Poisons Standard 2014 (Cth)
POISONS STANDARD 2014
I, ANTHONY GILL, a delegate of the Secretary to the Department of Health for the purposes of paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, prepare this new Poisons Standard, in substitution for the current Poisons Standard.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health
Dated this 8th of October 2014
Citation
This instrument is the Poisons Standard 2014.
The New Poisons Standard
The Poisons Standard 2014 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 5 (the SUSMP5) as set out in Schedule 1.
Commencement
The Poisons Standard 2014 commences on the day after registration.
Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
No. 5
October 2014
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in July 2014. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at inquiries should be directed to:
| The Secretary or by email to [email protected] | The Secretary or by email to [email protected] |
Media Liaison Unit
Australian Government Department of Health
Contents
INTRODUCTION
CLASSIFICATION
PRINCIPLES OF SCHEDULING
READING THE SCHEDULES
Availability of poisons
Preparations containing poisons listed in two or more Schedules
PART 1 - INTERPRETATION
PART 2 - LABELS AND CONTAINERS
LABELS
General requirements
Immediate wrapper
Primary packs and immediate containers
Statements of quantity, proportion or strength
Exemptions
Selected containers and measure packs
Ampoules, pre-filled syringes and injection vials
Transport containers and wrappings
Dispensary, industrial, laboratory and manufacturing poisons
Exemptions from label requirements in certain circumstances
Dispensed medicines
Gas cylinders
Paints
Camphor and naphthalene
Prohibitions
CONTAINERS
Containers for poisons other than Schedule 5 poisons
Containers for Schedule 5 poisons
Approved containers
Child-resistant closures
Schedule 8 poisons
Exemptions
Camphor and naphthalene
Prohibitions
PART 3 - MISCELLANEOUS REGULATIONS
ADVERTISING
SALE OR SUPPLY
Schedule 2 poisons
Schedule 3 poisons
Schedule 4 poisons
Schedule 7 poisons
PROHIBITIONS ON SALE, PRESCRIBING AND POSSESSION
STORAGE
PART 4 - THE SCHEDULES
SCHEDULE 1
SCHEDULE 2
SCHEDULE 3
SCHEDULE 4
SCHEDULE 5
SCHEDULE 6
SCHEDULE 7
SCHEDULE 8
SCHEDULE 9
PART 5 - THE APPENDICES
APPENDIX A - General exemptions
APPENDIX B - Substances considered not to require control by scheduling
APPENDIX C - Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use
APPENDIX D - Additional controls on possession or supply of poisons included in Schedule 4 or 8
APPENDIX E - First aid instructions for poisons
APPENDIX F - Warning statements and general safety directions for poisons
APPENDIX G - Dilute preparations
APPENDIX H - Schedule 3 poisons permitted to be advertised
APPENDIX I - Uniform Paint Standard
APPENDIX J - Conditions for availability and use of Schedule 7 poisons
APPENDIX K - Drugs required to be labelled with a sedation warning
APPENDIX L - Requirements for dispensing labels for human and veterinary medicines
INTRODUCTION
The Poisons Standard 2014, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. Further information on the scheduling amendments and the SPF can be accessed at Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).
The SUSMP serves two key purposes.
Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.
Secondly, the SUSMP includes model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. Other government agencies may also impose controls on certain products, for example cosmetics.
The requirements for labelling and containers in the SUSMP are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.
Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in the SUSMP as they are covered by Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)].Note, however that this exemption does not extend to controls on supply of these poisons.
The SUSMP is presented with a view to promoting uniform:
- scheduling of poisons throughout Australia;
- signal headings on labels for poisons throughout Australia;
- labelling and packaging requirements for poisons throughout Australia;
- additional controls on the availability and use of poisons in Australia.
The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:
- the Agricultural and Veterinary Chemicals Code Act 1994
- the Agricultural and Veterinary Chemicals Code Regulations 1995
- the Therapeutic Goods Act 1989
- Therapeutic Goods Order 69 – General requirements for labels for medicines
- Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
- the Required Advisory Statements for Medicine Labels (RASML).
CLASSIFICATION
Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with each relevant State or Territory authority.
Schedule 1. This Schedule is intentionally blank.
Schedule 2. Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.
Schedule 3. Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.
Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
Schedule 5. Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.
Schedule 6. Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Schedule 7. Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.
Schedule 8. Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.
Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
PRINCIPLES OF SCHEDULING
Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.
This Standard lists poisons in nine Schedules according to the degree of control recommended to be exercised over their availability to the public.
Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 with progression through these Schedules signifying increasingly restrictive regulatory controls.
For some medicines and agricultural, domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly stricter container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7. Products for domestic use must not include poisons listed in Schedule 7.
Schedule 9 contains substances that should be available only for teaching, training, medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State and Territory health authorities. Although appearing as a Schedule in this Standard, the method by which it is implemented in the States and Territories may vary.
Substances in products which have been considered for scheduling, but have been exempted from this Standard, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Appendix C contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties. It is recommended that the provisions of this Appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.
READING THE SCHEDULES
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are revised and replaced by individual entries as time permits, although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, Schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this Schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry, these have been emphasised by printing the word “except” in bold type.
Where the Schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation, such as pesticide registration, may apply.
Where a Schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.
Where a poison has been included in more than one Schedule, the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Part 1, Interpretation, subparagraph 1(2).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, toxicologically) to a scheduled poison or is readily converted (either physically or chemically) to a scheduled poison. However, a substance is only considered a derivative of a scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a scheduled poison, the same scheduling requirements as the scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using this Standard to determine the scheduling status of a poison, it may be necessary to search each relevant Schedule as well as Appendices A, B and C and the Index. In this process, if the poison is not found under its “approved name” it may be shown under a group term such as:
Group Example
the parent acid of salts “oxalic acid” to find sodium oxalate
the radical of a salt “chromates” to find potassium
chromate
the element “arsenic” to find arsenic trioxide
a chemical group with similar “hydrocarbons, liquid” to find
toxicological or pharmacological kerosene
activity
a pharmacological group “anabolic steroidal agents” to find
“androsterone”
Availability of poisons
The purpose of classification is to group substances into Schedules that require similar regulatory controls over their availability.
These Schedules have been developed over a long period and contain poisons that may be obsolete for various reasons. Also, as part of the move to harmonise the Australian and New Zealand classifications, many substances have been added to the Schedules for that purpose, irrespective of their availability in either country.
Inclusion of a poison in a Schedule indicates the degree of control required if it is marketed. It does not indicate:
- that the poison is available; nor
- that is has been approved or is efficacious for any use that may be specified in a Schedule; nor
- does it negate any obligation for registration of a therapeutic good, or agricultural or veterinary chemical product containing that poison.
Preparations containing poisons listed in two or more Schedules
If a preparation contains two or more poisons, the provisions relating to each of the Schedules in which those poisons are included apply.
Where it is not possible to comply both with a provision relating to one of those Schedules and with a provision relating to another of those Schedules, the provision of the more restrictive Schedule applies, unless a contrary intention is indicated in the Schedules or relevant legislation.
The Schedules listed in order of greatest to least restriction on access and availability are 9, 8, 4, 7, 3, 2, 6, 5.
Schedule 1 is not currently in use.
Some substances in certain circumstances are also subject to exemptions or additional restrictions as described in the Appendices of this Standard. The table below summarises the purpose of each of the Appendices and the controls imposed on substances included in them.
| Appendix | Title | Purpose/ controls imposed |
| Appendix A | General exemptions | List of classes of products or uses exempted from this Standard. |
| Appendix B | Substances considered not to require control by scheduling | List of poisons exempted from scheduling. |
| Appendix C | Substances, other than those included in Schedule 9, of such danger to health as to warrant prohibition of sale, supply and use | List of poisons prohibited from sale, supply or use because of their known potential for harm to human and/or animal health. |
| Appendix D | Additional controls on possession or supply of poisons included in Schedule 4 or 8 | List of poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply. |
| Appendix E | First aid instructions for poisons | First aid instructions for poisons (other than agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use). |
| Appendix F | Warning statements and general safety directions for poisons | Warning statements and general safety directions for poisons (other than human medicines, agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use). |
| Appendix G | Dilute preparations | Concentration cut-offs for specified poisons, below which the requirements of the Standard do not apply |
| Appendix H | Schedule 3 medicines permitted to be advertised | List of medicines included in Schedule 3 that are permitted to be advertised to the public. |
| Appendix I | Uniform Paint Standard | Requirements applying to poisons included in paints or tinters. |
| Appendix J | Conditions for availability and use of Schedule 7 poisons | List of poisons included in Schedule 7 where additional specified conditions apply to their availability and use. |
| Appendix K | Human medicines required to be labelled with a sedation warning | List of human medicines required to be labelled with a warning regarding their sedation potential. |
| Appendix L | Requirements for dispensing labels for medicines | Requirements applying to labels attached to medicines at the time of dispensing. |
This page is intentionally blank.
PART 1
INTERPRETATION
(1) In this Standard, unless the contrary intention appears —
“Agricultural chemical” means a substance that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
(a) destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing;
(b) destroying a plant;
(c) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity;
(d) modifying an effect of another agricultural chemical;
(e) attracting a pest for the purpose of destroying it; or
(f) any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an agricultural chemical product;
but does not include:
(g) a veterinary chemical.
“Agricultural chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.
“Animal” means any animal (other than a human being), whether vertebrate or not, and whether a food producing species or not, and includes mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs.
“Animal feed premix” means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.
“Appropriate authority” means:
(a) in the Australian Capital Territory, ACT Government Health Directorate;
(b) for the purpose of providing an exemption from all or part of paragraphs 2 to 12 in Part 2 of this Standard by the Australian Pesticides and Veterinary Medicines Authority, the Chief Executive Officer or their delegate;
(c) in New South Wales, the Director-General of the NSW Ministry of Health;
(d) in the Northern Territory, the Chief Health Officer of the Department of Health;
(e) in Queensland, the Chief Executive of Queensland Health;
(f) in South Australia, the Chief Executive of the Department for Health and Ageing;
(g) in Tasmania, the Secretary of the Department of Health and Human Services;
(h) for the purpose of providing an exemption from all or part of paragraphs 2 to 12 of this Standard
by the Therapeutic Goods Administration, the National Manager or their delegate;
(i) in Victoria, the Secretary to the Department of Health;
(j) in Western Australia, the Chief Executive Officer of the Department of Health.
“Approved name” means:
(a) in relation to a poison that is for human therapeutic use, the name approved for use by the Therapeutic Goods Administration;
(b) in relation to a poison that is for animal or agricultural use, the name approved for use by the Australian Pesticides and Veterinary Medicines Authority;
(c) in relation to all other poisons:
(i) the name used in an entry in these Schedules; or, if no such name is given,
(ii) the English name recommended by Standards Australia as the common name for the poison; or, if no such name is given,
(iii) the English name given to the poison by the International Organization for Standardization; or, if no such name is given,
(iv) the English name given to the poison by the British Standards Institution; or, if no such name is given,
(v) the name that would comply with the requirements of part (a) or (b) of this definition, or, if no such name is given,
(vi) the English name given to the poison by the European Committee for Standardization (CEN); or, if no such name is given,
(vii) the international non-proprietary name recommended for the poison by the World Health Organization; or, if no such name is given,
(viii) the International Nomenclature Cosmetic Ingredient name for the poison listed in the International Cosmetic Ingredient Dictionary & Handbook published by the Personal Care Products Council of America; or, if no such name is given,
(ix) the accepted scientific name or the name descriptive of the true nature and origin of the poison.
“Australian Code for the Transport of Dangerous Goods by Road and Rail” means the seventh edition of the document of that name.
“Authorised prescriber” means a registered medical, dental or veterinary practitioner or such other person authorised by the appropriate authority.
“Blood” means whole blood extracted from human donors.
“Blood components” means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except for products derived through fractionation of plasma.
“Child-resistant closure” means:
(a) a closure that complies with the requirements for a child-resistant closure in the Australian Standard AS 1928-2007 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) a closure approved by an order made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(c) in the case of a can fitted with a press-on lid, a lid of the design known as “double tight” or “triple tight”.
See also "Non-access packaging”.
“Child-resistant packaging” means packaging that:
(a) complies with the requirements of the Australian Standard AS 1928-2007 entitled
Child resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD);
(b) is reclosable and complies with the requirements of at least one of the following Standards:
(i) the International Organization for Standardization Standard ISO 8317:2003 entitled Child-resistant packaging – Requirements and testing procedures for reclosable packages;
(ii) the British Standards Institution Standard BS EN ISO 8317:2004 entitled
Child-resistant packaging. Requirements and testing procedures for reclosable packages;
(iii) the Canadian Standards Association Standard CSA Z76.1-06 entitled Reclosable Child-Resistant Packages;
(iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, entitled Poison prevention packaging standards and Section 1700.20, entitled Testing procedure for special packaging;
(c) is approved as child-resistant by any order made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(d) is in the form of blister or strip packaging in which a unit of use is individually protected until the time of release and that complies with Section 3 (Requirements for non-reclosable packages) of Australian Standard AS 1928-2001 entitled Child-resistant packages.
See also "Non-access packaging".
“Compounded” in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.
“Cosmetic” means:
(a) a substance or preparation intended for placement in contact with any external part of the human body, including:
(i) the mucous membranes of the oral cavity; and
(ii) the teeth;
with a view to:
(iii) altering the odours of the body; or
(iv) changing its appearance; or
(v) cleansing it; or
(vi) maintaining it in good condition; or
(vii) perfuming it; or
(viii) protecting it.
“Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
“Dermal use” means application to the skin primarily for localised effect.
“Designated solvent” means the following:
acetone
dimethylformamide
N-(N-dodecyl)-2-pyrrolidone
hydrocarbons, liquid
methanol when included in Schedule 5
methyl ethyl ketone
methyl isoamyl ketone
methyl isobutyl ketone
N-methyl-2-pyrrolidone
N-(N-octyl)-2- pyrrolidone
phenyl methyl ketone
styrene
tetrachloroethylene
1,1,1-trichloroethane
“Dispensing label” means the label attached to the immediate container of a substance for therapeutic use at the time of dispensing.
“Distributor” means a person who imports, sells or otherwise supplies a poison.
“Divided preparation” means a preparation manufactured and packed as discrete pre-measured dosage units prior to sale or supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
“Dosage unit” means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
“Drug” means a poison intended for human or animal therapeutic use.
“Essential oils” means products obtained from natural raw materials either by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation. For scheduling purposes it also means:
(a) oils of equivalent composition derived through synthetic means; or
(b) prepared mixtures of oils of equivalent composition comprising a mixture of synthetic and natural components.
“External” in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
“First Schedule Paint” means a paint containing the specified proportion of any substance in the First Schedule to Appendix I of this Standard.
“Free formaldehyde” includes all hydrated and non-hydrated formaldehyde present in aqueous solution, including methylene glycol.
“Graphic material” means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.
“Height” in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.
“Hemp seed oil” means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
“Immediate container” includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.
“Immediate wrapper” means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.
“Internal use” means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect;
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
“Label” means:
(a) a written statement on a container of a poison; and
(b) in relation to a therapeutic good, includes a display of printed information about the product:
(i) on, or attached to, the good;
(ii) on, or attached to, a container or primary pack in which the good is supplied; or
(iii) supplied with such a container or pack.
“Main label” means, where there are two or more labels on a container or a label is divided into two or more portions:
(a) the part of a label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and
(b) where there are two or more labels or two or more portions of a single label – that label or portion of the label where the product name is more or most conspicuously shown; or
(c) where the product name is equally conspicuous on two or more labels or portions of a label – each such label or portion.
“Manufacturer” means a person who manufactures, produces, or packs a poison.
“Measure pack” means a sealed container which contains a measured quantity of poison for use on one occasion as a pesticide or domestic product and one or more of which is enclosed in a primary pack.
“Medicine” means any poison for therapeutic use.
Note: To be preceded by “human” or “veterinary” where restriction of the “medicine” to human or animal use is intended.
“Name and address” means the name and address, in Australia, of the manufacturer or distributor of a poison but does not include a post office, cable, telegraphic or code address. Where such manufacturer or distributor is a company incorporated in accordance with the appropriate law of any State or Territory of the Commonwealth of Australia or a firm registered under the Business Names Act of any State or Territory, the inclusion in the label of the registered name of the corporation or firm or its branch or its division and the city or town in which a registered office is situated shall be deemed to comply with the requirements.
“Non-access packaging” is packaging that complies with the requirements of Australian Standard AS4710-2001 entitled Packages for chemicals not intended for access or contact with their contents by humans, in relation to products that are not intended for human therapeutic use.
See also "Child-resistant closure" and "Child-resistant packaging”.”.
“Non-volatile content” in relation to a paint or tinter means that portion of a paint or tinter determined to be the non-volatile content by Method 301.1 of Australian Standard AS 1580-301.1-2005 entitled Paints and related materials – Methods of test – Non-volatile content by mass.
“Oromucosal use” means administration to the oral mucosa, specifically the oral cavity and/or the pharynx.
“Paint”, without limiting the ordinary meaning, includes any substance used or intended to be used for application as a colouring or protective coating to any surface but does not include graphic material or paints for therapeutic use.
“Pesticide” means any substance or mixture of substances used or intended to be used:
(a) for preventing, destroying, repelling, attracting, inhibiting or controlling any insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of plant or animal life or viruses, which are pests; or
(b) as a plant regulator, promoter, defoliant or desiccant for food storage, household, industrial, commercial, agricultural and non-agricultural application, but does not include veterinary drugs, stock medicines, stock feeds, stock feed additives, drugs for human use, food additives or fertilisers.
“Poison” means any substance or preparation included in a Schedule to this Standard.
“Primary pack” means the pack in which a poison and its immediate container or immediate wrapper or measure pack are presented for sale or supply.
“Required Advisory Statements for Medicine Labels” means the document made under subsection 3(5A) of the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration.
“Restricted flow insert” means a restriction fitted, or moulded, in the neck of a container which:
(a) cannot readily be removed from the container by manual force; and
(b) limits the delivery of the contents to drops each of which is not more than 200 microlitres.
“Second Schedule Paint” means a paint containing the specified proportion of any substance in the Second Schedule to Appendix I of this Standard.
“Selected container” means:
(a) an injection vial having a nominal capacity of ten millilitres or less;
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of ten millilitres or less.
“Solid” is considered to include “powder” for the purposes of scheduling.
“Therapeutic good” has the meaning defined in the Commonwealth Therapeutic Goods Act 1989.
“Therapeutic use” means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals;
(b) influencing, inhibiting or modifying a physiological process in human beings or animals;
(c) testing the susceptibility of human beings or animals to a disease or ailment;
(d) influencing, controlling or preventing conception in persons or animals;
(e) testing for pregnancy in persons or animals; or
(f) the replacement or modification of parts of the anatomy in persons or animals.
“Third Schedule Paint” means a paint containing the specified proportion of any substance in the Third Schedule to Appendix I of this Standard.
“Tinter” means any pigment or admixture of pigment with other substances, in powder, semi-solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.
“Topical use” means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
“Toy” means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of fourteen years.
“Transdermal use” means application to the skin primarily for systemic effect.
“Veterinary chemical” means a substance that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
(a) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest;
(b) curing or alleviating an injury suffered by the animal;
(c) modifying the physiology of the animal:
(i) so as to alter its natural development, productivity, quality or reproductive capacity; or
(ii) so as to make it more manageable;
(d) modifying the effect of another veterinary chemical
(e) any vitamin, mineral substance, or additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (a), (b), (c) or (d); or
(f) any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an veterinary chemical product;
but does not include:
(g) an agricultural chemical.
“Veterinary chemical product” has the meaning defined in the Agricultural and Veterinary Chemicals Code Act 1994.
“Writing” includes the visible representation or reproduction of words or figures in any form, and “to write” and “written” have corresponding meanings.
(2) Unless the contrary intention appears a reference to a substance in a Schedule or an Appendix to this Standard includes:
(a) that substance prepared from natural sources or artificially; and
(b) where the substance is a plant (other than a plant included in Schedule 8 or 9), that plant or any part of that plant when packed or prepared for therapeutic use; and
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative; and
(d) every alkaloid of the substance and every salt of such an alkaloid; and
(e) every stereoisomer of the substance and every salt of such a stereoisomer; and
(f) every recombinant form of the substance; and
(g) a preparation or admixture containing any proportion of the substance,
but does not include:
(h) a preparation or product included in Appendix A, or a substance and the reason for its entry in Appendix B; or
(i) a substance included in Appendix G at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of that substance; or
(j) any other substance included in Schedules 1 to 6, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8; or
(k) any substance present as an impurity in a pesticide, at a concentration at or below the maximum content for that substance, specified for the pesticide in the Standards for Active Constituents, as published by the Australian Pesticides and Veterinary Medicines Authority.
(3) Unless the contrary intention appears where a concentration, strength or quantity is specified in a Schedule or an Appendix to this Standard in respect of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance that is listed in the Schedule or Appendix; and
(b) the expression “one per cent” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 millilitres of the preparation; or
(ii) in the case of a solid, semi-solid or pressurised spray aerosol preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning; and
(c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
(4) A reference to a boiling or distillation temperature in the Schedules means that temperature at an atmospheric pressure of 101.325 kPa (760 millimetres of mercury).
PART 2
LABELS AND CONTAINERS
LABELS
. 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.
Subparagraph 3(5) does not apply to a word, expression or statement on a container which has a capacity of 20 millilitres or less, or on the label of such a container if:
(1) an appropriate authority approves the use of smaller letters; and
(2) the letters are at least 1 millimetre in height.
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 of this Standard.
Primary packs and immediate containers
(1) The primary pack and immediate container of a poison must be labelled as follows:
(a) with the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the following table:
Schedule Purpose Signal words required
2 for any purpose PHARMACY MEDICINE
3 for any purpose PHARMACIST ONLY MEDICINE
4 for human use PRESCRIPTION ONLY MEDICINE
4 for animal use PRESCRIPTION ANIMAL REMEDY
5 for any purpose CAUTION
6 for any purpose POISON
7 for any purpose DANGEROUS POISON
8 for any purpose CONTROLLED DRUG
written:
(i) on the first line or lines of the main label; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least half the height of the largest letter or numeral on the label but need not be larger than:
(A) 6 millimetres on labels for packages having a nominal capacity of
2 litres or less; or
(B) 15 millimetres on labels for packages having a nominal capacity of more than 2 litres; and
(iv) if the poison:
(A) is a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail or a statement of the principal hazard of the poison, written on that line; or
(B) is not a Schedule 5 poison, with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on that line;
(b) if the poison is a Schedule 8 poison, with the cautionary statement –
POSSESSION WITHOUT AUTHORITY ILLEGAL
written:
(i) on a separate line or lines immediately below the signal words required by subparagraph 7(1)(a); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal words; and
(iv) with no other statement written on the same line;
(c) with the cautionary statement –
KEEP OUT OF REACH OF CHILDREN
written:
(i) on a separate line or lines:
(A) immediately below the signal word or words required by subparagraph 7(1)(a); or
(B) where the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by subparagraph 7(1)(b), on the line immediately below that statement; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(d) if the poison is a dry chlorinating compound containing more than 10 per cent of available chlorine, except for preparations certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FIRE AND EXPLOSION HAZARD
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(e) if the poison is an alkaline salt in a dishwashing machine product, with the cautionary statement –
BURNS SKIN AND THROAT
written:
(i) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line of the main label;
(f) if the poison is an aqueous solution of paraquat, with the cautionary statements –
CAN KILL IF SWALLOWED
DO NOT PUT IN DRINK BOTTLES
KEEP LOCKED UP
written:
(i) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same lines of the main label;
(g) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if safety directions are required on the label by subparagraph 7(1)(n), with the cautionary statement –
READ SAFETY DIRECTIONS BEFORE OPENING
OR USING
or with the cautionary statement –
READ SAFETY DIRECTIONS
written:
(i) on a separate line or lines;
(A) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by subparagraph 7(1)(c); or
(B) if one or more other cautionary statements is required to be on the line immediately below “KEEP OUT OF REACH OF CHILDREN”, immediately below that statement or those statements; and
(ii) in bold-face sans serif capital letters of uniform thickness; and
(iii) in letters at least four-tenths the height of the letters used for the signal word or words; and
(iv) with nothing, other than a Class label as specified in the Australian Code for the Transport of Dangerous Goods by Road and Rail, written on the same line;
(h) if the poison meets the criteria for a ‘flammable liquid’ in the Australian Code for the Transport of Dangerous Goods by Road and Rail, with the cautionary statement –
FLAMMABLE
written on the main label in bold-face sans serif capital letters of uniform thickness, unless already present in accordance with the requirements of the Australian Code for the Transport of Dangerous Goods by Road and Rail;
(i) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written on the main label in bold-face sans serif capital letters of uniform thickness;
(j) if the poison is a Schedule 5 poison intended for any purpose other than internal or pesticidal use, with the cautionary statement –
DO NOT SWALLOW
written in sans serif capital letters on the main label or as part of the directions for use;
(k) with the approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with paragraph 8:
(i) if the poison is for human therapeutic use, written in accordance with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act, 1989; or
(ii) if the poison is not for human therapeutic use, written in bold-face sans serif capital letters on the main label, unless:
(A) a list of approved names is required; and
(B) it is impractical to include the list on the main label; and
(C) an appropriate authority has authorised its inclusion on another part of the label; or
(iii) if the poison is a Schedule 5 poison referred to in column 1 of the following table the appropriate name opposite thereto in column 2 may be used as the approved name:
TABLE
Column 1 Column 2
Alkaline salts Alkaline salts
Amines for use as curing Aliphatic amines or
agents for epoxy resins aromatic amines
(unless separately specified
in the Schedules)
Epoxy resins, liquid Liquid epoxy resins
Hydrocarbons, liquid Liquid hydrocarbons
Quaternary ammonium Quaternary ammonium
compounds compound(s)
(iv) if a poison contains a mixture of designated solvents in excess of 25 per cent of the total volume of the poison but the proportion of one or more individual designated solvents in the mixture is equal to or less than 25 per cent, the approved names of those solvents may be expressed as follows:
(A) where the designated solvent is a liquid hydrocarbon as “liquid hydrocarbons”; or
(B) where the designated solvent is a ketone as “ketones”; or
(C) in any other case as “solvents” or “other solvents”;
(l) if the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, with the following expression written immediately below the approved name or the list of declared contents –
AN ANTICHOLINESTERASE COMPOUND
(i) the requirements of subparagraph 7(1)(l) do not apply to:
(A) dazomet, mancozeb, metiram, propineb, thiram, tri-allate, zineb or ziram; or
(B) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or
(C) an organophosphorus compound or carbamate contained in a
pressurised spray pack for household use;
(m) for any poison other than a poison for human therapeutic use labelled in accordance with Therapeutic Goods Order 69 General requirements for labels for medicines or in an agricultural or veterinary chemical product labelled in compliance with the Agricultural and Veterinary Chemicals Code Act 1994, if the poison is prepared, packed or sold for a specific purpose, with clear and adequate directions for use unless:
(i) the poison is included in Schedule 4 or Schedule 8; or
(ii) it is impractical to include such directions on the label and:
(A) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”; and
(B) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label; and
(C) the insert is enclosed in the primary pack;
(n) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if use of the poison may be harmful to the user, with appropriate safety directions (see Appendix F), grouped together as a distinct section of the label and prefaced by the words –
SAFETY DIRECTIONS
written in bold-face capital letters;
(o) for any poison other than a poison for human therapeutic use labelled in accordance with the Required Advisory Statements for Medicine Labels, if any warning statement or statements are required for the poison (see Appendix F), with that warning statement or those statements grouped together:
(i) if safety directions are included on the label, immediately after the words “SAFETY DIRECTIONS”; or
(ii) if there are no safety directions, immediately preceding the directions for use;
(p) if the poison is not for human internal use and is not a Schedule 3, Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):
(i) grouped together and prefaced by the words –
FIRST AID
written in bold-face capital letters; or
(ii) if a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:
(A) written on each immediate container as specified in subparagraph 7(1)(p)(i); and
(B) replaced on the primary pack with the statement –
FIRST AID: See inner packs;
(q) with the name and address of the manufacturer or distributor.
(2) For the purposes of subparagraph 7(1)(a)(iii) the term “largest letter or numeral” does not include:
(a) a single letter or numeral which is larger than other lettering on the label; or
(b) an affix forming part of the trade name; or
(c) in the case of a poison for therapeutic use, numerals used to distinguish the strength of a preparation from the strengths of other preparations of the same poison.
Statements of quantity, proportion or strength
The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:
(1) if the poison is for human therapeutic use, in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989;
(2) if the poison is for a purpose or purposes other than human therapeutic use and:
(a) if the poison is in a pressurised spray aerosol preparation, as the mass of the poison per stated mass of the preparation;
(b) if the poison is a liquid in a liquid preparation, as the mass or volume of the poison per stated volume of the preparation;
(c) if the poison is a liquid in a solid or semi-solid preparation, as the mass or volume of the poison per stated mass of the preparation;
(d) if the poison is a solid or semi-solid in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(e) if the poison is a solid or semi-solid in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(f) if the poison is a gas in a liquid preparation, as the mass of the poison per stated volume of the preparation;
(g) if the poison is a gas in a solid or semi-solid preparation, as the mass of the poison per stated mass of the preparation;
(h) if the poison is a gas in a gaseous preparation, as the mass of the poison per stated mass of the preparation;
(3) if the poison is a solution of a mineral acid, the proportion of the acid (un-neutralised by any bases present in the preparation) in a preparation may be expressed as the un-neutralised mass of the acid per stated mass of the preparation;
(4) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:
contains not more than 10 per cent of (insert name of the metal); or
contains not more than 30 per cent of (insert name of the metal); or
contains more than 30 per cent of (insert name of the metal);
(5) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5 per cent of the product;
(6) if the poison is a lead-based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non-volatile content of the paint;
(7) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.
(8) For the purposes of subparagraph 8(7) “derivative” includes alkaloid.
Exemptions
Selected containers and measure packs
The requirements of paragraph 7 do not apply to an immediate container that is a measure pack or a selected container (other than an ampoule, a pre-filled syringe or an injection vial to which paragraph 10 or 11 apply) when:
(1) the immediate container is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the immediate container is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) labelled with:
(i) the signal word or words relating to the Schedule in which the poison is included and the purpose for which it is to be used, as shown in the table to subparagraph 7(1)(a); and
(ii) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(iii) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(iv) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
Ampoules, pre-filled syringes and injection vials
The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:
(1) the selected container or ampoule is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the selected container or ampoule is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) labelled with:
(i) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(ii) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and
(iii) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:
(1) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) the strip is labelled in accordance with paragraph 10; and
(c) the ampoule is labelled with:
(i) the approved name of the poison or the trade name of the product; and
(ii) the quantity, proportion or strength of the poison in accordance with paragraph 8.
Transport containers and wrappings
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 Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)].
Exemptions from label requirements in certain circumstances
13A.(1) The labelling requirements of paragraphs 7 to 12 do not apply to a poison where an appropriate authority has granted a labelling exemption in whole or in part for these sections for a specified product; and
(2) the labelling exemption from an appropriate authority referred to in subparagraph (1) is limited to no more than 12 months from the effective date of the decision for retail supply of the product; and
(3) for the avoidance of doubt this paragraph does not apply to exemptions issued under subparagraph 7(1)(m)(ii)(B) of this Standard.
Dispensed medicines
Unless otherwise specified by regulation:
(1) The labelling requirements of this Standard do not apply to a medicine that:
(a) is supplied by an authorised prescriber or other person authorised to supply and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(b) is supplied on and in accordance with a prescription written by an authorised prescriber and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard; or
(c) is prepared and supplied by a pharmacist for an individual patient and is labelled in accordance with the requirements of Appendix L Part 1 of this Standard.
(2) A person must not supply a dispensed medicine for human use containing:
(a) a poison listed in column 1 of the table at Appendix L Part 2 of this Standard unless it is clearly labelled with the warning statement(s) specified in column 2 of that table; or
(b) a poison listed in Appendix K unless it is clearly labelled with a sedation warning (being statement 39, 40 or 90 as specified in Appendix F Part 1 of this Standard).
Gas cylinders
The requirements of subparagraphs 7(1)(a)(iv), 7(1)(c)(iv), and 7(1)(g)(iv) do not apply to a cylinder containing a poison that is a compressed gas.
Paints
The requirements of paragraph 7 do not apply to:
(1) paint (other than a paint for therapeutic or cosmetic use) which:
(a) contains only Schedule 5 poisons; or
(b) is a First Schedule or Second Schedule paint that is labelled with:
(i) the word “WARNING”, written in bold-face sans serif capital letters, the height of which is not less than 5 mm, on the first line of the main label with no other words written on that line; and
(ii) the expression “KEEP OUT OF REACH OF CHILDREN”, written in bold-face sans serif capital letters, the height of which is not less than 2.5 mm, on a separate line immediately below the word “WARNING”; and
(iii) the appropriate warnings specified for the paint in Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and
(iv) the name and proportion of the First Schedule or Second Schedule poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non-volatile content” or “in the dried film” of the paint; or
(2) a tinter which contains:
(a) only Schedule 5 poisons; or
(b) a poison included in the First Schedule or Second Schedule to Appendix I, provided that it is labelled with the name and proportion of that poison, and where the poison is a metal or metal salt, the proportion is expressed as the metallic element present as “calculated on the non-volatile content” or “in the dried film”.
Camphor and naphthalene
The labelling requirements of subparagraph 3(4) and paragraph 7 do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:
(1) complies with paragraph 28; and
(2) is sold or supplied in a primary pack labelled in accordance with paragraphs 3 and 7.
Prohibitions
. A label used in connection with any poison must not include:
(1) any reference to this Standard, or any comment on, reference to, or explanation of any expression required by this Standard that directly or by implication contradicts, qualifies or modifies such expression; or
(2) any expression or device suggesting or implying that the poison is safe, harmless, non-toxic, non-poisonous, or is recommended or approved by the Government or any government authority unless required by legislation; or
(3) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or
(4) any trade name or description that:
(a) represents any single constituent of a compound preparation; or
(b) misrepresents the composition or any property or quality of the poison; or
(c) gives any false or misleading indication of origin or place of manufacture of the poison.
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 subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances; and
(2) have the word “POISON”:
(a) in sans serif capital letters the height of which is at least one thirty second part of the length, height or width of the container, whichever is the greatest:
(i) embossed; or
(ii) indelibly written in a colour in distinct contrast to the background colour;
(b) on the side or shoulder of the container.
Containers for Schedule 5 poisons
(1) The container in which any Schedule 5 poison is sold or supplied must:
(a) comply with the container requirements of paragraph 21 or paragraph 22; or
(b) be readily distinguishable from a container in which food, wine or other beverage is sold; and
(i) comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216-1997 entitled Packaging for poisonous substances, excluding paragraph 1.4.3;
(ii) be securely closed and, except when containing a preparation for use on one occasion only, be capable of being re-closed to prevent spillage of its contents; and
(iii) have the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” embossed or indelibly written thereon, or printed on a permanent adhesive label designed to adhere to a substrate without lifting and which cannot be removed without damaging either the label or the substrate.
(2) Notwithstanding subparagraph 23(1), the following Schedule 5 poisons namely:
(a) methylated spirit(s);
(b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;
(c) petrol;
(d) toluene; or
(e) xylene,
must not be sold or supplied in a bottle or jar having a nominal capacity of 2 litres or less, unless the immediate container complies with the container requirements specified in paragraph 21.
Approved containers
Notwithstanding subparagraphs 21, 22 and 23 a poison may be packed in a container that does not comply with the tactile identification requirements of Australian Standard AS2216-1997 entitled Packaging for poisonous substances or the requirements of subparagraphs 22(2) or 23(1)(iii) if:
(1) the other safety factors are not diminished;
(2) the container is for a specific purpose; and
(3) an appropriate authority has approved the use of the container for that purpose.
Child-resistant closures
(1) If a poison, other than a poison included in a therapeutic good packaged in a manner compliant with orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989, listed in column 1 of the following table is sold or supplied in a container having a nominal capacity specified for that poison in column 2, it must be closed with a child-resistant closure.
TABLE
______________________________________________________________________
Column 1 Column 2
Name of the poison Nominal capacity
______________________________________________________________________
Alkaline salts included in Schedule 5, All sizes
when packed and labelled as dishwashing
machine tablets.
Alkaline salts included in Schedule 5, 5 litres /kilograms or less
when packed and labelled as dishwashing
machine liquids, solids or gels.
Alkaline salts included in Schedule 5, when 2.5 litres or less
packed and labelled as a food additive.
Anise oil when included in Schedule 5. 200 millilitres or less
Basil oil when included in Schedule 5. 200 millilitres or less
Bay oil when included in Schedule 6. 200 millilitres or less
Cajuput oil when included in Schedule 6. 200 millilitres or less
Cassia oil when included in Schedule 5. 200 millilitres or less
Cineole when included in Schedule 6. 2 litres or less
Cinnamon bark oil when included 200 millilitres or less
in Schedule 5.
Cinnamon leaf oil when included in Schedule 6. 200 millilitres or less
Clove oil when included in Schedule 6. 200 millilitres or less
Essential oils when included in Schedule 6 200 millilitres or less
because of their natural camphor component.
Ethylene glycol when included in Schedule 6. 5 litres or less
Ethylene glycol when included in 5 litres or less
Schedule 5 in preparations containing
more than 50 per cent of ethylene glycol.
Eucalyptus oil when included in Schedule 6. 2 litres or less
Eugenol when included in Schedule 6. 200 millilitres or less
Hydrocarbons, liquid, when packed 5 litres or less
as kerosene, lamp oil, mineral turpentine,
thinners, reducers, white petroleum spirit
or dry cleaning fluid.
Hydrochloric acid when included in Schedule 6. 5 litres or less
Leptospermum scoparium oil (manuka oil) 200 millilitres or less
when included in Schedule 6
Marjoram oil when included in Schedule 5. 200 millilitres or less
Melaleuca oil (tea-tree oil) when included 200 millilitres or less
in Schedule 6.
Methylated spirit excluding preparations or 5 litres or less
admixtures.
Methyl salicylate and preparations containing 200 millilitres or less
more than 50 per cent of methyl salicylate.
Nutmeg oil when included in Schedule 5. 200 millilitres or less
Oil of turpentine. 5 litres or less
Pennyroyal oil when included in Schedule 6. 200 millilitres or less
Potassium hydroxide as such. 2.5 litres or less
Potassium hydroxide in oven, hot plate or 5 litres or less
drain cleaners when included in Schedule 6
except when in pressurised spray packs.
d-Pulegone when included in Schedule 6. 200 millilitres or less
Sage oil (Dalmatian) when included 200 millilitres or less
in Schedule 6.
Sodium hydroxide as such. 2.5 litres or less
Sodium hydroxide in oven, hot plate or 5 litres or less
drain cleaners when included in Schedule 6
except when in pressurised spray packs.
Thujone when included in Schedule 6. 200 millilitres or less
Thyme oil when included in Schedule 5. 200 millilitres or less
(2) The manufacturer or packer of a poison must ensure that the child-resistant closure is appropriate for the container and the poison and that it retains its child-resistant properties for the expected life of the poison.
Schedule 8 poisons
25A. (1) A person who supplies any Schedule 8 poison must ensure that the Schedule 8 poison is packaged in such a way that its primary pack is so sealed that, when the seal is broken, it is readily distinguishable from other sealed primary packs.
(2) This paragraph does not apply to the supply of a Schedule 8 poison by an:
(a) authorised prescriber or other authorised supplier;
(b) pharmacist on the prescription of an authorised prescriber;
(c) pharmacist employed at a hospital, on the written requisition of a medical practitioner, a dentist or the nurse or midwife in charge of the ward in which the Schedule 8 poison is to be used or stored; or
(d) nurse or midwife on the direction in writing of an authorised prescriber.
Exemptions
(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, pellet or flake form for domestic use, if the device:
(1) in normal use, prevents removal or ingestion of its contents; and
(2) is incapable of reacting with the poison; and
(3) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and
(4) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.
Prohibitions
A person must not sell or supply camphor or naphthalene in ball, block, disc, pellet or flake form for domestic use unless the balls, blocks, discs, pellets or flakes are enclosed in a device which prevents removal or ingestion of its contents.
. 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 which is for internal use or any food, drink or condiment in a container prescribed by paragraph 21, 22 or 23 of this Standard.
31A. A person must not sell any poison in a container used expressly for any food, drink or condiment.
PART 3
MISCELLANEOUS REGULATIONS
(It is recommended that the States and Territories implement regulations which
provide controls similar to those included in this Part of the Standard.)
ADVERTISING
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 poison included in Schedule 9 or Appendix C 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
92. WARNING - Contains iodine - do not take when pregnant except on physician’s advice.
93. Causes severe burns, which are not likely to be immediately painful or visible.
94. WARNING - Contains nitrite. Substitution for table or cooking salt may be dangerous, particularly for young children.
CAUTION - Do not use for children under 12 years old unless a doctor has told you to.
96. CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a doctor.
. Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to by a doctor.
Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.
99. If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
100. Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.
101. Don’t use [this product/name of the product]:
If you have a stomach ulcer
In the last 3 months of pregnancy [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.]
If you are allergic to (name of substance) or anti-inflammatory medicines.
102. Unless a doctor has told you to, don’t use [this prouct/name of the product]:
For more than a few days at a time
With other medicines containing aspirin or other anti-inflammatory medicines
If you have asthma
In children under 12 years of age
In children 12-16 years of age with or recovering from chicken pox, influenza or fever
If you are pregnant.
103. See a doctor before taking [this product/name of the product] for thinning the blood or for your heart. [This statement may be omitted in products for inhibition of platelet aggregation or with additional active ingredients.]
104. Unless a doctor has told you to, don’t use [this product/name of the product]:
For more than a few days at a time
With other medicines containing (name of substance) or other anti-inflammatory medicines
If you have asthma
If you are pregnant [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea].
105. Do not use on the bedding or clothing of infants or in the bedrooms of children 3 years of age or less.
106. Contains formaldehyde.
APPENDIX F
PART 2
SAFETY DIRECTIONS - GENERAL
To be grouped together and prefaced with the words “SAFETY DIRECTIONS” (see Part 2, Labels and Containers, subparagraph 7(n) to this Standard).
1. Avoid contact with eyes.
2. Attacks eyes - protect eyes when using.
3. Wear eye protection when mixing or using.
4. Avoid contact with skin.
5. Wear protective gloves when mixing or using.
6. Wash hands after use.
7. Wash hands thoroughly after use.
8. Avoid breathing dust (or) vapour (or) spray mist.
9. Use only in well ventilated area.
10. Ensure adequate ventilation when using.
11. No smoking.
12. Do not allow product to come into contact with other chemicals, especially acids.
13. Do not allow product to come into contact with combustible materials such as paper, fabric, sawdust or kerosene.
14. Do not allow to get damp.
15. Store under cover in a dry, clean, cool, well ventilated place away from sunlight.
16. Store and transport in an upright container.
17. Do not mix with other chemicals.
18. Do not mix with different types of chlorinating chemicals.
19. Use clean containers for dispensing.
20. Mix with water only.
21. Do not add water to product - add product to water, but in case of fire drench with water.
22. In case of spillage flush with large quantities of water.
23. Keep away from heat, sparks and naked flames.
24. Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.
25. Avoid contact with food.
26. Avoid contact with clothing.
27. Wear a positive-pressure air-supplied full-face respirator whilst spraying and until spray mist has been effectively dispersed.
28. Do not mix with hot water.
29. Obtain a supply of calcium gluconate gel.
30. (Intentionally blank.)
31. Do not use on broken skin.
32. Do not use under occlusive dressing.
33. Mix strictly according to instructions.
34. May cause fire if it comes into contact with other chemicals, paper or other flammable materials.
35. Wash gloves thoroughly, immediately after use.
36. Protect cuticles with grease or oil.
APPENDIX F
PART 3
POISONS (other than agricultural and veterinary chemicals)
TO BE LABELLED WITH WARNING STATEMENTS
OR SAFETY DIRECTIONS
(Where more than one statement or direction is required, they may be combined to form simple sentences where appropriate.)
_________________________________________________________________________________
WARNING SAFETY
POISONSTATEMENTS DIRECTION
_________________________________________________________________________________
Acetic acid in concentrations of 80 per cent 2 1,4,8
or more except when in Schedule 2.
Acetic anhydride 2 1,4,8
Acetone in concentrations greater than 75 per cent. 1,4,8
Acitretin 7,62,76
Adapalene for topical use. 62,77
Alclometasone when included in Schedule 3. 38,72,73,74,75
Alkaline salts 4 1,4
Ambrisentan 7,62,76
Amines used as curing agentsfor epoxy resins. 1,3,4,5,8
Ammonia/ammonium hydroxide in concentrations 4 1,4,8
greater than 20 per cent ammonia except
in smelling salts.
Ammonium persulfate 5,21,25 1,5,23,33,34
Anhydrides, organic acid, for use as curing agents 1,3,4,5,8
for epoxy resins.
Aniline 13 1,4,8
Antihistamines not separately specified 39 or 40
in this Appendix except:
(a) dermal, ocular, parenteral and
paediatric preparations;
(b) oral preparations of astemizole,
desloratadine, fexofenadine,
loratadine or terfenadine;
(c) nasal preparations of azelastine; or
(d) preparations for the treatment of animals.
Aromatic extract oils 1,3,4,5,6
Aspirin
(a) for inhibition of platelet aggregation. 36
(b) in sustained release preparations 36
containing 650 mg or more of aspirin.
(c) in other preparations. 101,102,103
Astemizole 61
Azadirachta indica (neem) including its extracts
and derivatives when included in Schedule 6. 67
Azocyclotin 48
Benomyl 46
Benzene 12 1,4,9
1,2-Benzenediol (Catechol) 51,59 1,4,8
Benzoyl peroxide when included in Schedule 2. 55
Benzoyl peroxide when included in Schedule 5. 1,4,8
Bergamot oil 89
Beryllium 1,4,8
Bexarotene
(a) for human use. 7,62,76
(b) for topical use. 62,77
Bifluorides (including ammonium, potassium and sodium salts)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Bithionol for the treatment of animals. 1,4,8
Boron trifluoride (including mixtures that
generate boron trifluoride)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Bosentan 7,62,76
Bromoform 1,4,8
2-Butoxy-2’-thiocyanodiethyl ether 1,4,8
2-Butoxyethanol and its acetates 1,4,8
Camphor
(a) in block, ball, disc, pellet or flake form, 9
enclosed in a device which, in normal use,
prevents removal or ingestion of its contents.
(b) in other forms. 9 1
Carbamide peroxide
(a) more than 9 per cent up to 30 per cent. 5 1
(b) more than 30 per cent up to 60 per cent. 5 2
(c) more than 60 per cent. 2 2,4
Carbon disulphide 12 1,4,8,9,23
Carbon tetrachloride 12 1,4,8,9
Cassia oil 4
Chlorinating compounds
(a) in household cleaning or bleaching 20
preparations.
(b) in preparations containing less than 11 1,4,10
10 per cent of available chlorine.
(c) in liquid preparations containing 3,18 1,4,6,8,10, 15,16,
10 per cent or more of available chlorine. 17,18, 19,20,22,26
(d) in dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,
or more of available chlorine. 14,15,16,17, 18,
19,20,21, 22,26
(e) in dry preparations containing 10 per cent 10,18,22 1,4,8,12,13,
or more of available chlorine certified by a 14,15,16,17,
relevant State or Territory authority as not 18,19,20,21,
being a Dangerous Good of Class 5, 22,26
Division 5.1:Oxidising substances, as
specified in the Australian Code for the
Transport of Dangerous Goods by Road
and Rail.
(f) in compressed block or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of available chlorine 17,18,19,21
except in preparations for use in toilet
cisterns only, containing 15 g or less of
trichloroisocyanuric acid.
(g) in other compressed blocks or tablets 10,22 12,13,14,15,
containing 10 per cent or more of available 17,18,19,21
chlorine certified by a relevant State or
Territory authority as not being a Dangerous
Good of Class 5, Division 5.1: Oxidising
substances, as specified in the Australian
Code for the Transport of Dangerous Goods
by Road and Rail except in preparations for
use in toilet cisterns only, containing 15 g or
less of trichloroisocyanuric acid.
Chloroform when included in Schedule 6 1,4,8
alpha-Chlorohydrin 13,51 1,4,8,9
Chromates (including dichromates) of alkali metals or ammonia 1,4,8
Chromium trioxide 2,14,15,23 1,4,8,13
Cimetidine when included in Schedule 3 70,96
Cinnamon bark oil 4
Clobetasone when included in Schedule 3. 72,73,74,75,95
Clotrimazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Clove oil 1
Cyanides when included in Schedule 7. 13 4,8
Cyanuric acid 1,4,8
Cyclohexanone peroxide 1,4,8
Cysteamine 1
4,4-Diaminodiphenylmethane (methylene dianiline) 1,4,8
ortho-Dichlorobenzene 1,4,8
para-Dichlorobenzene 1,4
Dichloroethylene 1,4,8
Dichloroethyl ether 1,4,8
Dichloroisocyanurates
(a) in household cleaning or bleaching 20
preparations.
(b) in preparations containing less than 11 1,4,10
10 per cent of available chlorine. .
(c) in liquid preparations containing 10 per cent 3,18 1,4,6,8,10,
or more of available chlorine. 15,16,17,18,
. 19,20,22,26
(d) in dry preparations containing 10 per cent 10,18,22,23 1,4,8,12,13,14,
or more of available chlorine. 15,16,17,18,19,
. 20,21,22,26
(e) in dry preparations containing 10 per cent 10,18,22 1,4,8,12,13,14,
or more of available chlorine certified by a 15,16,17,18,19,
relevant State or Territory authority as not 20,21,22,26
being a Dangerous Good of Class 5,
Division 5.1: Oxidising substances, as
specified in the Australian Code for the
Transport of Dangerous Goods by Road
and Rail.
(f) in anti-bacterial tablets containing 2.5 g or 60
less of sodium dichloroisocyanurate..
(g) in other compressed blocks or tablets containing 10,22,23 12,13,14,15,
10 per cent or more of available chlorine except 17,18,19,21
in preparations containing 21 g or less of sodium
dichloroisocyanurate for use in toilet cisterns only.
(h) in other compressed blocks or tablets containing 10,22 12,13,14,15,17,
10 per cent or more of available chlorine 18,19,21
certified by a relevant State or Territory authority
as not being a Dangerous Good of Class 5,
Division 5.1: Oxidising substances, as specified
inthe Australian Code for the Transport of
Dangerous Goods by Road and Rail except in
preparations containing 21 g less of sodium
dichloroisocyanurate for use in toilet cisterns only.
(i) in other compressed blocks or tablets containing
10 per cent or more of available chlorine in
preparations containing 5 g or less of sodium
dichloroisocyanurate for use in toilet bowls only:
(i) during storage 10,22,23 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
(j) in other compressed blocks or tablets containing
10 per cent or more of available chlorine certified
by a relevant State or Territory authority as not
being a Dangerous Good of Class 5, Division 5.1:
Oxidising substances, as specified in the
Australian Code for the Transport of Dangerous
Goods by Road and Rail in preparations
containing 5 g or less of sodium dichloroisocyanurate
for use in toilet bowls only.
(i) during storage 10,22 12,13,14,15,17,
18,21
(ii) during use 5 1,4,7,12
Dichloromethane (methylene chloride)
(a) in paint or lacquer removers. 12,16 1,4,8,11
(b) other than in paint or lacquer removers 1,4,8,25
Diclofenac 101,104
Dienestrol 67
Diethanolamine when included in Schedule 5. 5 1,4
Diethanolamine when included in Schedule 6. 2,11,18 1,4,8
Diethyltoluamide for human use. 44
5,6-Dihydroxyindoline 21,28
Dimethylformamide 1,4,8
Dimethyl sulfate 2 1,4,8
Dimethyl sulfoxide
(a) when not packed and labelled for therapeutic use. 27 1,4,5,8
(b) when packed and labelled for treatment of animals. 49 1,4,5,8
Dinitrocresols (and their homologues) except when for 1,4,8
therapeutic use.
Dinitrophenols (and their homologues) except when 1,4,8
for therapeutic use.
Dinocap 47
Dioxane 1,4,8
Diphenoxylate when included in Schedule 3. 39 or 40,41
Econazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Ephedrine in nasal preparations for topical use. 29
Epichlorohydrin 2 1,4,8
Epoxy resins, liquid. 1,3,4,5,8
Ethanolamine when included in Schedule 5. 5 1,4
Ethanolamine when included in Schedule 6. 2,11,18 1,4,8
Ether when included in Schedule 5 or 6. 1,4,8
Ethoxyethylmercuric chloride 1,4
Ethyl bromide 1,4,8
Ethylene chlorohydrin 1,4,8
Ethylene glycol monoalkyl ethers and their acetates 1,4,8
except when separately specified.
Ethylene oxide 1,4,8
Ethylmercuric chloride 1,4
Ethyl methacrylate 28 4,9,23
Etretinate 7,62,76
Eugenol 1
Famotidine when included in Schedule 2. 96
Fenoterol in metered aerosols. 32
Fluconazole in oral preparations when included in 64
Schedule 3.
Fluorides (including silicofluorides) when included in 1,4
Schedule 5 or 6 except when separately specified.
Formaldehyde
(a) in nail hardener cosmetics. 106 1,4,8,36
(b) in other preparations. 106 1,4,8
Formic acid 1,4,8
Furfural 5 1,4
Glazing preparations containing lead compounds.. 50
Glutaraldehyde except when in Schedule 2
(a) 25 per cent or less. 5,59 1,4,5
(b) more than 25 per cent. 3,59 1,4,5,8
Glycolic acid 79 1,5,6,31
Hexachlorophane in preparations for skin cleansing 24
purposes containing 3 per cent or less of
hexachlorophane.
Hexyloxyethanol 2 1,4,8
Hydrazine 1,4,8
Hydrochloric acid
(a) 30 per cent or less of HCl. 1,4
(b) more than 30 per cent of HCl. 1,4,8
Hydrocortisone
(a) for dermal use when included in 38,72,73,74,75
Schedule 2 or 3.
(b) for topical rectal use when includeed 38,75
in Schedule 2 or 3.
Hydrocyanic acid when included in Schedule 7. 13 4,8
Hydrofluoric acid (including mixtures that generate
hydrofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
Hydrogen peroxide
(a) more than 3 per cent up to 10 per cent. 5 1
(b) more than 10 per cent up to 20 per cent. 5 2
(c) more than 20 per cent. 2 2,4
Hydroquinone
(a) when in Schedule 2. 45
(b) except when in Schedule 2 or 4. 1,4
Hydrosilicofluoric acid (including mixtures
that generate hydrosilicofluoric acid)
(a) when included in Schedule 5. 2 1,4
(b) when included in Schedule 6 or 7. 1,17,93 1,3,4,5,8,29,35
8-Hydroxyquinoline (including salts and 33
derivatives) when prepared for
internal use.
Ibuprofen 101,104
Iodine
(a) more than 20 per cent. 1,4,8
(b) in preparations for human internal therapeutic 91,92
use containing 300 micrograms or more of
iodine per recommended daily dose.
Ipratropium bromide in metered aerosols. 32
Isocyanates (free organic)
(a) when in paint. 28,52 1,5,8,10,27
(b) other than in paint. 28,52 1,4,8
Isoprenaline in metered aerosols 32
Isotretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Lead compounds
(a) in hair cosmetics. 25
(b) when in Schedule 6. 1,4,8
Leflunomide 7,62,87
Lemon oil 89
Lenalidomide 7,62,76
Levocabastine
(a) in eye or nasal preparations containing 62
0.5 mg/mL or less of levocabastine.
(b) in other preparations. 62 and
either 39 or 40
Lime oil 89
Loperamide when in Schedule 2. 41
Magnesium chlorate 1,4
Mefenamic acid 101,104
Mercuric thiocyanate 1,4
Metacresolsulphonic acid and formaldehyde 1,4
condensation product for the treatment of animals.
Methanol except in methylated spirit. 1,4,8
Methoxamine in nasal preparations for topical use. 29
Methyl chloride 1,4,8
Methyl ethyl ketone 5 1,4,8
Methyl ethyl ketone oxime 5,28 1,4
Methyl ethyl ketone peroxide 2 2,3,4,6
Methyl iso-amyl ketone 1,4,8
Methyl iso-butyl ketone 1,4,8
Methyl iso-thiocyanate 5,12 1,4,8
Methyl methacrylate 28 4,9,23
Methyldibromo glutaronitrile 28 1,4,7
Methylene bisthiocyanate 1,4
Methyleugenol 1,6
Methylnorbornylpyridine 59
1-(beta-Methyl sulphonamidoethyl)- 2-amino-3-
N,N-diethylaminobenzene 1,4,8
Miconazole in vaginal preparations when included 54,63,64,66
in Schedule 3.
Misoprostol 53
Naphazoline in nasal preparations for topical use. 29
Naphthalene
(a) in block, ball, disc, pellet or flake form, 9,105
enclosed in a device which, in normal
use, prevents removal or ingestion of its
contents.
(b) in other forms. 9,105 1
Naproxen 101,104
Nicotine except when in tobacco or when included 1,4
in Schedule 2.
Nitric acid
(a) 75 per cent or less HNO3. 2 1,4
(b) more than 75 per cent HNO3. 2 1,4,8
Nitrobenzene 1,4,8
Nitrophenols 1,4
Nitroprussides in aerosols. 84 8
Nizatidine when included in Schedule 2. 96
Noradrenaline in metered aerosols. 32
Nystatin in vaginal preparations when included 54,63,64,65,66
in Schedule 3.
Orange oil (bitter) 89
Orciprenaline in metered aerosols. 32
Oxalates, metallic 4,8
Oxalic acid 2 4,8
Oxymetazoline in nasal preparations for topical use. 29
Paint
(a) First Schedule paints. 83
(b) Second Schedule paints. 84
Paracetamol 97 and/or 98,99,100
Pentachlorophenol 1,4,8
Peracetic acid 2 1,4,8
Permanganates 2 24
2-Phenoxyethanol 5 1
Phenol and any other homologue of phenol. 1,4
Phenols 5
Phenylenediamines and alkylated
phenylenediamines
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Phenylephrine in nasal preparations 29
for topical use.
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,5-dimethanamine 5,28 1,4,5,10
N,N-bis(phenylmethylene)-bicyclo-
(2.2.1)heptane-2,6-dimethanamine 5,28 1,4,5,10
ortho-Phenylphenol except when in 1,4
antiseptics.
Phenylpropanolamine 56
Phenytoin in pastes for the treatment of horses. 9
Phosphonic acid 1,4
Phosphoric acid 1,4
Phosphorus (yellow) 2 1,4
ortho-Phthalaldehyde
(a) when included in Schedule 5. 51,52,59 1,4,5,8,10
(b) when included in Schedule 6. 51,52,59 2,4,5,8,10
Picric acid (more than 20 per cent). 1,4
Podophyllin
(a) in preparations specifically for use on 36
anal or genital area.
(b) in other liquid preparations when included 31
in Schedule 2 or Schedule 3.
(c) in other solid or semi-solid preparations 30
when included in Schedule 2.
Podophyllotoxin
(a) in preparations specifically for 36
use on anal or genital area.
(b) in other liquid preparations when included 31
in Schedule 2 or Schedule 3.
(c) in other solid or semi-solid preparations 30
when included in Schedule 2.
Polihexanide 1,4,8
Polyethanoxy (15) tallow amine 1,4
Poly(oxy-1,2-ethanediyl), α -[2-[(2-hydroxyethyl)amino] 5,88 1,5
-2-oxoethyl]- α -hydroxy-,mono-C13-15 -alkyl ethers
Potassium hydroxide
(a) in preparations containing 5 1,4,6
0.5 per cent or less of potassium
hydroxide.
(b) in solid preparations containing 2,10,78 3,5,28
more than 0.5 per cent of potassium
hydroxide.
(c) in liquid preparations containing 2,10,78 3,5
more than 0.5 per cent of potassium
hydroxide.
Potassium metabisulphite 5,26 1,4
Potassium nitrite in pickling or curing salts. 94
Potassium persulfate 5,21,25 1,5,23,33,34
Potassium sulfide 2 1,4
Propionic acid when in Schedule 6. 2 1,4
Ranitidine when included in Schedule 2. 96
Safrole
(a) in preparations for therapeutic use. 1
(b) other than for therapeutic use. 1,4
Salbutamol in metered aerosols or in dry 32
powder formulations.
Salicylamide 34 or 35
Sassafras oil
(a) in preparations for therapeutic use. 1
(b) other than for therapeutic use. 1,4
Selenium compounds except when for 1,4,8
therapeutic use (human or animal).
Silver in smoking deterrents. 42
Sitaxentan 7, 62, 76
Sodium aluminate 2 1,4
Sodium chlorate 1,4
Sodium dodecylbenzene sulfonate 79 1
Sodium fluoride in preparations for 43
human ingestion when in Schedule 2.
Sodium hydrogen sulfate 1,4,8
Sodium hydrosulfite 5,26 1,4,8
(more than 50 per cent)
Sodium hydroxide
(a) in preparations containing 0.5 per cent 5 1,4,6
or less of sodium hydroxide.
(b) in solid preparations containing more than 2,10,78 3,5,28
0.5 per cent of sodium hydroxide.
(c) in liquid preparations containing more than 2,10,78 3,5
0.5 per cent of sodium hydroxide.
Sodium laureth-6 carboxylate 79 1
Sodium metabisulphite 5,26 1,4
(more than 50 per cent)
Sodium nitrite in pickling or curing salts 94
Sodium persulfate 5,21,25 1,5,23,33,34
Sodium sulfide 2 1,4
Styrene 1,4,8
Sulfamic acid 2 1,4
Sulfuric acid 2 1,4
Symphytum spp. (Comfrey) when included in Schedule 5. 31,32
Tazarotene for topical use. 77,62
Terbutaline in metered aerosols or in dry powder formulations. 32
Terfenadine 61
Teriflunomide. 7,62,87
Terpenes, chlorinated 1,4,8
Tetrachloroethane 12 8
Tetrachloroethylene when in Schedule 5 or 6. 12,16 1,4,8,11
Tetrahydrozoline in nasal preparations for topical use. 29
Thalidomide 7,62,76
Thiourea 1,4
Toluene 1,4,8
Toluenediamine
(a) in hair dyes. 21
(b) in preparations other than hair dyes. 1,4,8
Tramazoline in nasal preparations for topical use. 29
Tretinoin
(a) for human oral use. 7,62,76
(b) for topical use. 62,77
Triamcinolone when in topical preparations 64 or 68
for the treatment of mouth ulcers.
Trichloroacetic acid except when for 2 1,4
therapeutic use.
1,1,1-trichloroethane 8,9
Trichloroethylene except when for 12 1,4,5,8,9
therapeutic use.
Trichlorophenol 1,4,8
Triethanolamine 5 1,4
Triethyl phosphate 1,4,8
Trifluoromethanesulfonic acid
(a) more than 10 per cent. 1,17 1,4,8
(b) 10 per cent or less. 1,4,8
Triisopropanolamine lauryl ether sulfate 1,4,6
3,6,9-Trioxaundecanedioic acid 5 1
Tymazoline in nasal preparations for topical use. 29
Vinclozolin 46
Xylene 1,4,8
Xylometazoline in nasal preparations for topical use. 29
Zinc chloride 1,4
Zinc sulfate when in Schedule 6. 1,4
APPENDIX G
DILUTE PREPARATIONS
The requirements of this Standard do not apply to a poison listed in Column 1 of this Appendix at a concentration not more than that specified in Column 2 in respect of that poison.
Column 1 Column 2
Poison Concentration
(quantity per litre
or kilogram)
ACETYLCHOLINE 1 mg
ALDOSTERONE 10 micrograms
ANTIMONY COMPOUNDS 1 mg
APOMORPHINE 1 mg
ARSENIC 1 mg
ATROPA BELLADONNA (belladonna) 300 micrograms
ATROPINE 300 micrograms
CANTHARIDIN 10 micrograms
CHLORINE 5 mg
CROTON TIGLIUM (croton oil) 1 mg
DIOXANE 100 mg
ERYSIMUM spp. 1 mg
FOLLICLE-STIMULATING HORMONE 100 micrograms
GELSEMIUM SEMPERVIRENS 1 mg
GLUCAGON 100 micrograms
GLYCERYL TRINITRATE 100 micrograms
GROWTH HORMONE 10 micrograms
HALOPERIDOL 1 mg
HYDROCYANIC ACID 1 microgram
HYOSCINE 300 micrograms
HYOSCYAMINE 300 micrograms
HYOSCYAMUS NIGER 300 micrograms
HYPOTHALAMIC RELEASING FACTORS 10 micrograms
INDOMETHACIN 1 mg
MERCURY 1 mg
METHYLMERCURY 300 micrograms
NAPHTHALENE 1 mg
NERIUM OLEANDER 1 mg
OESTRADIOL 10 micrograms
OESTRONE 100 micrograms
OXYTOCIN 1 microgram
PHOSPHORUS 1 mg
PODOPHYLLUM RESIN (podophyllin) 1 mg
PROGESTERONE 1 mg
PROPRANOLOL 1 mg
SELENIUM 100 micrograms
STROPHANTHUS spp. 1 mg
STRYCHNINE 1 mg
TESTOSTERONE 1 mg
THYROXINE 10 micrograms
APPENDIX H
SCHEDULE 3 POISONS PERMITTED TO BE ADVERTISED
Butoconazole.
Clotrimazole.
Diclofenac.
Dimenhydrinate for the prevention and relief of motion sickness.
Diphenoxylate.
Econazole.
Fluconazole.
Hydrocortisone.
Miconazole.
Nystatin.
APPENDIX I
UNIFORM PAINT STANDARD
This Appendix provides regulations for adoption by the States and Territories.
1. A person must not manufacture, sell, supply or use a First Schedule Paint for application to:
(1) a roof or any surface to be used for the collection or storage of potable water; or
(2) furniture; or
(3) any fence, wall, post, gate or building (interior or exterior) other than a building which is used exclusively for industrial purposes or mining or any oil terminal; or
(4) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
2. A person must not manufacture, sell, supply or use a Third Schedule paint.
3. A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD).
4. A person must not manufacture, sell, supply, or use a paint containing a pesticide except a fungicide, algicide, bactericide or antifouling agent.
The First Schedule
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
ANTIMONY or antimony compounds other than more than 5 per cent
antimony titanate pigments
BARIUM salts except barium sulfate or barium metaborate more than 5 per cent
CADMIUM or cadmium compounds more than 0.1 per cent
CHROMIUM as chromates of ammonia, barium, potassium, more than 5 per cent
sodium, strontium or zinc
SELENIUM or selenium compounds more than 0.1 per cent
The Second Schedule
Substance Proportion
CHROMIUM as chromates of ammonia, more than 5 per cent
barium, calcium, iron, potassium, sodium,
strontium or zinc
DICHLOROMETHANE (methylene chloride) more than 5 per cent by wt
ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates more than 10 per cent by vol
HEXYLOXYETHANOL more than 10 per cent by vol
TOLUENE more than 50 per cent by vol
XYLENE more than 50 per cent by vol
The Third Schedule
The proportion of a substance for the purposes of this Schedule is calculated as a percentage of the element present in the non-volatile content of the paint.
Substance Proportion
LEAD or lead compounds more than 0.1 per cent
APPENDIX J
CONDITIONS FOR AVAILABILITY AND USE OF
SCHEDULE 7 POISONS
PART 1
CONDITIONS FOR AVAILABILITY AND USE
The following controls are recommended for poisons only when included in Schedule 7. These conditions for availability and use may be implemented through poisons controls or other State or Territory legislation.
1. Not to be available except to authorised or licensed persons.
2. Not to be used in printing inks.
3. Not to be used except by or in accordance with the directions of accredited government vermin control officers.
4. Not to be used in industries which handle, process or store foods, animal feeds or packaging materials.
APPENDIX J
PART 2
A poison listed in this Appendix is to be available only in accordance with the conditions specified beside it in the “Conditions” column. The conditions apply only when the poison is included in Schedule 7.
_________________________________________________________________________________
POISONS CONDITIONS
_________________________________________________________________________________
Abamectin 1
Acibenzolar-s-methyl 1
Acrolein 1
Acrylonitrile 1
Alachlor 1
Allyl alcohol 1
4-Aminopyridine 1
Arprinocid 1
Arsenic 1
Azocyclotin 1
Benzene 1
Bifluorides (including ammonium, potassium and sodium salts) 1
Boron trifluoride 1
Brodifacoum 1
Bromadiolone 1
Bromine 1
Brucine 1
Calciferol 1
Captafol 1
Carbadox 1
Carbon tetrachloride 1
Carbonyl sulphide 1
Chlordecone 1
Chlordimeform 1
Chlorine 1
Chloromethiuron 1
Chloropicrin 1
4-Chloro-o-toluidine 1
Colecalciferol 1
Coumatetralyl 1
Cyanogen 1
Cyhexatin 1
4,4-Diaminodiphenylmethane (methylene dianiline) 1
1,2-Dibromo-3-chloropropane 1
1,3-Dichloropropene 1
Difenacoum 1
4-Dimethylaminoazobenzene 1
Dinitrocresols 1
Dinitrophenols 1
Dinoseb 1
Epichlorohydrin 1
Epidermal growth factor 1
Etaconazole 1
Ethylene dibromide 1
Ethylene oxide 1
Fluoracetamide 3
Fluoroacetic acid 3
Folpet 1
Halofuginone 1
Halogenated dibenzodioxins and dibenzofurans 1
HCB 1
Hydrocyanic acid and cyanides 1
Hydrofluoric acid 1
Hydrosilicofluoric acid 1
Iodomethane 1
Maduramicin 1
Mercury 1
Methacrifos 1
Methoxyethylmercuric acetate 1
Methoxyethylmercuric chloride 1
Methyl bromide 1
4,4’-Methylenebis[2-chloroaniline] 1
Mirex 1
Molinate 1
Nicotine 1
Nitrofen 1
Phenylmercuric acetate 1
Phosphides, metallic 1
Phosphine 1
Propylene oxide 1
Pyrinuron 1
Strychnine 1
Sulcofuron 1
Tetrachloroethane 1
2,2’,6,6’-Tetraisopropyl-diphenyl-carbodiimide 1
Thallium 3
ortho-Tolidine 1
Trichloroisocyanuric acid 1
Vinyl chloride 1
APPENDIX K
DRUGS REQUIRED TO BE LABELLED
WITH A SEDATION WARNING
(see Part 2, Labels and Containers, subparagraph 14(2))
ALPRAZOLAM
AMISULPRIDE
AMITRIPTYLINE
AMYLOBARBITONE
ARIPIPRAZOLE
ASENAPINE
AZATADINE
BACLOFEN
BENZTROPINE
BROMAZEPAM
BROMPHENIRAMINE
BUCLIZINE
BUPRENORPHINE
BUTOBARBITONE
CETIRIZINE
CHLORAL HYDRATE
CHLORDIAZEPOXIDE
CHLORMETHIAZOLE
CHLORPHENIRAMINE
CHLORPROMAZINE
CLEMASTINE
CLOMIPRAMINE
CLONAZEPAM
CLONIDINE
CLORAZEPATE
CLOZAPINE
CODEINEexcept when included in Schedule 2 or 3.
CYCLIZINE
CYCLOBARBITONE
CYCLOSERINE
CYPROHEPTADINE
CYSTEAMINE
DANTROLENE
DESIPRAMINE
DEXCHLORPHENIRAMINE
DEXTROMORAMIDE
DEXTROPROPOXYPHENE
DIAZEPAM
DIFENOXIN
DIHYDROCODEINE
DIMENHYDRINATE
DIMETHINDENE
DIPHENHYDRAMINE
DIPHENOXYLATE
DIPHENYLPYRALINE
DOTHIEPIN
DOXEPIN
DOXYLAMINE
DRONABINOL (delta-9-TETRAHYDROCANNABINOL)
DROPERIDOL
DULOXETINE
ETHYLMORPHINE
FENFLURAMINE
FLUNITRAZEPAM
FLUPENTHIXOL
FLUPHENAZINE
FLURAZEPAM
GABAPENTIN
GEMCITABINE
GLUTETHIMIDE
HALOPERIDOL
HYDROCODONE
HYDROMORPHONE
HYDROXYZINE
IMIPRAMINE
LAMOTRIGINE
LEVETIRACETAM
LEVOCABASTINE
LORAZEPAM
LURASIDONE.
MAZINDOL
MEBHYDROLIN
MECLOZINE
MEDAZEPAM
MEPROBAMATE
MEPYRAMINE
METHADONE
METHDILAZINE
METHOCARBAMOL
METHYLPHENOBARBITONE
MIANSERIN
MIRTAZAPINE
MORPHINE
NABIXIMOLS .
NALBUPHINE
NITRAZEPAM
NORMETHADONE
NORTRIPTYLINE
OLANZAPINE
OPIUM in any form except the alkaloids noscapine and papaverine.
OXAZEPAM
OXYCODONE
PALIPERIDONE
PAPAVERETUM
PENTAZOCINE
PENTOBARBITONE
PERAMPANEL
PERICYAZINE
PERPHENAZINE
PETHIDINE
PHENELZINE
PHENIRAMINE
PHENOBARBITONE
PHENOPERIDINE
PHENYLTOLOXAMINE
PHOLCODINE
PIMOZIDE
PIZOTIFEN
PRAZEPAM
PREGABALIN
PROCHLORPERAZINE
PROMAZINE
PROMETHAZINE
PROTRIPTYLINE
QUETIAPINE
QUINALBARBITONE
RETIGABINE
RISPERIDONE
ROTIGOTINE
RUPATADINE
SECBUTOBARBITONE
TAPENTADOL
TEMAZEPAM
THENYLDIAMINE
THIETHYLPERAZINE
THIOPROPAZATE
THIORIDAZINE
THIOTHIXENE
TRAMADOL
TRANYLCYPROMINE
TRIFLUOPERAZINE
TRIMEPRAZINE
TRIMIPRAMINE
TRIPROLIDINE
ZIPRASIDONE
ZOLPIDEM
ZONISAMIDE
ZOPICLONE
APPENDIX L
REQUIREMENTS FOR DISPENSING LABELS FOR
HUMAN AND VETERINARY MEDICINES
PART 1
GENERAL REQUIREMENTS FOR DISPENSING LABELS
(see Part 2, Labels and Containers, subparagraph 14(1))
(1) All details, words and other required information on a label on a container of a substance for therapeutic use must be in the English language in letters at least 1.5 millimetres in height.
(2) All symbols, numbers and words on a label must be in durable characters.
(3) The label on a container of a substance for therapeutic use must contain the following details:
(a) the name, address and telephone number of the dispenser supplying the substance;
(b) the approved name of the substance and/or its proprietary name (unless it is a preparation compounded in accordance with the dispenser’s own formula);
(c) adequate directions for use;
(d) the strength and form of the substance;
(e) the total quantity of the goods in the container;
(f) the words “KEEP OUT OF REACH OF CHILDREN” in red on a white background;
(g) if the substance is intended for external use only, the word “POISON”, or the words “FOR EXTERNAL USE ONLY”, in red on a white background;
(h) if the substance is a medicine, the name of the person for whom it was dispensed; and
(i) if the substance is a veterinary chemical, the species of animal, the name of the animal’s owner and the words “FOR ANIMAL TREATMENT ONLY”.
(4) The label on a container of a medicine or veterinary chemical that is supplied on prescription must also include:
(a) the prescription reference number;
(b) the date on which the prescription was supplied (unless that date is clear from the prescription reference number); and
(c) the directions for use set out in the prescription.
APPENDIX L
PART 2
ADDITIONAL LABELLING REQUIREMENTS FOR CERTAIN HUMAN MEDICINES
(see Part 2, Labels and Containers, subparagraph 14(2))
Medicines required to be labelled with certain warning statements A substance listed in Column 1 of the following table must be labelled with the warning statement in Appendix F, Part 1, as specified opposite in Column 2.
______________________________________________________________
Column 1 Column 2
Substance Warning statement
______________________________________________________________
Acitretin:
(i) for oral use. 7,62 and 76
(ii) for topical use. 62 and 77
Adapalene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Ambrisentan. 7, 62 and 76
Bexarotene:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Bosentan. 7, 62 and 76
Dienestrol. 67
Etretinate:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Fingolimod. 76
Isotretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Leflunomide. 7, 62 and 76
Lenalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Levocabastine. 62
Misoprostol. 53
Sitaxentan. 7, 62 and 76
Teriflunomide. 7, 62 and 87
Thalidomide:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
Tretinoin:
(i) for oral use. 7, 62 and 76
(ii) for topical use. 62 and 77
0
0
0