Commonwealth legislation

Poisons Standard 2013

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

8/10 complexity

This instrument compiles national scheduling decisions (Schedules 1–9) for medicines and poisons and supplies model rules on labelling, containers, storage and supply for adoption by States and Territories. It directly affects manufacturers, importers, distributors, pharmacists, prescribers and retailers by imposing specific labelling, packaging, storage and supply controls and by creating exemptions and concentration thresholds (Introduction; Part 2). Industry bears compliance costs for packaging, labelling and record‑keeping; Commonwealth delegates set schedules while designated ‘appropriate authorities’ may grant exemptions (Part 1; 13A).

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INTRODUCTION

The Poisons Standard 2013, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).

The SUSMP serves two key purposes.

Firstly, the SUSMP contains the decisions of the 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 i

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.

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;

(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;

(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

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

“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;

(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;

(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

(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

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;

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

(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

(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

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

(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 st

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 inject

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

(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 m

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 ce

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

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 Schedu

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;

(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.

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.

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

(2) label the container with his or her name or the name of the pharmacy and the address from which it was sold or supplied; and

(3) if required by regulation, make a record of the transaction in a prescription book or other approved recording system.

Schedule 4 poisons

A person, other than a medical, dental or veterinary practitioner in the ordinary course of their professions or a pharmacist dispensing a legal prescription must not sell or supply a Schedule 4 poison.
Paragraph 38 does not apply to a pharmacist who sells or supplies a Schedule 4 poison, other than a poison excepted by regulation from this provision, without a prescription if:

(1) the patient is under medical treatment with the poison and continuation of medication is essential; and

(2) the quantity sold or supplied does not exceed 3 days' medication; and

(3) the pharmacist is satisfied that an emergency exists.

Paragraphs 34, 36, 37 and 38 do not apply to sale by way of wholesale dealing to a pharmacist, medical practitioner, veterinary practitioner, dentist or a person licensed or otherwise authorised to possess, sell or supply such poisons.

Schedule 7 poisons

(1) A person must not possess or use a Schedule 7 poison for domestic or domestic garden purposes.

(2) A person must not sell or supply:

(a) a Schedule 7 poison for domestic or domestic garden purposes; or

(b) a Schedule 7 poison being a liquid preparation containing paraquat unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell; or

(c) a Schedule 7 poison for which an authorisation to possess or use is required by subparagraph (3) unless the purchaser produces his or her authorisation.

(3) A person must not possess or use any of the following Schedule 7 poisons unless he or she is authorised to do so by the appropriate authority:

Arsenic

Cyanides

Fluoroacetic acid

Fluoroacetamide

Hydrocyanic acid

Strychnine

Thallium.

(4) The appropriate authority may exempt a person or a class of persons from the requirement to hold an authorisation under subparagraph (3) and may vary or revoke the exemption by notice in writing.

Prohibitions on sale, prescribing and po

Prohibitions on sale, prescribing and possession

A person must not:

(1) knowingly have in his or her possession or sell, supply or use a poison listed in Appendix C of this Standard for the purpose or purposes indicated in relation to that poison in Appendix C; or

(2) sell or supply, other than by way of wholesale dealing, or prescribe a poison listed in Appendix D paragraphs 1, 2, 3 or 4 except in accordance with the provisions indicated for that poison in Appendix D; or

(3) knowingly have in his or her possession a poison listed in Appendix D paragraph 5 without authority.

STORAGE

A person who sells or supplies Schedule 2 poisons must keep those poisons in such a way that public access to advice from a pharmacist is available if required.
A person who sells or supplies Schedule 3, Schedule 4 or Schedule 7 poisons must keep those poisons in a part of the premises to which the public does not have access.

PART 4

THE SCHEDULES

PART 4 THE SCHEDULES

SCHEDULE 1

This Schedule is intentionally blank.

SCHEDULE 2

SCHEDULE 1

This Schedule is intentionally blank.

SCHEDULE 2

PART 4 THE SCHEDULES

SCHEDULE 1

This Schedule is intentionally blank.

SCHEDULE 2

SCHEDULE 3

SCHEDULE 4

SCHEDULE 5

SCHEDULE 6

SCHEDULE 7

SCHEDULE 8

SCHEDULE 9

PART 5

THE APPENDICES

PART 5 THE APPENDICES

APPENDIX A

GENERAL EXEMPTIONS

APPENDIX B

SUBSTANCES CONSIDERED NOT TO REQUIRE CON

SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROLBY SCHEDULING

SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL

BY SCHEDULING

(This Appendix should be read in conjunction with Appendix A.)

APPENDIX C

SUBSTANCES, OTHER THAN THOSE INCLUDED IN

SUBSTANCES, OTHER THAN THOSE INCLUDED IN SCHEDULE 9,

OF SUCH DANGER TO HEALTH AS TO WARRANT

PROHIBITION OF SALE, SUPPLY AND USE

ABRUS PRECATORIUS (Jequirity) seed or root for therapeutic use.

ACORUS CALAMUS (calamus) for human therapeutic use.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for domestic use:

(a) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5;

(b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or

(b) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

ALLYLISOPROPYLACETYLUREA for therapeutic use.

AMINOPHENAZONE (amidopyrine) and its derivatives for human therapeutic use.

AMYGDALIN for therapeutic use.

ANCHUSA OFFICINALIS for therapeutic use.

ARISTOLOCHIA spp. for therapeutic use.

ARISTOLOCHIC ACID(S) for human therapeutic use.

ASARUM spp. containing aristolochic acid(s) for human therapeutic use.

AZADIRACHTA INDICA (neem) including its extracts and derivatives, in preparations for human internal use except ‘debitterised neem seed oil’.

BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.

BITHIONOL for human therapeutic use.

BORAGO OFFICINALIS (Borage) for therapeutic use except the fixed oil derived from the seeds of Borago officinalis.

BRAGANTIA spp. containing aristolochic acid(s) for human therapeutic use.

BUCLOSAMIDE for therapeutic use.

BUNIODYL SODIUM for therapeutic use.

1,4-BUTANEDIOL (excluding its derivatives) in non-polymerised form in preparations for domestic use.

CACALIA spp. for therapeutic use.

CARBAMIDE PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 18 per cent of carbamide peroxide except in preparations manufactured for, and supplied solely by, registered dental practitioners as part of their dental practice.

CINCHOPHEN and its derivatives for therapeutic use.

CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when being used solely for experimental purposes in humans and where such use:

(a) is in accordance with:

(i) an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and

(ii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and

(iii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or

(b) is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.

COAL TAR for cosmetic use other than in therapeutic goods.

CONIUM MACULATUM (coniine) for therapeutic use.

COTARNINE for therapeutic use.

CROTALARIA spp. for therapeutic use.

CROTON TIGLIUM for therapeutic use.

CYNOGLOSSUM spp. for therapeutic use.

DICOPHANE (DDT) for therapeutic use.

DIETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of diethylene glycol.

DIETHYLHEXYL PHTHALATE for cosmetic use.

DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.

5,6-DIHYDROXYINDOLINE for cosmetic use in preparations containing more than 2 per cent of 5,6-dihydroxyindoline.

1,3-DIMETHYLAMYLAMINE (DMAA).

DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.

DULCIN for therapeutic use.

ETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of ethylene glycol.

ETHYLHEXANEDIOL for human use.

EUPATORIUM CANNABINUM (Hemp Agrimony) for therapeutic use.

FARFUGIUM JAPONICUM for therapeutic use.

FORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

(d) in all other cosmetic preparations containing 0.05 per cent or more of free formaldehyde except in preparations containing 0.2 per cent or less of free formaldehyde when labelled with the warning statement:

CONTAINS FORMALDEHYDE.

HELIOTROPIUM spp. for therapeutic use.

HYDROGEN PEROXIDE (excluding its salts and derivatives) in teeth whitening preparations containing more than 6 per cent (20 volume) of hydrogen peroxide except in preparations manufactured for, and supplied solely by, registered dental practitioners as part of their dental practice.

JUNIPERUS SABINE [savin(e)] for therapeutic use.

LEAD COMPOUNDS in paints, tinters, inks or ink additives except in preparations containing 0.1 per cent or less of lead calculated on the non-volatile content of the paint, tinter, ink or ink additive.

LIGULARIA DENTATA for therapeutic use.

MELIA AZEDARACH including its extracts and derivatives.

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use.

METHYL METHACRYLATE for cosmetic use except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.

OXYPHENISATIN for therapeutic use.

PARAFORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

CONTAINS FORMALDEHYDE.

PETASITES spp. for therapeutic use.

PHENYLENEDIAMINES in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

POTASSIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

PTERIDIUM spp. for therapeutic use.

PULMONARIA spp. for therapeutic use.

SAFROLE for internal therapeutic use except in preparations containing 0.1 per cent or less of safrole.

SENECIO spp. for therapeutic use.

SILICONES for injection or implantation except when included in Schedule 4.

SODIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

SYMPHYTUM spp. (Comfrey) for therapeutic or cosmetic use except when included in Schedule 5.

TOLUENEDIAMINE in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

1,1,1-TRICHLOROETHANE in pressurised spray packs for therapeutic use.

TRICHODESMA AFRICANA for therapeutic use.

TRIPARANOL for therapeutic use.

TUSSILAGO FARFARA for therapeutic use.

OF SUCH DANGER TO HEALTH AS TO WARRANT

SUBSTANCES, OTHER THAN THOSE INCLUDED IN SCHEDULE 9,

OF SUCH DANGER TO HEALTH AS TO WARRANT

PROHIBITION OF SALE, SUPPLY AND USE

ABRUS PRECATORIUS (Jequirity) seed or root for therapeutic use.

ACORUS CALAMUS (calamus) for human therapeutic use.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for domestic use:

(a) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5;

(b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or

(b) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

ALLYLISOPROPYLACETYLUREA for therapeutic use.

AMINOPHENAZONE (amidopyrine) and its derivatives for human therapeutic use.

AMYGDALIN for therapeutic use.

ANCHUSA OFFICINALIS for therapeutic use.

ARISTOLOCHIA spp. for therapeutic use.

ARISTOLOCHIC ACID(S) for human therapeutic use.

ASARUM spp. containing aristolochic acid(s) for human therapeutic use.

AZADIRACHTA INDICA (neem) including its extracts and derivatives, in preparations for human internal use except ‘debitterised neem seed oil’.

BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.

BITHIONOL for human therapeutic use.

BORAGO OFFICINALIS (Borage) for therapeutic use except the fixed oil derived from the seeds of Borago officinalis.

BRAGANTIA spp. containing aristolochic acid(s) for human therapeutic use.

BUCLOSAMIDE for therapeutic use.

BUNIODYL SODIUM for therapeutic use.

1,4-BUTANEDIOL (excluding its derivatives) in non-polymerised form in preparations for domestic use.

CACALIA spp. for therapeutic use.

CINCHOPHEN and its derivatives for therapeutic use.

CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when being used solely for experimental purposes in humans and where such use:

(a) is in accordance with:

(i) an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and

(ii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and

(iii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or

(b) is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.

COAL TAR for cosmetic use other than in therapeutic goods.

CONIUM MACULATUM (coniine) for therapeutic use.

COTARNINE for therapeutic use.

CROTALARIA spp. for therapeutic use.

CROTON TIGLIUM for therapeutic use.

CYNOGLOSSUM spp. for therapeutic use.

DICOPHANE (DDT) for therapeutic use.

DIETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of diethylene glycol.

DIETHYLHEXYL PHTHALATE for cosmetic use.

DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.

5,6-DIHYDROXYINDOLINE for cosmetic use in preparations containing more than 2 per cent of 5,6-dihydroxyindoline.

1,3-DIMETHYLAMYLAMINE (DMAA).

DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.

DULCIN for therapeutic use.

ETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of ethylene glycol.

ETHYLHEXANEDIOL for human use.

EUPATORIUM CANNABINUM (Hemp Agrimony) for therapeutic use.

FARFUGIUM JAPONICUM for therapeutic use.

FORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

CONTAINS FORMALDEHYDE.

HELIOTROPIUM spp. for therapeutic use.

JUNIPERUS SABINE [savin(e)] for therapeutic use.

LIGULARIA DENTATA for therapeutic use.

MELIA AZEDARACH including its extracts and derivatives.

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use.

METHYL METHACRYLATE for cosmetic use except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.

OXYPHENISATIN for therapeutic use.

PARAFORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

CONTAINS FORMALDEHYDE.

PETASITES spp. for therapeutic use.

PHENYLENEDIAMINES in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

POTASSIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

PTERIDIUM spp. for therapeutic use.

PULMONARIA spp. for therapeutic use.

SAFROLE for internal therapeutic use except in preparations containing 0.1 per cent or less of safrole.

SENECIO spp. for therapeutic use.

SILICONES for injection or implantation except when included in Schedule 4.

SODIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

SYMPHYTUM spp. (Comfrey) for therapeutic or cosmetic use except when included in Schedule 5.

TOLUENEDIAMINE in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

1,1,1-TRICHLOROETHANE in pressurised spray packs for therapeutic use.

TRICHODESMA AFRICANA for therapeutic use.

TRIPARANOL for therapeutic use.

TUSSILAGO FARFARA for therapeutic use.

PROHIBITION OF SALE, SUPPLY AND USE

ABRUS PRECATORIUS (Jequirity) seed or root for therapeutic use.

ACORUS CALAMUS (calamus) for human therapeutic use.

ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for domestic use:

(a) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5;

(b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 12.5; or

(b) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

ALLYLISOPROPYLACETYLUREA for therapeutic use.

AMINOPHENAZONE (amidopyrine) and its derivatives for human therapeutic use.

AMYGDALIN for therapeutic use.

ANCHUSA OFFICINALIS for therapeutic use.

ARISTOLOCHIA spp. for therapeutic use.

ARISTOLOCHIC ACID(S) for human therapeutic use.

ASARUM spp. containing aristolochic acid(s) for human therapeutic use.

AZADIRACHTA INDICA (neem) including its extracts and derivatives, in preparations for human internal use except ‘debitterised neem seed oil’.

BASIC ORANGE 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.

BITHIONOL for human therapeutic use.

BORAGO OFFICINALIS (Borage) for therapeutic use except the fixed oil derived from the seeds of Borago officinalis.

BRAGANTIA spp. containing aristolochic acid(s) for human therapeutic use.

BUCLOSAMIDE for therapeutic use.

BUNIODYL SODIUM for therapeutic use.

1,4-BUTANEDIOL (excluding its derivatives) in non-polymerised form in preparations for domestic use.

CACALIA spp. for therapeutic use.

CINCHOPHEN and its derivatives for therapeutic use.

CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when being used solely for experimental purposes in humans and where such use:

(a) is in accordance with:

(i) an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and

(ii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and

(iii) any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or

(b) is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.

COAL TAR for cosmetic use other than in therapeutic goods.

CONIUM MACULATUM (coniine) for therapeutic use.

COTARNINE for therapeutic use.

CROTALARIA spp. for therapeutic use.

CROTON TIGLIUM for therapeutic use.

CYNOGLOSSUM spp. for therapeutic use.

DICOPHANE (DDT) for therapeutic use.

DIETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of diethylene glycol.

DIETHYLHEXYL PHTHALATE for cosmetic use.

DIETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of diethylphthalate.

5,6-DIHYDROXYINDOLINE for cosmetic use in preparations containing more than 2 per cent of 5,6-dihydroxyindoline.

1,3-DIMETHYLAMYLAMINE (DMAA).

DIMETHYLPHTHALATE in sunscreens, personal insect repellents or body lotion preparations for human use except in preparations containing 0.5 per cent or less of dimethylphthalate.

DULCIN for therapeutic use.

ETHYLENE GLYCOL for use in toothpastes or mouthwashes except in preparations containing 0.25 per cent or less of ethylene glycol.

ETHYLHEXANEDIOL for human use.

EUPATORIUM CANNABINUM (Hemp Agrimony) for therapeutic use.

FARFUGIUM JAPONICUM for therapeutic use.

FORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

CONTAINS FORMALDEHYDE.

HELIOTROPIUM spp. for therapeutic use.

JUNIPERUS SABINE [savin(e)] for therapeutic use.

LIGULARIA DENTATA for therapeutic use.

MELIA AZEDARACH including its extracts and derivatives.

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use.

METHYL METHACRYLATE for cosmetic use except in preparations containing 1 per cent or less of methyl methacrylate as residual monomer in a polymer.

OXYPHENISATIN for therapeutic use.

PARAFORMALDEHYDE (excluding its derivatives):

(a) in oral hygiene preparations containing more than 0.1 per cent of free formaldehyde;

(b) in aerosol sprays for cosmetic use containing 0.005 per cent or more of free formaldehyde;

CONTAINS FORMALDEHYDE.

PETASITES spp. for therapeutic use.

PHENYLENEDIAMINES in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

POTASSIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

PTERIDIUM spp. for therapeutic use.

PULMONARIA spp. for therapeutic use.

SAFROLE for internal therapeutic use except in preparations containing 0.1 per cent or less of safrole.

SENECIO spp. for therapeutic use.

SILICONES for injection or implantation except when included in Schedule 4.

SODIUM HYDROXIDE (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

SYMPHYTUM spp. (Comfrey) for therapeutic or cosmetic use except when included in Schedule 5.

TOLUENEDIAMINE in preparations for skin colouration and dyeing of eyelashes or eyebrows except when included in Schedule 6.

1,1,1-TRICHLOROETHANE in pressurised spray packs for therapeutic use.

TRICHODESMA AFRICANA for therapeutic use.

TRIPARANOL for therapeutic use.

TUSSILAGO FARFARA for therapeutic use.

APPENDIX D

ADDITIONAL CONTROLS ON POSSESSION OR SUP

ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY OF POISONS INCLUDED IN SCHEDULE 4 OR 8

ADDITIONAL CONTROLS ON POSSESSION OR SUPPLY

OF POISONS INCLUDED IN SCHEDULE 4 OR 8

(The following controls apply for the substances shown only when included in Schedule 4 or Schedule 8.)

Poisons available only from or on the prescription or order of an authorised medical practitioner.

CLOMIPHENE for human use.

CLOZAPINE for human use.

CORIFOLLITROPIN ALFA (recombinant follicle stimulant) for human use.

CYCLOFENIL for human use.

DINOPROST for human use.

DINOPROSTONE for human use.

FOLLITROPIN ALPHA (recombinant human follicle-stimulating hormone) for human use.

FOLLITROPIN BETA (recombinant human follicle-stimulating hormone) for human use.

LUTEINISING HORMONE for human use.

NABIXIMOLS.

TERIPARATIDE for human use.

UROFOLLITROPIN (human follicle-stimulating hormone) for human use.

Poisons available only from or on the prescription or order of a specialist physician or a dermatologist and for which the prescriber must, where the patient is a woman of child-bearing age:

(1) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and

(2) if the drug is -

(a) acitretin or etretinate, advise the patient to avoid becoming pregnant during or for a period of 24 months after completion of treatment; or

(b) bexarotene, isotretinoin or thalidomide, advise the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment.

ACITRETIN for human use.

BEXAROTENE for human use.

ETRETINATE for human use.

ISOTRETINOIN for human oral use.

THALIDOMIDE for human use.

Poisons available only from or on the prescription or order of a medical practitioner authorised or approved by the Secretary of the Commonwealth Department of Health and Ageing under section 19 of the Therapeutic Goods Act 1989.

DRONABINOL (delta-9-tetrahydrocannabinol).

Poisons available only from or on the order of a specialist physician and for which the prescriber must, where the patient is a woman of child bearing age:

(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and

(b) advise the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment.

LENALIDOMIDE.

TRETINOIN for human oral use.

Poisons for which possession without authority is illegal (e.g. possession other than in accordance with a legal prescription).

ANABOLIC STEROIDAL AGENTS, including those separately specified in Schedule 4.

ANDROGENIC STEROIDAL AGENTS, including those separately specified in Schedule 4.

BENZODIAZEPINE DERIVATIVES, including those separately specified in Schedule 4 and Schedule 8.

DARBEPOETIN.

DEXTROPROPOXYPHENE.

EPHEDRINE.

EPOETINS.

ERYTHROPOIETIN.

ERYTHROPOIETINS except when separately specified in this Appendix.

FOLLISTATIN.

GLUTETHIMIDE.

INSULIN-LIKE GROWTH FACTORS.

PHENTERMINE.

SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM), including those separately specified in Schedule 4.

SOMATROPIN (human growth hormone).

Poisons available only from or on the prescription or order of a specialist physician and for which the prescriber must, where the patient is a woman of child-bearing age:

(a) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and

(b) advise the patient to avoid becoming pregnant during and for a period of 3 months after completion of treatment.

AMBRISENTAN for human use.

BOSENTAN for human use.

SITAXENTAN for human use.

Poisons available only from or on the prescription or order of a dermatologist.

ALEFACEPT for human use.

APPENDIX E

FIRST AID INSTRUCTIONS FOR POISONS

(other than agricultural and veterinary chemicals (including pesticides) registered by the

Australian Pesticides and Veterinary Medicines Authority and medicines for human use

when compliant with the requirements of the Required Advisory Statements for Medicine Labels)

INTRODUCTION

Directions for First Aid Attention

Under poisons legislation, scheduled substances and their preparations are required to be labelled with appropriate directions for first aid attention in case of poisoning. It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the first aid instructions included on the label of a poison are appropriate for a specific product. The following code has been prepared as a guide for health authorities and manufacturers in drafting suitable first aid directions for this purpose. Standard statements specified in this Appendix may be varied provided that the intent is not changed.

The directions listed for any particular substance may require modification to take into account combination of that substance with other substances, both toxic and non toxic, in a formulation, as well as the physical form and presentation of the product. Any such modification should be concise and readily understood.

These First Aid Instructions include action to be taken in case of eye contamination from substances recognised as causing direct poisoning via the eye, causing severe eye damage or requiring prolonged flushing to free the absorbed substance from the eye tissue. However, it is recognised that many other substances or preparations will require a statement of varying nature depending on the detailed formulation. While the necessity to flush the eyes in case of accident will be so self-evident as not to justify label space in many instances, a statement such as “If in eyes rinse well with water” may be appropriate.

Modified First Aid Instruction on Primary Pack

Where a primary pack contains two or more immediate containers of poisons each requiring different first aid instructions:

(a) each immediate container must be labelled with first aid instructions appropriate for its contents; and

(b) the primary pack must be labelled with the statement:

FIRST AID: See inner packs.

Exempt Preparations

This Appendix applies only to scheduled poisons. The directions are for substances and their preparations at the concentrations at which the Schedules apply. If it is thought desirable to show first aid instructions for a substance exempted from the schedules, it is the responsibility of the manufacturer to ensure they are appropriate.

Poisons Information Centre Telephone Numbers

Companies should use the Poisons Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766) appropriate to the country(ies) of sale for the product.

Companies wishing to use a poisons information centre telephone number other than the national telephone numbers for Australia and New Zealand must meet the following criteria:

the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and
calls must be logged and submitted for incorporation into the official collection of poisoning data.

APPENDIX F

WARNING STATEMENTS AND GENERAL SAFETY DI

WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS

(other than agricultural and veterinary chemicals (including pesticides) registered by the

Australian Pesticides and Veterinary Medicines Authority and medicines for human use

when compliant with the requirements of the Required Advisory Statements for Medicine Labels)

INTRODUCTION

Warning Statements and Safety Directions

It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the purchaser or user of a product is given sufficient information to be able to use it correctly and safely.

Under poisons legislation, scheduled substances, which may be harmful to the user, must be labelled with appropriate warning statements and/or safety directions. The selection of warning statements and safety directions will depend on the formulation of the product, and the use for which it is sold or supplied. The following code has been prepared as a guide for this purpose.

The wording of warning statements and safety directions specified in this Appendix may be varied provided that the intent is not changed. Additional statements also may be added to ensure that the user of a product is sufficiently advised of its harmful nature and how to avoid any deleterious effects.

Poisons Information Centre Telephone Numbers

Companies should use the Poisons Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766) appropriate to the country(ies) of sale for the product.

Companies wishing to use a poisons information centre telephone number other than the national telephone numbers for Australia and New Zealand in warning statement No. 99 in Part 1 of this Appendix must meet the following criteria:

the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and
calls must be logged and submitted for incorporation into the official collection of poisoning data.

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 ADVER

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.

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.

A person must not manufacture, sell, supply or use a Third Schedule paint.
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).
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 OFSC

CONDITIONS FOR AVAILABILITY AND USE OFSCHEDULE 7 POISONS

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.

Not to be available except to authorised or licensed persons.
Not to be used in printing inks.
Not to be used except by or in accordance with the directions of accredited government vermin control officers.
Not to be used in industries which handle, process or store foods, animal feeds or packaging materials.

APPENDIX K

DRUGS REQUIRED TO BE LABELLED

WITH A SEDATION WARNING

(see Part 2, Labels and Containers, subparagraph 14(2))

Alprazolam

Amisulpride

Amitriptyline

Amylobarbitone

Aripiprazole

ASENAPINE

Azatadine

Baclofen

Benztropine

Bromazepam

Brompheniramine

Buclizine

Buprenorphine

Butobarbitone

Cetirizine

Chloral hydrate

Chlordiazepoxide

Chlormethiazole

Chlorpheniramine

Chlorpromazine

Clemastine

Clomipramine

Clonazepam

Clonidine

Clorazepate

Clozapine

Codeine except when included in Schedule 2 or 3.

Cyclizine

Cyclobarbitone

Cycloserine

Cyproheptadine

Cysteamine

Dantrolene

Desipramine

Dexchlorpheniramine

Dextromoramide

Dextropropoxyphene

Diazepam

Difenoxin

Dihydrocodeine

Dimenhydrinate

Dimethindene

Diphenhydramine

Diphenoxylate

Diphenylpyraline

Dothiepin

Doxepin

Doxylamine

Dronabinol (delta-9-tetrahydrocannabinol)

Droperidol

Duloxetine

Ethylmorphine

Fenfluramine

Flunitrazepam

Flupenthixol

Fluphenazine

Flurazepam

Gabapentin

Gemcitabine

Glutethimide

Haloperidol

Hydrocodone

Hydromorphone

Hydroxyzine

Imipramine

Lamotrigine

Levetiracetam

Levocabastine

Lorazepam

LURASIDONE.

Mazindol

Mebhydrolin

Meclozine

Medazepam

Meprobamate

Mepyramine

Methadone

Methdilazine

Methocarbamol

Methylphenobarbitone

Mianserin

Mirtazapine

Morphine

Nabiximols

Nalbuphine

Nitrazepam

Normethadone

Nortriptyline

Olanzapine

Opium in any form except the alkaloids noscapine and papaverine.

Oxazepam

Oxycodone

Paliperidone

Papaveretum

Pentazocine

Pentobarbitone

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

WITH A SEDATION WARNING

(see Part 2, Labels and Containers, subparagraph 14(2))

Alprazolam

Amisulpride

Amitriptyline

Amylobarbitone

Aripiprazole

ASENAPINE

Azatadine

Baclofen

Benztropine

Bromazepam

Brompheniramine

Buclizine

Buprenorphine

Butobarbitone

Cetirizine

Chloral hydrate

Chlordiazepoxide

Chlormethiazole

Chlorpheniramine

Chlorpromazine

Clemastine

Clomipramine

Clonazepam

Clonidine

Clorazepate

Clozapine

Codeine except when included in Schedule 2 or 3.

Cyclizine

Cyclobarbitone

Cycloserine

Cyproheptadine

Cysteamine

Dantrolene

Desipramine

Dexchlorpheniramine

Dextromoramide

Dextropropoxyphene

Diazepam

Difenoxin

Dihydrocodeine

Dimenhydrinate

Dimethindene

Diphenhydramine

Diphenoxylate

Diphenylpyraline

Dothiepin

Doxepin

Doxylamine

Dronabinol (delta-9-tetrahydrocannabinol)

Droperidol

Duloxetine

Ethylmorphine

Fenfluramine

Flunitrazepam

Flupenthixol

Fluphenazine

Flurazepam

Gabapentin

Gemcitabine

Glutethimide

Haloperidol

Hydrocodone

Hydromorphone

Hydroxyzine

Imipramine

Lamotrigine

Levetiracetam

Levocabastine

Lorazepam

LURASIDONE.

Mazindol

Mebhydrolin

Meclozine

Medazepam

Meprobamate

Mepyramine

Methadone

Methdilazine

Methocarbamol

Methylphenobarbitone

Mianserin

Mirtazapine

Morphine

Nabiximols

Nalbuphine

Nitrazepam

Normethadone

Nortriptyline

Olanzapine

Opium in any form except the alkaloids noscapine and papaverine.

Oxazepam

Oxycodone

Paliperidone

Papaveretum

Pentazocine

Pentobarbitone

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

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);

(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

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);

(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

INDEX

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

INTRODUCTION INTRODUCTION

INTRODUCTION

The SUSMP serves two key purposes.