INHIBITOR (HUMAN).
ALPHADOLONE.
ALPHAXALONE.
ALPRENOLOL.
ALPROSTADIL.
ALSEROXYLON.
ALTEPLASE.
ALTRENOGEST.
ALTRETAMINE (hexamethylmelamine).
AMANTADINE.
AMBENONIUM CHLORIDE.
# AMBRISENTAN.
AMBUCETAMIDE.
AMBUTONIUM BROMIDE.
AMCINONIDE.
AMETHOCAINE except:
(a) when included in Schedule 2; or
(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances.
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.
AMODIAQUINE.
AMOROLFINE except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of tinea pedis.
AMOXAPINE.
AMOXYCILLIN.
AMPHOMYCIN.
AMPHOTERICIN.
AMPICILLIN.
AMPRENAVIR.
AMRINONE.
AMSACRINE.
AMYL NITRITE.
AMYLOBARBITONE when packed and labelled for injection.
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.
APIXABAN.
APOCYNUM spp.
APOMORPHINE.
APRACLONIDINE.
APRAMYCIN.
APREPITANT.
APRONAL.
APROTININ.
ARECOLINE.
ARIPIPRAZOLE.
ARSENIC for human therapeutic use except when separately specified in these Schedules.
ARTEMETHER.
ARTICAINE.
ASENAPINE.
ASPIRIN:
(a) when combined with caffeine, paracetamol or salicylamide or any derivative of these substances; or
(b) for injection.
ASTEMIZOLE.
# ATAMESTANE.
ATAZANAVIR.
ATENOLOL.
ATIPAMEZOLE.
ATOMOXETINE.
ATORVASTATIN.
ATOSIBAN.
ATOVAQUONE.
ATRACURIUM BESYLATE.
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.
BECLOMETHASONE except when included in Schedule 2.
BELATACEPT.
BELIMUMAB.
BEMEGRIDE.
BENACTYZINE.
BENAZEPRIL.
BENDROFLUAZIDE.
BENETHAMINE PENICILLIN.
BENORYLATE.
BENOXAPROFEN.
BENPERIDOL.
BENSERAZIDE.
BENZATHINE PENICILLIN.
BENZHEXOL.
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.
BENZTROPINE (benzatropine).
BENZYDAMINE except:
(a) when included in Schedule 2; or
(b) in preparations for dermal use.
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.
BOTULINUM TOXINS for human use except when separately specified in these Schedules.
BRETYLIUM TOSYLATE.
BRIMONIDINE.
BRINZOLAMIDE.
# 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.
BUTOCONAZOLE except when included in Schedule 3.
BUTRACONAZOLE.
BUTYL AMINOBENZOATE except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.
BUTYLCHLORAL HYDRATE.
BUTYL NITRITE.
CABAZITAXEL.
CABERGOLINE.
CADMIUM COMPOUNDS for human therapeutic use.
CALCIPOTRIOL.
CALCITONIN.
CALCITRIOL.
CALCIUM CARBIMIDE for therapeutic use.
CALCIUM POLYSTYRENE SULPHONATE.
CALOTROPIS GIGANTEA.
CALOTROPIS PROCERA.
# CALUSTERONE.
CAMPHORATED OIL for therapeutic use.
CAMPHOTAMIDE.
CANAGLIFLOZIN.
CANAKINUMAB.
CANDESARTAN CILEXETIL.
CANDICIDIN.
CANINE TICK ANTI-SERUM.
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.
CARINDACILLIN.
CARISOPRODOL.
CARMUSTINE.
CARNIDAZOLE.
CARPROFEN.
CARVEDILOL.
CASPOFUNGIN.
CATHINE.
CATUMAXOMAB.
CEFACETRILE.
CEFACLOR.
CEFADROXIL.
CEFALORIDINE.
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.
CEPHALEXIN.
CEPHALONIUM.
CEPHALOTHIN.
CEPHRADINE.
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 5 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.
CHLORPHENIRAMINE except when included in Schedule 2 or 3.
CHLORPHENTERMINE.
CHLORPROMAZINE.
CHLORPROPAMIDE.
CHLORPROTHIXENE.
CHLORQUINALDOL for human topical use.
CHLORTETRACYCLINE except when included in Schedule 5.
CHLORTHALIDONE.
CHLORZOXAZONE.
CHOLERA VACCINE.
CHOLESTYRAMINE (colestyramine) for human therapeutic use.
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.
CIDOFOVIR.
CILASTATIN.
CILAZAPRIL.
CILOSTAZOL.
CIMETIDINE except when included in Schedule 3.
CINACALCET.
CINCHOCAINE except when included in Schedule 2.
CINOXACIN.
CIPROFLOXACIN.
CISAPRIDE.
CISATRACURIUM BESYLATE.
CISPLATIN.
CITALOPRAM.
CLADRIBINE.
CLANOBUTIN.
CLARITHROMYCIN.
CLAVULANIC ACID.
CLEMASTINE except when included in Schedule 3.
CLEMIZOLE.
CLENBUTEROL.
CLEVIDIPINE.
CLIDINIUM BROMIDE.
CLINDAMYCIN.
† CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline 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.
# CLOMIPHENE.
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.
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.
COLASPASE.
COLCHICINE.
COLCHICUM AUTUMNALE.
COLESTIPOL.
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.
CRYSTAL VIOLET for human use except when used as a dermal marker.
CUPRIMYXIN.
CURARE.
CYCLANDELATE.
CYCLIZINE except when included in Schedule 3.
CYCLOBENZAPRINE.
# CYCLOFENIL.
CYCLOHEXIMIDE.
CYCLOPENTHIAZIDE.
CYCLOPENTOLATE.
CYCLOPHOSPHAMIDE.
CYCLOPROPANE for therapeutic use.
CYCLOSERINE.
CYCLOSPORIN.
CYCLOTHIAZIDE.
CYCRIMINE.
CYMARIN.
CYPROHEPTADINE except when included in Schedule 3.
CYPROTERONE.
CYSTEAMINE for human therapeutic use.
CYTARABINE.
DABRAFENIB MESILATE.
DABIGATRAN.
DACARBAZINE.
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.
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 (includes delavirdine mesylate).
DEMBREXINE except when included in Schedule 5.
DEMECARIUM.
DEMECLOCYCLINE.
DENOSUMAB.
DEOXYCORTONE.
DEOXYRIBONUCLEASE except:
(a) when separately specified in this Schedule; or
(b) for external use.
DERACOXIB.
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.
DEXCHLORPHENIRAMINE 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.
† DI-IODOHYDROXYQUINOLINE (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.
DOTHIEPIN.
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.
EFORMOTEROL.
ELETRIPTAN.
ELTENAC.
ELTROMBOPAG.
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.
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 MESYLATE.
ERLOTINIB.
ERTAPENEM.
ERYSIMUM spp.
ERYTHROMYCIN.
# ERYTHROPOIETIN.
# ERYTHROPOIETINS except when separately specified in these Schedules.
ESCITALOPRAM.
ESMOLOL.
ESOMEPRAZOLE except when included in Schedule 3.
ESTRAMUSTINE.
ESTROPIPATE (piperazine oestrone sulfate).
ETANERCEPT.
ETHACRYNIC ACID.
ETHAMBUTOL.
ETHAMIVAN.
ETHANOLAMINE in preparations for injection.
ETHCHLORVYNOL.
ETHER for use in anaesthesia.
ETHINAMATE.
ETHINYLOESTRADIOL.
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.
# ETHYLOESTRENOL.
ETHYNODIOL.
ETIDOCAINE.
ETIDRONIC ACID (includes disodium etidronate):
(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.
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 10 dosage units or less and not more than 5 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.
FIBRINOLYSIN except for external use.
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.
FLUMETHASONE.
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.
FLUPENTHIXOL.
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 ALPHA.
# FOLLITROPIN BETA.
FOMIVIRSEN.
FONDAPARINUX.
# FORMEBOLONE.
FORMESTANE.
FOSAMPRENAVIR.
FOSAPREPITANT.
FOSCARNET.
FOSFESTROL (diethylstilboestrol diphosphate).
FOSINOPRIL.
FOSPHENYTOIN.
FOTEMUSTINE.
FRAMYCETIN.
FULVESTRANT.
FURALTADONE.
# FURAZABOL.
FURAZOLIDONE.
FUROSEMIDE (frusemide).
FUSIDIC ACID.
GABAPENTIN.
GALANTAMINE.
GALANTHUS spp.
GALLAMINE.
GALSULFASE.
GANCICLOVIR.
GANIRELIX.
GATIFLOXACIN.
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.
GUAIPHENESIN for human therapeutic use except:
(a) when included in Schedule 2;
(b) in oral liquid preparations containing 2 per cent or less of guaiphenesin; or
(c) in divided preparations containing 200 mg or less of guaiphenesin per dosage unit.
GUANABENZ.
GUANACLINE.
GUANETHIDINE.
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.
HEXACHLOROPHANE:
(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 hexachlorophane.
HEXAMETHONIUM.
HEXETIDINE for human internal use.
HEXOBENDINE.
HEXOCYCLIUM.
HEXOPRENALINE.
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.
HYDROXYCHLOROQUINE.
HYDROXYEPHEDRINE.
HYDROXYPHENAMATE.
HYDROXYPROGESTERONE.
# HYDROXYSTENOZOL.
HYDROXYUREA.
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.
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.
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.
INDOMETHACIN 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.
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.
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 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.
LEFETAMINE.
LEFLUNOMIDE.
# LENALIDOMIDE.
LENOGRASTIM.
LEPIRUDIN.
LEPTAZOL.
LERCANIDIPINE.
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.
LEVODOPA.
LEVOMEPROMAZINE.
LEVONORGESTREL except when included in Schedule 3.
LEVOSIMENDAN.
LIDOFLAZINE.
LIGNOCAINE 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.
LINAGLIPTIN.
LINCOMYCIN.
LINDANE for human therapeutic use except when included in Schedule 2.
LINEZOLID.
LIOTHYRONINE.
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 5 dosage units or less; and
(ii) labelled with a recommended daily dose not exceeding 10 mg of loratadine.
# LORAZEPAM.
# LORMETAZEPAM.
LOSARTAN.
LOTEPREDNOL.
LOXAPINE.
LUMEFANTRINE.
LUMIRACOXIB.
LURASIDONE.
# LUTEINISING HORMONE except in ovulation test kits.
LYMECYCLINE.
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.
MENOTROPHIN.
MEPACRINE.
MEPENZOLATE.
MEPHENESIN.
MEPHENTERMINE.
MEPINDOLOL.
# MEPITIOSTANE.
MEPIVACAINE.
MEPROBAMATE.
MEPTAZINOL.
MEPYRAMINE except when included in Schedule 2 or 3.
MEQUITAZINE.
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.
METHALLENOESTRIL.
# 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.
METHYL MERCURY for therapeutic use.
METHYLNALTREXONE.
METHYLPENTYNOL.
METHYLPHENOBARBITONE.
METHYLPREDNISOLONE.
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.
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.
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.
NALOXONE.
NALTREXONE.
# NANDROLONE.
NAPROXEN except when included in Schedule 3 or in Schedule 2.
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 mesylate).
NEOMYCIN.
NEOSTIGMINE.
NEPAFENAC.
NERIUM OLEANDER.
NESIRITIDE.
NETILMICIN.
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.
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.
OCRIPLASMIN.
OCTAMYLAMINE.
OCTATROPINE.
OCTREOTIDE.
OCTYL NITRITE.
OESTRADIOL except when included in Schedule 5.
OESTRIOL.
OESTROGENS except when separately specified in these Schedules.
OESTRONE.
OFATUMUMAB.
OFLOXACIN.
OLANZAPINE.
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.
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 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.
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.
OXPENTIFYLLINE (pentoxifylline).
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 disodium pamidronate).
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.
PANTOPRAZOLE except when included in Schedule 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 of paracetamol;
(d) in non-slow release tablets or capsules containing more than 500 mg of paracetamol;
(e) in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol; or
(f) for injection.
PARALDEHYDE.
PARAMETHADIONE.
PARAMETHASONE.
PARECOXIB.
PARICALCITOL.
PAROMOMYCIN.
PAROXETINE.
PASIREOTIDE.
PAZOPANIB.
PECAZINE.
PEFLOXACIN.
PEGAPTANIB.
PEGFILGRASTIM.
PEGINTERFERON.
PEGVISOMANT.
PEMETREXED.
PEMOLINE.
PEMPIDINE.
PENBUTOLOL.
PENCICLOVIR except when included in Schedule 2.
PENETHAMATE.
PENICILLAMINE.
PENTAERYTHRITYL TETRANITRATE.
PENTAGASTRIN.
PENTAMETHONIUM.
PENTAMIDINE (includes pentamidine isethionate).
PENTHIENATE.
PENTOBARBITONE when packed and labelled for injection.
PENTOLINIUM.
PENTOSAN POLYSULFATE SODIUM.
# PERAMPANEL.
PERGOLIDE.
PERHEXILINE.
PERICYAZINE.
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.
PHENOBARBITONE.
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.
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 in the teabag does not exceed 3 g;
and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(b) in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or
(c) in dermal preparations.
PIPERACILLIN.
PIPERIDINE.
PIPERIDOLATE.
PIPOBROMAN.
PIPOTHIAZINE.
PIPRADROL.
PIRACETAM.
PIRBUTEROL.
PIRENOXINE (catalin).
PIRENZEPINE.
PIRETANIDE.
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.
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.
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.
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 PENICILLIN.
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 3.
RABIES VACCINE.
RACTOPAMINE except when included in Schedule 5.
RALOXIFENE.
RALTEGRAVIR.
RALTITREXED.
RAMIPRIL.
RANIBIZUMAB.
RANITIDINE except:
(a) when included in Schedule 2; or
(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.
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.
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.
SALBUTAMOL except when included in Schedule 3.
SALCATONIN.
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.
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.
# 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.
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.
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 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.
SOFOSBUVIR.
SOLASODINE.
SOLIFENACIN.
SOMATOSTATIN.
SOMATOTROPIN EQUINE.
# SOMATROPIN (human growth hormone).
SONTOQUINE.
SORAFENIB.
SOTALOL.
SPARFLOXACIN.
SPARTEINE.
SPECTINOMYCIN.
SPIRAMYCIN.
SPIRAPRIL.
SPIRONOLACTONE.
# STANOLONE.
# STANOZOLOL.
STAVUDINE.
# STENBOLONE.
STEROID HORMONES except when separately specified in these Schedules.
STILBOESTROL (diethylstilboestrol).
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.
TACRINE.
TACROLIMUS.
TADALAFIL.
TAFLUPROST.
TALIGLUCERASE ALFA.
TAMOXIFEN.
TAMSULOSIN.
TANACETUM VULGARE except in preparations containing 0.8 per cent or less of oil of tansy.
TASONERMIN.
TAZAROTENE.
TAZOBACTAM.
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.
TETRACOSACTRIN.
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.
THIOGUANINE.
# THIOMESTERONE (tiomesterone).
THIOPENTONE.
THIOPROPAZATE.
THIOPROPERAZINE.
THIORIDAZINE.
THIOSTREPTON.
THIOTEPA.
THIOTHIXENE.
THIOURACIL.
THIOUREA for therapeutic use except in preparations containing 0.1 per cent or less of thiourea.
THYMOXAMINE (includes thymoxamine hydrochloride).
THYROID except when separately specified in this Schedule.
THYROTROPHIN.
THYROXINE (includes thyroxine sodium).
TIAGABINE.
TIAMULIN.
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.
TIOTROPIUM.
TIPEPIDINE.
TIPRANAVIR.
TIRILAZAD.
TIROFIBAN.
TOBRAMYCIN.
TOCAINIDE.
TOCERANIB.
TOCILIZUMAB.
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.
TRILOSTANE.
TRIMEPRAZINE except when included in Schedule 2 or 3.
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.
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.
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.
VEMURAFENIB.
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.
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
(Substances marked † are listed in Appendix C)
ABAMECTIN in preparations, for internal use for the treatment of animals, containing 1 per cent 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.
ACRIFLAVINE in preparations for veterinary use containing 2.5 per cent or less of acriflavine.
AFOXOLANER for the treatment and prevention of flea infestations and control of ticks in dogs in oral divided preparations each containing 140 mg or less of afoxolaner per dosage unit.
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.
AMINACRINE in preparations for veterinary use containing 2.5 per cent or less of aminacrine.
AMINES for use as curing agents for epoxy resins except when separately specified in these Schedules.
AMINOPYRALID in water soluble gel formulations containing 0.5 per cent or less of aminopyralid.
AMITROLE.
AMINOCYCLOPYRACHLOR.
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.
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.
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.
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-MEXYL.
CLORSULON.
CLOTHIANIDIN in preparations containing 20 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.
CYANURIC ACID (excluding its salts and derivatives).
CYANTRANILIPROLE.
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.
CYSTEAMINE in cosmetic preparations containing 6 per cent or less of cysteamine except in preparations containing 1 per cent or less of cysteamine.
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 grams 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.
para-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.
DINICONAZOLE.
DI-N-PROPYL ISOCINCHOMERONATE except in preparations containing 25 per cent or less of di-N-propyl isocinchomeronate.
DIPHENAMID.
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.
1,2-ETHANEDIAMINE POLYMERWITH (CHLOROMETHYL)OXIRANE AND N-METHYLMETHANAMINE.
ETHANOLAMINE (excluding its salts and derivatives) in preparations containing 20 per cent or less of ethanolamine except:
(a) when included in Schedule 4; or
(b) in preparations containing 5 per cent or less of ethanolamine.
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.
FENOPROP.
FENOXAPROP-ETHYL.
FENOXAPROP-P-ETHYL.
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.
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.
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.
GLUTARALDEHYDE in preparations containing 5 per cent or less of glutaraldehyde except:
(a) when included in Schedule 2; or
(b) in preparations containing 0.5 per cent or less of glutaraldehyde 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).
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.
† 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.
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.
LIGNOCAINE in aqueous gel preparations containing 4.5 per cent or less of lignocaine, 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.
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.
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.
MESOTRIONE.
METAFLUMIZONE.
METALAXYL in preparations containing 35 per cent or less of metalaxyl.
METALDEHYDE in preparations containing 2 per cent or less of metaldehyde.
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.
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.
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.
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 for the prophylaxis of heartworm in dogs and cats.
MONENSIN in intraruminal implants for cattle, each containing 35 g or less of monensin.
MONEPANTEL.
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.
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.
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.
OESTRADIOL in implant preparations for growth promotion in animals.
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 3 per cent or less of such substances.
PHENYL METHYL KETONE except in preparations containing 25 per cent or less of designated solvents.
ortho-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.
ortho-PHTHALALDEHYDE in preparations containing 1 per cent or less of ortho-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.
POLIHEXANIDE except in preparations containing 5 percent or less of polihexanide.
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.
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.
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.
SAFLUFENACIL in water dispersible granule preparations.
SALICYLANILIDE.
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 treatment of ornamental caged birds or ornamental fish only.
SULFADIMIDINE when packed and labelled for treatment of ornamental caged birds or ornamental fish only.
SULFAMERAZINE when packed and labelled for 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 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 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.
1,3,5,7-TETRAAZATRICYLO[3.3.1.13,7] DECANE in cosmetic preparations, except in preparations containing 0.15 per cent or less of 1, 3, 5, 7-tetraazatricyclo [3.3.1.13,7] decane.
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.
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.
TRIETHANOLAMINE (excluding its salts and derivatives) except in preparations containing 5 per cent or less of triethanolamine.
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.
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
(Substances marked † are listed in Appendix C)
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.
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.
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 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 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).
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.
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 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.
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).
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 when included in Schedule 5.
CLOTRIMAZOLE for 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.
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.
CYSTEAMINE for cosmetic use except:
(a) when included in Schedule 5; or
(b) in preparations containing 1 per cent or less of cysteamine.
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.
DIAZINON except when included in Schedule 5.
DICAMBA (including its salts and derivatives) except when included in Schedule 5.
DICHLOBENIL.
DICHLOFENTHION.
DICHLOFLUANID.
ortho-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 Schedules 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.
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.
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.
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.
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 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.
ETHANOLAMINE (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 ethanolamine.
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.
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.
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.
GLUTARALDEHYDE except:
(a) when included in Schedule 2 or 5; or
(b) in preparations containing 0.5 per cent or less of glutaraldehyde 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 Safe Work Australia’s National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)];
(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.
HEXACHLOROPHANE in preparations for the treatment of animals.
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 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.
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 its 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.
† 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.
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.
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 in preparations intended to be in contact with the skin, including cosmetic use.
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 in preparations containing 1 per cent or less of methyl ethyl ketone oxime.
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.
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.
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.
METOSULAM.
METRAFENONE except when included in Schedule 5.
METRIBUZIN.
MICONAZOLE for the external treatment of animals.
MILBEMECTIN except when included in Schedule 5.
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.
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.
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 its derivatives and 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;
(b) when included in Schedule 5; or
(c) in preparations containing 3 per cent or less of such substances.
PHENOTHIAZINE (excluding its derivatives) except in preparations containing 10 per cent or less of phenothiazine.
† PHENYLENEDIAMINES and alkylated phenylenediamines 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.
ortho-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.
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;
(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; or
(c) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5, for domestic use.
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.
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.
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.
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.
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;
(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; or
(c) liquid or semi-solid food additive preparations, the pH of which is more than 11.5, for domestic use.
SODIUM LAURYL SULFATE (excluding its salts and derivatives) except:
(a) in wash-off preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent of sodium lauryl sulfate, 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 sodium lauryl sulfate;
(c) in toothpaste and oral hygiene preparations containing 5 per cent or less of sodium lauryl sulfate;
(d) in other preparations for animal use containing 2 per cent or less of sodium lauryl sulfate; or
(e) in other preparations containing 30 per cent or less of sodium lauryl sulfate and, if containing more than 5 per cent of sodium lauryl sulfate, 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.
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.
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 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.
ACRIFLAVINE 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.
AMINACRINE for veterinary use except when included in Schedule 5.
AMINOCARB except when included in Schedule 6.
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.
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
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
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 Schedules 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.
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 or 6.
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.
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.
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.
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 di-alkyl, tri-alkyl and tri-phenyl 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.
ortho-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
(Substances marked # are listed in Appendix D.)
ACETYLDIHYDROCODEINE.
ACETYLMETHADOL.
ACETYLMORPHINES.
ALFENTANIL.
ALPHACETYLMETHADOL.
ALPHAPRODINE.
# ALPRAZOLAM.
AMPHETAMINE.
AMYLOBARBITONE except when included in Schedule 4.
ANILERIDINE.
BENZYLMORPHINE.
BEZITRAMIDE.
BUPRENORPHINE.
BUTOBARBITONE.
BUTORPHANOL.
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).
CYCLOBARBITONE.
DEXAMPHETAMINE.
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.
ETHYLAMPHETAMINE.
ETHYLMORPHINE except when included in Schedule 2 or 4.
FENTANYL.
# FLUNITRAZEPAM.
HYDROCODONE.
HYDROMORPHINOL.
HYDROMORPHONE.
KETAMINE.
LEVAMPHETAMINE.
LEVOMETHAMPHETAMINE.
LEVOMORAMIDE.
LEVORPHANOL (excluding its stereoisomers).
LISDEXAMFETAMINE.
METHADONE.
METHYLAMPHETAMINE.
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: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol 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.
PENTOBARBITONE 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.
QUINALBARBITONE.
RACEMORAMIDE.
REMIFENTANIL.
SECBUTOBARBITONE.
# SODIUM OXYBATE for human therapeutic use.
SUFENTANIL.
TAPENTADOL.
THEBACON.
THEBAINE.
TILIDINE.
SCHEDULE 9
(Trivial or unofficial names are marked *)
ACETORPHINE.
ACETYL-ALPHA-METHYLFENTANYL.
ALKOXYAMPHETAMINES and substituted alkoxyamphetamines except when separately specified in these schedules.
ALKOXYPHENYLETHYLAMINES and substituted alkoxyphenylethylamines except when separately specified in these Schedules.
ALKYLTHIOAMPHETAMINES and substituted alkylthioamphetamines 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 except:
(a) when separately specified in these Schedules; or
(b) processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinol and products manufactured from such fibre.
CATHINONE.
CLONITAZENE.
COCA LEAF.
CODOXIME.
4-CYANO-2-DIMETHYLAMINO-4,4’-DIPHENYLBUTANE.
CYCLOHEXYLPHENOLS except when separately specified in these Schedules.
DESOMORPHINE.
DIAMPROMIDE.
DIBENZOPYRANS except when separately specified in these Schedules.
3,4-DICHLORO-N-{[1- (DIMETHYLAMINO)CYCLOHEXYL]METHYL}BENZAMIDE *(AH-7921).
DIETHYLTHIAMBUTENE.
N,N-DIETHYLTRYPTAMINE *(DET).
DIMENOXADOL.
DIMEPHEPTANOL.
2,5-DIMETHOXYAMPHETAMINE *(DMA).
2,5-DIMETHOXY-4-BROMOAMPHETAMINE *(DOB).
2,5-DIMETHOXY-4-ETHYL-a-AMPHETAMINE *(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-DIMETHYLAMPHETAMINE (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-METHYLAMPHETAMINE.
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-HYDROYXBUTANOIC 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.
MECLOQUALONE.
METAZOCINE.
METHAQUALONE.
METHCATHINONE.
5-METHOXY- α -METHYLTRYPTAMINE *(5-MeO-AMT).
5-METHOXY-3,4-METHYLENEDIOXYAMPHETAMINE *(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-METHYLENEDIOXYAMPHETAMINE *(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-METHYLTHIOAMPHETAMINE.
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.
NAPTHALEN-1-YL-(1-BUTYLINDOL-3-YL)METHANONE *(JWH-073).
NICOCODINE.
NICODICODINE.
NICOMORPHINE.
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.
RACEMETHORPHAN.
RACEMORPHAN.
ROLICYCLIDINE *(PHP or PCPY).
SALVIA DIVINORUM.
TENOCYCLIDINE *(TCP).
SYNTHETIC CANNABINOMIMETICS except when separately specified in these Schedules.
TETRAHYDROCANNABINOLS and their alkyl homologues except:
(a) when separately specified in this Schedule;
(b) when included in Schedule 8;
(c) in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with a warning statement:
Not for internal use; or
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.
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 the scheduling of a substance where adverse information becomes available about the Appendix B entry for that substance.
Applications are considered for scheduling. Applications for inclusion in Appendix B will not be accepted.
APPENDIX B
PART 1
REASONS FOR ENTRY
a Low Toxicity.
b Use pattern restricts hazard.
c Presentation/packaging restricts hazard.
d Industrial use only.
PART 2
AREAS OF USE
1. Agricultural
1.1 Herbicide
1.2 Insecticide
1.2.1 Insecticide for codling moth
1.2.2 Termiticide
1.3 Fungicide
1.3.1 On seed fungicide
1.4 Bird Repellent
1.5 Fertiliser
1.6 Plant Growth Regulator
1.7 Insect Pheromone
1.8 Mushroom Bactericide
1.9 Acaricide
1.10 Biological control agent
2. Veterinary
2.1 For animal use
2.2 Treatment of mastitis in cows
2.3 Coccidiostat
2.4 Feed additive
2.5 Antiseptic
2.6 Scabicide
2.7 Anthelmintic
2.8 Vitamin/Mineral
2.9 Growth Promotant
2.10 Ectoparasiticide
3. Domestic
3.1 Aromatherapy
3.2 Food additive
3.3 Cosmetic
3.4 Human use
3.5 Miticide
4. Industrial
4.1 Water treatment
4.2 Biological control agent
5. Environmental
5.1 Mosquito control
6. Human therapeutic use
6.1 Diagnostic agent
6.2 Medical device
6.3 Antiseptic
6.4 Sunscreen
6.5 External use
6.6 Laxative
6.7 Antiseborrheic
6.8 Cytoprotective
6.9 Vitamin/Mineral
6.10 Eye Drops
7. General
7.1 Any use
7.2 Excipient
7.3 Synergist
7.4 Flux
7.5 Pesticide
7.6 Insect repellent
7.7 Solvent
7.8 Disinfectant
7.9 Preservative
7.10 Antioxidant
7.11 Resin activator/accelerant
7.12 Sweetener artificial
7.13 Food additive
APPENDIX B
PART 3
SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL
BY SCHEDULING
_________________________________________________________________________________
REASON AREA
DATE OF FOR OF
SUBSTANCE ENTRY LISTING USE
_________________________________________________________________________________
4-[4-(ACETYLOXY)PHENYL]-2-
BUTANONE Feb 2005 b 1.7
AGROBACTERIUM RADIOBACTER Nov 1989 a 1
ALCOHOL, DEHYDRATED Aug 2000 b 6
ALUM May 1997 a 7.1
ALUMINIUM AMMONIUM SULFATE May 1997 a 7.1
ALUMINIUM POTASSIUM SULFATE May 1997 a 7.1
ALUMINIUM SILICATE Nov 1974 a 7.1
ALUMINIUM tris (ETHYLPHOSPHONATE) Aug 1986 a 1
AMETOCTRADIN May 2012 a 1.3
AMMONIUM PHOSPHATE Nov 1974 a 7.1
AMMONIUM THIOSULPHATE Nov 1974 a 7.1
AMPROLIUM Jun 1969 a 2.3
AMYL ACETATE Nov 1974 a 7.1
α -AMYLASE derived from Aspergillus niger Feb 2005 a 2.4
ANDROSTENEDIONE ALBUMEN
CONJUGATE WITH DEA DEXTRAN
ADJUNCT Jun 2004 a 2.1
ASPARTIC ACID - a 6
ASULAM May 1986 a 1
AZIMSULFURON Jun 2003 a 1.1
BACILLUS SPHAERICUS STRAIN 2362 Feb 2003 a 5.1
BACILLUS THURINGIENSIS May 1992 a 5.1
(excluding endotoxin) Jun 2003 a 2.10
BACILLUS TOYOI Aug 1980 a 2.9
BACULOVIRUS CYDIA POMONELLA Jun 2006 a 1.2
BENFLURALIN - a 1.1
BENSULFURON-METHYL Aug 1987 a 1
BENTONITE Jun 2002 a 7.1
BENZYL BENZOATE Aug 1989 a 1.3.4
BETAINE HYDROCHLORIDE Nov 1974 a 7.1
BIFENAZATE Oct 2002 a 1.9
BISMUTH SUBNITRATE Nov 1999 b, c 2.1
BISTRIFLURON Feb 2014 a 1.2.2
BIURET Nov 1974 a 2.4
BOSCALID June 2003 a 1.3
BOVINE SOMATOTROPHIN May 1992 a 2
BROMACIL Aug 1987 a 1
BROMOPROPYLATE Nov 1994 a 1
BUPIRIMATE Nov 1990 a 1
BUTAFENACIL May 2000 a 1
BUTOXYPOLYPROPYLENE GYLCOL Nov 1974 a 7.7
n-BUTYL BUTYRATE - a 7.1
n-BUTYL LACTATE - a 7.1
CARBETAMIDE Aug 1991 a 1
CARBOXIN Aug 1987 a 1
CARFENTRAZONE-ETHYL Aug 1998 a 1
CELLULASE derived from
Aspergillus niger Feb 2005 a 2.4
CETYL ALCOHOL Nov 1974 a 7.1
CHAMOMILE OIL Feb 2000 a 3.1
CHINA CLAY Nov 1974 a 7.1
CHLORANTRANILIPROLE Sep 2008 a 1.2
CHLORFLUAZURON Oct 2005 a 1.2.2
CHLORFLURENOL Feb 1974 a 1.6
CHLORIDAZON May 1988 a 1
CHLOROXYLENOLS Feb 1975 a 7.8
CITRONELLA OIL Feb 2000 a 7.1
CLARY SAGE OIL Feb 2000 a 7.1
CLOPIDOL Nov 1974 d 2.3
COBALT NAPHTHENATE - d 7.1
COLOPHONY Feb 1997 b 7.4
CROSPOVIDONE Aug 1996 a 2
CULICINOMYCES CLAVOSPORUS Nov 1982 a 5.1
CYCLAMIC ACID Nov 1971 a 7.1
CYCLOHEXANE Nov 1974 a 7.7
CYCLOHEXANOL ACETATE - a 7.7
CYROMAZINE Nov 1980 a 2
DICLAZURIL Nov 2001 a 2.3
DIETHYL CARBONATE - a 7.1
DIFLUFENICAN Feb 1987 a 1
DIKEGULAC-SODIUM Mar 1980 a 1.6
DIMETHICONE a 7.1
DIMETHYL ETHER Nov 1988 d 4
DIPHENYLAMINE Feb 1988 a 1
DIPROPYLENE GLYCOL
MONOMETHYL ETHER Nov 1987 a 4
DIURON Nov 1987 a 1
DOCUSATE SODIUM
(DIOCTYL SODIUM SULFOSUCCINATE) Feb 1970 a 7.1
2,2-DPA Nov 1989 a 1
drometrizole trisiloxane Oct 2003 a 6.4
EPSIPRANTEL Nov 1991 a 2
ETHAMETSULFURON-METHYL Nov 2000 a 1.1
ETHOPABATE Jun 1969 d 2.3
ETHYL ACETATE Nov 1974 a 7.1
ETHYL ALCOHOL Nov 1974 a 7.1
ETHYLBUTYLACETYL-
AMINOPROPRIONATE Aug 2000 a 3.4
ETHYL BUTYRATE - a 7.1
ETHYL LACTATE - a 7.1
ETOXAZOLE Oct 2003 a 1.2
EUBACTERIUM sp. strain DSM11798 Sep 2013 a 2.4
FENFURAM May 1977 a 1.3.1
FENHEXAMID Feb 1999 a 1
FENOXYCARB Feb 1988 a 1
FLUFENOXURON Feb 1997 a 1
FLUMETSULAM Feb 1992 a 1
FLUOMETURON Aug 1989 a 1
FLUTOLANIL Nov 2001 a 1.3
FLUROXYPYR May 1986 a, c 1
FORCHLORFENURON Feb 2005 a 1.6
FULLERS EARTH Nov 1974 a 7.1
FUNGAL PROTEASE derived from
Aspergillus niger Feb 2005 a 2.4
GERANIUM OIL Feb 2000 a 7.1
GIBBERELLIC ACID Nov 1974 a 1.6
b-GLUCANASE derived from Aspergillus niger Feb 2005 a 2.4
HALAUXIFEN METHYL Oct 2014 a 1, 1.1
HEXAFLURON Nov 1988 a 1
HEXYL ACETATE - a 7.7
HEXYTHIAZOX Feb 1988 a 1
HUMAN OSTEOGENIC PROTEIN-1 (OP-1) Aug 2001 b 6.2
HYDROPRENE Feb 1988 a 1
HYDROXYPROPYL CELLULOSE Nov 1982 a 7.1
ICODEXTRIN Nov 2000 b 6
INDOLE-3-ACETIC ACID Feb 1985 b 1.6
ISOPRENE ALCOHOL - a 7.1
IPRODIONE Feb 1997 a 1
ISOSTEARYL ALCOHOL ETHOXYLATE Nov 1999 a 5.1
KAOLIN Nov 1974 a 7.1
KRESOXIM-METHYL Aug 1999 a 1
KUNZEA OIL Feb 2000 a 7.1
LAURIC ACID Oct 2005 a 7.1
LAURYL ALCOHOL (1-DODECANOL) Nov 1974 a 7.1
LAVANDIN OIL Feb 2000 a 7.1
LAVENDER OIL Feb 2000 a 7.1
LEAD METALLIC - a 7.1
LEMONGRASS OIL Feb 2000 a 7.1
LEPIDOPTEROUS SEX PHEROMONES Nov 1990 a 1
LIMONENE (DIPENTENE) Jun 2002 a 7.1
LINOLEIC ACID Oct 2005 a 7.1
LINSEED FATTY ACIDS Aug 1990 a 2.1
LINURON Feb 1990 a 1
LIQUORICE, DEGLYCYRRHISINISED May 1999 a 7.1
MALEIC HYDRAZIDE Nov 1992 a 1
MANGANESE DIOXIDE May 1999 b 1
MEGASPHAERA ELSDENII strain 41125 Sep 2013 a 2.4
MESOLSULFURON-METHYL Feb 2002 a 1.1
METARHIZIUM ANISOPLIAE Feb 2000 b 4.2
METARHIZIUM ANISOPLIAE Jun 2003 a 1.10
METHOPRENE Aug 1987 a 1
METHOXYFENOZIDE Nov 2000 a 1
METHYL ACETATE - a 7.7
METHYL BENZOQUATE Nov 1974 d 2.3
1-METHYLCYCLOPROPENE Jun 2003 a 1.6
METHYL p-HYDROXYBENZOATE Nov 1974 a 7.9
METSULFURONMETHYL Nov 1985 a 1.1
MYRISTIC ACID Oct 2005 a 7.1
NAPROPAMIDE Aug 1987 a 1
NAPTHYL ACETAMIDE Nov 1974 a 1.6
NEROLI OIL Feb 2000 a 7.1
NICARBAZIN Jun 1969 d 2.3
NISIN Jun 2003 a 3.2
NORFLURAZON Nov 1983 a 1.1
NOVALURON Nov 2000 a 1
Nuclear Polyhedrosis Virus of
Helicoverpa armigera occlusion bodies Feb 2004 a 1.2
OCTYL ALCOHOLS Nov 1974 a 7.1
OLEIC ACID Oct 2005 a 7.1
ORANGE OIL, SWEET Aug 2000 a 7.1
OXABETRINIL Feb 1987 a 1
OXYFLUORFEN May 2001 a 1
PALMAROSA OIL Feb 2000 a 7.1
PALMITIC ACID Oct 2005 a 7.1
PATCHOULI OIL Feb 2000 a 7.1
PECTINASE derived from Aspergillus niger Feb 2005 a 2.4
PENCYCURON Aug 1994 a 1
PENTADECANOIC ACID Oct 2005 a 7.1
PEPPERMINT OIL Feb 2000 a 7.1
PHENMEDIPHAM May 1989 a 1.1
d-PHENOTHRIN Feb 1982 a 7.5, 1.2
PHYTASE Feb 1996 a 2.4
PICLORAM Aug 1987 a 1
PICOLINAFEN May 2000 a 1
PIMELIC ACID Oct 2005 a 7.1
PIPERONYL BUTOXIDE Aug 1991 a 7.5
POLOXALENE Nov 1974 a 7.1
POLY DIALLYL DIMETHYL AMMONIUM
CHLORIDE (PolyDADMAC) Nov 1997 a 4.1
POLYHEDROSIS VIRUS of
Helico zea occlusion bodies Nov 1996 a 1
POLY (GNRF) OVALBUMIN Feb 1990 a 2
POLYSORBATE 20 May 2001 a 1
PORCINE SOMATOTROPHIN Nov 1991 c 2
potassium sorbate Oct 2004 a 1.3
POTASSIUM BICARBONATE Jun 2004 a 1
PROPYL ACETATES - a 7.1
PROPYLENE GLYCOL Nov 1974 a 7.1
2-PROPYLENE GLYCOL 1-MONOMETHYL
ETHER Nov 1987 a 4
PROTHIOCONAZOLE June 2005 a 1.3.1
PSEUDOMONAS FLUORESCENS May 1985 a 1.8
PYRIMETHANIL Feb 1996 a 1
PYRIPROXYFEN Aug 1994 a 1
QUASSIA Nov 1974 d 6, 2.1
QUINOXYFEN Nov 2001 a 1.3
ROSEMARY OIL Feb 2000 a 7.1
SAGE OIL (Spanish) Feb 2000 a 7.1
SANDALWOOD OIL Feb 2000 a 7.1
SEAWEED & UNFRACTIONED
SEAWEED EXTRACTS Feb 1985 d 1.5
SIMAZINE Nov 1987 a 1.1
SODIUM BICARBONATE Jun 2004 a 1
sodium propionate Oct 2004 a 1.3
STERIC ACID Oct 2005 a 7.1
SUCRALFATE Aug 1982 a 6.8
SULESOMAB Jun 2002 b 6.1
SULFOSULFURON Feb 1998 a 1
SULPHATED POLYSACCHARIDES - a 7.1
TANNIC ACID Dec 1965 a 7.1
TANNIC ACID/BENZYL ALCOHOL
PRODUCT Nov 1993 a 7.1
TERBACIL Aug 1987 a 1
THAUMATIN Nov 1990 a 3.2
THIDIAZURON Nov 1989 a 1
TRIASULFURON Feb 1988 a 1
TRICHODERMA HARZIANUM May 1996 a 1
(Z)-9-TRICOSENE Aug 1991 a 1
TRIETHYLENE GLYCOL Nov 1974 a 7.1
TRIFLOXYSULFURON Feb 2002 a 1.1
TRIFLURALIN Aug 1990 a 1
TRIFORINE Aug 1987 a 1
Ulocladium oudemansii Oct 2003 a 1.10
UREA Nov 1974 a 7.1
13C-UREA May 2001 a 6.1
VETIVER OIL Feb 2000 a 7.1
VINYL ETHER Nov 1987 b 6
VITAMIN K Jul 1963 a 6.9, 2.8
XANTHOPHYLL (lutein) Nov 1974 a 7.1
XYLANASE derived from Aspergillus niger Feb 2005 a 2.4
YLANG YLANG OIL Feb 2000 a 7.1
ZINC NAPHTHENATE - a 1.3
APPENDIX C
SUBSTANCES, OTHER THAN THOSE INCLUDED IN SCHEDULE 9,
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
(b) 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.
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.
CINCHOPHEN and its derivatives for therapeutic use.
CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except 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.
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.
1,3-DIMETHYLAMYLAMINE (DMAA).
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.
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.
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.
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; 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.
PETASITES spp. for therapeutic use.
PHENYLENEDIAMINES in preparations for skin colouration 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) for therapeutic or cosmetic use except when included in Schedule 5.
TOLUENEDIAMINE in preparations for skin colouration 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.
APPENDIX D
ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY
OF POISONS INCLUDED IN SCHEDULE 4 OR 8
(The following controls apply for the substances shown only when included in Schedule 4 or Schedule 8.)
1. Poisons available only from or on the prescription or order of an authorised medical practitioner.
CLOMIPHENE for human use.
CLOZAPINE for human use.
CORIFOLLITROPIN ALFA (recombinant follicle stimulant) for human use.
CYCLOFENIL for human use.
DINOPROST for human use.
DINOPROSTONE for human use.
FOLLITROPIN ALPHA (recombinant human follicle-stimulating hormone) for human use.
FOLLITROPIN BETA (recombinant human follicle-stimulating hormone) for human use.
LUTEINISING HORMONE for human use.
NABIXIMOLS.
SODIUM OXYBATE for human use.
TERIPARATIDE for human use.
UROFOLLITROPIN (human follicle-stimulating hormone) for human use.
2. Poisons available only from or on the prescription or order of a specialist physician or a dermatologist and for which the prescriber must, where the patient is a woman of child-bearing age:
(1) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and
(2) if the drug is -
(a) acitretin or etretinate, advise the patient to avoid becoming pregnant during or for a period of 24 months after completion of treatment; or
(b) bexarotene, isotretinoin or thalidomide, advise the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment.
ACITRETIN for human use.
BEXAROTENE for human use.
ETRETINATE for human use.
ISOTRETINOIN for human oral use.
THALIDOMIDE for human use.
3. Poisons available only from or on the prescription or order of a medical practitioner authorised or approved by the Secretary of the Commonwealth Department of Health and Ageing under section 19 of the Therapeutic Goods Act 1989.
DRONABINOL (delta-9-tetrahydrocannabinol).
4. Poisons available only from or on the order of a specialist physician and for which the prescriber must, where the patient is a woman of child bearing age:
(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and
(b) advise the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment.
LENALIDOMIDE.
TRETINOIN for human oral use.
5. Poisons for which possession without authority is illegal (e.g. possession other than in accordance with a legal prescription).
ANABOLIC STEROIDAL AGENTS, including those separately specified in Schedule 4.
ANDROGENIC STEROIDAL AGENTS, including those separately specified in Schedule 4.
BENZODIAZEPINE DERIVATIVES, including those separately specified in Schedule 4 and Schedule 8.
DARBEPOETIN.
DEXTROPROPOXYPHENE.
EPHEDRINE.
EPOETINS.
ERYTHROPOIETIN.
ERYTHROPOIETINS except when separately specified in this Appendix.
FOLLISTATIN.
GLUTETHIMIDE.
INSULIN-LIKE GROWTH FACTORS.
PERAMPANEL for human use.
PHENTERMINE.
SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM), including those separately specified in Schedule 4.
SOMATROPIN (human growth hormone).
6. Poisons available only from or on the prescription or order of a specialist physician and for which the prescriber must, where the patient is a woman of child-bearing age:
(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and
(b) advise the patient to avoid becoming pregnant during and for a period of 3 months after completion of treatment.
AMBRISENTAN for human use.
BOSENTAN for human use.
SITAXENTAN for human use.
7. Poisons available only from or on the prescription or order of a dermatologist.
ALEFACEPT for human use.
APPENDIX E
FIRST AID INSTRUCTIONS FOR POISONS
(other than agricultural and veterinary chemicals (including pesticides) registered by the
Australian Pesticides and Veterinary Medicines Authority and medicines for human use
when compliant with the requirements of the Required Advisory Statements for Medicine Labels)
INTRODUCTION
Directions for First Aid Attention
Under poisons legislation, scheduled substances and their preparations are required to be labelled with appropriate directions for first aid attention in case of poisoning. It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the first aid instructions included on the label of a poison are appropriate for a specific product. The following code has been prepared as a guide for health authorities and manufacturers in drafting suitable first aid directions for this purpose. Standard statements specified in this Appendix may be varied provided that the intent is not changed.
The directions listed for any particular substance may require modification to take into account combination of that substance with other substances, both toxic and non toxic, in a formulation, as well as the physical form and presentation of the product. Any such modification should be concise and readily understood.
These First Aid Instructions include action to be taken in case of eye contamination from substances recognised as causing direct poisoning via the eye, causing severe eye damage or requiring prolonged flushing to free the absorbed substance from the eye tissue. However, it is recognised that many other substances or preparations will require a statement of varying nature depending on the detailed formulation. While the necessity to flush the eyes in case of accident will be so self-evident as not to justify label space in many instances, a statement such as “If in eyes rinse well with water” may be appropriate.
Modified First Aid Instruction on Primary Pack
Where a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:
(a) each immediate container must be labelled with first aid instructions appropriate for its contents; and
(b) the primary pack must be labelled with the statement:
FIRST AID: See inner packs.
Exempt Preparations
This Appendix applies only to scheduled poisons. The directions are for substances and their preparations at the concentrations at which the Schedules apply. If it is thought desirable to show first aid instructions for a substance exempted from the schedules, it is the responsibility of the manufacturer to ensure they are appropriate.
Poisons Information Centre Telephone Numbers
Companies should use the Poisons Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766) appropriate to the country(ies) of sale for the product.
Companies wishing to use a poisons information centre telephone number other than the national telephone numbers for Australia and New Zealand must meet the following criteria:
1. the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and
2. calls must be logged and submitted for incorporation into the official collection of poisoning data.
APPENDIX E
PART 1
STANDARD STATEMENTS
To be grouped together and prefaced with the words “FIRST AID” (see subparagraph 7(p) of this Standard).
Basic
A For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).
Z First aid is not generally required. If in doubt, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
General
G1 Urgent hospital treatment is likely to be needed.
(Note - the words ‘at once’ to be added to instruction A).
G2 If swallowed, give activated charcoal if instructed.
(Note - the words ‘at once’ to be added to instruction A).
G3 If swallowed, do NOT induce vomiting.
G4 Immediately give a glass of water.
G5 Avoid giving milk or oils.
G6 If sprayed in mouth, rinse mouth with water.
Eyes
E1 If in eyes wash out immediately with water.
E2 If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes.
Respiratory system
R1 If inhaled, remove from contaminated area. Apply artificial respiration if not breathing.
R2 If swallowed or inhaled, remove from contaminated area. Apply artificial respiration if not breathing. Do not give direct mouth-to-mouth resuscitation. To protect rescuer, use air-viva, oxy-viva or one-way mask. Resuscitate in a well-ventilated area.
Skin
S1 If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water.
S2 If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water. Continue flushing with water until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
S3 If on skin, remove any contaminated clothing, wash skin thoroughly with soap and water, then methylated spirit if available. Contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
S4 If on skin, immediately remove any contaminated clothing, wash skin with methylated spirit or PEG (polyethylene glycol) 300 or 400 if available, then flush under running water until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
S5 If skin contact occurs, immediately remove contaminated clothing. Flush skin under running water for 15 minutes. Then apply calcium gluconate gel. Contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766).
Special Purpose
SP1 If swallowed, splashed on skin or in eyes, or inhaled, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor at once. Remove any contaminated clothing and wash skin thoroughly. If swallowed, activated charcoal may be advised. Give atropine if instructed.
APPENDIX E
PART 2
FIRST AID INSTRUCTIONS
Standard statements in this Appendix apply to poisons other than agricultural and veterinary chemicals (including pesticides) registered by the Australian Pesticides and Veterinary Medicines Authority. Labelling is not required at concentrations below scheduled levels (see the Introduction to this Appendix).
POISON STANDARD STATEMENTS
Acetic acid A,G3,E2,S1
Acetic anhydride A,G3,E2,S1
Acetone A,G3
Acrolein A,G1,G2,G3,E2,R2,S2
Alkaline salts A,G3,E2,S1
Amines for use as curing agents A,G3,E1,S1
4-Aminopyridine A,G1,G2,E1,S1
Ammonia
• 5 per cent or less A
• above 5 per cent A,G3,E1,R1,S1
Ammonium persulfate A,G3,E2
Ammonium thiocyanate A
Anhydrides, organic acid, for use as
curing agents for epoxy resins A,G3,E1,S1
Aniline A,E2,R1,S1
Anise oil A,G3
Antimony chloride A,E2,S2
Antimony compounds, except antimony chloride A
Azadirachta indica (neem) including its extracts
and derivatives when included in Schedule 6. A,E1
Barium salts, except barium sulfate A
Basil oil A,G3
Bay oil A,G3
Benzalkonium chloride
• when included in Schedule 5 A,G3,E2
• when included in Schedule 6 A,G3,E2,S1
Benzene A,G3,E1,R1,S1
1,2-Benzenediol (Catechol) A,E1,S1
Benzoyl peroxide
• above 20 per cent A,E2,S1
• above 10 per cent up to 20 per cent A,E1
• 10 per cent or less A
Bergamot oil A,G3
Bifluorides
(including ammonium, potassium and sodium salts)
• when included in Schedule 5 A
• when included in Schedule 6 or 7 A,G3,E2,S5
Borax A
Boric acid A
Boron trifluoride
• when included in Schedule 5 A
• when included in Schedule 6 or 7 A,G3,E2,S5
Bromoform A,G3,E2,R1,S2
Brucine A,G1,G2,G3,R2
2-Butoxyethanol and its acetates A,E2,S1
Cadmium compounds A
Cajuput oil A,G3
Camphor A,G1,G3,G5
Carbamide peroxide
• more than 9 per cent up to 60 per cent A,G3,E2,S1
• more than 60 per cent A,G1,G3,G4,E2,S1
Carbon disulfide A,G3,E2,R1,S2
Carbon tetrachloride A,G3,E1,R1,S1
Cassia oil A,G3
Chlorinating compounds, except when
separately specified, containing
• above 4 per cent and below 10 per cent
of available chlorine A,G3,E1,S1
• 10 per cent or more of available chlorine A,G3,E2,S1
Chlorine (gas) A,E1,R1
Chlorocresol A,G3,E2,S2
Chloroform A,G3,E1,R1,S1
Chromates A,G3,E2,S1
Chromium trioxide A,G3,E2,S1
Cineole A,G1,G3
Cinnamon bark oil A,G3
Cinnamon leaf oil A,G3
Climbazole A
Clove oil A,G1,G3,E2
Copper sulfate A,G3,E2,S1
Creosote A,G3,E2,S1
Cresols A,G3,E2,S3
Cresols in pressurised spray packs A,G6,E1,S1
Cyanides A,G1,E1,R2
Cyanoacrylic acid esters A
Cyanuric acid A
Cyclohexanone peroxide A,G3,E2,S1
Cysteamine E1
ortho-Dichlorobenzene A,G3,E1,S1
para-Dichlorobenzene (PDB) A
Dichloroethyl ether A,G3,E1,R1,S1
Dichloroisocyanurates A,G3,E1,S1
Dichloromethane (methylene chloride) A,G3,G5,E1,R1,S1
• in pressurised spray packs A,G6,S1
Dichromates A,G1,G3,E2,S1
Didecyldimethylammonium salts A,G3
Diesel (distillate) A,G3
Diethanolamine
• when included in Schedule 5 A,G3
• when included in Schedule 6 A,G3,E2,S1
5,6-Dihydroxyindoline E1
Dimethylformamide
• less than 75 per cent A
• 75 per cent or more A,E1,R1,S1
Dimethyl sulfoxide A,G3,E1,S1
Dinitrocresols A,G1,E1,S1
Dinitrophenols A,G1,E1,S1
Dioxane A,G3,E1,R1,S1
Distillate A,G3
N-(N-Dodecyl)-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Epoxy resins liquid A,G3,E2,S1
Essential oils containing camphor as natural
component unless otherwise specified. A,G3
Ethanolamine
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Ether A,G3,E1,R1
Ethyl bromide A,E2,S1,R1
Ethylene glycol A
Ethylene glycol monoalkyl ethers and their
acetates, except when separately specified A,G3,E2,S1
Ethylene oxide A,E2,R1
Eucalyptus oil A,G1,G3
Eugenol A,G1,G3,E2
Fluorides except when separately specified
• when included in Schedule 5 A
• when included in Schedule 6 A,G1,G3,E2,S1
Formaldehyde (see also paraformaldehyde) A,G3,E2,R1,S1
Formic acid A,G3,E2,S1
Furfural A,E1,S1
Glutaraldehyde
• below 5 per cent A,G3,E1
• 5 per cent or more A,G3,E2,S1
Glycolic acid A,G3,E2
Guanidine when included in Schedule 6 A,G3,E2,S1
Hexachlorophane when included in Schedule 6 A
Hexyloxyethanol A,G3,E2,S1
Hydrazine A,G1,G3,E2,R1,S1
Hydrocarbons, liquid A,G3
Hydrochloric acid A,G3,E2,S1
• when included in Schedule 5 A,G3
Hydrofluoric acid and admixtures that
generate hydrofluoric acid
• when included in Schedule 5 A
• when included in Schedule 6 or 7 A,G3,E2,S5
Hydrogen peroxide
• more than 3 per cent up to 20 per cent A,G3,E2,S1
• more than 20 per cent A,G1,G3,G4,E2,S1
Hydroquinone
• when included in Schedule 2 A
• when included in Schedule 4 or 6 A,G2,G3,E2,R2,S1
Hydrosilicofluoric acid
• when included in Schedule 5 A
• when included in Schedule 6 or 7 A,G3,E2,S5
Iodine (excluding salts, derivatives and iodophors)
• 2.5 per cent or more for human external use A,E2
• 2.5 per cent or more for other uses A,E2,S1
• below 2.5 per cent A
Iodophors A
Isocyanates, free organic A,E2,S1
Isophorone A,G3,E2,S1
Kerosene A,G3
Laureth carboxylic acids
• leave-on or wash-off preparations above 5 per cent E1
• other preparations above 5 per cent E1,S1
Lauryl isoquinolinium bromide A,E1
Lead compounds
• in hair cosmetics A
• in other preparations A,S1
Lemon oil A,G3
Leptospermum scoparium oil (manuka oil) A,G1,G3
Lime oil A,G3
Magnesium chlorate A
Malathion at 20 per cent or less A
Marjoram oil A,G3
Melaleuca oil A,G1,G3
Mercuric chloride
• for external therapeutic use A
• for other uses A,G1,G3,E2,R2,S1
Mercuric iodide A,G1,G3,E2,R2,S1
Mercuric nitrate A,G1,G3,E2,R2,S1
Mercuric oxide A,G1,G3
Mercuric potassium iodide A,G1,G3,E2,R2,S1
Mercuric thiocyanate A,G1,G3,E2,R2,S1
Mercurochrome A
Mercurous chloride A
Mercury metallic A
Mercury, organic compounds A,S1
• in preparations for human external use A
Metaldehyde A,E1,S1
Methanol
• above 10 per cent A,G3
• 10 per cent or less A
Methylated spirit A,G3
Methyl ethyl ketone A,G3
Methyl ethyl ketone oxime A,E1,S1
Methyl ethyl ketone peroxide A,G3,E2,S1
Methyleugenol A
Methyl isoamyl ketone A,G3
Methyl isobutyl ketone A,G3
N-Methyl-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2
Methyl salicylate liquid when included
in Schedule 5 or 6 A,G3,E1
Naphthalene A,G1,G3
Nitric acid A,G3,E2,S1
Nitrobenzene A,G3,E1,S1
Nitrophenol A,G3,E2,S1
Nitroprussides
• in aerosols A,G6,R1
• in other preparations A,G3
Nonoxinol 9 A,E2
Nutmeg oil A,G3
2-Octyl-4-isothiazolin-3-one (Ocithilinone) A,G3,E2,S1
N-(N-Octyl)-2-pyrrolidone
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2
Orange oil (bitter) A,G3
Oxalic acid A,G3,E2,S1
Paraformaldehyde A,G3,E2,R1,S1
Pennyroyal oil A,G3
Peracetic acid
• when included in Schedule 5 A,G3,E1,S1
• when included in Schedule 6 A,G3,E2,S1
Petrol A,G3,R1
2-Phenoxyethanol A, E1
Phenols
• 25 per cent and less A,G3,E2,S3
• above 25 per cent A,G3,E2,S4
Phenols in pressurised spray packs A,E1
Phenylenediamines and
alkylated phenylenediamines
• in hair dyes A,E1
• in other preparations A,G1,G3,E1,S1
Phenyl methyl ketone
• as such, or in preparations of similar viscosity A,G3,E1
N,N-bis(phenylmethylene)-bicyclo
-(2.2.1)heptane-2,5-dimethanamine A,E2,S1
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine A,E2,S1
ortho-Phenylphenol A,G3,E2,S1
• in pressurised spray packs A,G6,E2,S1
Phosphonic acid A,G3,E2,S1
• neutralised to pH 6 (approx) A
• in spray packs A,E2,S1
Phosphoric acid A,G3,E2,S1
Phosphorus, yellow A,G1,G3,E2,R2,S2
ortho-Phthalaldehyde
• when included in Schedule 5 A,E1
• when included in Schedule 6 A,G3,E2,S1
Picric acid A,G1,G3,E2,R1,S1
Polyethanoxy (15) tallow amine A,E2,S1
Poly(oxy-1,2-ethanediyl), α -
[2-[(2-hydroxyethyl)amino]-2-
oxoethyl]- α -hydroxy-,mono-C13-15
-alkyl ethers A,E1
Potassium bromate A
Potassium chlorate A
Potassium cyanate A,E1,S1
Potassium hydroxide A,G3,E2,S1
Potassium metabisulphite A
Potassium nitrite
• when included in Schedule 7 A,G1,G3
• when included in Schedule 5 or 6 A,G3
Potassium peroxomonosulfate triple salt
• when included in Schedule 5 A,G3,E1
• when included in Schedule 6 A,G3,E2,S1
Potassium persulfate A,G3,E2
Potassium sulfide A,G3,E2,S1
Propionic acid A,G3,E1,S1
d-Pulegone A,G3
Pyrithione zinc A,E1
Quaternary ammonium compounds except
when separately specified
• above 20 per cent A,G3,E2
• 20 per cent and below A,E2
• in pressurised spray packs A,E2,G6
Safrole A,G1,G3
Sage oil (Dalmatian) A,G3
Sassafras oil A,G1,G3
Selenium compounds A,G1,E1,S1
Silicofluorides
• when included in Schedule 5 A
• when included in Schedule 6 A,G1,G3,E2,S1
Silver salts A,E2
Sodium aluminate A,G3,E2,S1
Sodium bromate A,G1
Sodium chlorate A
Sodium diacetate A,G3,E2,S1
Sodium dichloroisocyanurate A,G3,E1,S1
Sodium dodecylbenzene sulfonate A,G3,E2,S1
Sodium hydrogen sulfate A,G3,E1,S1
Sodium hydrosulfite A,G3,E2,S1
Sodium hydroxide A,G3,E2,S1
Sodium laureth-6 carboxylate A
Sodium lauryl sulfate
• leave-on or wash-off preparations above 5 per cent E1
• other preparations above 5 per cent E1,S1
Sodium metabisulphite A, G3
Sodium nitrite
• when included in Schedule 7 A,G1,G3
• when included in Schedule 5 or 6 A,G3
Sodium percarbonate
• when included in Schedule 5 A,G3,S1
• when included in Schedule 6 A,G3,E2,S1
Sodium persulfate A,G3,E2
Sodium stannate A,E1
Sodium sulfide A,G3,E2,S1
Sodium trichloroacetate A
Strychnine A,G1,G2,G3,R2
Styrene A,G3,S1,E1
Sulcofuron A
Sulfamic acid A,G3,E2,S1
Sulfuric acid A,G3,E2,S1
Terpenes, chlorinated A,G3
Tetrachloroethane A,G3,E1,R1,S1
Tetrachloroethylene A,G3,E2,R1,S1
Thiourea A
Thujone A,G3
Thyme oil A,G3
ortho-Tolidine A
Toluene
• above 75 per cent A,G3,E1,R1,S1
• 75 per cent and below A,G3
• in pressurised spray packs A
Toluenediamine
• in hair dyes A,E1
• in other preparations A,G1,G3,E1,S1
Trichloroacetic acid A,G3,E2,S1
Trichloroacetic acid alkali salts A
1,1,1-Trichloroethane A,G3,E1,R1,S1
Trichloroethylene A,G3,E1,R1,S1
Trichloroisocyanuric acid A,G3,E1,S1
Triethanolamine A,G3,E1,S1
Triethyl phosphate A,E1
Trifluoromethanesulfonic acid A,G3,E2
Triisopropanolamine lauryl ether sulfate A,E1,S1
Turpentine (mineral) A,G3
Turpentine oil (vegetable) A,G3,E2
White spirit A,G3
Xylene
• above 75 per cent A,G3,E1,R1,S1
• 75 per cent and below A,G3
• in pressurised spray packs A,G6,E1,S1
Xylenols A,G3,E2,S3
• in pressurised spray packs A,E1
Zinc chloride A,G3,E2,S1
Zinc sulfate A,G3,E2,S1
APPENDIX F
WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS
(other than agricultural and veterinary chemicals (including pesticides) registered by the
Australian Pesticides and Veterinary Medicines Authority and medicines for human use
when compliant with the requirements of the Required Advisory Statements for Medicine Labels)
INTRODUCTION
Warning Statements and Safety Directions
It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the purchaser or user of a product is given sufficient information to be able to use it correctly and safely.
Under poisons legislation, scheduled substances, which may be harmful to the user, must be labelled with appropriate warning statements and/or safety directions. The selection of warning statements and safety directions will depend on the formulation of the product, and the use for which it is sold or supplied. The following code has been prepared as a guide for this purpose.
The wording of warning statements and safety directions specified in this Appendix may be varied provided that the intent is not changed. Additional statements also may be added to ensure that the user of a product is sufficiently advised of its harmful nature and how to avoid any deleterious effects.
Poisons Information Centre Telephone Numbers
Companies should use the Poisons Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766) appropriate to the country(ies) of sale for the product.
Companies wishing to use a poisons information centre telephone number other than the national telephone numbers for Australia and New Zealand in warning statement No. 99 in Part 1 of this Appendix must meet the following criteria:
1. the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and
2. calls must be logged and submitted for incorporation into the official collection of poisoning data.
APPENDIX F
PART 1
WARNING STATEMENTS
1. Highly corrosive.
2. Corrosive.
3. Corrosive liquid.
4. Strongly alkaline.
5. Irritant.
6. May cause cancer.
7. WARNING - Causes birth defects.
8. WARNING - May be fatal to children.
9. Can be fatal to children if sucked or swallowed.
10. May produce severe burns.
11. WARNING - Vapour may be harmful.
12. Vapour is harmful to health on prolonged exposure.
13. May be fatal if inhaled, swallowed or absorbed through skin.
14. Dust will irritate and burn eyes, nose and skin.
15. Liquid will cause burns.
16. Forms dangerous gas near radiators or naked flames.
17. Contact with eyes even for short periods can cause blindness.
18. Product will irritate the eyes, nose, throat and skin.
19. WARNING - Skin contact may be dangerous. Take every precaution to avoid contact - wash off after spillage and after use.
20. May give off dangerous gas if mixed with other products.
21. WARNING - This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to 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.
22. Highly reactive oxidising chlorine compound.
23. May cause fire or explosion.
24. For external washing only. Rinse skin thoroughly after use.
25. Do not use on broken skin. Wash hands thoroughly after use.
26. (Powder) (and) (concentrated solutions) are dangerous if swallowed.
27. Not for therapeutic use.
28. (Over) (Repeated) exposure may cause sensitisation.
29. If congestion persists, consult your doctor or pharmacist.
30. WARNING - Do not use on face or on anal or genital areas.
31. WARNING - Do not use on face or on anal or genital areas except on doctor’s advice.
32. This preparation should be part of an overall treatment plan regularly assessed with your doctor.
33. Do not take for periods longer than four weeks except on medical advice.
34. WARNING - This medication may be dangerous when used in large amounts or for a long time (period).
35. CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful.
or
CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged or excessive use without medical supervision could be harmful.
36. For use under medical supervision only.
37. Consult a doctor before giving this medication to children or teenagers with chicken pox, influenza or fever.
38. CAUTION - Do not use for children under 2 years old unless a doctor has told you to.
39. This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.
40. This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.
41. Do not give to children under 12 years of age. Do not use beyond 48 hours or in pregnancy or lactation except on doctor’s advice.
42. WARNING - Overuse may stain the skin or mouth.
43. Use of this product is not necessary in areas supplied with fluoridated water.
44. 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.
45. WARNING - If a pigmented spot or mole has recently become darker, changed colour, become enlarged or itchy, or bleeds, do not use this product, see your doctor immediately. Do not use on children. Do not use near the eyes. Mild irritation may occur; stop use if it becomes severe. If fading is not evident in three months, seek doctor’s advice.
46. WARNING - Contains (name of substance) which causes birth defects in laboratory animals. Women of child bearing age should avoid contact with (name of substance).
47. WARNING - This product contains (name of substance) which causes birth defects in certain laboratory animals. Women of child bearing age are advised not to mix, load or spray this product. They should keep out of crops being sprayed.
48. WARNING - This product forms cyhexatin which causes birth defects in certain laboratory animals. Women of child bearing age are advised not to mix, load or spray this product. They should keep out of crops being sprayed.
49. WARNING - Do not mix with other medication except on veterinarian’s advice.
50. Unless adequately fired, utensils glazed with this preparation must not be used as containers for food or beverages; to do so may cause lead poisoning.
51. Irritant to skin, eyes, mucous membranes and upper respiratory tract.
52. Breathing vapour or spray mist is harmful and may cause an asthma-like reaction.
53. CAUTION - (Name of substance) should not be used by pregnant women.
54. Seek medical advice before first course of treatment.
55 Keep from eyes, lips, mouth and sensitive areas of the neck. If excessive swelling, irritation, redness or peeling occurs, discontinue use. If these persist, consult a physician. Avoid excessive exposure to sunlight and other sources of ultra violet light.
56. WARNING - Can cause elevated blood pressure and interact adversely with other medication.
57. Not to be applied to infants under 12 months of age unless on doctor’s advice.
58. Highly reactive oxidising bromine and chlorine compound.
59. May cause allergy.
60. Do not mix with detergents or other chemicals.
61. WARNING - Can react with other medicines. Ask your doctor or pharmacist before taking.
62. Do not use if pregnant.
63. See a doctor if you are pregnant or diabetic.
64. See a doctor (or) (dentist) if no better after (Insert number of days as per approved Product Information) days.
65. If getting better, keep using for (Insert number of days as per approved Product Information ) days.
66. See a doctor if problem returns.
67. Do not use if pregnant or likely to become pregnant.
68. If symptoms persist beyond 5 days consult a doctor (or) (dentist).
69. If symptoms recur within two weeks of completing the course, consult a doctor.
70. Use only under medical supervision if you are taking other medicines.
71. Do not use during the last three months of pregnancy.
72. Do not use in the eyes.
73. Do not use for acne.
74. Do not use under waterproof bandages unless a doctor has told you to.
75. Do not use for more than 7 days unless a doctor has told you to.
76. Do not become pregnant during use or within (Insert number of months as per approved Product Information) month(s) of stopping treatment.
77. WARNING - May cause birth defects.
78. Attacks skin and eyes.
79. Will irritate eyes.
80. (Intentionally blank)
81. (Intentionally blank)
82. (Intentionally blank)
83. This paint is dangerous to health, even when dry.
For industrial use only.
Do not use on toys or furniture.
Do not use on, in or around the home.
84. Breathing the vapour is dangerous.
Provide adequate ventilation during application.
Do not use in the presence of a naked flame.
Do not smoke.
85. This paint contains lead and is dangerous to health, even when dry.
For industrial use only.
Do not use on toys or furniture.
Do not use for painting any building or fixed structure.
Do not use where contact with food or drinking water is possible.
86. This tinter contains lead.
Do not add to any paint which is for application to any toy, furniture, building (interior or exterior), fixed structure or to anything which may contact food or drinking water.
87. (Insert brand name) remains in the body for many months after treatment has stopped. Do not become pregnant or father a child before consulting your doctor.
88. This product is not recommended for dyeing eyelashes or eyebrows. To do so may be injurious to the eye.
89. Application to skin may increase sensitivity to sunlight.
90. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.
91. CAUTION - Total iodine intake may exceed recommended level when taking this preparation.
92. WARNING - Contains iodine - do not take when pregnant except on physician’s advice.
93. Causes severe burns, which are not likely to be immediately painful or visible.
94. WARNING - Contains nitrite. Substitution for table or cooking salt may be dangerous, particularly for young children.
95. CAUTION - Do not use for children under 12 years old unless a doctor has told you to.
96. CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a doctor.
97. Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to by a doctor.
98. Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.
99. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
100. Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.
101. Don’t use [this product/name of the product]:
If you have a stomach ulcer
In the last 3 months of pregnancy [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.]
If you are allergic to (name of substance) or anti-inflammatory medicines.
102. Unless a doctor has told you to, don’t use [this prouct/name of the product]:
For more than a few days at a time
With other medicines containing aspirin or other anti-inflammatory medicines
If you have asthma
In children under 12 years of age
In children 12-16 years of age with or recovering from chicken pox, influenza or fever
If you are pregnant.
103. See a doctor before taking [this product/name of the product] for thinning the blood or for your heart. [This statement may be omitted in products for inhibition of platelet aggregation or with additional active ingredients.]
104. Unless a doctor has told you to, don’t use [this product/name of the product]:
For more than a few days at a time
With other medicines containing (name of substance) or other anti-inflammatory medicines
If you have asthma
If you are pregnant [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea].
105. Do not use on the bedding or clothing of infants or in the bedrooms of children 3 years of age or less.
106. Contains formaldehyde.
APPENDIX F
PART 2
SAFETY DIRECTIONS - GENERAL
To be grouped together and prefaced with the words “SAFETY DIRECTIONS” (see Part 2, Labels and Containers, subparagraph 7(n) to this Standard).
1. Avoid contact with eyes.
2. Attacks eyes - protect eyes when using.
3. Wear eye protection when mixing or using.
4. Avoid contact with skin.
5. Wear protective gloves when mixing or using.
6. Wash hands after use.
7. Wash hands thoroughly after use.
8. Avoid breathing dust (or) vapour (or) spray mist.
9. Use only in well ventilated area.
10. Ensure adequate ventilation when using.
11. No smoking.
12. Do not allow product to come into contact with other chemicals, especially acids.
13. Do not allow product to come into contact with combustible materials such as paper, fabric, sawdust or kerosene.
14. Do not allow to get damp.
15. Store under cover in a dry, clean, cool, well ventilated place away from sunlight.
16. Store and transport in an upright container.
17. Do not mix with other chemicals.
18. Do not mix with different types of chlorinating chemicals.
19. Use clean containers for dispensing.
20. Mix with water only.
21. Do not add water to product - add product to water, but in case of fire drench with water.
22. In case of spillage flush with large quantities of water.
23. Keep away from heat, sparks and naked flames.
24. Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.
25. Avoid contact with food.
26. Avoid contact with clothing.
27. Wear a positive-pressure air-supplied full-face respirator whilst spraying and until spray mist has been effectively dispersed.
28. Do not mix with hot water.
29. Obtain a supply of calcium gluconate gel.
30. (Intentionally blank.)
31. Do not use on broken skin.
32. Do not use under occlusive dressing.
33. Mix strictly according to instructions.
34. May cause fire if it comes into contact with other chemicals, paper or other flammable materials.
35. Wash gloves thoroughly, immediately after use.
36. Protect cuticles with grease or oil.
APPENDIX F
PART 3
POISONS (other than agricultural and veterinary chemicals)
TO BE LABELLED WITH WARNING STATEMENTS
OR SAFETY DIRECTIONS
(Where more than one statement or direction is required, they may be combined to form simple sentences where appropriate.)
_________________________________________________________________________________
WARNING SAFETY
POISON STATEMENTS DIRECTION
_________________________________________________________________________________
Acetic acid in concentrations of 80 per cent 2 1,4,8
or more except when in Schedule 2.
Acetic anhydride 2 1,4,8
Acetone in concentrations greater than 75 per cent. 1,4,8
Acitretin 7,62,76
Adapalene for topical use. 62,77
Alclometasone when included in Schedule 3. 38,72,73,74,75
Alkaline salts 4 1,4
Ambrisentan 7,62,76
Amines used as curing agentsfor epoxy resins. 1,3,4,5,8
Ammonia/ammonium hydroxide in concentrations 4 1,4,8
greater than 20 per cent ammonia except
in smelling salts.
Ammonium persulfate 5,21,25 1,5,23,33,34
Anhydrides, organic acid, for use as curing agents 1,3,4,5,8
for epoxy resins.
Aniline 13 1,4,8
Antihistamines not separately specified 39 or 40
in this Appendix except:
(a) dermal, ocular, parenteral and
paediatric preparations;
(b) oral preparations of astemizole,
desloratadine, fexofenadine,
loratadine or terfenadine;
(c) nasal preparations of azelastine; or
(d) preparations for the treatment of animals.
Aromatic extract oils 1,3,4,5,6
Aspirin
(a) for inhibition of platelet aggregation. 36
(b) in sustained release preparations 36
containing 650 mg or more of aspirin.
(c) in other preparations. 101,102,103
Astemizole 61
Azadirachta indica (neem) including its extracts
and derivatives when included in Schedule 6. 67
Azocyclotin 48
Benomyl 46
Benzene 12 1,4,9
1,2-Benzenediol (Catechol) 51,59 1,4,8
Benzoyl peroxide when included in Schedule 2. 55
Benzoyl peroxide when included in Schedule 5. 1,4,8
Bergamot oil 89
Beryllium 1,4,8
Bexarotene
(a) for human use. 7,62,76
(b) for topical use. 62,77
Bifluorides (including ammonium, potassium and sodium salts)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Bithionol for the treatment of animals. 1,4,8
Boron trifluoride (including mixtures that
generate boron trifluoride)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Bosentan 7,62,76
Bromoform 1,4,8
2-Butoxy-2’-thiocyanodiethyl ether 1,4,8
2-Butoxyethanol and its acetates 1,4,8
Camphor
(a) in block, ball, disc, pellet or flake form, 9
enclosed in a device which, in normal use,
prevents removal or ingestion of its contents.
(b) in other forms. 9 1
Carbamide peroxide
(a) more than 9 per cent up to 30 per cent. 5 1
(b) more than 30 per cent up to 60 per cent. 5 2
(c) more than 60 per cent. 2 2,4
Carbon disulphide 12 1,4,8,9,23
Carbon tetrachloride 12 1,4,8,9
Cassia oil 4
Chlorinating compounds
(a) in household cleaning or bleaching 20
preparations.
(b) in preparations containing less than 11 1,4,10
10 per cent of available chlorine.
(c) in liquid preparations containing 3,18 1,4,6,8,10, 15,16,
10 per cent or more of available chlorine. 17,18, 19,20,22,26
(d) in dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,
or more of available chlorine. 14,15,16,17, 18,
19,20,21, 22,26
(e) in dry preparations containing 10 per cent 10,18,22 1,4,8,12,13,
or more of available chlorine certified by a 14,15,16,17,
relevant State or Territory authority as not 18,19,20,21,
being a Dangerous Good of Class 5, 22,26
Division 5.1:Oxidising substances, as
specified in the Australian Code for the
Transport of Dangerous Goods by Road
and Rail.
(f) in compressed block or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of available chlorine 17,18,19,21
except in preparations for use in toilet
cisterns only, containing 15 g or less of
trichloroisocyanuric acid.
(g) in other compressed blocks or tablets 10,22 12,13,14,15,
containing 10 per cent or more of available 17,18,19,21
chlorine 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 except in preparations for
use in toilet cisterns only, containing 15 g or
less of trichloroisocyanuric acid.
Chloroform when included in Schedule 6 1,4,8
alpha-Chlorohydrin 13,51 1,4,8,9
Chromates (including dichromates) of alkali metals or ammonia 1,4,8
Chromium trioxide 2,14,15,23 1,4,8,13
Cimetidine when included in Schedule 3 70,96
Cinnamon bark oil 4
Clobetasone when included in Schedule 3. 72,73,74,75,95
Clotrimazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Clove oil 1
Cyanides when included in Schedule 7. 13 4,8
Cyanuric acid 1,4,8
Cyclohexanone peroxide 1,4,8
Cysteamine 1
4,4-Diaminodiphenylmethane (methylene dianiline) 1,4,8
ortho-Dichlorobenzene 1,4,8
para-Dichlorobenzene 1,4
Dichloroethylene 1,4,8
Dichloroethyl ether 1,4,8
Dichloroisocyanurates
(a) in household cleaning or bleaching 20
preparations.
(b) in preparations containing less than 11 1,4,10
10 per cent of available chlorine. .
(c) in liquid preparations containing 10 per cent 3,18 1,4,6,8,10,
or more of available chlorine. 15,16,17,18,
. 19,20,22,26
(d) in dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,14,
or more of available chlorine. 15,16,17,18,19,
. 20,21,22,26
(e) in dry preparations containing 10 per cent 10,18,22 1,4,8,12,13,14,
or more of available chlorine certified by a 15,16,17,18,19,
relevant State or Territory authority as not 20,21,22,26
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.
(f) in anti-bacterial tablets containing 2.5 g or 60
less of sodium dichloroisocyanurate..
(g) in other compressed blocks or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of available chlorine except 17,18,19,21
in preparations containing 21 g or less of sodium
dichloroisocyanurate for use in toilet cisterns only.
(h) in other compressed blocks or tablets containing 10,22 12,13,14,15,17,
10 per cent or more of available chlorine 18,19,21
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 except in
preparations containing 21 g less of sodium
dichloroisocyanurate for use in toilet cisterns only.
(i) in other compressed blocks or tablets containing
10 per cent or more of available chlorine in
preparations containing 5 g or less of sodium
dichloroisocyanurate for use in toilet bowls only:
(i) during storage 10,22,23 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
(j) in other compressed blocks or tablets containing
10 per cent or more of available chlorine 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 in preparations
containing 5 g or less of sodium dichloroisocyanurate
for use in toilet bowls only.
(i) during storage 10,22 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
Dichloromethane (methylene chloride)
(a) in paint or lacquer removers. 12,16 1,4,8,11
(b) other than in paint or lacquer removers 1,4,8,25
Diclofenac 101,104
Dienestrol 67
Diethanolamine when included in Schedule 5. 5 1,4
Diethanolamine when included in Schedule 6. 2,11,18 1,4,8
Diethyltoluamide for human use. 44
5,6-Dihydroxyindoline 21,28
Dimethylformamide 1,4,8
Dimethyl sulfate 2 1,4,8
Dimethyl sulfoxide
(a) when not packed and labelled for therapeutic use. 27 1,4,5,8
(b) when packed and labelled for treatment of animals. 49 1,4,5,8
Dinitrocresols (and their homologues) except when for 1,4,8
therapeutic use.
Dinitrophenols (and their homologues) except when 1,4,8
for therapeutic use.
Dinocap 47
Dioxane 1,4,8
Diphenoxylate when included in Schedule 3. 39 or 40,41
Econazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Ephedrine in nasal preparations for topical use. 29
Epichlorohydrin 2 1,4,8
Epoxy resins, liquid. 1,3,4,5,8
Ethanolamine when included in Schedule 5. 5 1,4
Ethanolamine when included in Schedule 6. 2,11,18 1,4,8
Ether when included in Schedule 5 or 6. 1,4,8
Ethoxyethylmercuric chloride 1,4
Ethyl bromide 1,4,8
Ethylene chlorohydrin 1,4,8
Ethylene glycol monoalkyl ethers and their acetates 1,4,8
except when separately specified.
Ethylene oxide 1,4,8
Ethylmercuric chloride 1,4
Ethyl methacrylate 28 4,9,23
Etretinate 7,62,76
Eugenol 1
Famotidine when included in Schedule 2. 96
Fenoterol in metered aerosols. 32
Fluconazole in oral preparations when included in 64
Schedule 3.
Fluorides (including silicofluorides) when included in 1,4
Schedule 5 or 6 except when separately specified.
Formaldehyde
(a) in nail hardener cosmetics. 106 1,4,8,36
(b) in other preparations. 106 1,4,8
Formic acid 1,4,8
Furfural 5 1,4
Glazing preparations containing lead compounds.. 50
Glutaraldehyde except when in Schedule 2
(a) 25 per cent or less. 5,59 1,4,5
(b) more than 25 per cent. 3,59 1,4,5,8
Glycolic acid 79 1,5,6,31
Hexachlorophane in preparations for skin cleansing 24
purposes containing 3 per cent or less of
hexachlorophane.
Hexyloxyethanol 2 1,4,8
Hydrazine 1,4,8
Hydrochloric acid
(a) 30 per cent or less of HCl. 1,4
(b) more than 30 per cent of HCl. 1,4,8
Hydrocortisone
(a) for dermal use when included in 38,72,73,74,75
Schedule 2 or 3.
(b) for topical rectal use when includeed 38,75
in Schedule 2 or 3.
Hydrocyanic acid when included in Schedule 7. 13 4,8
Hydrofluoric acid (including mixtures that generate
hydrofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Hydrogen peroxide
(a) more than 3 per cent up to 10 per cent. 5 1
(b) more than 10 per cent up to 20 per cent. 5 2
(c) more than 20 per cent. 2 2,4
Hydroquinone
(a) when in Schedule 2. 45
(b) except when in Schedule 2 or 4. 1,4
Hydrosilicofluoric acid (including mixtures
that generate hydrosilicofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
8-Hydroxyquinoline (including salts and 33
derivatives) when prepared for
internal use.
Ibuprofen 101,104
Iodine
(a) more than 20 per cent. 1,4,8
(b) in preparations for human internal therapeutic 91,92
use containing 300 micrograms or more of
iodine per recommended daily dose.
Ipratropium bromide in metered aerosols. 32
Isocyanates (free organic)
(a) when in paint. 28,52 1,5,8,10,27
(b) other than in paint. 28,52 1,4,8
Isoprenaline in metered aerosols 32
Isotretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Lead compounds
(a) in hair cosmetics. 25
(b) when in Schedule 6. 1,4,8
Leflunomide 7,62,87
Lemon oil 89
Lenalidomide 7,62,76
Levocabastine
(a) in eye or nasal preparations containing 62
0.5 mg/mL or less of levocabastine.
(b) in other preparations. 62 and
either 39 or 40
Lime oil 89
Loperamide when in Schedule 2. 41
Magnesium chlorate 1,4
Mefenamic acid 101,104
Mercuric thiocyanate 1,4
Metacresolsulphonic acid and formaldehyde 1,4
condensation product for the treatment of animals.
Methanol except in methylated spirit. 1,4,8
Methoxamine in nasal preparations for topical use. 29
Methyl chloride 1,4,8
Methyl ethyl ketone 5 1,4,8
Methyl ethyl ketone oxime 5,28 1,4
Methyl ethyl ketone peroxide 2 2,3,4,6
Methyl iso-amyl ketone 1,4,8
Methyl iso-butyl ketone 1,4,8
Methyl iso-thiocyanate 5,12 1,4,8
Methyl methacrylate 28 4,9,23
Methyldibromo glutaronitrile 28 1,4,7
Methylene bisthiocyanate 1,4
Methyleugenol 1,6
Methylnorbornylpyridine 59
1-(beta-Methyl sulphonamidoethyl)- 2-amino-3-
N,N-diethylaminobenzene 1,4,8
Miconazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Misoprostol 53
Naphazoline in nasal preparations for topical use. 29
Naphthalene
(a) in block, ball, disc, pellet or flake form, 9,105
enclosed in a device which, in normal
use, prevents removal or ingestion of its
contents.
(b) in other forms. 9,105 1
Naproxen 101,104
Nicotine except when in tobacco or when included 1,4
in Schedule 2.
Nitric acid
(a) 75 per cent or less HNO3. 2 1,4
(b) more than 75 per cent HNO3. 2 1,4,8
Nitrobenzene 1,4,8
Nitrophenols 1,4
Nitroprussides in aerosols. 84 8
Nizatidine when included in Schedule 2. 96
Noradrenaline in metered aerosols. 32
Nystatin in vaginal preparations when included 54,63,64,65,66
in Schedule 3.
Orange oil (bitter) 89
Orciprenaline in metered aerosols. 32
Oxalates, metallic 4,8
Oxalic acid 2 4,8
Oxymetazoline in nasal preparations for topical use. 29
Paint
(a) First Schedule paints. 83
(b) Second Schedule paints. 84
Paracetamol 97 and/or 98,99,100
Pentachlorophenol 1,4,8
Peracetic acid 2 1,4,8
Permanganates 2 24
2-Phenoxyethanol 5 1
Phenol and any other homologue of phenol. 1,4
Phenols 5
Phenylenediamines and alkylated
phenylenediamines
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Phenylephrine in nasal preparations 29
for topical use.
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,5-dimethanamine 5,28 1,4,5,10
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine 5,28 1,4,5,10
ortho-Phenylphenol except when in 1,4
antiseptics.
Phenylpropanolamine 56
Phenytoin in pastes for the treatment of horses. 9
Phosphonic acid 1,4
Phosphoric acid 1,4
Phosphorus (yellow) 2 1,4
ortho-Phthalaldehyde
(a) when included in Schedule 5. 51,52,59 1,4,5,8,10
(b) when included in Schedule 6. 51,52,59 2,4,5,8,10
Picric acid (more than 20 per cent). 1,4
Podophyllin
(a) in preparations specifically for use on 36
anal or genital area.
(b) in other liquid preparations when included 31
in Schedule 2 or Schedule 3.
(c) in other solid or semi-solid preparations 30
when included in Schedule 2.
Podophyllotoxin
(a) in preparations specifically for 36
use on anal or genital area.
(b) in other liquid preparations when included 31
in Schedule 2 or Schedule 3.
(c) in other solid or semi-solid preparations 30
when included in Schedule 2.
Polihexanide 1,4,8
Polyethanoxy (15) tallow amine 1,4
Poly(oxy-1,2-ethanediyl), α -[2-[(2-hydroxyethyl)amino] 5,88 1,5
-2-oxoethyl]- α -hydroxy-,mono-C13-15 -alkyl ethers
Potassium hydroxide
(a) in preparations containing 5 1,4,6
0.5 per cent or less of potassium
hydroxide.
(b) in solid preparations containing 2,10,78 3,5,28
more than 0.5 per cent of potassium
hydroxide.
(c) in liquid preparations containing 2,10,78 3,5
more than 0.5 per cent of potassium
hydroxide.
Potassium metabisulphite 5,26 1,4
Potassium nitrite in pickling or curing salts. 94
Potassium persulfate 5,21,25 1,5,23,33,34
Potassium sulfide 2 1,4
Propionic acid when in Schedule 6. 2 1,4
Ranitidine when included in Schedule 2. 96
Safrole
(a) in preparations for therapeutic use. 1
(b) other than for therapeutic use. 1,4
Salbutamol in metered aerosols or in dry 32
powder formulations.
Salicylamide 34 or 35
Sassafras oil
(a) in preparations for therapeutic use. 1
(b) other than for therapeutic use. 1,4
Selenium compounds except when for 1,4,8
therapeutic use (human or animal).
Silver in smoking deterrents. 42
Sitaxentan 7, 62, 76
Sodium aluminate 2 1,4
Sodium chlorate 1,4
Sodium dodecylbenzene sulfonate 79 1
Sodium fluoride in preparations for 43
human ingestion when in Schedule 2.
Sodium hydrogen sulfate 1,4,8
Sodium hydrosulfite 5,26 1,4,8
(more than 50 per cent)
Sodium hydroxide
(a) in preparations containing 0.5 per cent 5 1,4,6
or less of sodium hydroxide.
(b) in solid preparations containing more than 2,10,78 3,5,28
0.5 per cent of sodium hydroxide.
(c) in liquid preparations containing more than 2,10,78 3,5
0.5 per cent of sodium hydroxide.
Sodium laureth-6 carboxylate 79 1
Sodium metabisulphite 5,26 1,4
(more than 50 per cent)
Sodium nitrite in pickling or curing salts 94
Sodium persulfate 5,21,25 1,5,23,33,34
Sodium sulfide 2 1,4
Styrene 1,4,8
Sulfamic acid 2 1,4
Sulfuric acid 2 1,4
Symphytum spp. (Comfrey) when included in Schedule 5. 31,32
Tazarotene for topical use. 77,62
Terbutaline in metered aerosols or in dry powder formulations. 32
Terfenadine 61
Teriflunomide. 7,62,87
Terpenes, chlorinated 1,4,8
Tetrachloroethane 12 8
Tetrachloroethylene when in Schedule 5 or 6. 12,16 1,4,8,11
Tetrahydrozoline in nasal preparations for topical use. 29
Thalidomide 7,62,76
Thiourea 1,4
Toluene 1,4,8
Toluenediamine
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Tramazoline in nasal preparations for topical use. 29
Tretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Triamcinolone when in topical preparations 64 or 68
for the treatment of mouth ulcers.
Trichloroacetic acid except when for 2 1,4
therapeutic use.
1,1,1-trichloroethane 8,9
Trichloroethylene except when for 12 1,4,5,8,9
therapeutic use.
Trichlorophenol 1,4,8
Triethanolamine 5 1,4
Triethyl phosphate 1,4,8
Trifluoromethanesulfonic acid
(a) more than 10 per cent. 1,17 1,4,8
(b) 10 per cent or less. 1,4,8
Triisopropanolamine lauryl ether sulfate 1,4,6
3,6,9-Trioxaundecanedioic acid 5 1
Tymazoline in nasal preparations for topical use. 29
Vinclozolin 46
Xylene 1,4,8
Xylometazoline in nasal preparations for topical use. 29
Zinc chloride 1,4
Zinc sulfate when in Schedule 6. 1,4
APPENDIX G
DILUTE PREPARATIONS
The requirements of this Standard do not apply to a poison listed in Column 1 of this Appendix at a concentration not more than that specified in Column 2 in respect of that poison.
Column 1 Column 2
Poison Concentration
(quantity per litre
or kilogram)
ACETYLCHOLINE 1 mg
ALDOSTERONE 10 micrograms
ANTIMONY COMPOUNDS 1 mg
APOMORPHINE 1 mg
ARSENIC 1 mg
ATROPA BELLADONNA (belladonna) 300 micrograms
ATROPINE 300 micrograms
CANTHARIDIN 10 micrograms
CHLORINE 5 mg
CROTON TIGLIUM (croton oil) 1 mg
DIOXANE 100 mg
ERYSIMUM spp. 1 mg
FOLLICLE-STIMULATING HORMONE 100 micrograms
GELSEMIUM SEMPERVIRENS 1 mg
GLUCAGON 100 micrograms
GLYCERYL TRINITRATE 100 micrograms
GROWTH HORMONE 10 micrograms
HALOPERIDOL 1 mg
HYDROCYANIC ACID 1 microgram
HYOSCINE 300 micrograms
HYOSCYAMINE 300 micrograms
HYOSCYAMUS NIGER 300 micrograms
HYPOTHALAMIC RELEASING FACTORS 10 micrograms
INDOMETHACIN 1 mg
MERCURY 1 mg
METHYLMERCURY 300 micrograms
NAPHTHALENE 1 mg
NERIUM OLEANDER 1 mg
OESTRADIOL 10 micrograms
OESTRONE 100 micrograms
OXYTOCIN 1 microgram
PHOSPHORUS 1 mg
PODOPHYLLUM RESIN (podophyllin) 1 mg
PROGESTERONE 1 mg
PROPRANOLOL 1 mg
SELENIUM 100 micrograms
STROPHANTHUS spp. 1 mg
STRYCHNINE 1 mg
TESTOSTERONE 1 mg
THYROXINE 10 micrograms
APPENDIX H
SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED
Butoconazole.
Clotrimazole.
Diclofenac.
Dimenhydrinate for the prevention and relief of motion sickness.
Diphenoxylate.
Econazole.
Fluconazole.
Hydrocortisone.
Miconazole.
Nystatin.
APPENDIX I
UNIFORM PAINT STANDARD
This Appendix provides regulations for adoption by the States and Territories.
1. A person must not manufacture, sell, supply or use a First Schedule Paint for application to:
(1) a roof or any surface to be used for the collection or storage of potable water; or
(2) furniture; or
(3) 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
(4) 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 Third Schedule 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 containing a pesticide except a fungicide, algicide, bactericide or antifouling agent.
The First Schedule
The proportion of a substance for the purposes of this Schedule 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 more than 5 per cent
antimony titanate pigments
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, more than 5 per cent
sodium, strontium or zinc
SELENIUM or selenium compounds more than 0.1 per cent
The Second Schedule
Substance Proportion
CHROMIUM as chromates of ammonia, more than 5 per cent
barium, calcium, iron, potassium, sodium,
strontium or zinc
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
The Third Schedule
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
LEAD or lead compounds more than 0.1 per cent
APPENDIX J
CONDITIONS FOR AVAILABILITY AND USE OF
SCHEDULE 7 POISONS
PART 1
CONDITIONS FOR AVAILABILITY AND USE
The following controls are recommended for poisons only when included in Schedule 7. These conditions for availability and use may be implemented through poisons controls or other State or Territory legislation.
1. Not to be available except to authorised or licensed persons.
2. Not to be used in printing inks.
3. Not to be used except by or in accordance with the directions of accredited government vermin control officers.
4. Not to be used in industries which handle, process or store foods, animal feeds or packaging materials.
APPENDIX J
PART 2
A poison listed in this Appendix is to be available only in accordance with the conditions specified beside it in the “Conditions” column. The conditions apply only when the poison is included in Schedule 7.
_________________________________________________________________________________
POISONS CONDITIONS
_________________________________________________________________________________
Abamectin 1
Acibenzolar-s-methyl 1
Acrolein 1
Acrylonitrile 1
Alachlor 1
Allyl alcohol 1
4-Aminopyridine 1
Arprinocid 1
Arsenic 1
Azocyclotin 1
Benzene 1
Bifluorides (including ammonium, potassium and sodium salts) 1
Boron trifluoride 1
Brodifacoum 1
Bromadiolone 1
Bromine 1
Brucine 1
Calciferol 1
Captafol 1
Carbadox 1
Carbon tetrachloride 1
Carbonyl sulphide 1
Chlordecone 1
Chlordimeform 1
Chlorine 1
Chloromethiuron 1
Chloropicrin 1
4-Chloro-o-toluidine 1
Colecalciferol 1
Coumatetralyl 1
Cyanogen 1
Cyhexatin 1
4,4-Diaminodiphenylmethane (methylene dianiline) 1
1,2-Dibromo-3-chloropropane 1
1,3-Dichloropropene 1
Difenacoum 1
4-Dimethylaminoazobenzene 1
Dinitrocresols 1
Dinitrophenols 1
Dinoseb 1
Epichlorohydrin 1
Epidermal growth factor 1
Etaconazole 1
Ethylene dibromide 1
Ethylene oxide 1
Fluoracetamide 3
Fluoroacetic acid 3
Folpet 1
Halofuginone 1
Halogenated dibenzodioxins and dibenzofurans 1
HCB 1
Hydrocyanic acid and cyanides 1
Hydrofluoric acid 1
Hydrosilicofluoric acid 1
Iodomethane 1
Maduramicin 1
Mercury 1
Methacrifos 1
Methoxyethylmercuric acetate 1
Methoxyethylmercuric chloride 1
Methyl bromide 1
4,4’-Methylenebis[2-chloroaniline] 1
Mirex 1
Molinate 1
Nicotine 1
Nitrofen 1
Phenylmercuric acetate 1
Phosphides, metallic 1
Phosphine 1
Propylene oxide 1
Pyrinuron 1
Strychnine 1
Sulcofuron 1
Tetrachloroethane 1
2,2’,6,6’-Tetraisopropyl-diphenyl-carbodiimide 1
Thallium 3
ortho-Tolidine 1
Trichloroisocyanuric acid 1
Vinyl chloride 1
APPENDIX K
DRUGS REQUIRED TO BE LABELLED
WITH A SEDATION WARNING
(see Part 2, Labels and Containers, subparagraph 14(2))
Alprazolam
Amisulpride
Amitriptyline
Amylobarbitone
Aripiprazole
ASENAPINE
Azatadine
Baclofen
Benztropine
Bromazepam
Brompheniramine
Buclizine
Buprenorphine
Butobarbitone
Cetirizine
Chloral hydrate
Chlordiazepoxide
Chlormethiazole
Chlorpheniramine
Chlorpromazine
Clemastine
Clomipramine
Clonazepam
Clonidine
Clorazepate
Clozapine
Codeine except when included in Schedule 2 or 3.
Cyclizine
Cyclobarbitone
Cycloserine
Cyproheptadine
Cysteamine
Dantrolene
Desipramine
Dexchlorpheniramine
Dextromoramide
Dextropropoxyphene
Diazepam
Difenoxin
Dihydrocodeine
Dimenhydrinate
Dimethindene
Diphenhydramine
Diphenoxylate
Diphenylpyraline
Dothiepin
Doxepin
Doxylamine
Dronabinol (delta-9-tetrahydrocannabinol)
Droperidol
Duloxetine
Ethylmorphine
Fenfluramine
Flunitrazepam
Flupenthixol
Fluphenazine
Flurazepam
Gabapentin
Gemcitabine
Glutethimide
Haloperidol
Hydrocodone
Hydromorphone
Hydroxyzine
Imipramine
Lamotrigine
Levetiracetam
Levocabastine
Lorazepam
LURASIDONE.
Mazindol
Mebhydrolin
Meclozine
Medazepam
Meprobamate
Mepyramine
Methadone
Methdilazine
Methocarbamol
Methylphenobarbitone
Mianserin
Mirtazapine
Morphine
NABIXIMOLS .
Nalbuphine
Nitrazepam
Normethadone
Nortriptyline
Olanzapine
Opium in any form except the alkaloids noscapine and papaverine.
Oxazepam
Oxycodone
Paliperidone
Papaveretum
Pentazocine
Pentobarbitone
PERAMPANEL
Pericyazine
Perphenazine
Pethidine
Phenelzine
Pheniramine
Phenobarbitone
Phenoperidine
Phenyltoloxamine
Pholcodine
Pimozide
Pizotifen
Prazepam
Pregabalin
Prochlorperazine
Promazine
Promethazine
Protriptyline
Quetiapine
Quinalbarbitone
RETIGABINE
Risperidone
Rotigotine
RUPATADINE
Secbutobarbitone
TAPENTADOL
Temazepam
Thenyldiamine
Thiethylperazine
Thiopropazate
Thioridazine
Thiothixene
Tramadol
Tranylcypromine
Trifluoperazine
Trimeprazine
Trimipramine
Triprolidine
Ziprasidone
Zolpidem
Zonisamide
Zopiclone
APPENDIX L
REQUIREMENTS FOR DISPENSING LABELS FOR
HUMAN AND VETERINARY MEDICINES
PART 1
GENERAL REQUIREMENTS FOR DISPENSING LABELS
(see Part 2, Labels and Containers, subparagraph 14(1))
(1) All details, words and other required information on a label on a container of a substance for therapeutic use must be in the English language in letters at least 1.5 millimetres in height.
(2) All symbols, numbers and words on a label must be in durable characters.
(3) The label on a container of a substance for therapeutic use must contain the following details:
(a) the name, address and telephone number of the dispenser supplying the substance;
(b) the approved name of the substance and/or its proprietary name (unless it is a preparation compounded in accordance with the dispenser’s own formula);
(c) adequate directions for use;
(d) the strength and form of the substance;
(e) the total quantity of the goods in the container;
(f) the words “KEEP OUT OF REACH OF CHILDREN” in red on a white background;
(g) if the substance is intended for external use only, the word “POISON”, or the words “FOR EXTERNAL USE ONLY”, in red on a white background;
(h) if the substance is a medicine, the name of the person for whom it was dispensed; and
(i) if the substance is a veterinary chemical, the species of animal, the name of the animal’s owner and the words “FOR ANIMAL TREATMENT ONLY”.
(4) The label on a container of a medicine or veterinary chemical that is supplied on prescription must also include:
(a) the prescription reference number;
(b) the date on which the prescription was supplied (unless that date is clear from the prescription reference number); and
(c) the directions for use set out in the prescription.
APPENDIX L
PART 2
ADDITIONAL LABELLING REQUIREMENTS FOR CERTAIN HUMAN MEDICINES
(see Part 2, Labels and Containers, subparagraph 14(2))
Medicines required to be labelled with certain warning statements A substance listed in Column 1 of the following table must be labelled with the warning statement in Appendix F, Part 1, as specified opposite in Column 2.
______________________________________________________________
Column 1 Column 2
Substance Warning statement
______________________________________________________________
Acitretin:
(i) for oral use. 7,62 and 76
(ii) for topical use. 62 and 77
Adapalene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Ambrisentan. 7, 62 and 76
Bexarotene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Bosentan. 7, 62 and 76
Dienestrol. 67
Etretinate:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Fingolimod. 76
Isotretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Leflunomide. 7, 62 and 76
Lenalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Levocabastine. 62
Misoprostol. 53
Sitaxentan. 7, 62 and 76
Teriflunomide. 7, 62 and 87
Thalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Tretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
