POISONS STANDARD 2015
I, ANTHONY GILL, a delegate of the Secretary to the Department of Health for the purposes of paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, prepare this new Poisons Standard, in substitution for the current Poisons Standard.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health
Dated this 5 February 2015
- Citation
This instrument is the Poisons Standard 2015.
2. The New Poisons Standard
The Poisons Standard 2015 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 6 (the SUSMP6) as set out in Schedule 1.
3. Commencement
The Poisons Standard 2015 commences on the day after registration.
Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 6
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
No. 6
February 2015
The Poisons Standard 2015, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the Australian Health Ministers' Advisory Council. Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).
The SUSMP serves two key purposes.
Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.
Secondly, the SUSMP includes model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Other government agencies may also impose controls on certain products, for example cosmetics.
The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.
Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. Note, however that this exemption does not extend to controls on supply of these poisons.
The SUSMP is presented with a view to promoting uniform:
- scheduling of poisons throughout Australia;
- signal headings on labels for poisons throughout Australia;
- labelling and packaging requirements for poisons throughout Australia;
- additional controls on the availability and use of poisons in Australia.
The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:
- the Agricultural and Veterinary Chemicals Code Act 1994
- the Agricultural and Veterinary Chemicals Code Regulations 1995
- the Therapeutic Goods Act 1989
- Therapeutic Goods Order 69 – General requirements for labels for medicines
- Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
- the Required Advisory Statements for Medicine Labels (RASML).
Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with each relevant State or Territory authority.
Schedule 1. This Schedule is intentionally blank.
Schedule 2. Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.
Schedule 3. Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.
Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
Schedule 5. Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.
Schedule 6. Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Schedule 7. Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.
Schedule 8. Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.
Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
Schedule 10/
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.
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).
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are revised and replaced by individual entries as time permits, although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, Schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this Schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry, these have been emphasised by printing the word “except” in bold type.
Where the Schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation, such as pesticide registration, may apply.
Where a Schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.
Where a poison has been included in more than one Schedule, the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Part 1, Interpretation, subparagraph 1(2).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, toxicologically) to a scheduled poison or is readily converted (either physically or chemically) to a scheduled poison. However, a substance is only considered a derivative of a scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a scheduled poison, the same scheduling requirements as the scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using this Standard to determine the scheduling status of a poison, it may be necessary to search each relevant Schedule as well as Appendices A 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”
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.
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 | Requirements for dispensing labels for medicines | Requirements applying to labels attached to medicines at the time of dispensing. |
1. (1) In this Standard, unless the contrary intention appears —
“Agricultural chemical” means a substance that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
(a) destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing;
(b) destroying a plant;
(c) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity;
(d) modifying an effect of another agricultural chemical;
(e) attracting a pest for the purpose of destroying it; or
(f) any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an agricultural chemical product;
but does not include:
(g) a veterinary chemical.
“Agricultural chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.
“Animal” means any animal (other than a human being), whether vertebrate or not, and whether a food producing species or not, and includes mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs.
“Animal feed premix” means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.
“Appropriate authority” means:
(a) in the Australian Capital Territory, ACT Government Health Directorate;
(b) for the purpose of providing an exemption from all or part of paragraphs 2 to 12 in Part 2 of this Standard by the Australian Pesticides and Veterinary Medicines Authority, the Chief Executive Officer or their delegate;
(c) in New South Wales, the Director-General of the NSW Ministry of Health;
(d) in the Northern Territory, the Chief Health Officer of the Department of Health;
(e) in Queensland, the Chief Executive of Queensland Health;
(f) in South Australia, the Chief Executive of the Department for Health and Ageing;
(g) in Tasmania, the Secretary of the Department of Health and Human Services;
(h) for the purpose of providing an exemption from all or part of 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;
but does not include:
(g) an agricultural chemical.
“Veterinary chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.
“Writing” includes the visible representation or reproduction of words or figures in any form, and “to write” and “written” have corresponding meanings.
(2) Unless the contrary intention appears a reference to a substance in a Schedule or an Appendix to this Standard includes:
(a) that substance prepared from natural sources or artificially; and
(b) where the substance is a plant (other than a plant included in Schedule 8 or 9), that plant or any part of that plant when packed or prepared for therapeutic use; and
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative; and
(d) every alkaloid of the substance and every salt of such an alkaloid; and
(e) every stereoisomer of the substance and every salt of such a stereoisomer; and
(f) every recombinant form of the substance; and
(g) a preparation or admixture containing any proportion of the substance,
but does not include:
(h) a preparation or product included in Appendix A, or a substance and the reason for its entry in Appendix B; or
(i) a substance included in Appendix G at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of that substance; or
(j) any other substance included in Schedules 1 to 6, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8; or
(k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the Standards for Active Constituents, as published by the Australian Pesticides and Veterinary Medicines Authority.
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a Schedule or an Appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
(4) A reference to a boiling or distillation temperature in the Schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).
(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) 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) The primary pack and immediate container of a poison must be labelled as follows:
(a) with the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the following table:
Schedule Purpose Signal words required
2 for any purpose PHARMACY MEDICINE
3 for any purpose PHARMACIST ONLY MEDICINE
4 for human use PRESCRIPTION ONLY MEDICINE
4 for animal use PRESCRIPTION ANIMAL REMEDY
5 for any purpose CAUTION
6 for any purpose POISON
7 for any purpose DANGEROUS POISON
8 for any purpose CONTROLLED DRUG
written:
(i) on the first line or lines of the main label; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least half the height of the largest letter or numeral on the label but need not be larger than:
(A) 6 millimetres on labels for packages having a nominal capacity of
2 litres or less; or
(B) 15 millimetres on labels for packages having a nominal capacity of more than 2 litres; and
(iv) if the poison:
(A) is a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail or a statement of the principal hazard of the poison, written on that line; or
(B) is not a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on that line;
(b) if the poison is a Schedule 8 poison, with the cautionary statement –
POSSESSION WITHOUT AUTHORITY ILLEGAL
written:
(i) on a separate line or lines immediately below the signal words required by Section1.3(1)(a); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal words; and
(iv) with no other statement written on the same line;
(c) with the cautionary statement –
KEEP OUT OF REACH OF CHILDREN
written:
(i) on a separate line or lines:
(A) immediately below the signal word or words required by Section 1.3(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by Section 1.3(1)(b), on the line immediately below that statement; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(d) if the poison is a dry chlorinating compound containing more than 10 per cent of available chlorine, except for preparations certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FIRE AND EXPLOSION HAZARD
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section 1.3(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –
BURNS SKIN AND THROAT
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section 1.3(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line of the main label;
(f) if the poison is an aqueous solution of paraquat, with the cautionary statements –
CAN KILL IF SWALLOWED
DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP
written:
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section1.3(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;
(g) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if safety directions are required on the label by Section 1.3(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by Section (1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FLAMMABLE
written on the main label in bold-face sans serif capital letters of uniform thickness, unless already present in accordance with the requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail;
(i) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written on the main label in bold-face sans serif capital letters of uniform thickness;
(j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written in sans serif capital letters on the main label or as part of the directions for use;
(k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with Section 1.4:
(i) if the poison is for human therapeutic use, written in accordance with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sans serif capital letters on the main label, unless:
(A) 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) 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) The requirements of Section 1.3 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which Section 1.5.2 (1) and (2) apply) when:
(a) the immediate container is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the immediate container is:
(i) packed in a primary pack labelled in accordance with Section 1.3; and
(ii) labelled with:
(A) the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to Section 1.3(1)(a); and
(B) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; and
(C) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(D) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
(1) The requirements of Section 1.3 do not apply to a selected container, or an ampoule (other than an ampoule to which Section 1.5.2(2) applies) when:
(a) the selected container or ampoule is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the selected container or ampoule is:
(i) packed in a primary pack labelled in accordance with Section 1.3; and
(ii) labelled with:
(A) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with Section 1.4; and
(B) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(C) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
(2) The requirements of Section 1.3 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(a) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(b) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is:
(i) packed in a primary pack labelled in accordance with Section 1.3; and
(ii) the strip is labelled in accordance with Section 1.5.2; and
(iii) the ampoule is labelled with:
(A) the approved name of the poison or the trade name of the product; and
(B) the quantity, proportion or strength of the poison in accordance with Section 1.4.
(1) 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) 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) 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) Unless otherwise specified by regulation:
(a) The labelling requirements of this Standard do not apply to a medicine that:
(i) is supplied by an authorised prescriber or other person authorised to supply and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(ii) is supplied on and in accordance with a prescription written by an authorised prescriber and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(iii) is prepared and supplied by a pharmacist for an individual patient and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard.
(b) A person must not supply a dispensed medicine for human use containing:
(i) a poison listed in column 1 of the table at Appendix L Part 2 of this Standard unless it is clearly labelled with the warning statement(s) specified in column 2 of that table; or
(ii) a poison listed in Appendix K unless it is clearly labelled with a sedation warning (being statement 39, 40 or 90 as specified in Appendix F Part 1 of this Standard).
(1) 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) 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) 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) 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.
(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).
(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.
(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.
(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.
(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.
(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.
(1) A person must not sell or supply a poison in a container which has the name of another poison embossed or indelibly marked thereon.
(2) A person must not sell any poison which is for internal use or any food, drink or condiment in a container prescribed by Sections 2.1(2), 2.1(4) and Section 2.2 of this Standard.
(3) A person must not sell any poison in a container that is not readily distinguishable from a container in which food, alcohol, other beverage or condiment is sold..
SECTION THREE STORAGE
3.1 General requirements
(1) A person who sells or supplies Schedule 6 poisons by way of retail sale must keep those poisons in such a way as to prevent access by children.
(2) A person who sells or supplies Schedule 7 poisons must not keep those poisons for retail sale in any areas or in any area or in any manner that allows physical access by any person unless they are:
(a) the owner of the retail establishment; or
(b) an employee of the owner; or
(c) legally permitted to purchase the substance and are under the supervision of the owner or an employee of the owner.
(3) Controls on storage of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.
SECTION FOUR DISPOSAL
4.1 General requirements
(1) A person must not dispose of or cause to be disposed of a Schedule 5, Schedule 6 or Schedule 7 poison in any place or manner that constitutes or is likely to constitute a risk to public health or safety.
(2) Controls on disposal of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.
SECTION FIVE RECORD KEEPING
5.1 General Requirements
(1) A person who sells or supplies Schedule 7 poisons must keep a record of:
(a) Name and address of seller or supplier and purchaser; and
(b) Date of order and supply; and
(c) Approved name or trade name that identifies the poison to be supplied or sold; and
(d) Quantity supplied or sold; and
(e) Proof of purchaser authorisation must be recorded in jurisdictions where an authorisation is required for purchase.
(2) Records for sale or supply of Schedule 7 poisons must be kept for a minimum period of five years.
(3) Controls on record keeping for sale or supply of Schedule 2, 3, 4 and 8 poisons require referral to relevant legislation.
SECTION SIX SALE, SUPPLY, POSSESSION, or USE
6.1 General Requirements for Schedule 5 and Schedule 6 Product samples
(1) A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in any manner unless the recipient has the opportunity to refuse at the time of sale or supply.
(2) A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in an unsolicited manner for example via the post / mailbox or attached to any other product.
(3) A person must not sell or supply a Schedule 5 or Schedule 6 poison product sample in a manner that does not promote disposal in accordance with section four.
6.2 Schedule 7 Poisons
(1) A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.
(2) A person must not sell or supply:
(a) a Schedule 7 poison for domestic or domestic garden purposes; or
(b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or
(c) a Schedule 7 poison for which an authorisation to purchase, possess or use is required by the appropriate authority unless the purchaser produces his or her authorisation.
(3) A person must not sell, supply or distribute free product samples containing Schedule 7 poisons.
6.3 Schedule 10/Appendix C poisons
(1) A person must not knowingly have in his or her possession or sell, supply or use a poison listed in Schedule 10/Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Schedule 10/Appendix C;
6.4 Hawking
(1) A person must not sell by way of hawking a Schedule 7 poison.
(2) Controls on sale or supply or sale by way of hawking of Schedule 2, 3, 4 and 8 poisons require referral to Part 3 of this Standard and relevant legislation.
SECTION SEVEN/Appendix I PAINT OR TINTERS
7.1 General Requirements
(1) A person must not manufacture, sell, supply or use a First Group Paint for application to:
(a) a roof or any surface to be used for the collection or storage of potable water; or
(b) furniture; or
(c) any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or
(d) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
(2) A person must not manufacture, sell, supply or use a paint or tinter containing more than 0.1% Lead (the proportion of Lead for the purposes of this section is calculated as a percentage of the element present in the non-volatile content of the paint).
(3) A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD).
(4) A person must not manufacture, sell, supply, or use a paint or tinter containing a pesticide except a fungicide, 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
(It is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)
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.
(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.
(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.
(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.
(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.
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.
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(Substances marked are listed in Appendix C)
ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80 per cent of acetic acid (CH3COOH) for therapeutic use.
ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.
ACONITUM spp. for therapeutic use in adults:
(a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or
(b) in preparations for dermal use containing 0.02 per cent or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.
ALOXIPRIN.
AMETHOCAINE in preparations for topical use other than eye drops, containing 10 per cent or less of total local anaesthetic substances except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.
AMOROLFINE in preparations for topical use except in preparations for the treatment of tinea pedis.
ANTAZOLINE in eye drops.
ASPIRIN except:
(a) when included in Schedule 4, 5 or 6;
(b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when:
(i) enclosed in a primary pack that contains 12 or less such powders or sachets of granules; and
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325 mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500 mg or less of aspirin; and
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:
(i) packed in blister or strip packaging or in a container with a child-resistant
closure;
(ii) in a primary pack containing 100 or less tablets or capsules, each containing 100 mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.
ATROPA BELLADONNA (belladonna):
(a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or
(b) for oral use:
(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
ATROPINE (excluding atropine methonitrate) for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
AZELAIC ACID in dermal preparations.
AZELASTINE:
(a) in preparations for nasal use; or
(b) in topical eye preparations containing 0.05 per cent or less of azelastine.
BECLOMETHASONE in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
BENZOCAINE in preparations for topical use other than eye drops:
(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10 per cent or less of benzoyl peroxide except in preparations containing 5 per cent or less of benzoyl peroxide.
BENZYDAMINE in preparations for topical use, except in preparations for dermal use.
BEPHENIUM SALTS.
BIFONAZOLE in preparations for dermal use except:
(a) in preparations containing 1 per cent or less of bifonazole for the treatment of the scalp; or
(b) in preparations for the treatment of tinea pedis.
BROMHEXINE.
BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing brompheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
BUDESONIDE in aqueous nasal sprays delivering 50 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
CARBETAPENTANE except in preparations containing 0.5 per cent or less of carbetapentane.
CARBOCISTEINE.
CETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(a) in a primary pack containing not more than 5 days’ supply; and
(b) labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
CHLOPHEDIANOL.
CHLORBUTOL for human use in topical preparations containing 5 per cent or less of chlorbutol except in preparations containing 0.5 per cent or less of chlorbutol.
CHLOROFORM in preparations for therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations containing 0.5 per cent or less of chloroform.
CHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing chlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
CICLOPIROX:
(a) in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis; or
(b) in preparations for application to the nails containing 8 per cent or less of ciclopirox.
CINCHOCAINE in preparations for topical use other than eye drops, containing 0.5 per cent or less of total local anaesthetic substances.
CINNAMEDRINE.
CLOTRIMAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.
CODEINE in preparations for the treatment of coughs and colds when:
(a) not combined with any other opiate substance;
(b) compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance:
(i) in divided preparations containing 10 mg or less of codeine per dosage unit; or
(ii) in undivided preparations containing 0.25 per cent or less of codeine;
(c) labelled with a recommended daily dose not exceeding 60 mg of codeine; and
(d) in packs containing not more than 6 days' supply at the maximum dose recommended on the label.
CREOSOTE derived from wood other than beechwood for human therapeutic use, except in preparations containing 10 per cent or less of creosote derived from wood other than beechwood.
DATURA spp. for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids, or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,
except when separately specified in these Schedules.
DATURA STRAMONIUM (stramonium) for oral use when:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,
except for smoking or burning.
DATURA TATULA (stramonium) for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,
except for smoking or burning.
DELPHINIUM STAPHISAGRIA except in preparations containing 0.2 per cent or less of Delphinium staphisagria.
DESLORATADINE in preparations for oral use.
DEXCHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DEXTROMETHORPHAN (excluding its stereoisomers) when supplied in a pack containing 600 mg or less of dextromethorphan and with a recommended daily dose of 120 mg or less of dextromethorphan.
DIBROMOPROPAMIDINE for ophthalmic use.
DICLOFENAC when:
(a) in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac;
(b) in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 1 per cent or less of diclofenac or for the treatment of solar keratosis; or
(c) in transdermal preparations for topical use containing 140 mg or less of diclofenac.
DIHYDROCODEINE when compounded with aspirin and no other therapeutically active substance in divided preparations:
(a) containing 5 mg or less of dihydrocodeine per dosage unit;
(b) packed in blister or strip packaging or in a container with a child-resistant closure;
(c) enclosed in primary packs containing 25 or less dosage units; and
(d) labelled with a recommended dose not exceeding 10 mg of dihydrocodeine.
DIMENHYDRINATE in primary packs of 10 doses or less for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.
DIPHENHYDRAMINE in oral preparations:
(a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing diphenhydramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
DUBOISIA LEICHHARDTII for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
DUBOISIA MYOPOROIDES for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
ECONAZOLE for human use in dermal preparations except in preparations for the treatment of tinea pedis.
ETAFEDRINE.
ETHER for therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations containing 10 per cent or less of ether.
ETHYLMORPHINE when:
(a) compounded with one or more other therapeutically active substances:
(i) in divided preparations containing 10 mg or less of ethylmorphine per dosage unit; or
(ii) in undivided preparations containing 0.25 per cent or less of ethylmorphine;
(b) labelled with a recommended dose not exceeding 15 mg of ethylmorphine.
ETOFENAMATE in preparations for external use.
FAMOTIDINE when sold in the manufacturer’s original pack containing not more than 14 days' supply.
FELBINAC in preparations for external use.
FEXOFENADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(a) in a primary pack containing 10 dosage units or less and not more than 5 days’ supply; and
(b) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.
FLUORIDES for human use:
(a) in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or
(b) in liquid preparations for topical use containing 1000 mg/kg or less of fluoride ion, in a container with a child-resistant closure:
(i) for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of Required Advisory Statements for Medicine Labels; or
(ii) for non-therapeutic use when labelled with warnings to the following effect:
(A) Do not swallow; and
(B) Do not use [this product/name of product] in children six years of age or less,
except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect:
(A) Do not swallow; and
(B) Do not use [this product/name of product] in children six years of age or less,
except in preparations containing 15 mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority.
FLURBIPROFEN in preparations for topical oral use when:
(a) in divided preparations containing 10 mg or less of flurbiprofen per dosage unit; or
(b) in undivided preparations containing 0.25 per cent or less, or 10 mg or less per dose, of flurbiprofen.
FLUTICASONE in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
FOLIC ACID for human therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations containing 500 micrograms or less of folic acid per recommended daily dose.
FOLINIC ACID for human therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations containing 500 micrograms or less of folinic acid per recommended daily dose.
FORMALDEHYDE (excluding its derivatives) for human therapeutic use except:
(a) in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or
(b) in other preparations containing 0.2 per cent or less of free formaldehyde.
GUAIPHENESIN in a modified release dosage form of 1200 mg or less of guaiphenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.
GELSEMIUM SEMPERVIRENS.
GLUTARALDEHYDE for human therapeutic use.
HEXACHLOROPHANE in preparations for human use containing 3 per cent or less of hexachlorophane except:
(a) in preparations containing 0.75 per cent or less of hexachlorophane; or
(b) in preparations for use on infants, as specified in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5 per cent or less of hydrocortisone:
(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
(i) in undivided preparations in packs of 35 g or less; or
(ii) in packs containing 12 or less suppositories.
HYDROQUINONE (excluding monobenzone and alkyl ethers of hydroquinone included in Schedule 4) in preparations for human external therapeutic or cosmetic use containing 2 per cent or less of hydroquinone except:
(a) in hair preparations containing 0.3 per cent or less of hydroquinone; or
(b) in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.
8-HYDROXYQUINOLINE and its non-halogenated derivatives for human therapeutic use, except in preparations for external use containing 1 per cent or less of such substances.
HYOSCINE (excluding hyoscine butylbromide):
(a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
(b) for oral use:
(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.
HYOSCYAMINE:
(a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or
(b) for oral use:
(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less total solanaceous alkaloids.
HYOSCYAMUS NIGER for oral use:
(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3 mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,
except in a pack containing 0.03 mg or less of total solanaceous alkaloids.
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
(a) in liquid preparations when sold in the manufacturer’s original pack containing 8 grams or less of ibuprofen; or
(b) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
(i) as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
(ii) packed in blister or strip packaging or in a container with a child-resistant closure;
(iii) in a primary pack containing not more than 25 dosage units;
(iv) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(v) not labelled for the treatment of children 6 years of age or less; and
(vi) not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
INDANAZOLINE.
INDOMETHACIN in preparations for external use containing 1 per cent or less of indomethacin.
IODINE:
(a) in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or
(b) in preparations for human external therapeutic use containing more than 2.5 per cent of available iodine (excluding salts, derivatives or iodophors),
except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.
IPRATROPIUM in preparations for nasal use.
IRON COMPOUNDS (excluding iron oxides when present as an excipient, in divided preparations containing 10 mg or less of total iron oxides per dosage unit or in undivided preparations containing 1 per cent or less of total iron oxides) for human internal use except:
(a) when included in Schedule 4; or
(b) when labelled with a recommended daily dose of 24 mg or less of iron:
(i) in undivided preparations supplied in packs each containing 750 mg or less of iron; or
(ii) in divided preparations:
(A) containing more than 5 mg of iron per dosage unit in packs each containing 750 mg or less of iron; or
(B) containing 5 mg or less of iron per dosage unit.
ISOCONAZOLE for human use in dermal preparations.
ISOPROPAMIDE in preparations for dermal use containing 2 per cent or less of isopropamide.
KETOCONAZOLE in preparations for dermal use except:
(a) in preparations containing 1 per cent or less of ketoconazole for the treatment of the
scalp; or
(b) in preparations for the treatment of tinea pedis.
KETOTIFEN for ophthalmic use in preparations containing 0.025 per cent or less of ketotifen.
LEVOCABASTINE in topical eye or nasal preparations.
LIGNOCAINE in preparations for topical use other than eye drops:
(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
LINDANE in preparations for human external therapeutic use containing 2 per cent or less of lindane.
LITHIUM in preparations for dermal use containing 1 per cent or less of lithium except:
(a) when present as an excipient at 0.25 per cent or less of lithium; or
(b) in preparations containing 0.01 per cent or less of lithium.
LOBELIA INFLATA except for smoking or burning.
LOBELINE except in preparations for smoking or burning.
LODOXAMIDE in preparations for ophthalmic use.
LOPERAMIDE in divided preparations for oral use in packs of 20 dosage units or less except in preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.
LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(a) in a primary pack containing 5 dosage units or less; and
(b) labelled with a recommended daily dose not exceeding 10 mg of loratadine.
MACROGOLS in preparations for oral use as a liquid concentrate for laxative use.
MEBENDAZOLE for human therapeutic use.
MECLOZINE in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.
MEFENAMIC ACID in divided preparations for oral use in packs of 30 or less dosage units for the treatment of dysmenorrhoea.
MEPYRAMINE for dermal use.
MERCUROCHROME in preparations for external use containing 2 per cent or less of mercurochrome except when included in Schedule 6.
MERCURY for external use in preparations containing 0.5 per cent or less of mercury.
METHOXAMINE in preparations for external use except in preparations containing 1 per cent or less of methoxamine.
METHOXYPHENAMINE.
METHYLEPHEDRINE.
MICONAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.
MINOXIDIL in preparations for dermal use containing 5 per cent or less of minoxidil.
MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.
NAPHAZOLINE.
NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.
NICLOSAMIDE for human therapeutic use.
NIZATIDINE when sold in the manufacturer’s original pack containing not more than 14 days' supply.
NOSCAPINE.
NYSTATIN in dermal preparations.
OXETACAINE (oxethazaine) in preparations for internal use.
OXICONAZOLE for dermal use except in preparations for the treatment of tinea pedis.
OXYMETAZOLINE.
PAPAVERINE except when included in Schedule 4.
PARACETAMOL for therapeutic use except:
(a) when included in Schedule 4;
(b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesinor when combined with effervescent agents) when:
(i) enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iii) not labelled for the treatment of children 6 years of age or less; and
(iv) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
(c) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin or when combined with effervescent agents) when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(ii) in a primary pack containing not more than 20 tablets or capsules;
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(iv) not labelled for the treatment of children 6 years of age or less; and
(v) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.
PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:
(a) in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or
(b) in other preparations containing 0.2 per cent or less of free formaldehyde.
PENCICLOVIR for external use for the treatment of herpes labialis.
PHEDRAZINE.
PHENAZONE for human external use.
PHENIRAMINE:
(a) in eye drops; or
(b) when combined with one or more other therapeutically active substances in oral preparations when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing pheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:
(a) when included in Schedule 4; or
(b) in preparations for external use containing 3 per cent or less of such substances.
PHENYLEPHRINE except:
(a) when included in Schedule 4;
(b) in oral preparations containing 50 mg or less of phenylephrine per recommended daily dose in packs containing 250 mg or less of phenylephrine; or
(c) in topical eye or nasal preparations containing 1 per cent or less of phenylephrine.
PHOLCODINE:
(a) in liquid preparations containing 0.5 per cent or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine; or
(b) when compounded with one or more other therapeutically active substances in divided preparations containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine.
PIPERAZINE for human therapeutic use.
PODOPHYLLOTOXIN in preparations containing 0.5 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts.
PODOPHYLLUM EMODI (podophyllin) in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts.
PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts.
POTASSIUM CHLORATE for therapeutic use except in preparations containing 10 per cent or less of potassium chlorate.
PRILOCAINE in preparations for dermal use containing 10 per cent or less of total local anaesthetic substances.
PROCYCLIDINE in preparations containing 5 per cent or less of procyclidine for dermal use.
PROMETHAZINE in oral preparations:
(a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when:
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing promethazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
PROPAMIDINE for ophthalmic use.
PYRANTEL for human therapeutic use.
PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10 per cent of such substances.
PYRITHIONE ZINC for human therapeutic use, except in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.
RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days' supply except in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units.
SALICYLAMIDE except when included in Schedule 4.
SELENIUM in preparations for human therapeutic use except:
(a) for topical use containing 3.5 per cent or less of selenium sulfide;
(b) when included in Schedule 4; or
(c) for oral use with a recommended daily dose of 150 micrograms or less.
SILVER for therapeutic use except:
(a) in solutions for human oral use containing 0.3 per cent or less of silver when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(b) in other preparations containing 1 per cent or less of silver.
SODIUM CROMOGLYCATE in preparations for nasal or ophthalmic use.
SODIUM NITRITE for therapeutic use (excluding when present as an excipient).
SQUILL except in preparations containing 1 per cent or less of squill.
SULCONAZOLE in preparations for dermal use.
TERBINAFINE for dermal use except in preparations for the treatment of tinea pedis.
TETRACHLOROETHYLENE for human therapeutic use.
TETRAHYDROZOLINE.
THIABENDAZOLE for human therapeutic use.
TIOCONAZOLE in preparations for dermal use except in preparations for the treatment of tinea pedis.
TRAMAZOLINE.
TRIAMCINOLONE in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
TRIMEPRAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing trimeprazine in the bed-time dose where the day and night doses
are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing triprolidine in the bed-time dose where the day and night
doses are in the same immediate container or immediate wrapper,
except in preparations for the treatment of children under 2 years of age.
TUAMINOHEPTANE.
TYMAZOLINE.
XYLOMETAZOLINE.
ZINC CHLORIDE for human dermal use except in preparations containing 5 per cent or less of zinc chloride.
ADRENALINE in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.
ALCLOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.05 per cent or less of alclometasone in packs containing 30 g or less of the preparation.
AMINOPHYLLINE in liquid oral preparations containing 2 per cent or less of aminophylline.
AZATADINE in oral preparations.
BROMPHENIRAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
BUCLIZINE in oral preparations.
BUTOCONAZOLE in preparations for vaginal use.
CHLORAMPHENICOL for ophthalmic use only.
CHLORBUTOL in preparations for human use except:
(a) when included in Schedule 2; or
(b) in preparations containing 0.5 per cent or less of chlorbutol.
CHLORPHENIRAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
CICLOPIROX in preparations for dermal use and for application to the nails except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of tinea pedis.
CIMETIDINE in a primary pack containing not more than 14 days' supply.
CLEMASTINE in preparations for oral use.
CLOBETASONE (clobetasone-17-butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05 per cent or less of clobetasone in packs containing 30 g or less of the preparation.
CLOTRIMAZOLE in preparations for vaginal use.
CODEINE when:
(a) not combined with any other opiate substance;
(b) compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance:
(i) in divided preparations containing 12 mg or less of codeine per dosage unit; or
(ii) in undivided preparations containing 0.25 per cent or less of codeine;
(c) labelled with a recommended daily dose not exceeding 100 mg of codeine; and
(d) in packs containing not more than 5 days' of supply at the maximum dose recommended on the label,
except when included in Schedule 2.
CYCLIZINE in preparations for oral use.
CYPROHEPTADINE in oral preparations.
DEXCHLORPHENIRAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
DICLOFENAC in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2.
DIHYDROCODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing 10 mg or less per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or
(b) in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine,
except when included in Schedule 2.
DI-IODOHYDROXYQUINOLINE (iodoquinol) for vaginal use.
DIMENHYDRINATE in oral preparations except when included in Schedule 2.
DIMETHINDENE in oral preparations.
DIPHENHYDRAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate.
DITHRANOL for therapeutic use.
DOXYLAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
ECONAZOLE in preparations for vaginal use.
ERYTHRITYL TETRANITRATE for therapeutic use.
ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days supply.
FAMCICLOVIR for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).
FLAVOXATE.
FLUCONAZOLE in single-dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis.
FLUORIDES for human topical use:
(a) in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or
(b) in non-liquid preparations containing 5500 mg/kg or less of fluoride ion except:
(i) in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(ii) in preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:
(A) Do not swallow; and
(B) Do not use [this product/name of product] in children six years of age or less; or
(iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority.
GLUCAGON.
GLYCERYL TRINITRATE:
(a) in preparations for oral use; or
(b) in preparations for rectal use.
GLYCOPYRRONIUM except when included in Schedule 4.
HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1 per cent or less of hydrocortisone:
(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:
(i) in undivided preparations, in packs of 35 g or less; or
(ii) in packs containing 12 or less suppositories,
except when included in Schedule 2.
IBUPROFEN in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units when labelled:
(a) with a recommended daily dose of 1200 mg or less of ibuprofen; and
(b) not for the treatment of children under 12 years of age,
except when included in or expressly excluded from Schedule 2.
INOSITOL NICOTINATE.
ISOCONAZOLE in preparations for vaginal use.
ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.
KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.
LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
LEVONORGESTREL for emergency post-coital contraception.
MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.
MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.
Malathion in preparations for human external use except in preparations containing 2 per cent or less of malathion.
MANNITYL HEXANITRATE for therapeutic use.
MEPYRAMINE in oral preparations.
METHDILAZINE in oral preparations.
METOCLOPRAMIDE when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units.
MICONAZOLE for human use in topical preparations:
(a) for the treatment of oral candidiasis; or
(b) for vaginal use.
NAPROXEN in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.
NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except:
(a) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or
(b) nicotinamide.
NICOTINYL ALCOHOL except in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit.
NYSTATIN in preparations for topical use except when included in Schedule 2.
OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
ORLISTAT in oral preparations for weight-control purposes containing 120 mg or less of orlistat per dosage unit.
OXICONAZOLE in preparations for vaginal use.
PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less.
PHENIRAMINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PODOPHYLLUM EMODI (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.
PROCHLORPERAZINE in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.
PROMETHAZINE in oral preparations except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of children under 2 years of age.
PSEUDOEPHEDRINE (other than preparations for stimulant, appetite suppression or weight-control purposes) when supplied in a primary pack:
(a) in liquid preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its equivalent); or
(b) in other preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its equivalent).
RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
SALBUTAMOL as the only therapeutically active substance:
(a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
(b) in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose.
SALICYLIC ACID in preparations for dermal use except in preparations containing 40 per cent or less of salicylic acid.
SANTONIN.
SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.
SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical or surgical procedures.
SULFACETAMIDE in preparations for ophthalmic use containing 10 per cent or less of sulfacetamide.
TERBUTALINE as the only therapeutically active substance:
(a) in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose; or
(b) in dry powders for inhalation delivering 500 micrograms or less of terbutaline per dose.
THEOPHYLLINE in liquid oral preparations containing 2 per cent or less of theophylline.
TIOCONAZOLE in preparations for vaginal use.
TRIAMCINOLONE for buccal use in preparations containing 0.1 per cent or less of triamcinolone in a pack of 5 g or less.
TRIMEPRAZINE:
(a) in solid oral preparations except when included in Schedule 2; or
(b) in liquid oral preparations containing 10 mg or less of trimeprazine per 5 mL,
except in preparations for the treatment of children under 2 years of age.
TRIPROLIDINE in oral preparations except:
(a) when included in Schedule 2; or
(b) for the treatment of children under 2 years of age.
VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.
(Substances marked # are listed in Appendix D)
ABACAVIR.
ABATACEPT.
ABIRATERONE ACETATE.
ABCIXIMAB.
ACAMPROSATE CALCIUM.
ACARBOSE.
ACEBUTOLOL.
ACEPROMAZINE.
ACETANILIDE and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.
ACETARSOL.
ACETAZOLAMIDE.
ACETOHEXAMIDE.
ACETYL ISOVALERYLTYLOSIN.
ACETYLCARBROMAL.
ACETYLCHOLINE.
ACETYLCYSTEINE except:
(a) when included in Schedule 2; or
(b) in preparations for oral use when labelled with a recommended daily dose of 1 g or less of acetylcysteine.
ACETYLDIGITOXIN.
ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE.
ACETYLSTROPHANTHIDIN.
ACICLOVIR except in preparations containing 5 per cent or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less.
ACIPIMOX.
# ACITRETIN.
ACLIDINIUM BROMIDE.
ACOKANTHERA OUABAIO.
ACOKANTHERA SCHIMPERI.
ACONITUM spp. except:
(a) when included in Schedule 2;
(b) in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or
(c) in preparations for dermal use in adults containing 0.02 per cent or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids.
ACRIVASTINE.
ADALIMUMAB.
ADAPALENE.
ADEFOVIR.
ADENOSINE for human therapeutic use in preparations for injection.
ADIPHENINE.
ADONIS VERNALIS.
ADRAFINIL.
ADRENALINE. except:
(a) when included in Schedule 3; or
(b) in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.
ADRENOCORTICAL HORMONES except when separately specified in these Schedules.
AFAMELANOTIDE.
afatinib dimaleate.
AFLIBERCEPT.
AGALSIDASE.
AGLEPRISTONE.
AGOMELATINE.
ALATROFLOXACIN MESYLATE.
ALBENDAZOLE except:
(a) when included in Schedule 5 or 6; or
(b) in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals.
ALCLOFENAC.
ALCLOMETASONE except when included in Schedule 3.
ALCURONIUM.
ALDESLEUKIN.
ALDOSTERONE.
# ALEFACEPT.
ALEMTUZUMAB.
ALENDRONIC ACID.
ALFACALCIDOL.
ALFUZOSIN.
ALGLUCERASE.
ALGLUCOSIDASE.
ALISKIREN.
ALLERGENS.
ALLOPURINOL.
ALLYLOESTRENOL.
ALOGLIPTIN.
ALOSETRON.
ALPHA1-PROTEINASE INHIBITOR (HUMAN).
ALPHADOLONE.
ALPHAXALONE.
ALPRENOLOL.
ALPROSTADIL.
ALSEROXYLON.
ALTEPLASE.
ALTRENOGEST.
ALTRETAMINE (hexamethylmelamine).
AMANTADINE.
AMBENONIUM CHLORIDE.
# AMBRISENTAN.
AMBUCETAMIDE.
AMBUTONIUM BROMIDE.
AMCINONIDE.
AMETHOCAINE except:
(a) when included in Schedule 2; or
(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances.
AMIFOSTINE.
AMIKACIN.
AMILORIDE.
AMINOCAPROIC ACID.
AMINOGLUTETHIMIDE.
5-AMINOLEVULINIC ACID.
AMINOMETRADINE.
AMINOPHENAZONE (amidopyrine) and derivatives for the treatment of animals.
AMINOPHYLLINE except when included in Schedule 3.
AMINOPTERIN.
4-AMINOPYRIDINE for therapeutic use.
AMINOREX.
AMINOSALICYLIC ACID.
AMIODARONE.
AMIPHENAZOLE.
AMISOMETRADINE.
AMISULPRIDE.
AMITRIPTYLINE.
AMLODIPINE.
AMMI VISNAGA.
AMMONIUM BROMIDE for therapeutic use.
AMODIAQUINE.
AMOROLFINE except:
(a) when included in Schedule 2; or
(b) in preparations for the treatment of tinea pedis.
AMOXAPINE.
AMOXYCILLIN.
AMPHOMYCIN.
AMPHOTERICIN.
AMPICILLIN.
AMPRENAVIR.
AMRINONE.
AMSACRINE.
AMYL NITRITE.
AMYLOBARBITONE when packed and labelled for injection.
AMYLOCAINE.
# ANABOLIC STEROIDAL AGENTS.
ANAGRELIDE.
ANAKINRA.
ANASTROZOLE.
ANCESTIM.
ANCROD and its immunoglobulin antidote.
ANECORTAVE.
# ANDROGENIC STEROIDAL AGENTS.
# ANDROISOXAZOLE.
# ANDROSTANOLONE.
# ANDROSTENEDIOL.
# ANDROSTENEDIONE.
ANGIOTENSIN AMIDE.
ANIDULAFUNGIN.
ANISTREPLASE.
ANTAZOLINE except when included in Schedule 2.
ANTIBIOTIC SUBSTANCES except:
(a) when separately specified in these Schedules; or
(b) nisin.
ANTIGENS for human therapeutic use except when separately specified in this Schedule.
ANTIHISTAMINES except:
(a) when included in Schedule 2 or 3; or
(b) when separately specified in this Schedule.
ANTIMONY for therapeutic use except when separately specified in these Schedules.
ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules.
APIXABAN.
APOCYNUM spp.
APOMORPHINE.
APRACLONIDINE.
APRAMYCIN.
APREPITANT.
APRONAL.
APROTININ.
ARECOLINE.
ARIPIPRAZOLE.
ARSENIC for human therapeutic use except when separately specified in these Schedules.
ARTEMETHER.
ARTICAINE.
ASENAPINE.
ASPIRIN:
(a) when combined with caffeine, paracetamol or salicylamide or any derivative of these substances; or
(b) for injection.
ASTEMIZOLE.
# ATAMESTANE.
ATAZANAVIR.
ATENOLOL.
ATIPAMEZOLE.
ATOMOXETINE.
ATORVASTATIN.
ATOSIBAN.
ATOVAQUONE.
ATRACURIUM BESYLATE.
ATROPA BELLADONNA (belladonna) except when included in Schedule 2.
ATROPINE except when included in Schedule 2.
ATROPINE METHONITRATE.
AURANOFIN.
AUROTHIOMALATE SODIUM.
AVILAMYCIN except:
(a) in animal feed premixes containing 15 per cent or less of avilamycin activity; or
(b) in animal feeds containing 50 mg/kg or less of avilamycin activity.
AVIPTADIL.
AXITINIB.
AVOPARCIN.
AZACITIDINE.
AZACYCLONOL.
AZAPERONE.
AZAPROPAZONE.
AZARIBINE.
AZATADINE except when included in Schedule 3.
AZATHIOPRINE.
AZELAIC ACID except:
(a) when included in Schedule 2; or
(b) in preparations containing 1 per cent or less of azelaic acid for non-human use.
AZELASTINE except when included in Schedule 2.
AZITHROMYCIN.
AZLOCILLIN.
AZTREONAM.
BACAMPICILLIN.
BACITRACIN.
BACLOFEN.
BALSALAZIDE.
BAMBERMYCIN (flavophospholipol) except:
(a) when included in Schedule 6; or
(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.
BAMBUTEROL.
BAMETHAN.
BAMIPINE.
BARBITURATES except when separately specified in these Schedules.
BASILIXIMAB.
BAZEDOXIFENE.
BECAPLERMIN.
BECLAMIDE.
BECLOMETHASONE except when included in Schedule 2.
BELATACEPT.
BELIMUMAB.
BEMEGRIDE.
BENACTYZINE.
BENAZEPRIL.
BENDAMUSTINE.
BENDROFLUAZIDE.
BENETHAMINE PENICILLIN.
BENORYLATE.
BENOXAPROFEN.
BENPERIDOL.
BENSERAZIDE.
BENZATHINE PENICILLIN.
BENZHEXOL.
BENZILONIUM.
BENZOCAINE except:
(a) when included in Schedule 2;
(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(c) in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
# BENZODIAZEPINE derivatives except when separately specified in these Schedules.
BENZOYL PEROXIDE in preparations for human therapeutic use except:
(a) when included in Schedule 2; or
(b) in preparations for external use containing 5 per cent or less of benzoyl peroxide.
BENZPHETAMINE.
BENZTHIAZIDE.
BENZTROPINE (benzatropine).
BENZYDAMINE except:
(a) when included in Schedule 2; or
(b) in preparations for dermal use.
BENZYLPENICILLIN.
BEPRIDIL.
BERACTANT.
BESIFLOXACIN.
BETAHISTINE.
BETAMETHASONE.
BETAXOLOL.
BETHANECHOL CHLORIDE.
BETHANIDINE.
BEVACIZUMAB.
BEVANTOLOL.
# BEXAROTENE.
BEZAFIBRATE.
BICALUTAMIDE.
BIFONAZOLE except:
(a) when included in Schedule 2;
(b) in preparations for dermal use containing 1 per cent or less of bifonazole for the treatment of the scalp; or
(c) in preparations for dermal use for the treatment of tinea pedis.
BIMATOPROST.
BIPERIDEN.
BISMUTH COMPOUNDS for cosmetic use, except:
(a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per or less; or
(b) bismuth oxychloride.
BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3 per cent or less of bismuth.
BISOPROLOL.
BIVALIRUDIN.
BLEOMYCIN.
BOCEPREVIR.
# BOLANDIOL.
# BOLASTERONE.
# BOLAZINE.
# BOLDENONE (dehydrotestosterone).
# BOLENOL.
# BOLMANTALATE.
BORON, including boric acid and borax, for human therapeutic use except:
(a) in preparations for internal use containing 6 mg or less of boron per recommended daily dose;
(b) in preparations for dermal use containing 0.35 per cent or less of boron, which are not for paediatric or antifungal use; or
(c) when present as an excipient.
BORTEZOMIB.
# BOSENTAN.
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:
(a) for tissue augmentation; or
(b) for cosmetic use.
CALCIUM POLYSTYRENE SULPHONATE.
CALOTROPIS GIGANTEA.
CALOTROPIS PROCERA.
# CALUSTERONE.
CAMPHORATED OIL for therapeutic use.
CAMPHOTAMIDE.
CANAGLIFLOZIN.
CANAKINUMAB.
CANDESARTAN CILEXETIL.
CANDICIDIN.
CANINE TICK ANTI-SERUM.
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
(a) when included in Schedule 2; or
(b) in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
(i) in a primary pack containing not more than 5 days’ supply; and
(ii) labelled with a recommended daily dose not exceeding 10 mg of cetirizine.
CETRORELIX.
CETUXIMAB.
CHENODEOXYCHOLIC ACID.
CHLORAL FORMAMIDE.
CHLORAL HYDRATE except in preparations for topical use containing 2 per cent or less of chloral hydrate.
CHLORALOSE except when included in Schedule 6.
CHLORAMBUCIL.
CHLORAMPHENICOL except when included in Schedule 3.
# CHLORANDROSTENOLONE.
CHLORAZANIL.
CHLORCYCLIZINE.
# CHLORDIAZEPOXIDE.
CHLORMERODRIN.
CHLORMETHIAZOLE.
CHLORMEZANONE.
CHLOROFORM for use in anaesthesia.
# 4-CHLOROMETHANDIENONE.
2-(4-CHLOROPHENYL)-(1,2,4)TRIAZOLO[5,1-A]ISOQUINOLINE.
CHLOROQUINE.
CHLOROTHIAZIDE.
CHLOROTRIANISENE.
# CHLOROXYDIENONE.
CHLORPHENIRAMINE except when included in Schedule 2 or 3.
CHLORPHENTERMINE.
CHLORPROMAZINE.
CHLORPROPAMIDE.
CHLORPROTHIXENE.
CHLORQUINALDOL for human topical use.
CHLORTETRACYCLINE except when included in Schedule 5.
CHLORTHALIDONE.
CHLORZOXAZONE.
CHOLERA VACCINE.
CHOLESTYRAMINE (colestyramine) for human therapeutic use.
CHYMOPAPAIN for human therapeutic use.
CICLACILLIN.
CICLESONIDE.
CICLOPIROX except:
(a) when included in Schedule 2 or 3; or
(b) in preparations for the treatment of tinea pedis.
CIDOFOVIR.
CILASTATIN.
CILAZAPRIL.
CILOSTAZOL.
CIMETIDINE except when included in Schedule 3.
CINACALCET.
CINCHOCAINE except when included in Schedule 2.
CINOXACIN.
CIPROFLOXACIN.
CISAPRIDE.
CISATRACURIUM BESYLATE.
CISPLATIN.
CITALOPRAM.
CLADRIBINE.
CLANOBUTIN.
CLARITHROMYCIN.
CLAVULANIC ACID.
CLEMASTINE except when included in Schedule 3.
CLEMIZOLE.
CLENBUTEROL.
CLEVIDIPINE.
CLIDINIUM BROMIDE.
CLINDAMYCIN.
CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human topical use except when separately specified in this Schedule.
CLOBAZAM.
CLOBETASOL.
CLOBETASONE (clobetasone-17-butyrate) except when included in Schedule 3.
CLOCORTOLONE.
CLODRONIC ACID (includes sodium clodronate).
CLOFARABINE.
CLOFAZIMINE.
CLOFENAMIDE.
CLOFIBRATE.
# CLOMIPHENE.
CLOMIPRAMINE.
CLOMOCYCLINE.
# CLONAZEPAM.
CLONIDINE.
CLOPAMIDE.
CLOPIDOGREL.
CLOPROSTENOL.
# CLORAZEPATE.
CLOREXOLONE.
CLORPRENALINE.
# CLOSTEBOL (4-chlorotestosterone).
CLOTRIMAZOLE except:
(a) when included in Schedule 2, 3 or 6; or
(b) in preparations for dermal use for the treatment of tinea pedis.
CLOXACILLIN.
# CLOZAPINE.
COBALT for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.
COBICISTAT.
CODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing 30 mg or less of codeine per dosage unit; or
(b) in undivided preparations containing 1 per cent or less of codeine,
except when included in Schedule 2 or 3.
CO-DERGOCRINE.
COLASPASE.
COLCHICINE.
COLCHICUM AUTUMNALE.
COLESTIPOL.
COLFOSCERIL PALMITATE for human therapeutic use.
COLISTIN.
COLLAGEN in preparations for injection or implantation:
(a) for tissue augmentation; or
(b) for cosmetic use.
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM.
CONVALLARIA KEISKI.
CONVALLARIA MAJALIS.
COPPER COMPOUNDS for human use except:
(a) when separately specified in these Schedules;
(b) in preparations for human internal use containing 5 mg or less of copper per recommended daily dose; or
(c) in other preparations containing 5 per cent or less of copper compounds.
# CORIFOLLITROPIN ALFA.
CORONILLA spp.
CORTICOSTERONE.
CORTICOTROPHIN.
CORTISONE.
CO-TRIMOXAZOLE.
COUMARIN for therapeutic use (excluding when present as an excipient).
CRIZOTINIB.
CROFELEMER.
CRYSTAL VIOLET for human use except when used as a dermal marker.
CUPRIMYXIN.
CURARE.
CYCLANDELATE.
CYCLIZINE except when included in Schedule 3.
CYCLOBENZAPRINE.
# CYCLOFENIL.
CYCLOHEXIMIDE.
CYCLOPENTHIAZIDE.
CYCLOPENTOLATE.
CYCLOPHOSPHAMIDE.
CYCLOPROPANE for therapeutic use.
CYCLOSERINE.
CYCLOSPORIN.
CYCLOTHIAZIDE.
CYCRIMINE.
CYMARIN.
CYPROHEPTADINE except when included in Schedule 3.
CYPROTERONE.
CYSTEAMINE for human therapeutic use.
CYTARABINE.
DABRAFENIB MESILATE.
DABIGATRAN.
DACARBAZINE.
DACLIZUMAB.
DACTINOMYCIN.
DALFOPRISTIN.
DALTEPARIN (includes dalteparin sodium).
DANAPAROID (includes danaparoid sodium).
# DANAZOL.
DANTHRON for human use.
DANTROLENE.
DAPAGLIFLOZIN.
DAPOXETINE.
DAPSONE.
DAPTOMYCIN.
# DARBEPOETIN.
DARIFENACIN.
DARUNAVIR.
DATURA spp. except:
(a) when included in Schedule 2; or
(b) when separately specified in this Schedule.
DASATINIB.
DATURA STRAMONIUM (stramonium) except:
(a) when included in Schedule 2; or
(b) for smoking or burning.
DATURA TATULA (stramonium) except:
(a) when included in Schedule 2; or
(b) for smoking or burning.
DAUNORUBICIN.
DEANOL for therapeutic use.
DEBRISOQUINE.
DECAMETHONIUM.
DEFERASIROX.
DEFERIPRONE.
DEFLAZACORT.
DEGARELIX.
# DEHYDROCHLOROMETHYLTESTOSTERONE.
DEHYDROCORTICOSTERONE.
DELAVIRDINE (includes delavirdine mesylate).
DEMBREXINE except when included in Schedule 5.
DEMECARIUM.
DEMECLOCYCLINE.
DENOSUMAB.
DEOXYCORTONE.
DEOXYRIBONUCLEASE except:
(a) when separately specified in this Schedule; or
(b) for external use.
DERACOXIB.
DESFERRIOXAMINE.
DESFLURANE.
DESIPRAMINE.
DESIRUDIN.
DESLANOSIDE.
DESLORATADINE except when included in Schedule 2.
DESLORELIN.
DESMOPRESSIN (D.D.A.V.P.).
DESOGESTREL.
DESONIDE.
DESOXYMETHASONE.
DESVENLAFAXINE.
DETOMIDINE.
DEXAMETHASONE.
DEXCHLORPHENIRAMINE except when included in Schedule 2 or 3.
DEXFENFLURAMINE.
DEXMEDETOMIDINE.
DEXTROMETHORPHAN (excluding its stereoisomers) except when included in Schedule 2.
# DEXTROPROPOXYPHENE:
(a) in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit; or
(b) liquid preparations containing 2.5 per cent or less of dextropropoxyphene.
DEXTRORPHAN (excluding its stereoisomers).
DIAMTHAZOLE.
DIAVERIDINE.
# DIAZEPAM.
DIAZOXIDE.
DIBENZEPIN.
DIBOTERMIN.
DIBROMOPROPAMIDINE for therapeutic use except when included in Schedule 2.
DICHLORALPHENAZONE.
DICHLOROPHEN for human therapeutic use.
DICHLORPHENAMIDE.
DICLOFENAC except:
(a) when included in Schedule 2 or 3; or
(b) in preparations for dermal use unless:
(i) for the treatment of solar keratosis; or
(ii) containing more than 4 per cent of diclofenac.
DICLOXACILLIN.
DICYCLOMINE.
DIDANOSINE.
DIENESTROL.
DIENOGEST.
DIETHAZINE.
DIETHYLCARBAMAZINE for human therapeutic use.
DIETHYLPROPION.
DIFENOXIN in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulfate equivalent to at least 5 per cent of the dose of difenoxin.
DIFLORASONE.
DIFLOXACIN.
DIFLUCORTOLONE.
DIFLUNISAL.
DIGITALIS LANATA.
DIGITALIS PURPUREA.
DIGITOXIN.
DIGOXIN.
DIGOXIN-SPECIFIC ANTIBODY FRAGMENT F (Ab).
DIHYDRALAZINE.
DIHYDROCODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or
(b) in undivided preparations with a concentration of not more than 2.5 per cent of dihydrocodeine,
except when included in Schedule 2 or 3.
DIHYDROERGOTOXINE.
# DIHYDROLONE.
DIHYDROSTREPTOMYCIN.
DIHYDROTACHYSTEROL.
DI-IODOHYDROXYQUINOLINE (iodoquinol) except:
(a) when included in Schedule 3; or
(b) for human internal use.
DIISOPROPYLAMINE DICHLOROACETATE.
DILTIAZEM.
DIMENHYDRINATE except when included in Schedule 2 or 3.
DIMERCAPROL.
# DIMETHANDROSTANOLONE.
# DIMETHAZINE.
DIMETHINDENE except when included in Schedule 3.
DIMETHOTHIAZINE.
DIMETHOXANATE.
DIMETHYL FUMARATE.
DIMETHYL SULFOXIDE (excluding dimethyl sulfone) for therapeutic use except:
(a) when included in Schedule 6; or
(b) in in vitro test kits.
DIMETRIDAZOLE.
2,4-DINITROCHLOROBENZENE for therapeutic use.
DINITROCRESOLS for therapeutic use except when separately specified in these Schedules.
DINITRONAPHTHOLS for therapeutic use except when separately specified in these Schedules.
DINITROPHENOLS for therapeutic use.
DINITROTHYMOLS for therapeutic use except when separately specified in these Schedules.
# DINOPROST.
# DINOPROSTONE.
DIPERODON.
DIPHEMANIL except in preparations for dermal use.
DIPHENHYDRAMINE except when included in Schedule 2 or 3.
DIPHENIDOL.
DIPHENOXYLATE in preparations containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate except when included in Schedule 3.
DIPHENYLPYRALINE.
DIPHTHERIA TOXOID.
DIPIVEFRIN.
DIPYRIDAMOLE.
DIRITHROMYCIN.
DIRLOTAPIDE.
DISOPHENOL.
DISOPYRAMIDE.
DISTIGMINE.
DISULFIRAM for therapeutic use.
DISULPHAMIDE.
DITHIAZANINE except when included in Schedule 6.
DITIOCARB.
DOBUTAMINE.
DOCETAXEL.
DOFETILIDE.
DOLASETRON.
DOLUTEGRAVIR.
DOMPERIDONE.
DONEPEZIL.
DOPAMINE.
DOPEXAMINE.
DORIPENEM.
DORNASE.
DORZOLAMIDE.
DOTHIEPIN.
DOXANTRAZOLE.
DOXAPRAM.
DOXAZOSIN.
DOXEPIN.
DOXORUBICIN.
DOXYCYCLINE.
DOXYLAMINE except when included in Schedule 2 or 3.
DRONEDARONE.
DROPERIDOL.
DROSPIRENONE.
# DROSTANOLONE.
DROTRECOGIN.