Sch 9Prohibited 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.
Start here
Get a plain-English read of Sch 9
Turn the raw legal text into a practical explanation grounded in Poisons Standard 2015.
Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
Schedule 10/
Appendix C. Substances of such danger to health as to warrant prohibition of sale, supply and use - Substances which are prohibited for the purpose or purposes listed for each poison.
PRINCIPLES OF SCHEDULING
Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.
This Standard lists poisons in 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.
Schedule 10/Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties.
Substances in products which have been considered for scheduling, but have been exempted from this Standard, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
READING THE SCHEDULES
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Schedule Sch 9 - Poisons Standard 2015 - 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. | Zoe
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 and B, the Index and the Cross Reference 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, 10, 8, 4, 7, 3, 2, 6, 5.
Schedule 1 is not currently in use.
Some substances in certain circumstances are also subject to exemptions or additional restrictions as described in the Appendices of this Standard. The table below summarises the purpose of each of the Appendices and the controls imposed on substances included in them.
Appendix
Title
Purpose/ controls imposed
Appendix A
General exemptions
List of classes of products or uses exempted from this Standard.
Appendix B
Substances considered not to require control by scheduling
List of poisons exempted from scheduling.
Appendix C
Appendix is intentionally left blank
Appendix D
Additional controls on possession or supply of poisons included in Schedule 4 or 8
List of poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply.
Appendix E
First aid instructions for poisons
First aid instructions for poisons (other than agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).
Appendix F
Warning statements and general safety directions for poisons
Warning statements and general safety directions for poisons (other than human medicines, agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).
Appendix G
Dilute preparations
Concentration cut-offs for specified poisons, below which the requirements of the Standard do not apply
Appendix H
Schedule 3 medicines permitted to be advertised
List of medicines included in Schedule 3 that are permitted to be advertised to the public.
Appendix I
Appendix is intentionally left blank
Appendix J
Conditions for availability and use of Schedule 7 poisons
List of poisons included in Schedule 7 where additional specified conditions apply to their availability and use.
Appendix K
Human medicines required to be labelled with a sedation warning
List of human medicines required to be labelled with a warning regarding their sedation potential.
Appendix L<br>
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;
(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 Section 1.1 to Section 1.5.3 of this Standard by the Therapeutic Goods Administration, the National Manager or their delegate;
(i) in Victoria, the Secretary to the Department of Health;
(j) in Western Australia, the Chief Executive Officer of the Department of Health.
“Approved name” means:
(a) in relation to a poison that is for human therapeutic use, the name approved for use by the Therapeutic Goods Administration;
(b) in relation to a poison that is for animal or agricultural use, the name approved for use by the Australian Pesticides and Veterinary Medicines Authority;
(c) in relation to all other poisons:
(i) the name used in an entry in these Schedules; or, if no such name is given,
(ii) the English name recommended by Standards Australia as the common name for the poison; or, if no such name is given,
(iii) the English name given to the poison by the International Organization for Standardization; or, if no such name is given,
(iv) the English name given to the poison by the British Standards Institution; or, if no such name is given,
(v) the name that would comply with the requirements of part (a) or (b) of this definition, or, if no such name is given,
(vi) the English name given to the poison by the European Committee for Standardization (CEN); or, if no such name is given,
(vii) the international non-proprietary name recommended for the poison by the World Health Organization; or, if no such name is given,
(viii) the International Nomenclature Cosmetic Ingredient name for the poison listed in the International Cosmetic Ingredient Dictionary & Handbook published by the Personal Care Products Council of America; or, if no such name is given,
(ix) the accepted scientific name or the name descriptive of the true nature and origin of the poison.
“Australian Code for the Transport of Dangerous Goods by Road and Rail” means the seventh edition of the document of that name.
“Authorised prescriber” means a registered medical, dental or veterinary practitioner or such other person authorised by the appropriate authority.
“Blood” means whole blood extracted from human donors.
“Blood components” means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except for products derived through fractionation of plasma.
“Child-resistant closure” means:
(a) a closure that complies with the requirements for a child-resistant closure in the Australian Standard AS 1928-2007 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) a closure approved by an order made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(c) in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”.
See also "Non-access packaging”.
“Child-resistant packaging” means packaging that:
(a) complies with the requirements of the Australian Standard AS 1928-2007 entitled
Child resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) is reclosable and complies with the requirements of at least one of the following Standards:
(i) the International Organization for Standardization Standard ISO 8317:2003 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages;
(ii) the British Standards Institution Standard BS EN ISO 8317:2004 entitled
Child-resistant packaging. Requirements and testing procedures for reclosable packages;
(iii) the Canadian Standards Association Standard CSA Z76.1-06 entitled Reclosable Child-Resistant Packages;
(iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, entitled Poison prevention packaging standards and Section 1700.20, entitled Testing procedure for special packaging;
(c) is approved as child-resistant by any order made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(d) is in the form of blister or strip packaging in which a unit of use is individually protected until the time of release and that complies with Section 3 (Requirements for non-reclosable packages) of Australian Standard AS 1928-2001 entitled Child-resistant packages.
See also "Non-access packaging".
“Compounded” in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.
“Cosmetic” means:
(a) a substance or preparation intended for placement in contact with any external part of the human body, including:
(i) the mucous membranes of the oral cavity; and
(ii) the teeth;
with a view to:
(iii) altering the odours of the body; or
(iv) changing its appearance; or
(v) cleansing it; or
(vi) maintaining it in good condition; or
(vii) perfuming it; or
(viii) protecting it.
“Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
“Dermal use” means application to the skin primarily for localised effect.
“Designated solvent” means the following:
acetone
dimethylformamide
N-(N-dodecyl)-2-pyrrolidone
hydrocarbons, liquid
methanol when included in Schedule 5
methyl ethyl ketone
methyl isoamyl ketone
methyl isobutyl ketone
N-methyl-2-pyrrolidone
N-(N-octyl)-2- pyrrolidone
phenyl methyl ketone
styrene
tetrachloroethylene
1,1,1-trichloroethane
“Dispensing label” means the label attached to the immediate container of a substance for therapeutic use at the time of dispensing.
“Distributor” means a person who imports, sells or otherwise supplies a poison.
“Divided preparation” means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
“Dosage unit” means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
“Drug” means a poison intended for human or animal therapeutic use.
“Essential oils” means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. For scheduling purposes it also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) prepared mixtures of oils of equivalent composition comprising a mixture of synthetic and natural components.
“External” in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
“First Schedule Paint” means a paint containing the specified proportion of any substance in the First Group to Part 2 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 Group to Part 2 Section 7 of this Standard.
“Selected container” means:
(a) an injection vial having a nominal capacity of ten millilitres or less;
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.
“Solid” is considered to include “powder” for the purposes of scheduling.
“Therapeutic good” has the meaning defined in the Commonwealth Therapeutic Goods Act 1989.
“Therapeutic use” means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals;
(b) influencing, inhibiting or modifying a physiological process in human beings or animals;
(c) testing the susceptibility of human beings or animals to a disease or ailment;
(d) influencing, controlling or preventing conception in 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.
“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;
(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,
(h) a preparation or product included in Appendix A, or a substance and the reason for its entry in Appendix B; or
(i) a substance included in Appendix G at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of that substance; or
(j) any other substance included in Schedules 1 to 6, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8; or
(k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the Standards for Active Constituents, as published by the Australian Pesticides and Veterinary Medicines Authority.
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a Schedule or an Appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
(4) A reference to a boiling or distillation temperature in the Schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).
PART 2
CONTROL ON MEDICINES AND POISONS
SECTION ONE LABELS
1.1 General requirements
(1) A person must not sell or supply a poison unless it is labelled in accordance with Part 2 Section 1 of this Standard .
(2) Any word, expression or statement required by this Standard to be written on a label or container must be written:
(a) on the outside face of the label or container; and
(b) in the English language; and
(c) in durable characters; and
(d) in a colour or colours to provide a distinct contrast to the background colour; and
(e) in letters at least 1.5 millimetres in height.
(3) Section 1.1(2)(e) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:
(a) an appropriate authority approves the use of smaller letters; and
(b) the letters are at least 1 millimetre in height.
(4) The label must be printed on, or securely attached to:
(a) the outside of the immediate container; and
(b) if the immediate container is enclosed in a primary pack, the outside of that primary pack.
1.2 Immediate wrapper
(1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with Section 1.3 of this Standard; and
(2) the immediate wrapper must be conspicuously labelled with:
(a) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and
(b) the approved name of the poison; and
(c) a statement of the quantity or strength of the poison in accordance with Section 1.4 of this Standard.
1.3 Primary packs and immediate containers
(1) The primary pack and immediate container of a poison must be labelled as follows:
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
(i) on the first line or lines of the main label; 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
(i) on a separate line or lines immediately below the signal words required by Section1.3(1)(a); 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
(i) on a separate line or lines:
(A) immediately below the signal word or words required by Section 1.3(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by Section 1.3(1)(b), on the line immediately below that statement; and
(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
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section 1.3(1)(c); and
(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
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section 1.3(1)(c); and
(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
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section1.3(1)(c); and
(iii) in letters at least four-tenths the height of the letters used for the signal words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;
(g) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if safety directions are required on the label by Section 1.3(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section (1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(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 –
written on the main label in bold-face sans serif capital letters of uniform thickness;
(j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written in sans serif capital letters on the main label or as part of the directions for use;
(k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with Section 1.4:
(i) if the poison is for human therapeutic use, written in accordance with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sans serif capital letters on the main label, unless:
(A) 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 Section 1.3(1)(l) do not apply to:
(A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or
(C) an organophosphorus compound or carbamate contained in a
pressurised spray pack for household use;
(m) for any poison other than a poison for human therapeutic use labelled in accordance with Therapeutic Goods Order 69 General requirements for labels for medicines or in an agricultural or veterinary chemical product labelled in compliance with the Agricultural and Veterinary Chemicals Code Act 1994, if the poison is prepared, packed or sold for a specific purpose, with clear and adequate directions for use unless:
(i) the poison is included in Schedule 4 or Schedule 8; or
(ii) it is impractical to include such directions on the label and:
(A) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”; and
(B) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label; and
(C) the insert is enclosed in the primary pack;
(n) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if use of the poison may be harmful to the user, with appropriate safety directions (see Appendix F), grouped together as a distinct section of the label and prefaced by the words –
SAFETY DIRECTIONS
written in bold-face capital letters;
(o) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if any warning statement or statements are required for the poison (see Appendix F), with that warning statement or those statements grouped together:
(i) if safety directions are included on the label, immediately after the words “SAFETY DIRECTIONS”; or
(ii) if there are no safety directions, immediately preceding the directions for use;
(p) if the poison is not for human internal use and is not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):
(i) grouped together and prefaced by the words –
FIRST AID
written in bold-face capital letters; or
(ii) if a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:
(A) written on each immediate container as specified in Section 1.3(1)(p)(i); and
(B) replaced on the primary pack with the statement –
FIRST AID: See inner packs;
(q) with the name and address of the manufacturer or distributor.
(2) For the purposes of Section 1.3(1)(a)(iii) the term “largest letter or numeral” does not include:
(a) a single letter or numeral which is larger than other lettering on the label; or
(b) an affix forming part of the trade name; or
(c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.
1.4 Statements of quantity, proportion or strength
(1) The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(a) if the poison is for human therapeutic use, in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989;
(b) if the poison is for a purpose or purposes other than human therapeutic use and:
(i) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(ii) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(iii) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;
(iv) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(v) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(vi) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(vii) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(viii) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;
(c) if the poison is a solution of a mineral acid, the proportion of the acid (un-neutralised by any bases present in the preparation) in a preparation may be expressed as the un-neutralised mass of the acid per stated mass of the preparation;
(d) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:
contains not more than 10 per cent of (insert name of the metal); or
contains not more than 30 per cent of (insert name of the metal); or
contains more than 30 per cent of (insert name of the metal);
(e) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;
(f) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;
(g) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.
(h) For the purposes of Section 1.4(1)(g) “derivative” includes alkaloid.
1.5 Exemptions
1.5.1 Selected containers and measure packs
(1) The requirements of Section 1.3 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which Section 1.5.2 (1) and (2) apply) when:
(a) the immediate container is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the immediate container is:
(ii) labelled with:
(A) the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to Section 1.3(1)(a); and
(B) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; and
(C) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(D) if the poison is for the treatment of animals, with the cautionary statement –
written in sans serif capital letters.
1.5.2 Ampoules, pre-filled syringes and injection vials
(1) The requirements of Section 1.3 do not apply to a selected container, or an ampoule (other than an ampoule to which Section 1.5.2(2) applies) when:
(a) the selected container or ampoule is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the selected container or ampoule is:
(ii) labelled with:
(A) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; and
(B) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(C) if the poison is for the treatment of animals, with the cautionary statement –
written in sans serif capital letters.
(2) The requirements of Section 1.3 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(a) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is:
(ii) the strip is labelled in accordance with Section 1.5.2; and
(iii) the ampoule is labelled with:
(A) the approved name of the poison or the trade name of the product; and
(B) the quantity, proportion or strength of the poison in accordance with Section 1.4.
1.5.3 Transport containers and wrappings
(1) The labelling requirements of this Standard do not apply to a transparent cover, or to any wrapper, hamper, packing case, crate or other cover used solely for the purposes of transport or delivery.
1.5.4 Dispensary, industrial, laboratory and manufacturing poisons
(1) The labelling requirements of this Standard do not apply to a poison that:
(a) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and
(b) is labelled in accordance with Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)].
1.5.5 Exemptions from label requirements in certain circumstances
(1) The labelling requirements of Sections 1.3 to 1.5.3 do not apply to a poison where an appropriate authority has granted a labelling exemption in whole or in part for these sections for a specified product; and
(2) the labelling exemption from an appropriate authority referred to in Section 1.5.5(1) is limited to no more than 12 months from the effective date of the decision for retail supply of the product; and
(3) for the avoidance of doubt this paragraph does not apply to exemptions issued under Section 1.3(1)(m)(ii)(B) of this Standard.
1.5.6 Dispensed medicines
(1) Unless otherwise specified by regulation:
(a) The labelling requirements of this Standard do not apply to a medicine that:
(i) is supplied by an authorised prescriber or other person authorised to supply and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(ii) is supplied on and in accordance with a prescription written by an authorised prescriber and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(iii) is prepared and supplied by a pharmacist for an individual patient and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard.
(b) A person must not supply a dispensed medicine for human use containing:
a poison listed in column 1 of the table at Appendix L Part 2 of this Standard unless it is clearly labelled with the warning statement(s) specified in column 2 of that table; or
(ii) a poison listed in Appendix K unless it is clearly labelled with a sedation warning (being statement 39, 40 or 90 as specified in Appendix F Part 1 of this Standard).
1.5.7 Gas cylinders
(1) The requirements of Sections 1.3(1)(a)(iv), 1.3(1)(c)(iv), and 1.3(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.
1.5.8 Paints
(1) The requirements of Section 1.3 do not apply to:
(a) paint (other than a paint for therapeutic or cosmetic use) which:
(i) contains only Schedule 5 poisons; or
(ii) is a First Group or Second Group paint that is labelled with:
(A) the word “WARNING”, written in bold-face sans serif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line; and
(B) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sans serif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and
(C) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(D) the name and proportion of the First Group or Second Group poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint; or
(b) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Group or Second Group in Part 2 Section 7, provided that it is labelled with the name and proportion of that poison, and where the poison is a metal or metal salt, the proportion is expressed as the metallic element present as “calculated on the non-volatile content” or “in the dried film”.
1.5.9 Camphor and naphthalene
(1) The labelling requirements of Section1.1(2)(d) and Section 1.3 do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:
(1) complies with Section 2.7; and
(2) is sold or supplied in a primary pack labelled in accordance with Section 1.1 and Section 1.3.
1.6 Prohibitions
(1) A label used in connection with any poison must not include:
(a) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or
(b) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or
(c) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or
(d) any trade name or description that:
(i) represents any single constituent of a compound preparation; or
(ii) misrepresents the composition or any property or quality of the poison; or
(iii) gives any false or misleading indication of origin or place of manufacture of the poison.
(2) A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure:
(a) any expression required by this Standard to be written or embossed on the container or pack; or
(b) any of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as appropriate.
SECTION TWO CONTAINERS
2.1 Containers for poisons other than Schedule 5 poisons
(1) A person must not sell or supply a poison unless the immediate container complies with the requirements of Sections 2.1 and 2.3 to 2.7 of this Standard.
(2) If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of 2 litres or less, the container must comply with Australian Standard AS 2216-1997, entitled Packaging for poisonous substances.
(3) Notwithstanding Section 2.1(2), a poison which is in Schedule 6 and is an essential oil may be packed in an amber glass container which does not comply with the tactile identification requirements of Australian Standard AS 2216-1997, entitled Packaging for poisonous substances, if:
(a) the other safety factors are not diminished; and
(b) the container has a restricted flow insert and a child-resistant closure.
(4) If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of more than 2 litres, the container must:
(a) comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances; and
(b) have the word “POISON”:
(ia) in sans serif capital letters the height of which is at least one thirty second part of the length, height or width of the container, whichever is the greatest:
(A) embossed; or
(B) indelibly written in a colour in distinct contrast to the background colour;
(ii) on the side or shoulder of the container.
2.2 Containers for Schedule 5 poisons
(1) The container in which any Schedule 5 poison is sold or supplied must:
(a) comply with the container requirements of Sections 2.1(2) or 2.1(4); or
(b) be readily distinguishable from a container in which food, wine or other beverage is sold; and
(i) comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances, excluding paragraph 1.4.3;
(ii) be securely closed and, except when containing a preparation for use on one occasion only, be capable of being re-closed to prevent spillage of its contents; and
(iii) have the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” embossed or indelibly written thereon, or printed on a permanent adhesive label designed to adhere to a substrate without lifting and which cannot be removed without damaging either the label or the substrate.
(2) Notwithstanding Section 2.2(1), the following Schedule 5 poisons namely:
(a) methylated spirit(s);
(b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in Section 2.1(2).
2.3 Approved containers
(1) Notwithstanding 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 Section 2.1(4)(b) or Section 2.2(1)(b)(iii) if:
(a) the other safety factors are not diminished;
(b) the container is for a specific purpose; and
(c) an appropriate authority has approved the use of the container for that purpose.
2.4 Child-resistant closures
(1) If a poison, other than a poison included in a therapeutic good packaged in a manner compliant with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989, listed in column 1 of the following table is sold or supplied in a container having a nominal capacity specified for that poison in column 2, it must be closed with a child-resistant closure.
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.
2.5 Schedule 8 poisons
(1) A person who supplies any Schedule 8 poison must ensure that the Schedule 8 poison is packaged in such a way that its primary pack is so sealed that, when the seal is broken, it is readily distinguishable from other sealed primary packs.
(2) This paragraph does not apply to the supply of a Schedule 8 poison by an:
(a) authorised prescriber or other authorised supplier;
(b) pharmacist on the prescription of an authorised prescriber;
(c) pharmacist employed at a hospital, on the written requisition of a medical practitioner, a dentist or the nurse or midwife in charge of the ward in which the Schedule 8 poison is to be used or stored; or
(d) nurse or midwife on the direction in writing of an authorised prescriber.
2.6 Exemptions
(1) Section 2.1(2), Section 2.1(4) and Section 2.2 do not apply to the immediate container of a poison prepared, packed and sold:
(a) for human internal or animal internal use; or
(b) as a solid or semi-solid preparation for human external or animal external use; or
(c) as a paint, other than a paint for therapeutic or cosmetic use; or
(d) in containers having a nominal capacity of 15 millilitres or less; or
(e) for use in automatic photographic or photocopy processing machines if the container is specifically designed to fit into the machines; or
(f) solely for dispensary, industrial, laboratory or manufacturing purposes.
(2) Section 2.4 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.
(3) The tactile identification or embossing required by Section 2.1(2), Section 2.1(4) and Section (2.2) of this Standard or Australian Standard AS 2216-1997 entitled Packaging for poisonous substances do not apply to a container that is an aerosol container, a collapsible tube, or a measure pack which is a flexible sachet.
2.7 Camphor and naphthalene
(1) The container requirements of Section 2.1(2) do not apply to a device that contains only camphor or naphthalene in block, ball, disc, pellet or flake form for domestic use, if the device:
(a) in normal use, prevents removal or ingestion of its contents; and
(b) is incapable of reacting with the poison; and
(c) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and
(d) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.
(2) A person must not sell or supply camphor or naphthalene in ball, block, disc, pellet or flake form for domestic use unless the balls, blocks, discs, pellets or flakes are enclosed in a device which prevents removal or ingestion of its contents.
2.8 Prohibitions
(1) A person must not sell or supply a poison in a container which has the name of another poison embossed or indelibly marked thereon.
(2) A person must not sell any poison which is for internal use or any food, drink or condiment in a container prescribed by Sections 2.1(2), 2.1(4) and Section 2.2 of this Standard.
(3) A person must not sell any poison in a container that is not readily distinguishable from a container in which food, alcohol, other beverage or condiment is sold..
SECTION THREE STORAGE
3.1 General requirements
A person who sells or supplies Schedule 6 poisons by way of retail sale must keep those poisons in such a way as to prevent access by children.
A person who sells or supplies Schedule 7 poisons must not keep those poisons for retail sale in any areas or in any area or in any manner that allows physical access by any person unless they are:
the owner of the retail establishment; or
an employee of the owner; or
legally permitted to purchase the substance and are under the supervision of the owner or an employee of the owner.
(3) Controls on storage of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.
SECTION FOUR DISPOSAL
4.1 General requirements
A person must not dispose of or cause to be disposed of a Schedule 5, Schedule 6 or Schedule 7 poison in any place or manner that constitutes or is likely to constitute a risk to public health or safety.
Controls on disposal of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.
SECTION FIVE RECORD KEEPING
5.1 General Requirements
A person who sells or supplies Schedule 7 poisons must keep a record of:
(a) Name and address of seller or supplier and purchaser; and
(b) Date of order and supply; and
(c) Approved name or trade name that identifies the poison to be supplied or sold; and
(d) Quantity supplied or sold; and
(e) Proof of purchaser authorisation must be recorded in jurisdictions where an authorisation is required for purchase.
Records for sale or supply of Schedule 7 poisons must be kept for a minimum period of five years.
Controls on record keeping for sale or supply of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.
SECTION SIX SALE, SUPPLY, POSSESSION, or USE
6.1 General Requirements for Schedule 5 and Schedule 6 Product samples
A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in any manner unless the recipient has the opportunity to refuse at the time of sale or supply.
A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in an unsolicited manner for example via the post / mailbox or attached to any other product.
A person must not sell or supply a Schedule 5 or Schedule 6 poison product sample in a manner that does not promote disposal in accordance with section four.
6.2 Schedule 7 Poisons
A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.
A person must not sell or supply:
(a) a Schedule 7 poison for domestic or domestic garden purposes; or
(b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or
(c) a Schedule 7 poison for which an authorisation to purchase, possess or use is required by the appropriate authority unless the purchaser produces his or her authorisation.
A person must not sell, supply or distribute free product samples containing Schedule 7 poisons.
6.3 Schedule 10/Appendix C poisons
A person must not knowingly have in his or her possession or sell, supply or use a poison listed in Schedule 10/Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Schedule 10/Appendix C;
6.4 Hawking
A person must not sell by way of hawking a Schedule 7 poison.
Controls on sale or supply or sale by way of hawking of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.
SECTION SEVEN/Appendix I PAINT OR TINTERS
7.1 General Requirements
(1) A person must not manufacture, sell, supply or use a First Group Paint for application to:
(a) a roof or any surface to be used for the collection or storage of potable water; or
(b) furniture; or
(c) any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or
(d) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
A person must not manufacture, sell, supply or use a paint or tinter containing more than 0.1% Lead (the proportion of Lead for the purposes of this section is calculated as a percentage of the element present in the non-volatile content of the paint).
(3) A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD).
(4) A person must not manufacture, sell, supply, or use a paint or tinter containing a pesticide except a fungicide, algicide, bactericide or antifouling agent.
The First Group
The proportion of a substance for the purposes of this Group is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
ANTIMONY or antimony compounds other than 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 Group
Substance Proportion
DICHLOROMETHANE (methylene chloride) more than 5 per cent by wt
ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates more than 10 per cent by vol
TOLUENE more than 50 per cent by vol
XYLENE more than 50 per cent by vol
PART 3
MISCELLANEOUS REGULATIONS
(It is recommended that the States and Territories implement regulations which provide controls similar to those included in this Part of the Standard.)
SECTION ONE ADVERTISING
3.1 General requirements
(1) A person must not include any reference to a poison included in:
(a) Schedule 3 unless included in Appendix H; or
(b) Schedule 4 or Schedule 8,
of this Standard in any advertisement except in genuine professional or trade journals or other publications intended for circulation only within the medical, nursing, veterinary, dental or pharmaceutical professions or the wholesale drug industry.
(2) A person must not include any reference to a poison included in Schedule 9 or Schedule 10/Appendix C of this Standard in any advertisement.
SECTION TWO SALE OR SUPPLY
3.2 Schedule 2 poisons
(1) A person, other than a pharmacist (or an assistant under the direction of a pharmacist) or a medical, dental or veterinary practitioner in the lawful practice of their professions, must not sell or supply a Schedule 2 poison unless licensed to do so.
(2) A person is not eligible to be granted a licence to sell a Schedule 2 poison by way of retail sale unless:
(a) he or she is carrying on the business of selling goods by retail; and
(b) the premises from which the poison will be sold is more than 25 kilometres by the shortest practical route from the nearest pharmacy; and
(c he or she produces such evidence, as may be required, that he or she is a fit and proper person to be so licensed.
3.3 Schedule 3 poisons
(1) A person, other than a pharmacist, or a medical, dental or veterinary practitioner, in the lawful practice of his or her profession, must not sell or supply a Schedule 3 poison.
(2) The person who sells or supplies a Schedule 3 poison must:
(a) provide adequate instructions for use, either written or verbal, at the time of supply or sale; and
(b) label the container with his or her name or the name of the pharmacy and the address from which it was sold or supplied; and
(c) if required by regulation, make a record of the transaction in a prescription book or other approved recording system.
3.4 Schedule 4 poisons
(1) A person, other than a medical, dental or veterinary practitioner in the ordinary course of their professions or a pharmacist dispensing a legal prescription must not sell or supply a Schedule 4 poison.
(2) Section 3.4(1) does not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than a poison excepted by regulation from this provision, without a prescription if:
(a) the patient is under medical treatment with the poison and continuation of medication is essential; and
(b) the quantity sold or supplied does not exceed 3 days' medication; and
(c) the pharmacist is satisfied that an emergency exists.
(3) Section 3.2(1), Sections 3.3(1) and (2) and Section 3.4(1) do not apply to sale by way of wholesale dealing to a pharmacist, medical practitioner, veterinary practitioner, dentist or a person licensed or otherwise authorised to possess, sell or supply such poisons.
3.5 Prohibitions on sale, prescribing and possession
(1) A person must not:
(a) sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions indicated for that poison in Appendix D; or
(b) knowingly have in his or her possession a poison listed in Appendix D paragraph 5 without authority.
SECTION 3 STORAGE
3.6 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.
3.7 A person who sells or supplies Schedule 3 or Schedule 4 poisons must keep those poisons in a part of the premises to which the public does not have access.
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
(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
BROMHEXINE.
BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(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,
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:
in a primary pack containing not more than 5 days’ supply; and
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:
(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:
(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,
CICLOPIROX:
in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis; or
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:
not combined with any other opiate substance;
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:
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;
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:
(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,
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:
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;
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
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:
(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,
DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(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,
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:
(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:
in a primary pack containing 10 dosage units or less and not more than 5 days’ supply; and
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:
(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:
(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:
(b) in preparations containing 500 micrograms or less of folic acid per recommended daily dose.
FOLINIC ACID for human therapeutic use except:
(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:
in hair preparations containing 0.3 per cent or less of hydroquinone; or
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
(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
(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:
(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
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:
enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;
compliant with the requirements of the Required Advisory Statements for Medicine Labels;
not labelled for the treatment of children 6 years of age or less; and
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:
packed in blister or strip packaging or in a container with a child-resistant closure;
in a primary pack containing not more than 20 tablets or capsules;
compliant with the requirements of the Required Advisory Statements for Medicine Labels;
not labelled for the treatment of children 6 years of age or less; and
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:
(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,
PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:
(b) in preparations for external use containing 3 per cent or less of such substances.
PHENYLEPHRINE except:
(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:
(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,
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:
(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,
TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:
(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,
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:
BUCLIZINE in oral preparations.
BUTOCONAZOLE in preparations for vaginal use.
CHLORAMPHENICOL for ophthalmic use only.
CHLORBUTOL in preparations for human use except:
(b) in preparations containing 0.5 per cent or less of chlorbutol.
CHLORPHENIRAMINE in oral preparations except:
CICLOPIROX in preparations for dermal use and for application to the nails except:
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,
CYCLIZINE in preparations for oral use.
CYPROHEPTADINE in oral preparations.
DEXCHLORPHENIRAMINE in oral preparations except:
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,
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:
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:
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:
(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,
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:
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:
(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,
TRIPROLIDINE in oral preparations except:
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 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:
(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:
(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:
(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:
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:
(b) nisin.
ANTIGENS for human therapeutic use except when separately specified in this Schedule.
ANTIHISTAMINES except:
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:
(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:
(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.
BENDAMUSTINE.
BENDROFLUAZIDE.
BENETHAMINE PENICILLIN.
BENORYLATE.
BENOXAPROFEN.
BENPERIDOL.
BENSERAZIDE.
BENZATHINE PENICILLIN.
BENZHEXOL.
BENZILONIUM.
BENZOCAINE except:
(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:
(b) in preparations for external use containing 5 per cent or less of benzoyl peroxide.
BENZPHETAMINE.
BENZTHIAZIDE.
BENZTROPINE (benzatropine).
BENZYDAMINE except:
(b) in preparations for dermal use.
BENZYLPENICILLIN.
BEPRIDIL.
BERACTANT.
BESIFLOXACIN.
BETAHISTINE.
BETAMETHASONE.
BETAXOLOL.
BETHANECHOL CHLORIDE.
BETHANIDINE.
BEVACIZUMAB.
BEVANTOLOL.
BEXAROTENE.
BEZAFIBRATE.
BICALUTAMIDE.
BIFONAZOLE except:
(b) in preparations for dermal use containing 1 per cent or less of bifonazole for the treatment of the scalp; or
(c) in preparations for dermal use for the treatment of tinea pedis.
BIMATOPROST.
BIPERIDEN.
BISMUTH COMPOUNDS for cosmetic use, except:
(a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per or less; or
(b) bismuth oxychloride.
BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.
BISOPROLOL.
BIVALIRUDIN.
BLEOMYCIN.
BOCEPREVIR.
BOLANDIOL.
BOLASTERONE.
BOLAZINE.
BOLDENONE (dehydrotestosterone).
BOLENOL.
BOLMANTALATE.
BORON, including boric acid and borax, for human therapeutic use except:
(a) in preparations for internal use containing 6 mg or less of boron per recommended daily dose;
(b) in preparations for dermal use containing 0.35 per cent or less of boron, which are not for paediatric or antifungal use; or
(c) when present as an excipient.
BORTEZOMIB.
BOSENTAN.
BOSUTINIB.
BOTULINUM TOXINS for human use except when separately specified in these Schedules.
BRENTUXIMAB VEDOTIN.
BRETYLIUM 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 HYDROXYLAPATITE in preparations for injection or implantation:
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.
CARGLUMIC ACID (N-carbomoyl-L-glutamic acid)
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
(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.
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:
when included in Schedule 2 or 3; or
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:
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:
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.
CONVALLARIA KEISKI.
CONVALLARIA MAJALIS.
COPPER COMPOUNDS for human use except:
(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:
DASATINIB.
DATURA STRAMONIUM (stramonium) except:
(b) for smoking or burning.
DATURA TATULA (stramonium) except:
(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:
(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:
(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:
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.
ELOSULFASE ALFA.
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;
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:
(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:
(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:
when included in Schedule 2; or
in hair preparations containing 0.3 per cent or less of hydroquinone; or
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:
(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:
(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
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:
(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:
(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:
when included in Schedule 2; or
in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
in a primary pack containing 5 dosage units or less; and
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.
MACITENTAN for human use.
MAFENIDE except when included in Schedule 6.
MANDRAGORA OFFICINARUM.
MANNOMUSTINE.
MAPROTILINE.
MARAVIROC.
MARBOFLOXACIN.
MAROPITANT.
MAVACOXIB.
MAZINDOL.
MEASLES VACCINE.
MEBANAZINE.
MEBEVERINE.
MEBHYDROLIN.
MEBOLAZINE.
MEBUTAMATE.
MECAMYLAMINE.
MECASERMIN.
MECILLINAM.
MECLOCYCLINE.
MECLOFENAMATE.
MECLOFENOXATE.
MECLOZINE except when included in Schedule 2.
MEDAZEPAM.
MEDETOMIDINE.
MEDIGOXIN (methyldigoxin).
MEDROXYPROGESTERONE.
MEDRYSONE.
MEFENAMIC ACID except when included in Schedule 2.
MEFENOREX.
MEFLOQUINE.
MEFRUSIDE.
MEGESTROL.
MELAGATRAN.
MELATONIN for human use.
MELENGESTROL except when included in Schedule 6.
MELOXICAM.
MELPHALAN.
MEMANTINE.
MENINGOCOCCAL VACCINE.
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:
(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:
(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:
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
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.
NAPROXEN except when included in Schedule 3 or in Schedule 2.
NARASIN except:
(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:
(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.
OCLACITNIB.
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:
(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:
(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:
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
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,
PHOSPHODIESTERASE TYPE 5 INHIBITORS except:
(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:
PODOPHYLLUM EMODI (podophyllin) for human use:
PODOPHYLLUM PELTATUM (podophyllin) for human use:
POLIDEXIDE.
POLIOMYELITIS VACCINE.
POLYACRYLAMIDE in preparations for injection or implantation:
POLYCAPROLACTONE in preparations for injection or implantation:
POLYESTRADIOL.
POLYLACTIC ACID in preparations for injection or implantation:
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
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.
RIOCIGUAT.
RISEDRONIC ACID.
RISPERIDONE.
RITODRINE.
RITONAVIR.
RITUXIMAB.
RIVAROXABAN.
RIVASTIGMINE.
RIZATRIPTAN.
ROBENACOXIB.
ROCURONIUM.
ROFECOXIB.
ROFLUMILAST.
ROLITETRACYCLINE.
romidepsin.
ROMIFIDINE.
ROMIPLOSTIM.
RONIDAZOLE.
ROPINIROLE.
ROPIVACAINE.
ROSIGLITAZONE.
ROSOXACIN.
ROSUVASTATIN.
ROTIGOTINE.
ROXIBOLONE.
ROXITHROMYCIN.
RUBELLA VACCINE.
RUBOXISTAURIN.
RUPATADINE.
RUXOLITINIB.
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:
(b) when included in Schedule 3, 5 or 6; or
(c) when packed and labelled solely for use as a herbicide.
SULFONMETHANE (sulfonal and alkyl sulfonals).
SULINDAC.
SULTAMICILLIN.
SULTHIAME.
SUMATRIPTAN.
SUNITINIB.
SUPROFEN.
SUTILAINS.
SUXAMETHONIUM.
SUXETHONIUM.
SUVOREXANT.
TACRINE.
TACROLIMUS.
TADALAFIL.
TAFLUPROST.
TALIGLUCERASE ALFA.
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:
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:
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.
TRIETHANOLAMINE when in preparations for tattoo removal.
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:
in preparations containing 25 micrograms or less of vitamin D per recommended daily dose ; or
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
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
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:
(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:
(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:
(c) in preparations containing 0.4 per cent or less of bergamot oil;
(e) in medicines for human therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
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:
(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:
(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:
(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:
(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:
when impregnated in plastic resin strip material containing 4 per cent or less of deltamethrin;
in aqueous preparations containing 5 per cent or less of deltamethrin when no organic solvent other than a glycol is present;
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;
in water-dispersible tablets each containing 500 mg or less of deltamethrin in child-resistant packaging; or
in other preparations containing 0.5 per cent or less of deltamethrin,
in factory prepared mosquito nets containing 1 per cent or less deltamethrin; or
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:
(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
FLURALANER for the treatment and preventation of flea infestations and control of ticks in dogs in oral divided preparations each containing 1400 mg or less of fluralaner per dosage unit.
FLUVALINATE in aqueous preparations containing 25 per cent or less of fluvalinate.
FLUXAPYROXAD.
FORAMSULFURON.
FORMIC ACID (excluding its salts and derivatives) except in preparations containing 0.5 per cent or less of formic acid.
FOSPIRATE when impregnated in plastic resin strip material containing 20 per cent or less of fospirate.
FURALAXYL.
FURATHIOCARB in microencapsulated suspensions containing 50 per cent or less of furathiocarb.
GAMMA-CYHALOTHRIN in aqueous preparations containing 15 per cent or less of microencapsulated gamma-cyhalothrin.
GLUFOSINATE-AMMONIUM.
GLUTARALDEHYDE in preparations containing 5 per cent or less of glutaraldehyde except:
(b) in preparations containing 0.5 per cent or less of glutaraldehyde when labelled with the statements:
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
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:
(c) in preparations containing 0.05 per cent or less of lemon oil;
(e) in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
LEVAMISOLE in preparations containing 15 per cent or less of levamisole for the treatment of animals except:
(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:
(c) in preparations containing 0.5 per cent or less of lime oil;
(e) in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
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:
(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.
METHOFLUTHRIN in impregnated fabric mosquito repellent preparations for use in a vaporiser containing 15 mg or less of metofluthrin per disk.
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:
(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:
(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:
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
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:
(c) in preparations containing 1.4 per cent or less of orange oil (bitter);
(e) in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
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:
(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.
(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
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:
(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
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:
(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:
(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:
(b) containing 40 per cent or less of tetracycline when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.
(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:
(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:
(a) when in Schedule 4;or
(b) 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
ABAMECTIN:
in preparations for pesticidal use containing 4 per cent or less of abamectin except when included in Schedule 5; or
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:
(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:
(b) in preparations containing 20 per cent or less of alkoxylated fatty alkylamine polymer.
ALLETHRIN except:
(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,
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:
(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:
(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:
(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:
(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.
(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.
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:
(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:
(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,
BENQUINOX.
BENSULIDE.
BENZALKONIUM CHLORIDE except:
(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:
(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 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 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:
(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:
(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:
(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:
(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:
(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:
(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:
(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:
(b) in preparations containing 1 per cent or less of chlorhexidine; or
(c) when in solid preparations.
CHLORINATING COMPOUNDS except:
(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.
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:
(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:
(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:
(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:
(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:
(e) in preparations containing 25 per cent or less of cinnamon leaf oil.
CLIMBAZOLE except:
(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:
(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:
(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:
(f) in preparations containing 25 per cent or less of clove oil.
N-COCO-1,3-DIAMINOPROPANE.
COCOYL GLYCINATE in cosmetic preparations except:
(a) in leave-on preparations containing 5 per cent or less of cocoyl glycinate; or
(b) in wash-off preparations containing 30 per cent or less of cocoyl glycinate and, when containing more than 5 per cent of cocoyl glycinate labelled with a warning to the following effect:
IF IN EYES WASH OUT IMMEDIATELY WITH WATER.
COPPER ACETATE except:
(b) in preparations containing 5 per cent or less of copper acetate.
COPPER COMPOUNDS except:
(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:
(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:
(c) in marine paints; or
(d) in other preparations containing 5 per cent or less of copper oxides.
COPPER OXYCHLORIDE except:
(b) in preparations containing 12.5 per cent of less of copper oxychloride.
COPPER SULFATE except:
(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:
(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:
(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:
(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:
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;
in wettable granular preparations containing 25 per cent or less of deltamethrin;
in water-dispersible tablets each containing 500 mg or less of deltamethrin;
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
in other preparations containing 3 per cent or less of deltamethrin,
(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:
(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:
DIELDRIN.
DIETHANOLAMINE (excluding its salts and derivatives) except:
(b) in preparations containing 5 per cent or less of diethanolamine.
DIETHYLENE GLYCOL (excluding its salts and derivatives) except:
(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:
(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:
DINITROPHENOLS and their homologues in preparations containing 5 per cent or less of such compounds except:
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:
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:
(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:
(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:
(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:
(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:
(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:
(e) in preparations containing 25 per cent or less of eucalyptus oil.
EUGENOL except:
(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:
(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:
(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:
(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:
(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:
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:
(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:
(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:
(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:
(b) in preparations containing 5 per cent or less of imidacloprid.
IMIDOCARB.
iminoctadine trialbesilate.
IMIPROTHRIN except:
(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:
(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.
containing not more than 0.7 per cent of free organic isocyanates boiling below 300°C.
ISOEUGENOL except:
(b) in preparations containing 10 per cent or less of isoeugenol.
LAMBDA-CYHALOTHRIN:
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:
(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.
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:
(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;
(e) in preparations containing 25 per cent or less of Leptospermum scoparium oil.
LEVAMISOLE for the treatment of animals except:
(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:
(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:
(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:
(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:
METHYL SALICYLATE except:
(b) in preparations for therapeutic use; or
(c) in preparations containing 5 per cent or less of methyl salicylate.
METOFLUTHRIN except when included in Schedule 5.
METOSULAM.
METRAFENONE except when included in Schedule 5.
METRIBUZIN.
MICONAZOLE for the external treatment of animals.
MILBEMECTIN except when included in Schedule 5.
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:
(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,
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:
(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:
(b) in preparations containing 25 per cent or less of nonoxinol 9 when labelled with the statements:
(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:
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:
(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:
(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:
(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.
PHOSALONE.
PHOSMET.
PHOSPHORIC ACID (excluding its salts and derivatives) except:
(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:
(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:
(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:
(b) in preparations containing 0.5 per cent or less of potassium nitrite;
(d) in aerosols containing 2 per cent or less of potassium nitrite.
POTASSIUM PEROXOMONOSULFATE TRIPLE SALT except:
(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:
(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:
(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:
(b) for human use in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(c) in semi-solid hair preparations for animal use;
(d) in shampoos for animal use containing 2 per cent or less of pyrithione zinc when labelled with the statements “Keep out of eyes” and “If in eyes rinse well with water”;
(e) when immobilised in solid preparations containing 0.5 per cent or less of pyrithione zinc; or
(f) in paints, jointing materials or sealants containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content.
PYRIOFENONE.
PYROXASULFONE.
PYROXSULAM.
QUATERNARY AMMONIUM COMPOUNDS except:
(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:
(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:
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:
(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:
(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:
(b) in preparations containing 0.5 per cent or less of sodium nitrite;
(d) in aerosols containing 2 per cent or less of sodium nitrite.
SODIUM PERCARBONATE (CAS No. 15630-89-4) except:
(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:
(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:
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.
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:
(b) in fertilisers containing 5 g/kg or less of triadimefon.
TRICHLORFON except metrifonate included in Schedule 4.
TRICHLOROACETIC ACID except:
(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:
(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:
(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
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.
3,4,5-TRIMETHOXYPHENETHYLAMINE (mescaline) and other substances structurally derived from methoxy-phenylethylamine except:
(a) methoxyphenamine; or
1-(3,4,5-TRIMETHOXYPHENYL)-2-AMINOBUTANE.
SCHEDULE 10/APPENDIX C
SUBSTANCES OF SUCH DANGER TO HEALTH AS TO WARRANT
PROHIBITION OF SALE, SUPPLY AND USE
ABRUS PRECATORIUS (Jequirity) seed or root for therapeutic use.
ACORUS CALAMUS (calamus) for human therapeutic use.
ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for domestic use:
in liquid or semi-solid food additive preparations, the pH of which is more than 11.5;
in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or
in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5;
when in Scheule 6.
ALLYLISOPROPYLACETYLUREA for therapeutic use.
AMINOPHENAZONE (amidopyrine) and its derivatives for human therapeutic use except:
when in Schedule 4; or
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’; or
BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows except when in Schedule 6.
1,2-BENZENEDIAMINE in preparations for cosmetic use and skin colouration (including tattooing).
1,3-BENZENEDIAMINE in preparations for cosmetic use and skin colouration (including tattooing).
BITHIONOL for human therapeutic use except when in Schedule 6.
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; or
CINCHOPHEN and its derivatives for therapeutic use.
CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when in Schedule 4 or when being used solely for experimental purposes in humans and where such use:
(a) is in accordance with:
(i) an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and
(ii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and
(iii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or
(b) is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.
COAL TAR for cosmetic use other than in therapeutic goods.
CONIUM MACULATUM (coniine) for therapeutic use.
COTARNINE for therapeutic use.
CROTALARIA spp. for therapeutic use.
CROTON TIGLIUM for therapeutic use.
CYNOGLOSSUM spp. for therapeutic use.
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; or
when in Schedule 6
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 except when in Schedule 6.
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; or
ETHYLHEXANEDIOL for human use except when in Schedule 4.
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; o
(d) in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde ;
in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE;
when in Schedule 2; or
when in Schedule 6.
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;
when in Schedule 4;
when in Schedule 5; or
when in Schedule 6.
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 except when in Schedule 6.
METHYL METHACRYLATE for cosmetic use except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer except when in Schedule 6.
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; o
(d) in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde ;
in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE;
when in Schedule 2; or
when in Schedule 6.
PETASITES spp. for therapeutic use.
PHENYLENEDIAMINES, including alkylated and arylated derivatives, 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 except:
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; or
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 except:
SYMPHYTUM spp. (Comfrey) for therapeutic or cosmetic use except when included in Schedule 5.
2,4-TOLUENEDIAMINE in preparations for skin colouration (including tattooing) and dyeing of hair, eyelashes or eyebrows.
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 except when in Schedule 5.
TRICHODESMA AFRICANA for therapeutic use.
TRIPARANOL for therapeutic use.
TUSSILAGO FARFARA for therapeutic use.
PART 5
THE APPENDICES
APPENDIX A
GENERAL EXEMPTIONS
This Standard does not apply to a poison in any of the following products:
ALGICIDES, BACTERIOCIDES OR SLIMICIDES for industrial use that do not fit the definition of an agvet chemical product.
BACTERIAL CULTURE MEDIA containing antibiotics.
CERAMICS.
CHEMISTRY SETS for toy and educational use, when complying with the requirements of Australian Standard AS 8124.4-2003 Safety of toys entitled Part 4: Experimental sets for chemistry and related activities.
COPPER COMPOUNDS in paints.
DEXTRANS, GELATIN SUCCINYLATED & ETHERIFIED STARCHES used as plasma substitutes/blood volume expanders.
ELECTRICAL ACCUMULATORS, BATTERIES, COMPONENTS or LAMPS.
ELECTRONIC COMPONENTS.
ENHANCING AGENTS for use in ultrasonic and magnetic resonance imaging.
EXPLOSIVES.
FOOD except:
(a) food additives before incorporation into food; or
(b) when used as a means of administering a poison for therapeutic use.
FRITTED GLAZING OR ENAMELLING PREPARATIONS in which the poison is confined as a non-migratory component of glassy solid flakes or granules.
GLASS (including CRYSTAL WARE).
GLAZED POTTERY.
HUMAN BLOOD PRODUCTS including:
(a) whole blood;
(b) blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and
(c) the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives:
(i) albumin;
(ii) anticoagulation complex;
(iii) C1 esterase inhibitors;
(iv) clotting factors;
(v) fibrinogen;
(vi) protein C;
(vii) prothrombin complex concentrate (PCC) ; and
(viii) thrombin.
IN VITRO DIAGNOSTIC AND ANALYTICAL PREPARATIONS containing 0.001 per cent or less of a poison included in Schedules 1 to 8.
INTRAOCULAR VISCOELASTIC PRODUCTS.
LUBRICANTS except soluble oils and solvent-deposited lubricating agents.
MATCHES.
MEDICAL AND VETERINARY ADHESIVES, GLUES AND CEMENTS.
MEDICAL DEVICES classified as Class III by the classification rules set out in Schedule 2 to the Therapeutic Goods (Medical Devices) Regulation 2002, except:
(a) injectable tissue reconstructive, augmentation and restoration materials, including collagen;
(b) medical devices which include anticoagulants;
(c) artificial tears;
(d) urinary catheters; or
(e) intra-articular fluids.
MOTOR, HEATING or FURNACE FUELS except:
(a) when the contrary intention appears in any Schedule;
(b) when containing methanol;
(c) toy or hobby fuels; or
(d) petrol or kerosene when packed in containers having a capacity of 20 litres or less.
NUTRITION REPLACEMENT PREPARATIONS FOR PARENTERAL ADMINISTRATION.
PAPER except:
(a) when prepared for pesticidal use; or
(b) when containing a poison included in Schedule 8 or 9.
PHOTOGRAPHIC PAPER or FILM.
PIGMENTS when immobilised in a polymer.
PORCELAIN.
PRINTING INKS or INK ADDITIVES except:
(a) when containing a pesticide; or
(b) preparations containing more than 0.1 per cent of lead calculated on the non-volatile content of the ink or ink additive.
RADIOGRAPHIC CONTRAST MEDIA (radiopaques) for therapeutic use.
RADIOISOTOPES for therapeutic use.
SEEDS treated with seed protectants.
SINGLE-USE TUBES for the estimation of alcohol content of breath.
TERMITE BARRIERS consisting of an active ingredient, other than arsenic, approved by the relevant registration authority, and laminated between impervious sheeting.
TIMBER or WALLBOARD.
VITREOUS ENAMELS.
WRITING CORRECTION PENS which do not allow ingestion of the contents and which contain no scheduled poison other than designated solvents included in Schedule 5.
APPENDIX B
SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING
(This Appendix should be read in conjunction with Appendix A.)
INTRODUCTION
Substances for which the available information suggests that inclusion in the Poisons Schedules is not necessary, or not the most appropriate means of controlling the risk to public health, have been considered at various times.
Listing in Appendix B indicates that a decision has been taken not to list substances anywhere in the Schedules, either for a specific purpose, or generally. It is an inclusive, but not an exhaustive, list i.e. there may be substances not included in the Schedules, and not included in Appendix B, which may be hazardous or non-hazardous, but have not been considered in relation to the need for scheduling.
Substances may be included in Appendix B because they have intrinsically low toxicity, or where other factors suggest that the potential public health risk would be minimal. Factors which are considered when determining an Appendix B entry include:
• the toxicology profile was adequately characterised and not consistent with inclusion in any of the Schedules;
• the use, purpose or product presentation minimised any hazard to the public such as to not require scheduling; or
• the public access was limited such that scheduling was inappropriate or unnecessary.
The list was developed from scheduling files and historical records. For transparency, where the reason for entry and/or purpose or use for the substance was apparent in the consideration, this has been included in the columns “Reason for Entry” and “Area of Use”.
Inclusion in Appendix B will not prevent reconsideration of 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.