Poisons Standard 2009 (Cth)
Poisons Standard 2009
as amended
made under paragraph 52D(2)(a) of the
Therapeutic Goods Act 1989.
Compilation start date: 1 May 2010
Includes amendments up to: Poisons Standard Amendment No. 1 of 2010 / F2010L00966
Prepared by the Therapeutic Goods Administration
About this compilation
This compilation
This is a compilation of the Poisons Standard 2009 as in force on 1 May 2010. It includes any commenced amendment affecting the legislation to that date.
This compilation was prepared on 23 January 2015.
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.
Uncommenced amendments
The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.
Provisions ceasing to have effect
If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.
Citation
This instrument is the Poisons Standard 2009.
Commencement
This instrument commences on 14 August 2009.
The New Poisons Standard
For the purposes of paragraph 52(2)(b) of the Act the new Poisons Standard is the Poisons Standard 2009, prepared by the National Drugs and Poisons Schedule Committee, which consist of the Standard for the Uniform Scheduling of Drugs and Poisons No 24, published by the Committee in 2009 as set out in Schedule 1.
Schedule 1-Standard for the Uniform Scheduling of Drugs and Poisons No. 24 published by the National Drugs and Poisons Scheduling Committee in 2009
STANDARD FOR THE UNIFORM SCHEDULING OF
DRUGS AND POISONS
No. 24
June 2009
PREFACE
The Standard for the Uniform Scheduling of Drugs and Poisons is the decisions of the National Drugs and Poisons Schedule Committee, regarding classification of drugs and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. It also includes model provisions about containers and labels, and recommendations about other controls on drugs and poisons.
This document is presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia.
INTRODUCTION
CLASSIFICATION
Drugs and poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with the relevant State or Territory Authority.
Schedule 1. [This Schedule is intentionally blank.]
Schedule 2. Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.
Schedule 3. Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.
Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
Schedule 5. Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.
Schedule 6. Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Schedule 7. Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.
Schedule 8. Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.
Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
Availability of drugs and poisons
The purpose of classification is to group drugs and poisons into Schedules that require similar regulatory controls over their availability.
These Schedules have been developed over a long period and contain drugs and poisons that may be obsolete for various reasons. Also as part of the move to harmonise the Australian and New Zealand classifications many substances have been added to the Schedules for that purpose, irrespective of their availability in either country.
Inclusion of a drug or poison in a Schedule indicates the degree of control required if it is marketed. It does not indicate:
• that the drug or poison is available; nor
• that it has been approved or is efficacious for any use that may be specified in a Schedule,
nor does it negate any obligation for registration of a therapeutic good or an agricultural or veterinary chemical containing that drug or poison.
Preparations containing poisons listed in two or more schedules.
If a preparation contains two or more poisons, the provisions relating to each of the Schedules in which those poisons are included apply.
Where it is not possible to comply both with a provision relating to one of those Schedules and with a provision relating to another of those Schedules, the provision of the more restrictive Schedule applies, unless a contrary intention is indicated in the Schedules or relevant legislation.
The Schedules listed in order of greatest to least restriction are 9, 8, 4, 7, 3, 2, 6, 5.
Schedule 1 is not currently in use.
PRINCIPLES OF SCHEDULING
PRINCIPLES OF SCHEDULING
Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.
This Standard now lists poisons in nine Schedules according to the degree of control recommended to be exercised over their availability to the public.
Poisons for therapeutic use (drugs) are included in Schedules 2, 3, 4 and 8 with progression through these schedules signifying increasingly strict controls.
For agricultural, domestic and industrial poisons Schedules 5, 6 and 7 represent increasingly strict container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7.
Schedule 9 contains substances that should be available only for medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State/Territory Health Authorities. Although appearing as a Schedule in this Standard the method by which it is implemented in the States/Territories may vary.
Substances in products which have been considered for scheduling but have been exempted from this standard may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. It is recommended that provisions of this appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.
READING THE SCHEDULES
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are now scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are being revised and replaced by individual entries as time permits although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry these have been emphasised by printing the word “except” in bold type.
Where the schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation such as pesticide registration may apply.
Where a 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 Interpretation PART 1 [paragraph 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 the Standard to determine the scheduling status of a poison it may be necessary to search each relevant Schedule as well as Appendices A, B and C and the Index. In this process if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find kerosene
toxicological or pharmacological
activity
a pharmacological group “anabolic steroidal agents” to find
“androsterone”
PART 1
INTERPRETATION
(1) In this Standard, unless the contrary intention appears —
“Animal feed premix” means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.
“Appropriate authority” means:
(a) in the Australian Capital Territory, ACT Health;
(b) in New South Wales, the Director-General of New South Wales Health;
(c) in the Northern Territory, the Chief Health Officer of the Department of Health & Families;
(d) in Queensland, the Chief Executive of Queensland Health;
(e) in South Australia, the Chief Executive of the Department of Health;
(f) in Tasmania, the Secretary of the Department of Health and Human Services;
(g) in Victoria, the Secretary to the Department of Human Services;
(h) in Western Australia, the Chief Executive Officer of the Department of Health.
“Approved name” means:
(a) in relation to a poison that is for therapeutic use —
(i) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic
Goods Administration Approved Terminology for Medicines”,
July 1999, or its successor, published by the Therapeutic Goods Administration, Canberra; or, if the poison is not listed in
that publication,
(ii) the international non-proprietary name recommended for the
poison by the World Health Organisation; or, if no such name
is recommended,
(iii) the English name, not including synonyms, by which the
poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical
Formulary and Handbook or the British Pharmacopoeia
(Veterinary); or, if the poison is not described in any of
those publications,
(iv) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,
(v) the accepted scientific name or the name descriptive of the true nature and origin of the poison;
(b) in relation to a poison that is not for therapeutic use —
(i) the English name recommended by the Standards Association of Australia as the common INTERPRETATION—continued
name for the poison; or, if no such name is recommended,
(ii) the English name given to the poison by the International Organisation for Standardisation; or, if no such name is given,
(iii) the English name given to the poison by the British Standards Institution; or, if no such name is given,
(iv) the Australian Approved Name for the poison, not including synonyms, as listed in the publication entitled “Therapeutic Goods Administration Approved Terminology for Drugs”, January 1993 (ISBN 0 644 28628 8), or its successor, published by the Australian Government Publishing Service; or, if the poison is not listed in that publication,
(v) the English name, not including synonyms, by which the poison is described in the British Pharmacopoeia, the British Pharmaceutical Codex, the Australian Pharmaceutical Formulary and Handbook or the British Pharmacopoeia (Veterinary); or, if the poison is not described in any of those publications,
(vi) the approved name given to the poison by the Medicines Commission of Great Britain; or, if no such name is given,
(vii) the international non-proprietary name recommended for the poison by the World Health Organisation; or, if no such name is recommended,
(viii) the accepted scientific name or the name descriptive of the true nature and origin of the poison.
“Australian Code for the Transport of Dangerous Goods by Road and Rail” means the seventh edition of the document of that name.
“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 section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(c) in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”.
“Child-resistant packaging” means packaging that:
(a) complies with the requirements of the Australian Standard
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- INTERPRETATION—continued
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 section 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(d) is in the form of blister or strip packaging in which a unit of use is individually protected until the time of release and that complies with Section 3 (Requirements for non-reclosable packages) of Australian Standard AS 1928-2001 entitled Child-resistant packages.
“Compounded” in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.
“Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
“Dermal use” means application to the skin primarily for localised effect.
“Designated solvent” means the following:
acetone
dimethylformamide
N-(N-dodecyl)-2-pyrrolidone
hydrocarbons, liquid
methanol when included in Schedule 5
methyl ethyl ketone
methyl isoamyl ketone
methyl isobutyl ketone
N-methyl-2-pyrrolidone
N-(N-octyl)-2- pyrrolidone
phenyl methyl ketone
styrene
tetrachloroethylene
1,1,1-trichloroethane
“Distributor” means a person who imports, sells or otherwise supplies a poison.
“Divided preparation” means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
“Dosage unit” means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
“Drug” means a poison intended for human or animal therapeutic use.
INTERPRETATION—continued
“Essential oils” means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. For scheduling purposes it also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) prepared mixtures of oils of equivalent composition comprising a mixture of synthetic and natural components.
“External” in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
“First Schedule Paint” means a paint containing the specified proportion of any substance in the First Schedule to Appendix I of this Standard.
“Graphic material” means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.
“Height” in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.
“Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
“Immediate container” includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.
“Immediate wrapper” means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.
“Internal use” means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect,
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
“Label” means a statement in writing on a container of a poison.
“Main label” means, where there are two or more labels on a container or a label is divided into two or more portions:
(a) that label or portion of the label on which the name of the product is most prominently shown and which is primarily designed to attract attention; or
(b) where the name of the product is equally prominent on two or more labels or portions of a label, each of those labels or portions of the label on which the name of the product is equally prominent.
“Manufacturer” means a person who manufactures, produces, or packs a poison.
“Measure pack” means a sealed container which contains a measured quantity of poison for use on one occasion as a pesticide or domestic product and one or more of which is enclosed in a primary pack.
INTERPRETATION—continued
“Name and address” means the name and address, in Australia, of the manufacturer or distributor of a poison but does not include a post office, cable, telegraphic or code address. Where such manufacturer or distributor is a company incorporated in accordance with the appropriate law of any State or Territory of the Commonwealth of Australia or a firm registered under the Business Names Act of any State or Territory, the inclusion in the label of the registered name of the corporation or firm or its branch or its division and the city or town in which a registered office is situated shall be deemed to comply with the requirements.
“Non-access packaging” is packaging that complies with the requirements of Australian Standard AS4710-2001 entitled Packages for chemicals not intended for access or contact with their contents by humans, in relation to products that are not intended for human therapeutic use.
“Non-volatile content” in relation to a paint or tinter means that portion of a paint or tinter determined to be the non-volatile content by Method 301.1 of Australian Standard AS 1580-301.1-2005 entitled Paints and related materials – Methods of test – Non-volatile content by mass.
“Paint”, without limiting the ordinary meaning, includes any substance used or intended to be used for application as a colouring or protective coating to any surface but does not include graphic material.
“Pesticide” means any substance or mixture of substances used or intended to be used:
(a) for preventing, destroying, repelling, attracting, inhibiting or controlling any insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of plant or animal life or viruses, which are pests; or
(b) as a plant regulator, promoter, defoliant or desiccant for food storage, household, industrial, commercial, agricultural and non-agricultural application, but does not include veterinary drugs, stock medicines, stock feeds, stock feed additives, drugs for human use, food additives or fertilisers.
“Poison” means any substance or preparation included in a Schedule to this Standard.
“Primary pack” means the pack in which a poison and its immediate container or immediate wrapper or measure pack are presented for sale or supply.
“Required Advisory Statements for Medicine Labels” means the document of that name, as published by the Therapeutic Goods Administration in September 2008.
“Restricted flow insert” means a restriction fitted, or moulded, in the neck of a container which:
(a) cannot readily be removed from the container by manual force; and
(b) limits the delivery of the contents to drops each of which is not more than 200 microlitres.
“Second Schedule Paint” means a paint containing the specified proportion of any substance in the Second Schedule to Appendix I of this Standard.
“Selected container” means:
(a) an injection vial having a nominal capacity of ten millilitres or less;
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.
“Solid” is considered to include “powder” for the purposes of scheduling.
INTERPRETATION—continued
“Therapeutic use” means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals;
(b) influencing, inhibiting or modifying a physiological process in human beings or animals; or
(c) testing the susceptibility of human beings or animals to a disease or ailment.
“Third Schedule Paint” means a paint containing the specified proportion of any substance in the Third Schedule to Appendix I of this Standard.
“Tinter” means any pigment or admixture of pigment with other substances, in powder, semi-solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.
“Topical use” means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
“Toy” means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of fourteen years.
“Transdermal use” means application to the skin primarily for systemic effect.
“Writing” includes the visible representation or reproduction of words or figures in any form, and “to write” and “written” have corresponding meanings.
(2) Unless the contrary intention appears a reference to a substance in a schedule or an appendix to this Standard includes:
(a) that substance prepared from natural sources or artificially; and
(b) where the substance is a plant (other than a plant included in Schedule 8 or 9), that plant or any part of that plant when packed or prepared for therapeutic use; and
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative; and
(d) every alkaloid of the substance and every salt of such an alkaloid; and
(e) 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
INTERPRETATION—continued
(k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the Standards for Active Constituents, as published by the Australian Pesticides and Veterinary Medicines Authority.
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a schedule or an appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance
per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation,
1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine such concentration, strength or quantity is calculated as anhydrous codeine.
(4) A reference to a boiling or distillation temperature in the schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).
PART 2
LABELS AND CONTAINERS
LABELS
. A person must not sell or supply a poison unless it is labelled in accordance with paragraphs 3 to 19 of this Standard.
General requirements
Any word, expression or statement required by this Standard to be written on a label or container must be written:
(1) on the outside face of the label or container; and
(2) in the English language; and
(3) in durable characters; and
(4) in a colour or colours to provide a distinct contrast to the background colour; and
(5) in letters at least 1.5 millimetres in height.
Sub-paragraph 3(5) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:
(1) an appropriate authority approves the use of smaller letters; and
(2) the letters are at least 1 millimetre in height.
The label must be printed on, or securely attached to:
(1) the outside of the immediate container; and
(2) if the immediate container is enclosed in a primary pack, the outside of that primary pack.
Immediate wrapper
(1) A poison enclosed in an immediate wrapper must be contained in a primary pack labelled in accordance with paragraph 7 of this Standard; and
(2) the immediate wrapper must be conspicuously labelled with:
(a) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and
(b) the approved name of the poison; and
(c) a statement of the quantity or strength of the poison in accordance with
paragraph 8.
Primary packs and immediate containers
(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:
LABELS AND CONTAINERS—continued
Schedule Purpose Signal words required
2 for any purpose PHARMACY MEDICINE
3 for any purpose PHARMACIST ONLY MEDICINE
4 for human use PRESCRIPTION ONLY MEDICINE
4 for animal use PRESCRIPTION ANIMAL REMEDY
5 for any purpose CAUTION
6 for any purpose POISON
7 for any purpose DANGEROUS POISON
8 for any purpose CONTROLLED DRUG
written:
(i) on the first line or lines of the main label; and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least half the height of the largest letter or numeral on the label but need not be larger than:
(A) 6 millimetres on labels for packages having a nominal capacity of
2 litres or less; or
(B) 15 millimetres on labels for packages having a nominal capacity of more than 2 litres; and
(iv) if the poison:
(A) is a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail or a statement of the principal hazard of the poison, written on that line; or
(B) is not a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on that line;
(b) if the poison is a Schedule 8 poison, with the cautionary statement –
POSSESSION WITHOUT AUTHORITY ILLEGAL
written:
(i) on a separate line or lines immediately below the signal words required by sub-paragraph 7(1)(a); and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal words; and
(iv) with no other statement written on the same line;
LABELS AND CONTAINERS—continued
(c) with the cautionary statement –
KEEP OUT OF REACH OF CHILDREN
written:
(i) on a separate line or lines:
(A) immediately below the signal word or words required by sub-paragraph 7(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by sub-paragraph 7(1)(b), on the line immediately below that statement; and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(d) if the poison is a dry chlorinating compound containing more than 10 per cent of available chlorine, except for preparations certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5.1 (oxidising substances) 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 sub-paragraph 7(1)(c); and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –
BURNS SKIN AND THROAT
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal word; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line of the main label;
LABELS AND CONTAINERS—continued
(f) if the poison is an aqueous solution of paraquat, with the cautionary statements –
CAN KILL IF SWALLOWED
DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP
written:
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;
(g) if safety directions are required on the label by sub-paragraph 7(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by sub-paragraph 7(1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(ii) in bold-face sanserif capital letters of uniform thickness; and
(iii) in letters at least four tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FLAMMABLE
written on the main label in bold-face sanserif capital letters of uniform thickness, unless already present in accordance with the requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail Rail;
(i) if the poison is for the treatment of animals, with the cautionary statement –
LABELS AND CONTAINERS—continued
FOR ANIMAL TREATMENT ONLY
written on the main label in bold-face sanserif capital letters of uniform thickness;
(j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written in sanserif capital letters on the main label or as part of the directions for use;
(k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with paragraph 8:
(i) if the poison is for human therapeutic use, written in accordance with orders made under section 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sanserif capital letters on the main label, unless:
(A) a list of approved names is required; and
(B) it is impractical to include the list on the main label; and
(C) an appropriate authority has authorised its inclusion on another part of the label; or
(iii) if the poison is a Schedule 5 poison referred to in column 1 of the following table the appropriate name opposite thereto in column 2 may be used as the approved name:
TABLE
Column 1 Column 2
Alkaline salts Alkaline salts
Amines for use as curing Aliphatic amines or
agents for epoxy resins aromatic amines
(unless separately specified
in the Schedules)
Epoxy resins, liquid Liquid epoxy resins
Hydrocarbons, liquid Liquid hydrocarbons
Quaternary ammonium Quaternary ammonium
compounds compound(s)
(iv) if a poison contains a mixture of designated solvents in excess of 25 per cent of the total volume of the poison but the proportion of one or more individual designated solvents in the mixture is equal to or less than 25 per cent, the approved names of those solvents may be expressed as follows:
(A) where the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or
(B) where the designated solvent is a ketone as “ketones”; or
(C) in any other case as “solvents” or “other solvents”;
LABELS AND CONTAINERS—continued
(l) if the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, with the following expression written immediately below the approved name or the list of declared contents –
AN ANTICHOLINESTERASE COMPOUND
(i) the requirements of sub-paragraph 7(1)(l) do not apply to:
(A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or
(C) an organophosphorus compound or carbamate contained in a
pressurised spray pack for household use;
(m) if the poison is prepared, packed or sold for a specific purpose, with clear and adequate directions for use unless:
(i) the poison is included in Schedule 4 or Schedule 8; or
(ii) it is impractical to include such directions on the label and:
(A) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”; and
(B) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label; and
(C) the insert is enclosed in the primary pack;
(n) if use of the poison may be harmful to the user, with appropriate safety directions (see Appendix F), grouped together as a distinct section of the label and prefaced by the words –
SAFETY DIRECTIONS
written in bold-face capital letters;
(o) if any warning statement or statements are required for the poison
(see Appendix F), with that warning statement or those statements grouped together:
(i) if safety directions are included on the label, immediately after the words “SAFETY DIRECTIONS”; or
(ii) if there are no safety directions, immediately preceding the directions for use;
(p) if the poison is not for human internal use and is not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):
(i) grouped together and prefaced by the words –
FIRST AID
written in bold-face capital letters; or
(ii) if a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:
LABELS AND CONTAINERS—continued
(A) written on each immediate container as specified in sub-paragraph 7(1)(p)(i); and
(B) replaced on the primary pack with the statement –
FIRST AID: See inner packs;
(q) with the name and address of the manufacturer or distributor.
(2) For the purposes of sub-paragraph 7(1)(a)(iii) the term “largest letter or numeral” does not include:
(a) a single letter or numeral which is larger than other lettering on the label; or
(b) an affix forming part of the trade name; or
(c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.
Statements of quantity, proportion or strength
The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(1) if the poison is for human therapeutic use, in the manner prescribed by orders made under section 10(3) of the Commonwealth Therapeutic Goods Act 1989;
(2) if the poison is for a purpose or purposes other than human therapeutic use and:
(a) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(b) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(c) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;
(d) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(e) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(f) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(g) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(h) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;
(3) if the poison is a solution of a mineral acid, the proportion of the acid may be expressed as the mass of the acid per stated mass of the preparation;
(4) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate: contains not more than 10 per cent (name of the metal); or
LABELS AND CONTAINERS—continued
contains not more than 30 per cent (name of the metal); or contains more than 30 per cent of (name of the metal);
(5) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;
(6) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;
(7) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.
(8) For the purposes of sub-paragraph 8(7) “derivative” includes alkaloid.
Exemptions
Selected containers and measure packs
The requirements of paragraph 7 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which paragraphs 10 or 11 apply) when:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(2) labelled with:
(a) the signal word or words, relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to sub-paragraph 7(1)(a); and
(b) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(c) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(d) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sanserif capital letters.
Ampoules, pre-filled syringes and injection vials
The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(2) labelled with:
(a) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
LABELS AND CONTAINERS—continued
(b) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(c) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sanserif capital letters.
The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(1) packed in a primary pack labelled in accordance with paragraph 7; and
(2) the strip is labelled in accordance with paragraph 10; and
(3) the ampoule is labelled with:
(a) the approved name of the poison or the trade name of the product; and
(b) the quantity, proportion or strength of the poison in accordance with paragraph 8.
Transport containers and wrappings
The labelling requirements of this Standard do not apply to a transparent cover, or to any wrapper, hamper, packing case, crate or other cover used solely for the purposes of transport or delivery.
Dispensary, industrial, laboratory and manufacturing poisons
The labelling requirements of this Standard do not apply to a poison that:
(1) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and
(2) is labelled in accordance with the National Occupational Health and Safety Commission’s National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012 (1994)].
Dispensed medicines
Unless otherwise specified by regulation, the labelling requirements of this Standard do not apply to a poison for therapeutic use that:
(1) is supplied by a medical, dental or veterinary practitioner in the ordinary course of their professional practice; or
(2) is supplied on and in accordance with a prescription written by a medical, dental or veterinary practitioner or any other person authorised to prescribe drugs and poisons; or
(3) is prepared and supplied by a pharmacist for an individual patient.
Gas cylinders
The requirements of sub-paragraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.
Paints
The requirements of paragraph 7 do not apply to:
LABELS AND CONTAINERS—continued
(1) paint (other than a paint for therapeutic or cosmetic use) which:
(a) contains only Schedule 5 poisons; or
(b) is a First Schedule or Second Schedule paint that is labelled with:
(i) the word “WARNING”, written in bold-face sanserif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line; and
(ii) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sanserif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and
(iii) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(iv) the name and proportion of the First Schedule or Second Schedule poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint; or
(2) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Schedule or Second Schedule to Appendix I, provided that it is labelled with the name and proportion of that poison, and where the poison is a metal or metal salt, the proportion is expressed as the metallic element present as “calculated on the non-volatile content” or “in the dried film”.
Camphor and naphthalene
The labelling requirements of sub-paragraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc or pellet form if the device:
(1) complies with paragraph 28; and
(2) is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.
Prohibitions
. A label used in connection with any poison must not include:
(1) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or
(2) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or
(3) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or
(4) any trade name or description that:
(a) represents any single constituent of a compound preparation; or
(b) misrepresents the composition or any property or quality of the poison; or
LABELS AND CONTAINERS—continued
(c) gives any false or misleading indication of origin or place of manufacture of the poison.
A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure:
(1) any expression required by this Standard to be written or embossed on the container or pack; or
(2) any of the ribs or embossed or printed words required by paragraph 21, 22 or 23 as appropriate.
CONTAINERS
A person must not sell or supply a poison unless the immediate container complies with the requirements of paragraphs 21 to 28 of this Standard.
Containers for poisons other than Schedule 5 poisons
If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of 2 litres or less, the container must comply with Australian Standard AS 2216-1997, entitled Packaging for poisonous substances.
21a.Notwithstanding subparagraph 21, a poison which is in Schedule 6 and is an essential oil may be packed in an amber glass container which does not comply with the tactile identification requirements of Australian Standard AS 2216-1997, entitled Packaging for poisonous substances, if:
(1) the other safety factors are not diminished; and
(2) the container has a restricted flow insert and a child-resistant closure.
. If a poison, other than a Schedule 5 poison, is sold or supplied in a container with a nominal capacity of more than 2 litres, the container must:
(1) comply with sub-section 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances; and
(2) have the word “POISON”:
(a) in sanserif capital letters the height of which is at least one thirty second part of the length, height or width of the container, whichever is the greatest:
(i) embossed; or
(ii) indelibly written in a colour in distinct contrast to the background colour;
(b) on the side or shoulder of the container.
Containers for Schedule 5 poisons
(1) The container in which any Schedule 5 poison is sold or supplied must:
(a) comply with the container requirements of paragraph 21 or paragraph 22; or
(b) be readily distinguishable from a container in which food, wine or other beverage is sold; and
(i) comply with sub-section 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances, excluding paragraph 1.4.3;
LABELS AND CONTAINERS—continued
(ii) be securely closed and, except when containing a preparation for use on one occasion only, be capable of being re-closed to prevent spillage of its contents; and
(iii) have the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” embossed or indelibly written thereon, or printed on a permanent adhesive label designed to adhere to a substrate without lifting and which cannot be removed without damaging either the label or the substrate.
(2) Notwithstanding sub-paragraph 23(1), the following Schedule 5 poisons namely:
(a) methylated spirit(s);
(b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in paragraph 21.
Approved containers
Notwithstanding sub-paragraphs 21, 22 and 23 a poison may be packed in a
container that does not comply with the tactile identification requirements of
Australian Standard AS2216-1997 entitled Packaging for poisonous substances or the requirements of paragraphs 22(2) or 23(1)(iii) if:
(1) the other safety factors are not diminished;
(2) the container is for a specific purpose; and
(3) an appropriate authority has approved the use of the container for that purpose.
Child-resistant closures
(1) If a poison listed in column 1 of the following table is sold or supplied in a container having a nominal capacity specified for that poison in column 2 it must be closed with a child-resistant closure.
LABELS AND CONTAINERS—continued
TABLE
Column 1 Column 2
Name of the poison Nominal capacity
Alkaline salts included All sizes
in Schedule 5, when packed and labelled
as dishwashing machine tablets.
Alkaline salts included in Schedule 5, 5 litres / kilograms or less
when packed and labelled as
dishwashing machine liquids,
solids or gels.
Alkaline salts included in Schedule 5, 2.5 litres or less
when packed and labelled as a food
additive.
Anise oil when included in Schedule 5. 200 millilitres or less
Basil oil when included in Schedule 5. 200 millilitres or less
Bay oil when included in Schedule 6. 200 millilitres or less
Cajuput oil when included in Schedule 6. 200 millilitres or less
Cassia oil when included in Schedule 5. 200 millilitres or less
Cineole when included in Schedule 6. 2 litres or less
Cinnamon bark oil when included 200 millilitres or less
in Schedule 5.
Cinnamon leaf oil when included 200 millilitres or less
in Schedule 6.
Clove oil when included in Schedule 6. 200 millilitres or less
Essential oils when included in 200 millilitres or less
Schedule 6 because of their natural
camphor component.
Ethylene glycol when included in 5 litres or less
Schedule 6.
Ethylene glycol when included in 5 litres or less
Schedule 5 in preparations containing
more than 50 per cent of ethylene glycol.
Eucalyptus oil when included 2 litres or less
in Schedule 6.
Eugenol when included in Schedule 6. 200 millilitres or less
Hydrocarbons, liquid, when packed 5 litres or less
as kerosene, lamp oil, mineral turpentine,
thinners, reducers, white petroleum spirit
LABELS AND CONTAINERS—continued
TABLE
Column 1 Column 2
Name of the poison Nominal capacity
or dry cleaning fluid.
Hydrochloric acid when included 5 litres or less
in Schedule 6.
Marjoram oil when included in Schedule 5. 200 millilitres or less
Melaleuca oil (tea-tree oil) when 200 millilitres or less
included in Schedule 6.
Methylated spirit excluding 5 litres or less
preparations or admixtures.
Methyl salicylate and preparations 200 millilitres or less
containing more than 50 per cent
of methyl salicylate.
Nutmeg oil when included in Schedule 5. 200 millilitres or less
Oil of turpentine. 5 litres or less
Pennyroyal oil when included 200 millilitres or less
in Schedule 6.
Potassium hydroxide as such. 2.5 litres or less
Potassium hydroxide in oven, 5 litres or less
hot plate or drain cleaners
when included in Schedule 6
except when in pressurised spray packs.
d-Pulegone when included 200 millilitres or less
in Schedule 6.
Sage oil (Dalmatian) when 200 millilitres or less
included in Schedule 6.
Sodium hydroxide as such. 2.5 litres or less
Sodium hydroxide in oven, 5 litres or less
hot plate or drain cleaners
when included in Schedule 6
except when in pressurised spray packs.
Thujone when included in Schedule 6. 200 millilitres or less
Thyme oil when included in Schedule 5. 200 millilitres or less
(2) The manufacturer or packer of a poison must ensure that the child-resistant closure is appropriate for the container and the poison and that it retains its child-resistant properties for the expected life of the poison.
LABELS AND CONTAINERS—continued
Schedule 8 poisons
25A. (1) A person who supplies any Schedule 8 poison must ensure that the Schedule 8 poison is packaged in such a way that its primary pack is so sealed that, when the seal is broken, it is readily distinguishable from other sealed primary packs.
(2) This paragraph does not apply to the supply of a Schedule 8 poison by a:
(a) medical practitioner, dentist or veterinary surgeon in the practice of his or her profession;
(b) pharmacist on the prescription of a medical practitioner, dentist or veterinary surgeon;
(c) pharmacist employed at a hospital, on the written requisition of a medical practitioner, a dentist or the nurse in charge of the ward in which the Schedule 8 poison is to be used or stored; or
(d) nurse on the direction in writing of a medical practitioner or dentist.
Exemptions
(1) Paragraphs 21, 22 and 23 do not apply to the immediate container of a poison prepared, packed and sold:
(a) for human internal or animal internal use; or
(b) as a solid or semi-solid preparation for human external or animal external use; or
(c) as a paint, other than a paint for therapeutic or cosmetic use; or
(d) in containers having a nominal capacity of 15 millilitres or less; or
(e) for use in automatic photographic or photocopy processing machines if the container is specifically designed to fit into the machines; or
(f) solely for dispensary, industrial, laboratory or manufacturing purposes.
(2) Paragraph 25 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.
. The tactile identification or embossing required by paragraphs 21, 22 or 23 of this Standard or Australian Standard AS 2216-1997 entitled Packaging for poisonous substances do not apply to a container that is an aerosol container, a collapsible tube, or a measure pack which is a flexible sachet.
Camphor and naphthalene
. The container requirements of paragraph 21 do not apply to a device that contains only camphor or naphthalene in block, ball, disc or pellet form for domestic use, if the device:
(1) in normal use, prevents removal or ingestion of its contents; and
(2) is incapable of reacting with the poison; and
(3) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and
(4) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.
LABELS AND CONTAINERS—continued
Prohibitions
A person must not sell or supply camphor or naphthalene in ball, block, disc or pellet form for domestic use unless
the balls, blocks, discs or pellets are enclosed in a device which prevents removal or ingestion of its contents.
. A person must not sell or supply a poison in a container which has the name of another poison embossed or indelibly marked thereon.
. A person must not sell any poison, drug or medicine which is for internal use or
any food, drink or condiment in a container prescribed by paragraphs 21, 22 or 23 of this Standard.
PART 3
MISCELLANEOUS REGULATIONS
(It is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)
ADVERTISING
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.
A person must not include any reference to a substance included in Schedule 9 of this Standard in any advertisement.
SALE OR SUPPLY
Schedule 2 poisons
. 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.
. A person is not eligible to be granted a licence to sell a Schedule 2 poison by way of retail sale unless:
(1) he or she is carrying on the business of selling goods by retail; and
(2) the premises from which the poison will be sold is more than 25 kilometres by the shortest practical route from the nearest pharmacy; and
(3) he or she produces such evidence, as may be required, that he or she is a fit and proper person to be so licensed.
Schedule 3 poisons
. 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.
The person who sells or supplies a Schedule 3 poison must:
(1) provide adequate instructions for use, either written or verbal, at the time of supply or sale; and
(2) label the container with his or her name or the name of the pharmacy and the address from which it was sold or supplied; and
(3) if required by regulation, make a record of the transaction in a prescription book or other approved recording system.
Schedule 4 poisons
. 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.
MISCELLANEOUS REGULATIONS—continued
Paragraph 38 does not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than a poison excepted by regulation from this provision, without a prescription if:
(1) the patient is under medical treatment with the poison and continuation of medication is essential; and
(2) the quantity sold or supplied does not exceed 3 days medication; and
(3) the pharmacist is satisfied that an emergency exists.
Paragraphs 34, 36, 37 and 38 do not apply to sale by way of wholesale dealing to a pharmacist, medical practitioner, veterinary practitioner, dentist or a person licensed or otherwise authorised to possess, sell or supply such poisons.
Schedule 7 poisons
(1) A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.
(2) A person must not sell or supply:
(a) a Schedule 7 poison for domestic or domestic garden purposes; or
(b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or
(c) a Schedule 7 poison for which an authorisation to possess or use is required by sub-paragraph (3) unless the purchaser produces his or her authorisation.
(3) A person must not possess or use any of the following Schedule 7 poisons unless he or she is authorised to do so by the appropriate authority:
Arsenic
Cyanides
Fluoroacetic acid
Fluoroacetamide
Hydrocyanic acid
Strychnine
Thallium.
(4) The appropriate authority may exempt a person or a class of persons from the requirement to hold an authorisation under sub-paragraph (3) and may vary or revoke the exemption by notice in writing.
Prohibitions on sale, prescribing and possession
A person must not:
(1) knowingly have in his or her possession or sell, supply or use a substance listed in Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Appendix C; or
(2) sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions indicated for that poison in Appendix D; or
(3) knowingly have in his or her possession a poison listed in Appendix D paragraph 5 without authority.
STORAGE
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.
MISCELLANEOUS REGULATIONS—continued
. A person who sells or supplies Schedule 3, Schedule 4 or Schedule 7 poisons must keep those poisons in a part of the premises to which the public does not have access.
DISPENSED MEDICINES
45.A person must not supply a dispensed medicine for human use containing:
(1) a poison for internal use listed in Appendix K unless it is clearly labelled with warning statement 39, 40 or 90 as specified in Appendix F, Part 1; or
(2) levocabastine, unless it is clearly labelled with warning statement 62 in Appendix F, Part 1; or
(3) acitretin, adapalene, bexarotene, etretinate, isotretinoin, lenalidomide, thalidomide or tretinoin:
(i) for oral use unless it is clearly labelled with warning statements 7, 62 and 76 in Appendix F, Part 1;
(ii) for topical use unless it is clearly labelled with warning statements 62 and 77 in Appendix F, Part 1; or
(4) leflunomide unless it is clearly labelled with warning statements 7, 62 and 87 in Appendix F, Part 1; or
(5) misoprostol unless it is clearly labelled with warning statement 53 in Appendix F, Part 1; or
(6) dienestrol unless it is clearly labelled with warning statement 67 in Appendix F,
Part 1.
PART 4
THE SCHEDULES
SCHEDULE 1
This Schedule is intentionally blank.
SCHEDULE 2
(Substances marked are listed in Appendix C)
ACETIC ACID (excluding its salts and derivatives) and preparations containing
more than 80 per cent of acetic acid (CH3COOH) for therapeutic use.
ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.
ACONITUM spp. for therapeutic use in adults:
(a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or
(b) in preparations for dermal use containing 0.02 per cent or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.
ALOXIPRIN.
AMETHOCAINE in preparations for topical use other than eye drops, containing
10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.AMOROLFINE for topical use in preparations containing 0.25 per cent or less of amorolfine except in preparations for the treatment of tinea pedis.
ANTAZOLINE in eye drops.
ASPIRIN except:
(a) when included in Schedule 4, 5 or 6;
(b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when:
(i) enclosed in a primary pack that contains 12 or less such powders or sachets of granules; and
(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;
(c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:
(i) packed in blister or strip packaging or in a container with a child-resistant closure;
(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
SCHEDULE 2–continued
(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 in preparations for nasal use.
BECLOMETHASONE in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing
200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
BENZOCAINE in preparations for topical use other than eye drops:
(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.
BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10 per cent or less of benzoyl peroxide except in preparations containing 5 per cent or less of benzoyl peroxide.
BENZYDAMINE in preparations for topical use, 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.
SCHEDULE 2–continued
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.
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 in preparations for dermal use and for application to the nails containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis.
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
SCHEDULE 2–continued
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 of 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
SCHEDULE 2–continued
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
Clotrimazole in vaginal preparations 54,63,64,66
when included in Schedule 3.
Clove oil 1
Cyanides when included in Schedule 7. 13 4,8
Cyanuric acid 1,4,8
Cyclohexanone peroxide 1,4,8
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Cysteamine 1
4,4-Diaminodiphenylmethane 1,4,8
(methylene dianiline)
ortho-Dichlorobenzene 1,4,8
para-Dichlorobenzene 1,4
Dichloroethylene 1,4,8
Dichloroethyl ether 1,4,8
Dichloroisocyanurates
(a) in household cleaning or 20
bleaching preparations.(b) in preparations containing 11 1,4,10
less than 10 per cent of
available chlorine.(c) in liquid preparations containing 3,18 1,4,6,8,10,
10 per cent or more of available 15,16,17,18,
chlorine. 19,20,22,26(d) in dry preparations containing 10,18,22,23 1,4,8,12,13,14,
10 per cent or more of available 15,16,17,18,19,
chlorine. 20,21,22,26(e) in dry preparations containing 10,18,22 1,4,8,12,13,14,
10 per cent or more of available 15,16,17,18,19,
chlorine certified by a relevant 20,21,22,26
State or Territory authority as not
being a Dangerous Good of
Class 5.1 (oxidising substances),
as specified in the Australian Code
for the Transport of Dangerous
Goods by Road and Rail.
(f) in anti-bacterial tablets 60
containing 2.5 g or less of sodium
dichloroisocyanurate.(g) in other compressed blocks or 10,22,23 12,13,14,15,
tablets containing 10 per cent or 17,18,19,21
more of available chlorine
except in preparations containing 21 g
or less of sodium dichloroisocyanurate
for use in toilet cisterns only.
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
(h) in other compressed blocks or tablets 10,22 12,13,14,15,17,
containing 10 per cent or more of 18,19,21
available chlorine certified by a
relevant State or Territory authority
as not being a Dangerous Good of
Class 5.1 (oxidising substances), as
specified in the Australian Code for
the Transport of Dangerous Goods
by Road and Rail except in preparations
containing 21 g or less of sodium
dichloroisocyanurate for use in toilet
cisterns only.
(i) in other compressed blocks or
tablets containing 10 per cent
or more of available chlorine
in preparations containing 5 g
or less of sodium
dichloroisocyanurate for use in
toilet bowls only.
(i) during storage 10,22,23 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
(j) in other compressed blocks or tablets
containing 10 per cent or more of available
chlorine certified by a relevant State or
Territory authority as not being a
Dangerous Good of Class 5.1 (oxidising
substances) as specified in the
Australian Code for the Transport of
Dangerous Goods by Road and Rail
in preparations containing 5 g or less of
sodium dichloroisocyanurate for use in
toilet bowls only.
(i) during storage 10,22 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
Dichloromethane (methylene chloride)
(a) in paint or lacquer removers. 12,16 1,4,8,11
(b) other than in paint or lacquer 1,4,8,25
removers.
Diclofenac 101,104
Dienestrol 67
Diethanolamine when included in Schedule 5. 5 1,4
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Diethanolamine when included in Schedule 6. 2,11,18 1,4,8
Diethyltoluamide for human use. 44
5,6-Dihydroxyindoline 21,28
Dimethylformamide 1,4,8
Dimethyl sulfate 2 1,4,8
Dimethyl sulfoxide
(a) when not packed and labelled 27 1,4,5,8
for therapeutic use.
(b) when packed and labelled 49 1,4,5,8
for treatment of animals.
Dinitrocresols (and their homologues) 1,4,8
except when for therapeutic use.
Dinitrophenols (and their homologues) 1,4,8
except when for therapeutic use.
Dinocap 47
Dioxane 1,4,8
Diphenoxylate when included in Schedule 3. 39 or 40, 41
Econazole in vaginal preparations when 54,63,64,66
included in Schedule 3.
Ephedrine in nasal preparations 29
for topical use.
Epichlorohydrin 2 1,4,8
Epoxy resins, liquid. 1,3,4,5,8
Ethanolamine when included in Schedule 5. 5 1,4
Ethanolamine when included in Schedule 6. 2,11,18 1,4,8
Ether when included in Schedule 5 or 6. 1,4,8
Ethoxyethylmercuric chloride 1,4
Ethyl bromide 1,4,8
Ethylene chlorohydrin 1,4,8
Ethylene glycol monoalkyl ethers and 1,4,8
their acetates except when separately specified.
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Ethylene oxide 1,4,8
Ethylmercuric chloride 1,4
Ethyl methacrylate 28 4,9,23
Etretinate 7,62,76
Eugenol 1
Famotidine when included in Schedule 2. 96
Fenoterol in metered aerosols. 32
Fluconazole in oral preparations when 64
included in Schedule 3.
Fluorides (including silicofluorides) 1,4
when included in Schedule 5 or 6
except when separately specified.
Formaldehyde
(a) in nail hardener cosmetics. 106 1,4,8,36
(b) in other preparations. 106 1,4,8
Formic acid 1,4,8
Glazing preparations containing lead compounds. 50
Glutaraldehyde except when in Schedule 2
(a) 25 per cent or less. 5,59 1,4,5
(b) more than 25 per cent. 3,59 1,4,5,8
Glycolic acid 79 1,5,6,31
Hexachlorophane in preparations 24
for skin cleansing purposes
containing 3 per cent or
less of hexachlorophane.
Hydrazine 1,4,8
Hydrochloric acid
(a) 30 per cent or less of HCl. 1,4
(b) more than 30 per cent of HCl. 1,4,8
Hydrocortisone
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
(a) for dermal use when included 38,72,73,74,75
in Schedule 2 or 3.
(b) for topical rectal use when 38,75
included in Schedule 2 or 3.
Hydrocyanic acid when included in 13 4,8
Schedule 7.
Hydrofluoric acid (including mixtures
that generate hydrofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Hydrogen peroxide
(a) more than 3 per cent up to 10 per cent. 5 1
(b) more than 10 per cent up to 20 per cent. 5 2
(c) more than 20 per cent. 2 2,4
Hydroquinone
(a) when in Schedule 2. 45
(b) except when in Schedule 2 or 4. 1,4
Hydrosilicofluoric acid (including mixtures
that generate hydrosilicofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
8-Hydroxyquinoline (including salts and 33
derivatives) when prepared for
internal use.
Ibuprofen 101,104
Iodine
(a) more than 20 per cent. 1,4,8
(b) in preparations for human 91,92
internal therapeutic use
containing 300 micrograms
or more of iodine per
recommended daily dose.Ipratropium bromide in metered aerosols. 32
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Isocyanates (free organic)
(a) when in paint. 28,52 1,5,8,10,27
(b) other than in paint. 28,52 1,4,8
Isoprenaline in metered aerosols 32
Isotretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Lead compounds
(a) in hair cosmetics. 25
(b) when in Schedule 6. 1,4,8
Leflunomide 7,62,87
Lemon oil 89
Levocabastine
(a) in eye or nasal preparations containing 62
0.5 mg/mL or less of levocabastine.
(b) in other preparations. 62 and
either 39 or 40
Lime oil 89
Loperamide when in Schedule 2. 41
Magnesium chlorate 1,4
Mefanamic acid 101,104
Mercuric thiocyanate 1,4
Metacresolsulphonic acid and formaldehyde 1,4
condensation product for the
treatment of animals.
Methanol except in methylated spirit. 1,4,8
Methoxamine in nasal preparations for 29
topical use.
Methyl chloride 1,4,8
Methyldibromo glutaronitrile 28 1,4,7
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Methylene bisthiocyanate 1,4
Methyl ethyl ketone 5 1,4,8
Methyl ethyl ketone peroxide 2 2,3,4,6
Methyleugenol 1,6
Methyl iso-amyl ketone 1,4,8
Methyl iso-butyl ketone 1,4,8
Methyl iso-thiocyanate 5,12 1,4,8
Methyl methacrylate 28 4,9,23
Methylnorbornylpyridine 59
1-(beta-Methyl sulphonamidoethyl)-
2-amino-3-N,N-diethylaminobenzene 1,4,8
Miconazole in vaginal preparations 54,63,64,66
when included in Schedule 3.
Misoprostol 53
Naphazoline in nasal preparations for 29
topical use.
Naphthalene
(a) in block, ball, disc or pellet form, 9,105
enclosed in a device which, in
normal use, prevents removal or
ingestion of its contents;
(b) in other forms. 9,105 1
Naproxen 101,104
Nicotine except when in tobacco 1,4
or when included in Schedule 2.
Nitric acid
(a) 75 per cent or less HNO3. 2 1,4
(b) more than 75 per cent HNO3. 2 1,4,8
Nitrobenzene 1,4,8
Nitrophenols 1,4
Nitroprussides in aerosols. 84 8
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Nizatidine when included in Schedule 2. 96
Noradrenaline in metered aerosols. 32
Nystatin in vaginal preparations 54,63,64,65,66
when included in Schedule 3.
Orange oil (bitter) 89
Orciprenaline in metered aerosols. 32
Oxalates, metallic 4,8
Oxalic acid 2 4,8
Oxymetazoline in nasal preparations 29
for topical use.
Paint
(a) First Schedule paints. 83
(b) Second Schedule paints. 84
Paracetamol 97 and/or 98,99,100
Pentachlorophenol 1,4,8
Peracetic acid 2 1,4,8
Permanganates 2 24
Phenol and any other homologue of phenol 1,4
Phenols 5
Phenylenediamines and alkylated
phenylenediamines
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Phenylephrine in nasal preparations 29
for topical use.
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,5-dimethanamine 5,28 1,4,5,10
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine 5,28 1,4,5,10
ortho-Phenylphenol except when in 1,4
antiseptics.
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Phenylpropanolamine 56
Phenytoin in pastes for the treatment of horses. 9
Phosphonic acid 1,4
Phosphoric acid 1,4
Phosphorus (yellow) 2 1,4
ortho-Phthalaldehyde
• when included in Schedule 6. 51,52,59 2,4,5,8,10
• when included in Schedule 5. 51,52,59 1,4,5,8,10
Picric acid (more than 20 per cent). 1,4
Podophyllin
(a) in preparations specifically for 36
use on anal or genital area.
(b) in other liquid preparations 31
when included in Schedule 2 or
Schedule 3.
(c) in other solid or semi-solid 30
preparations when included in
Schedule 2.
Podophyllotoxin
(a) in preparations specifically for 36
use on anal or genital area.
(b) in other liquid preparations 31
when included in Schedule 2
or Schedule 3.
(c) in other solid or semi-solid 30
preparations when included
in Schedule 2.
Polihexanide 1,4,8
Polyethanoxy (15) tallow amine 1,4
Poly(oxy-1,2-ethanediyl), a-[2-[(2-hydroxyethyl)amino]
-2-oxoethyl]-w-hydroxy-,mono-C13-15
-alkyl ethers 5,88 1,5Potassium hydroxide
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
(a) in preparations containing 5 1,4,6
0.5 per cent or less of potassiumhydroxide.
(b) in solid preparations containing 2,10,78 3,5,28
more than 0.5 per cent of potassium
hydroxide.(c) in liquid preparations containing 2,10,78 3,5
more than 0.5 per cent of potassium
hydroxide.Potassium metabisulphite 5,26 1,4
Potassium nitrite in pickling or curing salts 94
Potassium persulfate 5,21,25 1,5,23,33,34
Potassium sulfide 2 1,4
Propionic acid when in Schedule 6. 2 1,4
Ranitidine when included in Schedule 2. 96
Safrole
(a) in preparations for
therapeutic use. 1
(b) other than for therapeutic use. 1,4
Salbutamol in metered aerosols or in dry 32
powder formulations.Salicylamide 34 or 35
Sassafras oil
(a) in preparations for therapeutic use. 1
(b) other than for therapeutic use. 1,4
Selenium compounds except when for 1,4,8
therapeutic use (human or animal).
Silver in smoking deterrents. 42
Sodium aluminate 2 1,4
Sodium chlorate 1,4
Sodium dodecylbenzene sulfonate 79 1
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Sodium fluoride in preparations for 43
human ingestion when in Schedule 2.
Sodium hydrogen sulfate 1,4,8
Sodium hydrosulfite 5,26 1,4,8
(more than 50 per cent)
Sodium hydroxide
(a) in preparations containing 5 1,4,6
0.5 per cent or less of sodium
hydroxide.(b) in solid preparations containing 2,10,78 3,5,28
more than 0.5 per cent of sodium
hydroxide.
(c) in liquid preparations containing 2,10,78 3,5
more than 0.5 per cent of sodium
hydroxide.Sodium laureth-6 carboxylate 79 1
Sodium metabisulphite 5,26 1,4
(more than 50 per cent)
Sodium nitrite
• in pickling or curing salts 94
Sodium persulfate 5,21,25 1,5,23,33,34
Sodium sulfide 2 1,4
Styrene 1,4,8
Sulfamic acid 2 1,4
Sulfuric acid 2 1,4
Symphytum spp. (Comfrey) 31,32
when included in Schedule 5.
Tazarotene for topical use. 77,62
Terbutaline in metered aerosols or in 32
dry powder formulations.
Terfenadine 61
Terpenes, chlorinated 1,4,8
Tetrachloroethane 12 8
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Tetrachloroethylene when in Schedule 5 or 6. 12,16 1,4,8,11
Tetrahydrozoline in nasal 29
preparations for topical use.
Thalidomide 7,62,76
Thiourea 1,4
Toluene 1,4,8
Toluenediamine
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Tramazoline in nasal preparations 29
for topical use.
Tretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Triamcinolone when in topical preparations 64 or 68
for the treatment of mouth ulcers.
Trichloroacetic acid except when for 2 1,4
therapeutic use.
1,1,1-trichloroethane 8,9
Trichloroethylene except when for 12 1,4,5,8,9
therapeutic use.
Trichlorophenol 1,4,8
Triethanolamine 5 1,4
Triethyl phosphate 1,4,8
Trifluoromethanesulfonic acid
(a) more than 10 per cent. 1,17 1,4,8
(b) 10 per cent or less. 1,4,8
Triisopropanolamine lauryl ether sulfate 1,4,6
3,6,9-Trioxaundecanedioic acid 5 1
APPENDIX F, Part 3–continued
POISON WARNING SAFETY
STATEMENTS DIRECTION
Tymazoline in nasal preparations for topical use. 29
Vinclozolin 46
Xylene 1,4,8
Xylometazoline in nasal preparations for topical use. 29
Zinc chloride 1,4
Zinc sulfate when in Schedule 6. 1,4
APPENDIX G
DILUTE PREPARATIONS
The requirements of this Standard do not apply to a poison listed in Column 1 of this Appendix at a concentration not more than that specified in Column 2 in respect of
that poison.
Column 1 Column 2
Poison Concentration
(quantity per litre
or kilogram)
ACETYLCHOLINE 1 mg
ALDOSTERONE 10 micrograms
ANTIMONY COMPOUNDS 1 mg
APOMORPHINE 1 mg
ARSENIC 1 mg
ATROPA BELLADONNA (belladonna) 300 micrograms
ATROPINE 300 micrograms
CANTHARIDIN 10 micrograms
CHLORINE 5 mg
CROTON TIGLIUM (croton oil) 1 mg
DIOXANE 100 mg
ERYSIMUM spp. 1 mg
FOLLICLE-STIMULATING HORMONE 100 micrograms
GELSEMIUM SEMPERVIRENS 1 mg
GLUCAGON 100 micrograms
GLYCERYL TRINITRATE 100 micrograms
GROWTH HORMONE 10 micrograms
HALOPERIDOL 1 mg
HYDROCYANIC ACID 1 microgram
HYOSCINE 300 micrograms
HYOSCYAMINE 300 micrograms
HYOSCYAMUS NIGER 300 micrograms
HYPOTHALAMIC RELEASING FACTORS 10 micrograms
INDOMETHACIN 1 mg
MERCURY 1 mg
METHYLMERCURY 300 micrograms
NAPHTHALENE 1 mg
NERIUM OLEANDER 1 mg
OESTRADIOL 10 micrograms
OESTRONE 100 micrograms
OXYTOCIN 1 microgram
PHOSPHORUS 1 mg
PODOPHYLLUM RESIN (podophyllin) 1 mg
PROGESTERONE 1 mg
PROPRANOLOL 1 mg
SELENIUM 100 micrograms
STROPHANTHUS spp. 1 mg
STRYCHNINE 1 mg
TESTOSTERONE 1 mg
THYROXINE 10 micrograms
APPENDIX H
SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED
Amorolfine.
Azelastine.
Butoconazole.
Clotrimazole.
Diclofenac.
Dimenhydrinate for the prevention and relief of motion sickness.
Diphenoxylate.
Econazole.
Fluconazole.
Hydrocortisone.
Miconazole.
Nystatin.
Pseudoephedrine.
APPENDIX I
UNIFORM PAINT STANDARD
This Appendix provides regulations for adoption by the States and Territories.
1. A person must not manufacture, sell, supply or use a First Schedule Paint for application to:
(1) a roof or any surface to be used for the collection or storage of potable water; or
(2) furniture; or
(3) any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or
(4) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
2. A person must not manufacture, sell, supply or use a Third Schedule paint.
3. A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2003 entitled Safety of toys Part 3: Migration of certain elements.
4. A person must not manufacture, sell, supply, or use a paint containing a pesticide except a fungicide, algicide, bactericide or antifouling agent.
The First Schedule
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
ANTIMONY or antimony compounds
other than antimony titanate pigments more than 5 per cent
BARIUM salts except barium sulfate or
barium metaborate more than 5 per cent
CADMIUM or cadmium compounds more than 0.1 per cent
CHROMIUM as chromates of ammonia,
barium, potassium, sodium, strontium or zinc more than 5 per cent
SELENIUM or selenium compounds more than 0.1 per cent
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
APPENDIX I–continued
The Third Schedule
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
LEAD or lead compounds more than 0.1 per cent
APPENDIX J
CONDITIONS FOR AVAILABILITY AND USE OF
SCHEDULE 7 POISONS
PART 1
CONDITIONS FOR AVAILABILITY AND USE
(NOTE - the following controls are recommended for poisons only when included in Schedule 7. These conditions for availability and use may be implemented through poisons controls or other State or Territory legislation.)
1. Not to be available except to authorised or licensed persons.
2. Not to be used in printing inks.
3. Not to be used except by or in accordance with the directions of accredited government vermin control officers.
4. Not to be used in industries which handle, process or store foods, animal feeds or packaging materials.
APPENDIX J–continued
PART 2
A poison listed in this Appendix is to be available only in accordance with the conditions specified beside it in the “Conditions” column. The conditions apply only when the poison is included in Schedule 7.
POISON CONDITIONS
Abamectin 1
Acibenzolar-s-methyl 1
Acrolein 1
Acrylonitrile 1
Alachlor 1
Allyl alcohol 1
4-Aminopyridine 1
Arprinocid 1
Arsenic 1
Azocyclotin 1
Benzene 1
Bifluorides (including ammonium, potassium and sodium salts) 1
Boron trifluoride 1
Brodifacoum 1
Bromadiolone 1
Bromine 1
Brucine 1
Calciferol 1
Captafol 1
Carbadox 1
Carbon tetrachloride 1
Chlordecone 1
Chlordimeform 1
Chlorine 1
Chloromethiuron 1
APPENDIX J, Part 2–continued
POISON CONDITIONS
Chloropicrin 1
4-Chloro-oh-toluidine 1
Colecalciferol 1
Coumatetralyl 1
Cyanogen 1
Cyhexatin 1
4,4-Diaminodiphenylmethane (methylene dianiline) 1
1,2-Dibromo-3-chloropropane 1
1,3-Dichloropropene 1
Difenacoum 1
4-Dimethylaminoazobenzene 1
Dinitrocresols 1
Dinitrophenols 1
Dinoseb 1
Epichlorohydrin 1
Epidermal growth factor 1
Etaconazole 1
Ethylene dibromide 1
Ethylene oxide 1
Fluoracetamide 3
Fluoroacetic acid 3
Folpet 1
Halofuginone 1
Halogenated dibenzodioxins and dibenzofurans 1
HCB 1
Hydrocyanic acid and cyanides 1
Hydrofluoric acid 1
Hydrosilicofluoric acid 1
APPENDIX J, Part 2–continued
POISON CONDITIONS
Iodomethane 1
Maduramicin 1
Mercury 1
Methacrifos 1
Methoxyethylmercuric acetate 1
Methoxyethylmercuric chloride 1
Methyl bromide 1
4,4’-Methylenebis[2-chloroaniline] 1
Mirex 1
Molinate 1
Nicotine 1
Nitrofen 1
Phenylmercuric acetate 1
Phosphides, metallic 1
Phosphine 1
Propylene oxide 1
Pyrinuron 1
Rotigotine
Strychnine 1
Sulcofuron 1
Tetrachloroethane 1
2,2’,6,6’-Tetraisopropyl-diphenyl-carbodiimide 1
Thallium 3
ortho-Tolidine 1
Trichloroisocyanuric acid 1
Vinyl chloride 1
APPENDIX K
DRUGS REQUIRED TO BE LABELLED
WITH A SEDATION WARNING
(See Part 3 Paragraph 45)
Alprazolam
Amisulpride
Amitriptyline
Amylobarbitone
Aripiprazole
Azatadine
Baclofen
Benztropine
Bromazepam
Brompheniramine
Buclizine
Buprenorphine
Butobarbitone
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlormethiazole
Chlorpheniramine
Chlorpromazine
Clemastine
Clomipramine
Clonazepam
Clonidine
Clorazepate
Clozapine
Codeine except when included in Schedule 2 or 3.
Cyclizine
Cyclobarbitone
Cycloserine
Cyproheptadine
Cysteamine
Dantrolene
Desipramine
Dexchlorpheniramine
Dextromoramide
Dextropropoxyphene
Diazepam
Difenoxin
Dihydrocodeine
Dimenhydrinate
Dimethindene
Diphenhydramine
Diphenoxylate
Diphenylpyraline
Dothiepin
Doxepin
Doxylamine
Dronabinol (delta-9-tetrahydrocannabinol)
Droperidol
Duloxetine
Ethylmorphine
Fenfluramine
APPENDIX K–continued
Flunitrazepam
Flupenthixol
Fluphenazine
Flurazepam
Gabapentin
Gemcitabine
Glutethimide
Haloperidol
Hydrocodone
Hydromorphone
Hydroxyzine
Imipramine
Lamotrigine
Levetiracetam
Levocabastine
Lorazepam
Mazindol
Mebhydrolin
Meclozine
Medazepam
Meprobamate
Mepyramine
Methadone
Methdilazine
Methocarbamol
Methylphenobarbitone
Mianserin
Mirtazapine
Morphine
Nabiximols
Nalbuphine
Nitrazepam
Normethadone
Nortriptyline
Olanzapine
Opium in any form except the alkaloids Noscapine and Papaverine.
Oxazepam
Oxycodone
Paliperidone
Papaveretum
Pentazocine
Pentobarbitone
Pericyazine
Perphenazine
Pethidine
Phenelzine
Pheniramine
Phenobarbitone
Phenoperidine
Phenyltoloxamine
Pholcodine
Pimozide
Pizotifen
Prazepam
Pregabalin
Prochlorperazine
Promazine
Promethazine
APPENDIX K–continued
Protriptyline
Quetiapine
Quinalbarbitone
Risperidone
Rotigotine
Secbutobarbitone
Temazepam
Thenyldiamine
Thiethylperazine
Thiopropazate
Thioridazine
Thiothixene
Tramadol
Tranylcypromine
Trifluoperazine
Trimeprazine
Trimipramine
Triprolidine
Ziprasidone
Zolpidem
Zonisamide
Zopiclone
Endnotes
Endnote 1—About the endnotes
The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Endnote 5—Uncommenced amendments
Endnote 6—Modifications
Endnote 7—Misdescribed amendments
Endnote 8—Miscellaneous
If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.
Abbreviation key—Endnote 2
The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.
Uncommenced amendments—Endnote 5
The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.
Modifications—Endnote 6
If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.
Misdescribed amendments—Endnote 7
An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.
Miscellaneous—Endnote 8
Endnote 8 includes any additional information that may be helpful for a reader of the compilation.
Endnote 2—Abbreviation key
| ad = added or inserted | pres = present |
| am = amended | prev = previous |
| c = clause(s) | (prev) = previously |
| Ch = Chapter(s) | Pt = Part(s) |
| def = definition(s) | r = regulation(s)/rule(s) |
| Dict = Dictionary | Reg = Regulation/Regulations |
| disallowed = disallowed by Parliament | reloc = relocated |
| Div = Division(s) | renum = renumbered |
| exp = expired or ceased to have effect | rep = repealed |
| hdg = heading(s) | rs = repealed and substituted |
| LI = legislative instrument | s = section(s) |
| LIA = Legislative Instruments Act 2003 | Sch = Schedule(s) |
| mod = modified/modification | Sdiv = Subdivision(s) |
| No = Number(s) | SLI = Select Legislative Instrument |
| o = order(s) | SR = Statutory Rules |
| Ord = Ordinance | Sub-Ch = Sub-Chapter(s) |
| orig = original | SubPt = Subpart(s) |
| par = paragraph(s)/subparagraph(s) | |
| /sub-subparagraph(s) |
Endnote 3—Legislation history
| Name | FRLI registration | Commencement | Application, saving and transitional provisions |
| Poisons Standard 2009 | 6/8/2009 (see F2009L03012) | 14/8/2009 | — |
| Poisons Standard Amendment No. 2 of 2009 | 11/8/2009 (see F2009L03013) | 1/9/2009 | — |
| Poisons Standard Amendment No. 3 of 2009 | 04/12/2009 (see F2009L04454) | 1/1/2010 | — |
| Poisons Standard Amendment No. 1 of 2010 | 16/04/2010 (see F2010L00966) | 1/5/2010 | — |
Endnote 4—Amendment history
| Provision affected | How affected |
| Part 4, Schedule 2 | am F2009L03013; am F2009L04454; am F2010L00966 |
| Part 4, Schedule 3 | am F2009L04454; am F2010L00966 |
| Part 4, Schedule 4 | am F2009L03013; am F2009L04454; am F2010L00966 |
| Part 4, Schedule 5 | am F2009L03013; am F2009L04454; am F2010L00966 |
| Part 4, Schedule 6 | am F2009L03013; am F2009L04454; am F2010L00966 |
| Part 4, Schedule 7 | am F2009L04454 |
| Part 4, Schedule 8 | am F2010L00966 |
| Part 4, Schedule 9 | am F2009L03013 |
| Part 5, Appendix C | am F2009L03013; am F2009L04454 |
| Part 5, Appendix D | am F2009L03013; am F2009L04454; am F2010L00966 |
| Part 5, Appendix E, Part 2 | am F2009L04454 |
| Part 5, Appendix F, Part 3 | am F2009L04454 |
| Part 5, Appendix K | am F2010L00966 |
Endnote 5—Uncommenced amendments – [None]
Endnote 6—Modifications – [None]
Endnote 7—Misdescribed amendments – [None]
Endnote 8—Miscellaneous – [None]
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