Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023

Part 1—Preliminary and interpretation

1  Name

2  Commencement

3  Authority

4  Repeal and transitional provisions

5  Reader’s guide and Index

6  Definitions

7  References to substances

8  References to concentration, strength or quantity of substances

9  References to boiling or distillation temperatures

10  References to standards

Part 2—Controls on substances

Division 1—Preliminary

11  Application of Part 2

12  Preparations containing poisons included in different schedules

Division 2—Labels

Subdivision A—General

13  General requirements

14  Immediate wrapper

Subdivision B—Primary packs and immediate containers

15  Primary packs and immediate containers

16  Signal words

17  Cautionary statement—possession without authority illegal

18  Cautionary statement—keep out of reach of children

19  Cautionary statement—fire and explosion hazard

20  Cautionary statement—burns skin and throat

21  Cautionary statements for aqueous solution of paraquat

22  Cautionary statement—read safety directions

23  Cautionary statement—flammable

24  Cautionary statement—for animal treatment only

25  Cautionary statement—do not swallow

26  Approved name and quantity, proportion or strength

27  Statement—an anticholinesterase compound

28  Directions for use

29  Safety directions

30  Warning statements

31  First aid

32  Name and address of manufacturer or distributor

33  Warning statements and sedation warnings for certain medicines for human use

Subdivision C—Statements of quantity, proportion or strength

34  Statements of quantity, proportion or strength

Subdivision D—Exemptions from labelling requirements

35  Selected containers and measure packs

36  Ampoules, pre‑filled syringes and injection vials

37  Transport containers and wrappings

38  Dispensary, industrial, laboratory and manufacturing poisons

39  Exemptions from label requirements in certain circumstances

40  Dispensed medicines

41  Gas cylinders

42  Paints

43  Camphor and naphthalene

Subdivision E—Prohibitions

44  Prohibitions

Division 3—Containers

45  General requirements

46  Containers for poisons other than poisons included in Schedule 5

47  Containers for poisons included in Schedule 5

48  Approved containers

49  Child‑resistant closures

50  Poisons included in Schedule 8

51  Exemptions

52  Camphor and naphthalene

53  Prohibitions—use of containers for poisons

Division 4—Storage

54  General storage requirements

Division 5—Disposal

55  General disposal requirements

Division 6—Record keeping

56  General record‑keeping requirements

Division 7—Advertising

57  General advertising requirements

Division 8—Supply, prescribing, possession or use

58  Poisons included in Schedule 2

59  Poisons included in Schedule 3

60  Poisons included in Schedule 4

61  Poisons included in Schedules 5 and 6

62  Poisons included in Schedule 7

63  Poisons included in Schedule 10

64  Poisons included in Schedule 4 or 8 and Appendix D

65  Hawking

Division 9—Paints and tinters

66  General requirements

67  Definition of first group paint

68  Definition of second group paint

Schedule 1—Blank

Schedule 2—Pharmacy medicines

Schedule 3—Pharmacist only medicines

Schedule 4—Prescription only medicines and prescription animal remedies

Schedule 5—Caution

Schedule 6—Poisons

Schedule 7—Dangerous poisons

Schedule 8—Controlled drugs

Schedule 9—Prohibited substances

Schedule 10—Substances of such danger to health as to warrant prohibition of supply and use

Appendix A—General exemptions

1  Exempt preparations and products

Appendix B—Substances considered not to require control by scheduling

1  Reasons for including substances in the table in clause 3

2  Areas of use in relation to substances included in the table in clause 3

3  Substances exempt in certain uses

Appendix C—Blank

Appendix D—Additional controls on possession or supply of poisons included in Schedule 4 or 8

1  Poisons available for human use only from or on the prescription or order of an authorised medical practitioner

2  Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist

3  Poisons available only from or on the prescription or order of a medical practitioner approved or authorised under section 19 of the Act

4  Poisons available only from or on the order of a specialist physician

5  Poisons for which possession without authority is illegal

6  Poisons available for human use only from or on the prescription or order of a specialist physician

7  Poisons available for human use only from or on the prescription or order of a dermatologist

8  Poison available for initial treatment of a patient only if authorised by certain health practitioners

9  Poisons which must be stored in a locked container to prevent unauthorised access

Appendix E—First aid instructions for poisons

1  Standard statements for first aid instructions

2  Poisons information centre contact information in statements

3  First aid instructions for poisons

Appendix F—Warning statements and general safety directions for poisons

1  Warning statements

2  Safety directions—general

3  Poisons information centre contact information in statements

4  Poisons that must be labelled with warning statements and safety directions

Appendix G—Dilute preparations

1  Substances exempt at or below certain concentrations

Appendix H—Schedule 3 medicines permitted to be advertised

1  Schedule 3 medicines permitted to be advertised

Appendix I—Blank

Appendix J—Conditions for availability and use of certain poisons included in Schedule 7

1  Conditions for supply of certain poisons included in Schedule 7

Appendix K—Human medicines required to be labelled with a sedation warning

1  Human medicines required to be labelled with a sedation warning

Appendix L—Requirements for dispensing labels for medicines

1  General

2  Additional warning statements for certain human medicines

Appendix M—Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist

Index 

Reader’s guide

Introduction

This instrument is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act), and is a compilation of decisions made under section 52D of the Act. This instrument should be read in conjunction with the Scheduling Policy Framework (the SPF) of the Australian Health Ministers’ Advisory Council. Further information on the scheduling amendments and the SPF can be viewed on the Therapeutic Goods Administration’s website (www.tga.gov.au). Refer to section 6 for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).

This instrument serves 2 key purposes.

Firstly, this instrument contains the decisions of the Secretary of the Department of Health and Aged Care or the Secretary’s delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.

Secondly, this instrument includes provisions for labelling, containers, storage, disposal, record‑keeping, supply and possession of poisons in general which are intended to be adopted for use in each jurisdiction of Australia. Other government agencies may also impose controls on certain products.

The requirements for labelling and containers in this instrument 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 this instrument as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time. Note, however that this exemption does not extend to controls on supply of these poisons.

This instrument is presented with a view to promoting uniform:

• scheduling of poisons throughout Australia; and
• signal headings on labels for poisons throughout Australia; and
• labelling and packaging requirements for poisons throughout Australia; and
• additional controls on the availability and use of poisons in Australia.

The various Commonwealth Acts, legislative instruments and other documents, which integrate with this instrument include the following:

• the Act;
• the Agricultural and Veterinary Chemicals Code Act 1994;
• the Agricultural and Veterinary Chemicals Code Regulations 1995;
• the Therapeutic Goods Order No. 91 ‑ Standard for labels of prescription and related medicines;
• the Therapeutic Goods Order No. 92 ‑ Standard for labels of non‑prescription medicines;
• the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017;
• the Therapeutic Goods Order No. 95 ‑ Child‑resistant packaging requirements for medicines 2017 (TGO 95);
• the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021;
• the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 – Schedule 1 Required Advisory Statements for Medicine Labels No. 6 (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.

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 instrument lists poisons in 10 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 instrument, the method by which it is implemented in the States and Territories may vary.

Schedule 10 (previously Appendix C) contains a list of substances or preparations, the supply or use of which should be prohibited because of their known dangerous properties.

Substances in products which have been considered for scheduling, but have been exempted from this instrument, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).

Reading the schedules

Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.

Firstly, poisons are scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned below. 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 2 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 instrument 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 section 7).

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, and 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 instrument to determine the scheduling status of a poison, it may be necessary to search each relevant Schedule as well as Appendices A, B 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 toxicological or pharmacological activity | “hydrocarbons, liquid” to find kerosene | | 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; or
• indicate that it is has been approved or is efficacious for any use that may be specified in a Schedule; or
• negate any obligation for registration of therapeutic goods, or agricultural or veterinary chemical product containing that poison.

Appendices

Some substances in certain circumstances are also subject to exemptions or additional restrictions as described in the Appendices of this instrument. The table below summarises the purpose of each of the Appendices and the controls imposed on substances included in them.

Appendix A (General exemptions)

Appendix A lists preparations and products that are exempted from this instrument.

Appendix B (Substances considered not to require control by scheduling)

Substances for which the available information suggests that inclusion in the Poisons Schedules is not necessary, or not the most appropriate means of controlling the risk to public health, have been considered at various times.

Inclusion in Appendix B indicates that a decision has been taken not to include substances anywhere in the Schedules, either for a specific purpose, or generally. It is an inclusive, but not an exhaustive, list (that is, there may be substances not included in the Schedules, and not included in Appendix B, which may be hazardous or non‑hazardous, but have not been considered in relation to the need for scheduling).

Substances may be included in Appendix B because they have intrinsically low toxicity, or where other factors suggest that the potential public health risk would be minimal. Factors which are considered when determining an Appendix B entry include:

• the toxicology profile was adequately characterised and not consistent with inclusion in any of the Schedules;
• the use, purpose or product presentation minimised any hazard to the public such as to not require scheduling; or
• the public access was limited such that scheduling was inappropriate or unnecessary.

The list of substances included in Appendix B was developed from scheduling files and historical records. For transparency, where the reason for entry and/or purpose or use for the substance was apparent in the consideration, this has been included in the columns “Reason for Entry” and “Area of Use”.

Inclusion in Appendix B will not prevent reconsideration of the scheduling of a substance where adverse information becomes available about the Appendix B entry for that substance.

Applications are considered for scheduling. Applications for inclusion in Appendix B will not be accepted.

Appendix C (blank)

Appendix C is intentionally blank.

Appendix D (Additional controls on possession or supply of poisons included in Schedule 4 or 8)

Appendix D lists poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply.

Appendix E (First aid instructions for poisons)

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. Standard statements have been prepared as a guide for health authorities and manufacturers in drafting suitable first aid directions for this purpose. Standard statements specified in Appendix E 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.

The 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.

Appendix F (Warning statements and general safety directions for poisons)

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. Warning statements and safety directions have been prepared as a guide for this purpose.

The wording of warning statements and safety directions specified in Appendix F 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.

Appendix G (Dilute preparations)

Appendix G lists concentration cut‑offs for specified substances, below which the requirements of this instrument do not apply.

Appendix H (Schedule 3 medicines permitted to be advertised)

Appendix H lists medicines included in Schedule 3 that are permitted to be advertised to the public.

Appendix I (blank)

Appendix I is intentionally blank.

Appendix J (Conditions for availability and use of certain poisons included in Schedule 7)

All poisons included in Appendix J are not to be available except to authorised or licensed persons.

The use of a poison may be restricted for a particular purpose. Controls recommended for the Schedule 7 poisons included in Appendix J may be implemented through poisons controls or other State or Territory legislation.

Appendix K (Human medicines required to be labelled with a sedation warning)

Medicines for human use that contain a poison included in Appendix K are required to be labelled with a warning regarding their sedation potential.

Appendix L (Requirements for dispensing labels for medicines)

Appendix L sets out the requirements for labels attached to medicines at the time of dispensing.

Appendix M (blank)

Appendix M is intentionally blank and is reserved for future use.

Poisons Information Centre telephone numbers for first aid instructions, warning statements and general safety directions for poisons

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:

1. the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and

2. calls must be logged and submitted for incorporation into the official collection of poisoning data.

Part 1—Preliminary and interpretation

1  Name

 (1) This instrument is the Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023.

 (2) This instrument may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons No. 40.

Note: This instrument is the current Poisons Standard for the purposes of the Act until a document is prepared in substitution for it (see sections 52A and 52D of the Act).

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

• Commencement information
• Column 1 Column 2 Column 3
• Provisions Commencement Date/Details
• 1. The whole of this instrument 1 June 2023. 1 June 2023

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989.

4  Repeal and transitional provisions

Repeal

 (1) The Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023 is repealed.

Saving—things done under the repealed instrument

 (2) If:

 (a) a thing was done for a particular purpose under the Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023 as in force immediately before that instrument was repealed; and

 (b) the thing could be done for that purpose under this instrument;

the thing has effect for the purposes of this instrument as if it had been done for that purpose under this instrument.

 (3) Without limiting subsection (2), a reference in that subsection to a thing being done includes a reference to an approval, authorisation, certificate, exemption, requirement or other instrument being given, made, granted or issued.

5  Reader’s guide and Index

 (1) The Reader’s guide is not part of this instrument.

 (2) The Index is not part of this instrument.

6  Definitions

Note 1: The following expressions used in this instrument are defined in the Act:

(a) current Poisons Standard;

(b) poison;

(c) Register;

(d) Secretary;

(e) supply;

(f) therapeutic goods.

Note 2: The definition of poison in the Act is as follows:

 poison means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

agricultural chemical means:

 (a) a substance that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:

 (i) 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; or

 (ii) destroying a plant; or

 (iii) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or

 (iv) modifying an effect of another agricultural chemical; or

 (v) attracting a pest for the purpose of destroying it; or

 (b) an 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 a veterinary chemical.

agricultural chemical product has the same meaning as in the Agricultural and Veterinary Chemicals Code set out in the Schedule to 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: each of the following is an appropriate authority:

 (a) each person who is the head of the body (however described) in a State or Territory that is responsible for the administration of matters relating to health in that State or Territory;

 (b) the Deputy Secretary of the Department with responsibility for the part of the Department known as the Therapeutic Goods Administration, or their delegate;

 (c) the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, or their delegate.

approved name means:

 (a) for a poison that is for human therapeutic use—the name for the poison in the Australian Approved Names List within the meaning of the Therapeutic Goods Regulations 1990; or

 (b) for a poison that is for animal or agricultural use—the name approved for use by the Australian Pesticides and Veterinary Medicines Authority under the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994; or

 (c) for any other poison—the name for the poison mentioned in the first‑occurring of the following paragraphs that applies to the poison:

 (i) the name used for the poison in this instrument;

 (ii) the name recommended by Standards Australia as the common name for the poison;

 (iii) the English name given to the poison by the International Organization for Standardization;

 (iv) the name given to the poison by the British Standards Institution;

 (v) the English name given to the poison by the European Committee for Standardization (CEN);

 (vi) the international non‑proprietary name recommended for the poison by the World Health Organization;

 (vii) 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;

 (viii) the accepted scientific name or the name descriptive of the true nature and origin of the poison.

Australian Dangerous Goods Code means the Australian Code for the Transport of Dangerous Goods by Road & Rail, published by the National Transport Commission, as existing from time to time.

Note: The Australian Dangerous Goods Code could in 2022 be viewed on the Commission’s website (www.ntc.gov.au).

authorised prescriber means any of the following:

 (a) a dental practitioner;

 (b) a medical practitioner;

 (c) a veterinarian;

 (d) a person for whom an authorisation, given for the purposes of this paragraph by an appropriate authority, is in effect.

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 Australian Standard AS 1928‑2007, Child‑resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD); or

 (b) a closure that complies with the requirements for child‑resistant closures specified in Therapeutic Goods Order No. 95 ‑ Child‑resistant packaging requirements for medicines 2017 (TGO 95); or

 (c) a closure that is taken to comply with the requirements mentioned in paragraph (b) under Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021; or

 (d) in the case of a can fitted with a press‑on lid, a lid of the design known as “double tight” or “triple tight”.

Note: See also the definition of non‑access packaging.

child‑resistant packaging means packaging that:

 (a) complies with the requirements of Australian Standard AS 1928‑2007, Child resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD); or

 (b) is reclosable and complies with the requirements of at least one of the following:

 (i) the International Organization for Standardization Standard ISO 8317:2015, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

 (ii) the British Standards Institution Standard BS EN ISO 8317:2004, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

 (iii) the Canadian Standards Association Standard CSA Z76.1‑06, Reclosable Child‑Resistant Packages;

 (iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, Poison prevention packaging standards and Section 1700.20, Testing procedure for special packaging, as in force from time to time; or

 (c) a closure that complies with the requirements for child‑resistant packaging specified in Therapeutic Goods Order No. 95 ‑ Child‑resistant packaging requirements for medicines 2017 (TGO 95); or

 (d) a closure that is taken to comply with the requirements mentioned in paragraph (c) under Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021; or

 (e) is in the form of blister or strip packaging:

 (i) in which a unit of use is individually protected until the time of release; and

 (ii) that complies with section 3 (Requirements for non‑reclosable packages) of Australian Standard AS 1928‑2001, Child‑resistant packages.

Note: See also the definition of 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 substance or preparation intended for placement in contact with any external part of the human body, including:

 (a) the mucous membranes of the oral cavity; and

 (b) the teeth;

with a view to:

 (c) altering the odours of the body; or

 (d) changing its appearance; or

 (e) cleansing it; or

 (f) maintaining it in good condition; or

 (g) perfuming it; or

 (h) protecting it.

debitterised neem seed oil means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.

dental practitioner means a person who is registered, in a State or internal Territory, as a dental practitioner (other than a dental therapist, dental hygienist, dental prosthetist or oral health therapist).

dermal use means application to the skin primarily for localised effect.

designated solvent means the following:

 (a) acetone;

 (b) dimethylformamide;

 (c) N‑(N‑dodecyl)‑2‑pyrrolidone;

 (d) hydrocarbons, liquid;

 (e) methanol when included in Schedule 5;

 (f) methyl ethyl ketone;

 (g) methyl isoamyl ketone;

 (h) methyl isobutyl ketone;

 (i) N‑methyl‑2‑pyrrolidone;

 (j) N‑(N‑octyl)‑2‑pyrrolidone;

 (k) phenyl methyl ketone;

 (l) styrene;

 (m) tetrachloroethylene;

 (n) 1,1,1‑trichloroethane.

dispensing label, for a substance for therapeutic use, means the label attached to the immediate container of the substance at the time of dispensing.

Note: See section 40 and Appendix L.

distributor means a person who imports or supplies a poison.

divided preparation means a preparation manufactured and packed as discrete pre‑measured dosage units prior to 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:

 (a) products obtained from natural raw materials by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation; or

 (b) oils of equivalent composition to products mentioned in paragraph (a) that are derived through synthetic means; or

 (c) prepared mixtures of oils of equivalent composition to products mentioned in paragraph (a) that comprise 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 group paint: see section 67.

free formaldehyde includes all hydrated and non‑hydrated formaldehyde present in aqueous solution, including methylene glycol and formaldehyde released from formaldehyde donors.

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.

hand sanitiser preparation means an antimicrobial skin care product that:

 (a) consists of, contains or generates one or more antimicrobial active substances; and

 (b) is represented in any way to be, or is likely to be taken to be (whether because of the way in which it is presented or for any other reason):

 (i) for use on hands when soap and water are not available; and

 (ii) applied to the hands without rinsing off; and

 (iii) intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any microbes on the skin.

hawking means to supply (including peddle or distribute or cause to be distributed) in a public place.

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:

 (a) means a written statement on a container of a poison; and

 (b) in relation to therapeutic goods, includes a display of printed information about the product:

 (i) on, or attached to, the goods; or

 (ii) on, or attached to, a container or primary pack in which the goods are supplied; or

 (iii) supplied with such a container or pack.

main label, for a container of poison, means:

 (a) the part of the label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and

 (b) if there are 2 or more labels:

 (i) the label or the part of the label where the product name is more or most conspicuously shown; or

 (ii) if the product name is equally more or most conspicuously displayed on more than one of those labels—each of the labels on which the product name is equally more or most conspicuously displayed.

manufacturer of a poison means a person who manufactures, produces, or packs a poison.

marker dyes or pigments means any product that is added to a liquid used in agricultural or veterinary chemicals to identify or distinguish treated from untreated objects, land or organisms by temporarily imparting colour on the relevant object, land or organism through, for example, spot‑ or boom‑spraying.

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.

medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.

medicine means any poison for therapeutic use.

midwife means a person who is registered, in a State or internal Territory, as a midwife.

non‑access packaging, for a product that is not intended for human therapeutic use, means packaging that complies with the requirements of AS 4710‑2001, Packages for chemicals not intended for access or contact with their contents by humans.

Note: See also the definitions of 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, Paints and related materials – Methods of test – Non‑volatile content by mass.

nurse means a person who is registered, in a State or internal Territory, as a nurse.

oromucosal use means administration to the oral mucosa, specifically the oral cavity and/or the pharynx.

paint 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.

pharmacist means a person who is registered, in a State or internal Territory, as a pharmacist.

primary pack, in relation to a poison, means the pack in which the poison and its immediate container or immediate wrapper or measure pack are presented for supply.

product sample means a packed poison supplied directly to a consumer:

 (a) free of charge or for a nominal charge; and

 (b) as a mechanism to promote the supply of the product; and

 (c) in the form of:

 (i) a small pack produced specifically for the purposes of promotion; or

 (ii) a normal commercial pack that in other circumstances could be purchased by the consumer.

public place means any place where members of the public are lawfully entitled, invited or permitted to be present in their capacity as members of the public.

Note: Examples of a public place include a street, road, footway, court, alley or thoroughfare that the public may use in any residential premises or to get from door to door, place to place or house to house.

required advisory statements for medicine labels means the Therapeutic Goods (Medicines Advisory Statements) Specification 2021.

restricted flow insert means a restriction:

 (a) that is fitted or moulded in the neck of a container; and

 (b) that cannot readily be removed from the container by manual force; and

 (c) that limits the delivery of the contents of the container to drops each of which is not more than 200 microlitres.

second group paint: see section 68.

selected container means:

 (a) an injection vial having a nominal capacity of 10 ml or less; or

 (b) a single use syringe; or

 (c) any other container for substances for therapeutic use having a nominal capacity of 10 ml or less.

solid includes powder.

substance has the same meaning as in Part 6‑3 of the Act.

Note 1: In general terms, that definition covers an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals.

Note 2: See also section 7.

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; or

 (b) influencing, inhibiting or modifying a physiological process in human beings or animals; or

 (c) testing the susceptibility of human beings or animals to a disease or ailment; or

 (d) influencing, controlling or preventing conception in human beings or animals; or

 (e) testing for pregnancy in human beings or animals; or

 (f) the replacement or modification of parts of the anatomy in human beings or animals.

tinter means any pigment or admixture of pigment with other substances, in powder, semi‑solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.

topical use means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.

toy means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of 14 years.

transdermal use means application to the skin primarily for systemic effect.

veterinarian means a person who is registered under the law of a State or Territory as a veterinarian, a veterinary practitioner or a veterinary surgeon.

veterinary chemical means:

 (a) 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:

 (i) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or

 (ii) curing or alleviating an injury suffered by the animal; or

 (iii) modifying the physiology of the animal:

 (A) so as to alter its natural development, productivity, quality or reproductive capacity; or

 (B) so as to make it more manageable; or

 (iv) modifying the effect of another veterinary chemical; or

 (b) any vitamin, mineral substance, or additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (a); or

 (c) any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be a veterinary chemical product;

but does not include an agricultural chemical.

veterinary chemical product has the same meaning as in the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

7  References to substances

  In this instrument, unless the contrary intention appears, a reference to a substance includes the following:

 (a) that substance prepared from natural sources or artificially;

 (b) if 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;

 (c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative;

 (d) every alkaloid of the substance and every salt of such an alkaloid;

 (e) every stereoisomer of the substance and every salt of such a stereoisomer;

 (f) every recombinant form of the substance;

 (g) a preparation or admixture containing any proportion of the substance.

Note: Part 2 (controls on substances) does not apply in relation to certain substances (see section 11).

8  References to concentration, strength or quantity of substances

  In this instrument, for a reference to a concentration, strength or quantity 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; and

 (b) the expression “1%” means:

 (i) in the case of a liquid preparation, 1 g of the substance per 100 mL of the preparation; or

 (ii) in the case of a solid, semi‑solid or pressurised spray aerosol preparation, 1 g of the substance per 100 g of the preparation; and

 (iii) any expression of greater or lesser percentages shall have a corresponding meaning; and

 (c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.

9  References to boiling or distillation temperatures

  In this instrument, a reference to a boiling or distillation temperature means that temperature at an atmospheric pressure of 101.325 kPa (760 mm of mercury).

10  References to standards

  A reference in this instrument to an Australian standard, an international standard or a standard of a foreign country is a reference to that standard as it exists from time to time.

Part 2—Controls on substances

Division 1—Preliminary

11  Application of Part 2

  This Part applies to a substance or preparation included in a schedule to this instrument, other than the following:

 (a) a preparation or product included in the table in clause 1 of Appendix A;

 (b) a substance included in the table in clause 3 of Appendix B when used in an area, sub‑area or sub‑sub‑area of use specified in the table in relation to that substance;

 (c) a substance included in the table in clause 1 of Appendix G at a concentration not exceeding the concentration specified in that table in relation to that substance;

 (d) 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;

 (e) 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 Agricultural and Veterinary Chemicals Code (Agricultural Active Constituents) Standards 2022, published by the Australian Pesticides and Veterinary Medicines Authority, as existing from time to time.

Note: For paragraph (e), the Agricultural and Veterinary Chemicals Code (Agricultural Active Constituents) Standards 2022 is a legislative instrument that could in 2023 be accessed at www.legislation.gov.au.

12  Preparations containing poisons included in different schedules

 (1) If a preparation contains 2 or more poisons, the provisions relating to each of the schedules in which those poisons are included apply to the preparation.

 (2) However, if 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 relating to the more restrictive schedule applies, unless a contrary intention is indicated in the schedules or relevant State or Territory legislation.

 (3) The Schedules listed in order of greatest to least restrictiveness are 9, 10, 8, 4, 7, 3, 2, 6, 5.

Note: Schedule 1 is not currently in use.

Division 2—Labels

Subdivision A—General

13  General requirements

 (1) A poison must not be supplied unless it is labelled in accordance with this Division.

 (2) Any word, expression or statement required by this instrument to be written on a label or container must be written:

 (a) on the outside face of the label or container; and

 (b) in English; and

 (c) in durable characters; and

 (d) in a colour or colours to provide a distinct contrast to the background colour; and

 (e) in letters at least 1.5 mm in height.

 (3) Paragraph (2)(e) does not apply to a word, expression or statement on a container which has a capacity of 20 ml or less, or on the label of such a container if:

 (a) an appropriate authority approves the use of smaller letters; and

 (b) the letters are at least 1 mm in height.

 (4) The label must be printed on, or securely attached to:

 (a) the outside of the immediate container; and

 (b) if the immediate container is enclosed in a primary pack—the outside of that primary pack.

14  Immediate wrapper

  If a poison is enclosed in an immediate wrapper:

 (a) the poison must be contained in a primary pack labelled in accordance with section 15; and

 (b) the immediate wrapper must be conspicuously labelled with:

 (i) 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

 (ii) the approved name of the poison; and

 (iii) a statement of the quantity, proportion or strength of the poison in accordance with section 34.

Subdivision B—Primary packs and immediate containers

15  Primary packs and immediate containers

  This Subdivision sets out how the primary pack and immediate container of a poison must be labelled.

16  Signal words

 (1) The signal word or words for the poison, as shown in the following table, must be written:

 (a) on the first line or lines of the main label; and

 (c) subject to subsection (3), in letters at least half the height of the largest letter or numeral on the label; and

 (d) with nothing else other than the following written on the same line or lines:

 (i) if the poison is included in Schedule 5—a class label as specified in the Australian Dangerous Goods Code or a statement of the principal hazard of the poison;

 (ii) if the poison is not included in Schedule 5—a class label as specified in the Australian Dangerous Goods Code.

• Signal word or words for poisons
• Item For a poison included in the following schedule … that is to be used for the following purpose … the signal word or words are …
• 1 Schedule 2 for any purpose PHARMACY MEDICINE
• 2 Schedule 3 for any purpose PHARMACIST ONLY MEDICINE
• 3 Schedule 4 for human use PRESCRIPTION ONLY MEDICINE
• 4 Schedule 4 for animal use PRESCRIPTION ANIMAL REMEDY
• 5 Schedule 5 for any purpose CAUTION
• 6 Schedule 6 for any purpose POISON
• 7 Schedule 7 for any purpose DANGEROUS POISON
• 8 Schedule 8 for any purpose CONTROLLED DRUG

 (2) For the purposes of paragraph (1)(c), the 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 for the poison; 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.

 (3) For the purposes of paragraph (1)(c), the letters need not be larger than:

 (a) 6 mm on labels for packages having a nominal capacity of 2 L or less; or

 (b) 15 mm on labels for packages having a nominal capacity of more than 2 L.

17  Cautionary statement—possession without authority illegal

  If the poison is included in Schedule 8, the cautionary statement:

POSSESSION WITHOUT AUTHORITY ILLEGAL

 (a) on a separate line or lines immediately below the signal words required by section 16; and

 (c) in letters at least four‑tenths the height of the letters used for the signal words; and

 (d) with no other statement written on the same line or lines.

18  Cautionary statement—keep out of reach of children

  The cautionary statement:

KEEP OUT OF REACH OF CHILDREN

 (a) on a separate line or lines:

 (i) immediately below the signal word or words required by section 16; or

 (ii) if the cautionary statement “POSSESSION WITHOUT AUTHORITY ILLEGAL” is required by section 17—immediately below that statement; and

 (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines.

19  Cautionary statement—fire and explosion hazard

 (1) If the poison is a dry chlorinating compound containing more than 10% of available chlorine, the cautionary statement:

FIRE AND EXPLOSION HAZARD

 (a) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by section 18; and

 (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines.

 (2) This section does not apply to a preparation 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 Dangerous Goods Code.

20  Cautionary statement—burns skin and throat

  If the poison is an alkaline salt in a dishwashing machine product, the cautionary statement:

BURNS SKIN AND THROAT

 (a) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by section 18; and

 (c) in letters at least four‑tenths the height of the letters used for the signal word; and

 (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines of the main label.

21  Cautionary statements for aqueous solution of paraquat

  If the poison is an aqueous solution of paraquat, the cautionary statements:

CAN KILL IF SWALLOWED

DO NOT PUT IN DRINK BOTTLES

KEEP LOCKED UP

 (a) on separate lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by section 18; and

 (c) in letters at least four‑tenths the height of the letters used for the signal words; and

 (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same lines of the main label.

22  Cautionary statement—read safety directions

 (1) If safety directions are required on the label by section 29, the following cautionary statement:

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

or the following cautionary statement:

READ SAFETY DIRECTIONS

 (a) on a separate line or lines:

 (i) immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by section 18; or

 (ii) 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

 (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines.

 (2) This section does not apply to a medicine for human use that is labelled in accordance with the required advisory statements for medicine labels.

23  Cautionary statement—flammable

  If the poison meets the criteria for a “flammable liquid” in the Australian Dangerous Goods Code, the cautionary statement:

FLAMMABLE

must be 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 Dangerous Goods Code.

24  Cautionary statement—for animal treatment only

  If the poison is only for the treatment of animals, the cautionary statement:

must be written on the main label in bold‑face sans serif capital letters of uniform thickness.

25  Cautionary statement—do not swallow

  If the poison is included in Schedule 5 and is intended for any purpose other than internal or pesticidal use, the cautionary statement:

DO NOT SWALLOW

must be written in sans serif capital letters on the main label or as part of the directions for use.

26  Approved name and quantity, proportion or strength

 (1) The approved name of the poison and a statement of the quantity, proportion or strength of the poison in accordance with section 34 must be:

 (a) if the poison is for human therapeutic use—written on the main label in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or

 (b) if the poison is not for human therapeutic use—written in bold‑face sans serif capital letters on the main label, unless:

 (i) a list of approved names is required; and

 (ii) it is impractical to include the list on the main label; and

 (iii) it is included on another part of the label in accordance with an authorisation given by an appropriate authority.

 (2) If the poison is included in Schedule 5 and is referred to in column 1 of an item of the following table, the appropriate name in column 2 of that item may be used as the approved name.

• Appropriate names for poisons
• Item Column 1 Poison Column 2 Appropriate name
• 1 Alkaline salts Alkaline salts
• 2 Amines for use as curing agents for epoxy resins (unless separately specified in the Schedules) Aliphatic amines or aromatic amines
• 3 Epoxy resins, liquid Liquid epoxy resins
• 4 Hydrocarbons, liquid Liquid hydrocarbons
• 5 Quaternary ammonium compounds Quaternary ammonium compound(s)

 (3) If a poison contains a mixture of designated solvents in excess of 25% 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%, the approved names of those solvents may be expressed as follows:

 (a) where the designated solvent is a liquid hydrocarbon—as “liquid hydrocarbons”;

 (b) where the designated solvent is a ketone—as “ketones”;

 (c) in any other case—as “solvents” or “other solvents”.

27  Statement—an anticholinesterase compound

 (1) If the poison is an organophosphorus compound or carbamate for pesticidal use or for the treatment of animals, the following expression:

AN ANTICHOLINESTERASE COMPOUND

must be written immediately below the approved name or the list of declared contents on the label.

 (2) This section does not apply to:

 (a) dazomet, mancozeb, metiram, propineb, thiram, tri‑allate, zineb or ziram; or

 (b) an organophosphorus compound or carbamate contained in impregnated plastic resin strips, medallions or granules; or

 (c) an organophosphorus compound or carbamate contained in a pressurised spray pack for household use.

28  Directions for use

  If the poison is prepared, packed or sold for a specific purpose, it must be labelled with clear and adequate directions for use, unless:

 (a) it is a medicine for human use that is labelled in accordance with:

 (i) Therapeutic Goods Order No. 91 ‑ Standard for labels of prescription and related medicines; or

 (ii) Therapeutic Goods Order No. 92 ‑ Standard for labels of non‑prescription medicines; or

 (b) it is in an agricultural or veterinary chemical product labelled in compliance with the Agricultural and Veterinary Chemicals Code Act 1994; or

 (c) it is included in Schedule 4 or 8; or

 (d) all of the following apply:

 (i) it is impractical to include such directions on the label;

 (ii) the primary pack and the immediate container are labelled with the statement “DIRECTIONS FOR USE: See package insert”;

 (iii) an appropriate authority has authorised the directions for use to be written on a package insert instead of the label;

 (iv) the insert is enclosed in the primary pack.

29  Safety directions

 (1) If the poison is included in the table in clause 4 of Appendix F, it must be labelled with each safety direction required for the poison by that clause, grouped together as a distinct section of the label and prefaced by the words:

SAFETY DIRECTIONS

written in bold‑face capital letters.

 (ii) is a registered chemical product within the meaning of the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

30  Warning statements

 (1) If the poison is included in the table in clause 4 of Appendix F, it must be labelled with each warning statement required for the poison by that clause, grouped together:

 (a) if safety directions are included on the label—immediately after the words “SAFETY DIRECTIONS”; or

 (b) if there are no safety directions—immediately preceding the directions for use.

 (ii) is a registered chemical product within the meaning of the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

31  First aid

 (1) If the poison is included in the table in clause 3 of Appendix E, it must be labelled with each statement required for the poison by clause 3 of Appendix E:

 (a) grouped together and prefaced by the following words:

FIRST AID

  written in bold‑face capital letters; or

 (b) if a primary pack contains 2 or more immediate containers of poisons each requiring different first aid instructions:

 (i) written on each immediate container as specified in paragraph (a); and

 (ii) replaced on the primary pack with the statement:

FIRST AID: See inner packs.

 (i) is for human internal use; and

 (ii) is included in Schedule 3, 4 or 8;

 (c) a poison that:

 (ii) is a registered chemical product within the meaning of the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.

32  Name and address of manufacturer or distributor

 (1) The poison must be labelled with the name and address of its manufacturer or distributor. The address:

 (a) must be a physical address in Australia; and

 (b) must not be a post office, cable, telegraphic or code address.

 (2) However, if the manufacturer or distributor is a company incorporated under the law of a State or Territory, or a firm registered under a law of a State or Territory dealing with business names, the name and address may be:

 (a) the registered name of the corporation or firm, or its branch or division; and

 (b) the city or town in which a registered office of the company or firm is situated.

33  Warning statements and sedation warnings for certain medicines for human use

Warning statements for certain medicines

 (1) A dispensed medicine for human use containing a poison included in column 1 of the table in clause 2 of Appendix L must be clearly labelled with each warning statement required for the poison by that clause.

Sedation warning for certain medicines

 (2) A dispensed medicine for human use containing a poison included in Appendix K must be clearly labelled with a warning statement set out in item 39, 40 or 90 of the table in clause 1 of Appendix F.

Subdivision C—Statements of quantity, proportion or strength

34  Statements of quantity, proportion or strength

 (1) The statement of the quantity, proportion or strength of a poison must be expressed in the most appropriate of the following forms:

 (a) if the poison is for human therapeutic use—the manner required by the standards for the goods specified in orders made under subsection 10(1) of the Act;

 (b) if the poison is for a purpose or purposes other than human therapeutic use—as follows:

 (i) if the poison is in a pressurised spray aerosol preparation—as the mass of the poison per stated mass of the preparation;

 (ii) if the poison is a liquid in a liquid preparation—as the mass or volume of the poison per stated volume of the preparation;

 (iii) if the poison is a liquid in a solid or semi‑solid preparation—as the mass or volume of the poison per stated mass of the preparation;

 (iv) if the poison is a solid or semi‑solid in a liquid preparation—as the mass of the poison per stated volume of the preparation;

 (v) if the poison is a solid or semi‑solid in a solid or semi‑solid preparation—as the mass of the poison per stated mass of the preparation;

 (vi) if the poison is a gas in a liquid preparation—as the mass of the poison per stated volume of the preparation;

 (vii) if the poison is a gas in a solid or semi‑solid preparation—as the mass of the poison per stated mass of the preparation;

 (viii) if the poison is a gas in a gaseous preparation—as the mass of the poison per stated mass of the preparation;

 (c) if the poison is a solution of a mineral acid, the proportion of the acid (un‑neutralised by any bases present in the preparation) in a preparation may be expressed as the un‑neutralised mass of the acid per stated mass of the preparation;

 (d) if the poison is an inorganic pigment, the proportion may be expressed as a percentage of the metal present using one of the following expressions as appropriate:

 (i) “contains not more than 10 per cent of (insert name of the metal)”;

 (ii) “contains not more than 30 per cent of (insert name of the metal)”;

 (iii) “contains more than 30 per cent of (insert name of the metal)”;

 (e) if the poison is included in a paint, other than a paint for therapeutic or cosmetic use, the proportion may be expressed as a range provided that the limits of the range do not differ by more than 5% of the product;

 (f) if the poison is a lead‑based pigment included in automotive paint, the proportion may be expressed as the maximum content of the lead that may be present in the non‑volatile content of the paint;

 (g) if a preparation contains more than one derivative of a poison, the quantity or proportion of the poison may be expressed as the equivalent quantity or proportion of one of the derivatives present which it would contain if all of the derivatives were that derivative.

 (2) In paragraph (1)(g):

derivative includes alkaloid.

Note: For requirements to state the quantity, proportion or strength of a poison, see subparagraph 14(b)(iii), section 26 and sub‑subparagraphs 35(b)(ii)(B) and 36(1)(b)(ii)(A) and (2)(b)(iii)(B).

Subdivision D—Exemptions from labelling requirements

35  Selected containers and measure packs

  The requirements of Subdivision B do not apply to an immediate container of poison that is a measure pack or a selected container (other than an ampoule, a pre‑filled syringe or an injection vial to which subsections 36(1) or (2) applies) if:

 (a) the poison is therapeutic goods and is labelled in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or

 (b) the immediate container is:

 (i) packed in a primary pack labelled in accordance with Subdivision B; and

 (ii) labelled with:

 (A) the signal word or words for the poison as shown in the table in subsection 16(1); and

 (B) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with section 34; and

 (C) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and

 (D) if the poison is only for the treatment of animals—the cautionary statement:

  written in sans serif capital letters.

36  Ampoules, pre‑filled syringes and injection vials

 (1) The requirements of Subdivision B do not apply to a selected container of poison or an ampoule of poison (other than an ampoule to which subsection (2) applies) when:

 (a) the poison is therapeutic goods and is labelled in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or

 (b) the selected container or ampoule is:

 (i) packed in a primary pack labelled in accordance with Subdivision B; and

 (ii) labelled with:

 (A) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with section 34; and

 (B) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and

 (C) if the poison is only for the treatment of animals—the cautionary statement:

  written in sans serif capital letters.

 (2) The requirements of Subdivision B do not apply to a selected container of poison that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:

 (a) the poison is therapeutic goods and is labelled in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or

 (b) the poison is not therapeutic goods and all of the following apply:

 (i) the ampoule is packed in a primary pack labelled in accordance with Subdivision B;

 (ii) the strip is labelled in accordance with this section;

 (iii) the ampoule is labelled with:

 (A) the approved name of the poison or the trade name of the poison; and

 (B) the quantity, proportion or strength of the poison in accordance with section 34.

37  Transport containers and wrappings

  The labelling requirements of this instrument 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.

38  Dispensary, industrial, laboratory and manufacturing poisons

  The labelling requirements of this instrument do not apply to a poison that:

 (a) is packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes; and

 (b) is labelled in accordance with requirements under applicable jurisdictional work health and safety laws, as in force from time to time.

39  Exemptions from label requirements in certain circumstances

 (1) A requirement specified in Subdivision B or section 35 or 37 does not apply to a poison if an appropriate authority has granted a labelling exemption under this subsection in relation to that requirement for the poison.

 (2) A labelling exemption granted by an appropriate authority under subsection (1) remains in force:

 (a) if the exemption relates to a product that is indicated for the treatment or prevention of the coronavirus known as COVID‑19:

 (i) for the period specified in the exemption; or

 (ii) if no period is specified—until revoked by the appropriate authority; or

 (b) in any other case:

 (i) for the period, specified in the exemption, that is 12 months or less from the date of commencement of the exemption; or

 (ii) if no period is specified—12 months from the date of commencement of the exemption.

 (3) For the avoidance of doubt, this section does not apply to an authorisation given under subparagraph 28(d)(iii).

40  Dispensed medicines

  Unless otherwise specified in relevant State or Territory legislation and subject to section 33, the labelling requirements of this instrument do not apply to a medicine that:

 (a) is:

 (i) supplied by an authorised prescriber; or

 (ii) supplied on and in accordance with a prescription written by an authorised prescriber; or

 (iii) prepared and supplied by a pharmacist for an individual patient; and

 (b) is labelled in accordance with the requirements of clause 1 of Appendix L.

41  Gas cylinders

  The requirements of paragraph 16(1)(d) and paragraphs 18(d) and 22(1)(d) do not apply to a cylinder containing a poison that is a compressed gas.

42  Paints

  The requirements of Subdivision B do not apply to:

 (a) a paint (other than a paint for therapeutic or cosmetic use) that contains only poisons included in Schedule 5; or

 (b) a first group paint or second group 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 required for the paint by clause 4 of Appendix F, written immediately below the expression “KEEP OUT OF REACH OF CHILDREN”; and

 (iv) the name and proportion of the first group or second group poisons it contains, provided that where the substance is a metal or metal salt the proportion is expressed as the metallic element present “calculated on the non‑volatile content” or “in the dried film” of the paint; or

 (c) a tinter which contains only poisons included in Schedule 5; or

 (d) a tinter that contains a poison mentioned in a table in section 67 or 68, if:

 (i) the tinter is labelled with the name and proportion of the poison; and

 (ii) if 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”.

43  Camphor and naphthalene

  The labelling requirements of paragraph 13(2)(d) and Subdivision B do not apply to a device that contains camphor or naphthalene in block, ball, disc, pellet or flake form if the device:

 (a) complies with section 52; and

 (b) is sold or supplied in a primary pack labelled in accordance with section 13 and Subdivision B.

Subdivision E—Prohibitions

44  Prohibitions

 (1) A label used in connection with a poison must not include:

 (a) any reference to this instrument, or any comment on, reference to, or explanation of any expression required by this instrument that directly or by implication contradicts, qualifies or modifies such expression; or

 (b) any expression or device suggesting or implying that the poison is safe, harmless, non‑toxic, non‑poisonous, or is recommended or approved by a government or government authority unless required by legislation; or

 (c) any expression or device which is false or misleading in any particular concerning the safety of the poison or any of its ingredients; or

 (d) any trade name or description that:

 (i) represents any single constituent of a compound preparation; or

 (ii) misrepresents the composition or any property or quality of the poison; or

 (iii) gives any false or misleading indication of origin or place of manufacture of the poison.

 (2) A label must not be attached to the immediate container or primary pack used in connection with any poison in such a manner as to obscure any of the ribs or any expression required by this instrument to be written or embossed on the container or pack.

Division 3—Containers

45  General requirements

  A poison must not be supplied unless the requirements of this Division for the immediate container for the poison are met.

46  Containers for poisons other than poisons included in Schedule 5

 (1) If a poison, other than a poison included in Schedule 5, is supplied in a container with a nominal capacity of 2 L or less, the container must comply with Australian Standard AS 2216‑1997, Packaging for poisonous substances.

 (2) Despite subsection (1), a poison included in Schedule 6 that 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, Packaging for poisonous substances, if:

 (a) other safety factors are not diminished; and

 (b) the container has a restricted flow insert and a child‑resistant closure.

 (3) If a poison, other than a poison included in Schedule 5, is supplied in a container with a nominal capacity of more than 2 L:

 (a) the container must comply with subsection 1.4 (General Requirements) of Australian Standard AS 2216‑1997, Packaging for poisonous substances; and

 (b) the word “POISON” must be embossed, or indelibly written in a colour in distinct contrast to the background colour, on the side or shoulder of the container, 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.

47  Containers for poisons included in Schedule 5

 (1) The container in which a poison included in Schedule 5 is supplied must:

 (a) comply with the container requirements of subsection 46(1) or (3); or

 (b) comply with subsection (2).

 (2) A container complies with this subsection if:

 (a) it is readily distinguishable from a container in which food (including a condiment) or drink is sold; and

 (b) it complies with subsection 1.4 (General Requirements) of Australian Standard AS 2216‑1997, Packaging for poisonous substances, excluding paragraph 1.4.3; and

 (c) it is securely closed and, except when containing a preparation for use on one occasion only, is capable of being re‑closed to prevent spillage of its contents; and

 (d) the expression “POISON”, “NOT TO BE TAKEN” or “NOT TO BE USED AS A FOOD CONTAINER” is:

 (i) embossed or indelibly written on the container; or

 (ii) printed on a label that complies with subsection (3) that is attached to the container.

 (3) For the purposes of subparagraph (2)(d)(ii), the label must be 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.

 (4) Despite subsection (1), the following poisons included in Schedule 5:

 (a) methylated spirit(s);

 (b) liquid hydrocarbons when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid;

 (c) petrol;

 (d) toluene;

 (e) xylene;

must not be supplied in a bottle or jar having a nominal capacity of 2 L or less, unless the immediate container complies with the container requirements of subsection 46(1).

48  Approved containers

  Despite subsections 46(1) and (3) and section 47, a poison may be packed in a container that does not comply with the tactile identification requirements of AS2216‑1997 (Packaging for poisonous substances) or the requirements of paragraph 46(3)(b) or 47(2)(d) if:

 (a) other safety factors are not diminished; and

 (b) the container is for a specific purpose; and

 (c) an appropriate authority has approved the use of the container for that purpose.

49  Child‑resistant closures

 (1) If a poison specified in column 1 of an item of the following table is supplied in a container having a nominal capacity specified in column 2 of the item, it must be closed with a child‑resistant closure that:

 (a) is appropriate for the container and the poison; and

 (b) will retain its child‑resistant properties for the expected life of the poison.

• Poisons that must be closed with a child‑resistant closure
• Item Column 1 Poison Column 2 Nominal capacity of container
• 1 Alkaline salts included in Schedule 5, when packed and labelled as dishwashing machine tablets All sizes
• 2 Alkaline salts included in Schedule 5, when packed and labelled as dishwashing machine liquids, solids or gels 5 L/kg or less
• 3 Alkaline salts included in Schedule 5, when packed and labelled as a food additive 2.5 L or less
• 4 Anise oil when included in Schedule 5 200 mL or less
• 5 Basil oil when included in Schedule 5 200 mL or less
• 6 Bay oil when included in Schedule 6 200 mL or less
• 7 Cajuput oil when included in Schedule 6 200 mL or less
• 8 Cassia oil when included in Schedule 5 200 mL or less
• 9 Cineole when included in Schedule 6 2 L or less
• 10 Cinnamon bark oil when included in Schedule 5 200 mL or less
• 11 Cinnamon leaf oil when included in Schedule 6 200 mL or less
• 12 Clove oil when included in Schedule 6 200 mL or less
• 13 CYCLOSILAZANES, DI‑ME, ME HYDROGEN, POLYMERS WITH DI‑ME, ME HYDROGEN SILAZANES, REACTION PRODUCTS WITH 3‑(TRIETHOXYSILYL)‑1‑PROPANAMINE (CAS 475645‑84‑2) when included in Schedule 6, when presented in a wipe All sizes
• 14 Essential oils when included in Schedule 6 because of their natural camphor component 200 mL or less
• 15 Ethylene glycol when included in Schedule 6 5 L or less
• 16 Ethylene glycol when included in Schedule 5 in preparations containing more than 50% of ethylene glycol 5 L or less
• 17 Eucalyptus oil when included in Schedule 6 2 L or less
• 18 Eugenol when included in Schedule 6 200 mL or less
• 19 Fennel oil when included in Schedule 5 200 mL or less
• 20 Hydrocarbons, liquid, when packed as kerosene, lamp oil, mineral turpentine, thinners, reducers, white petroleum spirit or dry cleaning fluid 5 L or less
• 21 Hydrochloric acid when included in Schedule 6 5 L or less
• 22 Leptospermum scoparium oil (manuka oil) when included in Schedule 6 200 mL or less
• 23 Marjoram oil when included in Schedule 5 200 mL or less
• 24 Melaleuca oil (tea‑tree oil) when included in Schedule 6 200 mL or less
• 25 Methylated spirit excluding preparations or admixtures 5 L or less
• 26 Methyl salicylate and preparations containing more than 50% of methyl salicylate 200 mL or less
• 27 Nicotine in liquid preparations when included in Schedule 4. All sizes
• 28 Nutmeg oil when included in Schedule 5 200 mL or less
• 29 Oil of turpentine 5 L or less
• 30 Paracetamol included in Schedule 4, when packed and labelled for the treatment of animals All sizes
• 31 Pennyroyal oil when included in Schedule 6 200 mL or less
• 32 Potassium hydroxide as such 2.5 L or less
• 33 Potassium hydroxide in oven, hot plate or drain cleaners when included in Schedule 6 except when in pressurised spray packs 5 L or less
• 34 D‑Pulegone when included in Schedule 6 200 mL or less
• 35 Sage oil (Dalmatian) when included in Schedule 6 200 mL or less
• 36 Sodium hydroxide as such 2.5 L or less
• 37 Sodium hydroxide in oven, hot plate or drain cleaners when included in Schedule 6 except when in pressurised spray packs 5 L or less
• 38 Thujone when included in Schedule 6 200 mL or less
• 39 Thyme oil when included in Schedule 5 200 mL or less

 (2) This section does not apply to a poison included in therapeutic goods that are packaged in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act.

50  Poisons included in Schedule 8

 (1) If a poison included in Schedule 8 is supplied, it must be 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 poison included in Schedule 8:

 (a) by an authorised prescriber or other authorised supplier; or

 (b) by a pharmacist on the prescription of an authorised prescriber; or

 (c) by a pharmacist employed at a hospital, on the written requisition of:

 (i) a medical practitioner or dental practitioner; or

 (ii) the nurse or midwife in charge of the ward in which the poison is to be used or stored; or

 (d) by a nurse or midwife on the direction in writing of an authorised prescriber.

51  Exemptions

 (1) Subsections 46(1) and (3) and section 47 do not apply to the immediate container of a poison prepared, packed and sold:

 (a) for human internal or animal internal use; or

 (b) as a solid or semi‑solid preparation for human external or animal external use; or

 (c) as a paint, other than a paint for therapeutic or cosmetic use; or

 (d) in containers having a nominal capacity of 15 mL or less; or

 (e) for use in automatic photographic or photocopy processing machines if the container is specifically designed to fit into the machines; or

 (f) solely for dispensary, industrial, laboratory or manufacturing purposes.

 (2) Section 49 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.

 (3) The tactile identification or embossing required by subsections 46(1) and (3) and section 47 or Australian Standard AS 2216‑1997, Packaging for poisonous substances, do not apply to a container that is an aerosol container, a collapsible tube, or a measure pack which is a flexible sachet.

52  Camphor and naphthalene

 (1) The container requirements of subsection 46(1) do not apply to a device that contains only camphor or naphthalene in block, ball, disc, pellet or flake form for domestic use, if the device:

 (a) in normal use, prevents removal or ingestion of its contents; and

 (b) is incapable of reacting with the poison; and

 (c) is sufficiently strong to withstand the ordinary risks of handling, storage or transport; and

 (d) has the word “POISON” and the approved name of the poison embossed or indelibly printed on it.

 (2) Camphor or naphthalene must not be supplied in ball, block, disc, pellet or flake form for domestic use unless the balls, blocks, discs, pellets or flakes are enclosed in a device which prevents removal or ingestion of its contents.

53  Prohibitions—use of containers for poisons

 (1) A poison must not be supplied in a container that is embossed or indelibly marked with the name of another poison.

 (2) A container that complies with subsection 46(1) or (3) or section 47 must not be used to supply a poison for internal use.

 (3) A container that complies with subsection 46(1) or (3) or section 47 must not be used to supply food (including a condiment) or drink.

 (4) A poison must not be supplied in a container that is not readily distinguishable from a container in which food (including a condiment) or drink is sold.

Division 4—Storage

54  General storage requirements

Poisons included in Schedule 2

 (1) A poison included in Schedule 2 that is stored at premises for supply to the public must be stored in such a way that public access to advice from a pharmacist is available if required.

Poisons included in Schedules 3 and 4

 (2) A poison included in Schedule 3 or 4 that is stored at premises for supply to the public must be stored in a part of the premises to which the public does not have access.

Poisons included in Schedule 6

 (3) A poison included in Schedule 6 that is stored at premises for supply by way of retail sale must be stored in such a way as to prevent access by children.

Poisons included in Schedule 7

 (4) A poison included in Schedule 7 that is stored at premises for supply by retail sale must be stored in an area of the premises, and in a manner, that allows physical access only by the following:

 (a) the owner of the retail establishment;

 (b) an employee of the owner;

 (c) a person who is legally permitted to purchase the poison and is under the supervision of the owner or an employee of the owner.

Division 5—Disposal

55  General disposal requirements

  A poison included in Schedule 5, 6 or 7 must not be disposed of in any place or manner that constitutes or is likely to constitute a risk to public health or safety.

Note: Controls on the disposal of poisons included in Schedules 2, 3, 4 and 8 are dealt with in State and Territory legislation.

Division 6—Record keeping

56  General record‑keeping requirements

 (1) If a poison included in Schedule 7 is supplied, a record of the following must be kept:

 (a) the name and address of the supplier and of the purchaser;

 (b) the date of the order and supply;

 (c) the approved name or trade name of the poison;

 (d) the quantity supplied or sold;

 (e) if an authorisation is required for purchase of the poison under the law of the jurisdiction in which the purchaser purchases the poison—proof that the purchaser has the required authorisation.

 (2) The records mentioned in subsection (1) must be kept for at least 5 years.

Note: Controls on record keeping for the supply of poisons included in Schedules 2, 3, 4 and 8 are dealt with in State and Territory legislation.

Division 7—Advertising

57  General advertising requirements

Poisons included in Schedule 3, 4 and 8

 (1) A reference to a poison included in:

 (a) Schedule 3, unless included in Appendix H; or

 (b) Schedule 4; or

 (c) Schedule 8;

must not be included 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.

Poisons included in Schedules 9 and 10

 (2) A reference to a poison included in Schedule 9 or Schedule 10 must not be included in any advertisement.

Note: Schedule 10 includes poisons previously listed in Appendix C.

Division 8—Supply, prescribing, possession or use

58  Poisons included in Schedule 2

 (1) A poison included in Schedule 2 must not be supplied by a person other than:

 (a) a person who:

 (i) is a pharmacist (or an assistant under the direction of a pharmacist) or a medical practitioner, dental practitioner or veterinarian; and

 (ii) is acting in the lawful practice of the person’s profession; or

 (b) a person who is licensed to supply the poison under the law of the jurisdiction from which the person will supply the poison.

 (2) A person is not eligible to be granted a licence to supply a poison included in Schedule 2 unless:

 (a) the person is carrying on the business of supplying goods by retail sale; and

 (b) the premises from which the poison will be supplied is more than 25 km by the shortest practicable route from the nearest pharmacy; and

 (c) if required by the law of the jurisdiction from which the person will supply the poison—the person produces evidence that the person is a fit and proper person to be so licensed.

 (3) Subsection (1) does not apply to the supply of a poison included in Schedule 2 by way of wholesale dealing to:

 (b) another person who is licensed or otherwise authorised, under the law of the jurisdiction from which the person supplies the poison, to possess or supply the poison.

59  Poisons included in Schedule 3

 (1) A poison included in Schedule 3 must not be supplied by a person other than a person who:

 (a) is a pharmacist, medical practitioner, dental practitioner or veterinarian; and

 (b) is acting in the lawful practice of the person’s profession.

 (2) The following requirements apply if a poison included in Schedule 3 is supplied:

 (a) adequate instructions for use, either written or verbal, must be provided at the time of supply;

 (b) the container of the poison must be labelled with:

 (i) the name of the supplier or the name of the pharmacy (as applicable); and

 (ii) the address from which it was supplied;

 (c) if required by the law of the jurisdiction from which the supplier supplies the poison—a record of the transaction must be made in a prescription book or other approved recording system.

 (3) This section does not apply to the supply of a poison included in Schedule 3 by way of wholesale dealing to:

 (b) another person who is licensed or otherwise authorised, under the law of the jurisdiction from which the person supplies the poison, to possess or supply the poison.

60  Poisons included in Schedule 4

 (1) A poison included in Schedule 4 must not be supplied by a person other than:

 (a) a person who:

 (i) is a medical practitioner, dental practitioner or veterinarian; and

 (ii) is acting in the lawful practice of the person’s profession; or

 (b) a pharmacist dispensing a legal prescription for the poison; or

 (c) a pharmacist supplying the poison without a prescription as permitted by subsection (2).

 (2) A poison included in Schedule 4 may be supplied to a person (the patient) by a pharmacist without a prescription if:

 (a) the poison is not excepted from this provision by the law of the jurisdiction from which the pharmacist supplies the poison; and

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

 (c) the quantity supplied does not exceed 3 days’ medication; and

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

 (3) Subsection (1) does not apply to the supply of a poison included in Schedule 4 by way of wholesale dealing to:

 (b) another person who is licensed or otherwise authorised, under the law of the jurisdiction from which the person supplies the poison, to possess or supply the poison.

61  Poisons included in Schedules 5 and 6

 (1) A product sample containing a poison included in Schedule 5 or 6 must not be supplied in any manner unless the recipient has the opportunity to refuse at the time of supply.

 (2) A product sample containing a poison included in Schedule 5 or 6 must not be supplied in an unsolicited manner (for example by post or by attaching the sample to another product).

 (3) A product sample containing a poison included in Schedule 5 or 6 must not be supplied in a manner that does not promote disposal in accordance with Division 5.

62  Poisons included in Schedule 7

Possession or use for domestic or domestic garden purposes prohibited

 (1) A poison included in Schedule 7 must not be possessed or used for domestic or domestic garden purposes.

Supply for domestic or domestic garden purposes prohibited

 (2) A poison included in Schedule 7 must not be supplied for domestic or domestic garden purposes.

Supply of liquid preparations containing paraquat

 (3) A poison included in Schedule 7 that is a liquid preparation containing paraquat must not be supplied unless it is coloured blue or green and contains sufficient stenching agent to produce an offensive smell.

Supply if authorisation required by appropriate authority

 (4) A poison included in Schedule 7 for which an authorisation to purchase, possess or use is required by the appropriate authority must not be supplied unless the purchaser produces the required authorisation.

Product samples prohibited

 (5) A product sample containing a poison included in Schedule 7 must not be supplied.

Supply of poisons included in Appendix J

 (6) A poison included in Schedule 7 that is included in the table in clause 1 of Appendix J may be supplied only in accordance with that clause.

63  Poisons included in Schedule 10

  A poison included in Schedule 10 must not be possessed, supplied or used for a purpose indicated in relation to that poison in Schedule 10.

Note: Schedule 10 includes poisons previously listed in Appendix C.

64  Poisons included in Schedule 4 or 8 and Appendix D

 (1) This section applies to a poison included in Schedule 4 or 8.

Supply or prescribing

 (2) A poison included in a table in clause 1, 2, 3, 4, 6 or 7 of Appendix D must not be supplied, other than by way of wholesale dealing, or prescribed, except in accordance with the clause that contains the table.

 (3) A poison referred to in clause 8 or 10 of Appendix D must not be supplied, other than by way of wholesale dealing, or prescribed, except in accordance with clause 8 or 10 (as applicable) of Appendix D.

Possession

 (4) A poison included in the table in clause 5 of Appendix D must not be possessed by a person without authority under the law of the jurisdiction in which the possession occurs.

Storage

 (5) A poison included in the table in clause 9 of Appendix D must be stored in a locked container to prevent unauthorised access.

65  Hawking

  A poison included in Schedule 7 must not be supplied by way of hawking.

Note: Controls on supply by way of hawking of poisons included in Schedules 2, 3, 4 and 8 are dealt with in State and Territory legislation.

Division 9—Paints and tinters

Note: Paints and tinters are poisons that were previously listed in Appendix I.

66  General requirements

 (1) A first group paint must not be manufactured, supplied or used for application to:

 (a) a roof or any surface to be used for the collection or storage of potable water; or

 (b) furniture; or

 (c) any fence, wall, post, gate or building (interior or exterior) other than a building that is used exclusively for industrial purposes or mining or as an oil terminal; or

 (d) any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.

 (2) An anti‑fouling or anti‑corrosive paint containing more than 0.1% lead (the proportion of lead for the purposes of this section is calculated as a percentage of the element present in the non‑volatile content of the paint) must not be manufactured, supplied or used.

 (3) A paint (other than an anti‑fouling or anti‑corrosive paint) or tinter containing more than 0.009% lead (calculated as a percentage of the element present in the non‑volatile content of the paint) must not be manufactured, supplied or used.

 (4) A paint for application to toys must not be manufactured, supplied or used unless it complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012, Safety of toys Part 3: Migration of certain elements (ISO 8124‑03:2010, MOD), published jointly by, or on behalf of, Standards Australia and Standards New Zealand.

 (5) A paint or tinter containing a pesticide other than a fungicide, algaecide, bactericide or antifouling agent must not be manufactured, supplied or used.

67  Definition of first group paint

  A paint containing a substance mentioned in column 1 of an item in the following table in the proportion (calculated as a percentage of the element present in the non‑volatile content of the paint) specified in column 2 of the item is a first group paint.

• First group paints
• Item Column 1 Substance Column 2 Proportion
• 1 ANTIMONY or antimony compounds other than antimony titanate pigments more than 5%
• 2 BARIUM salts except barium sulfate or barium metaborate more than 5%
• 3 CADMIUM or cadmium compounds more than 0.1%
• 4 CHROMIUM as chromates of ammonia, barium, potassium sodium, strontium or zinc more than 5%
• 5 SELENIUM or selenium compounds more than 0.1%

68  Definition of second group paint

  A paint containing a substance mentioned in column 1 of an item in the following table in the proportion specified in column 2 of the item is a second group paint.

• Second group paints
• Item Column 1 Substance Column 2 Proportion
• 1 DICHLOROMETHANE (methylene chloride) more than 5% by weight
• 2 ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates more than 10% by volume
• 3 HEXYLOXYETHANOL more than 10% by volume
• 4 TOLUENE more than 50% by volume
• 5 XYLENE more than 50% by volume

Schedule 1—Blank

Note: Schedule 1 is intentionally blank.

Schedule 2—Pharmacy medicines

Note: See section 16, subsection 54(1) and section 58.

ACETIC ACID (excluding its salts and derivatives) and preparations containing more than 80% of acetic acid (CH3COOH) for therapeutic use.

ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.

ACONITUM spp. for therapeutic use in adults:

 (a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or

 (b) in preparations for dermal use containing 0.02% or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.

ALIMEMAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:

 (b) in a day‑night pack containing alimemazine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

ALOXIPRIN.

AMOROLFINE in preparations for topical use except in preparations for the treatment of tinea pedis.

ANTAZOLINE in eye drops.

ASPIRIN except when:

 (a) included in Schedule 4, 5 or 6; or

 (b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than when combined with an effervescent agent, that are:

 (i) enclosed in a primary pack that contains 12 or less individually wrapped powders or sachets of granules; and

 (ii) compliant with the requirements of the required advisory statements for medicine labels; or

 (c) in tablets or capsules containing aspirin as the only therapeutically active constituent other than when combined with an effervescent agent, that are:

 (i) either:

 (A) packed in blister or strip packing; or

 (B) in a container with a child-resistant closure; and

 (ii) either:

 (A) in a primary pack that contains not more than 25 tablets or capsules, each containing 325 mg or less of aspirin; or

 (B) in a primary pack that contains not more than 16 tablets or capsules, each containing 500 mg or less of aspirin; or

 (C) in a primary pack that contains not more than 100 tablets or capsules, each containing 100 mg or less of aspirin, and that is labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and

 (iii) compliant with the requirements of the required advisory statements for medicine labels.

ATROPA BELLADONNA (belladonna):

 (a) for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or

 (i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ATROPINE (excluding atropine methonitrate) for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

AZELAIC ACID in dermal preparations.

AZELASTINE:

 (a) in preparations for nasal use; or

 (b) in topical eye preparations containing 0.05% or less of azelastine.

BECLOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of beclometasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

BENZOCAINE in preparations for topical use other than eye drops:

 (a) containing 10% or less of total local anaesthetic substances, except in dermal preparations containing 2% or less of total local anaesthetic substances; or

 (b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10% or less of benzoyl peroxide except in preparations containing 5% or less of benzoyl peroxide.

BENZYDAMINE in preparations for topical use, except:

 (a) in preparations for dermal use; or

 (b) in divided topical oral preparations containing 3 mg or less of benzydamine; or

 (c) in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL.

BEPHENIUM SALTS.

BIFONAZOLE in preparations for dermal use except:

 (a) in preparations containing 1% or less of bifonazole for the treatment of the scalp; or

BRIMONIDINE in ophthalmic preparations for adult use containing not more than 0.025% of brimonidine.

BROMHEXINE.

BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (b) in a day‑night pack containing brompheniramine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

BUDESONIDE in aqueous nasal sprays delivering 64 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

CARBETAPENTANE except in preparations containing 0.5% or less of carbetapentane.

CARBOCISTEINE.

CETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 6 years of age and over when:

 (a) in a primary pack containing not more than 10 days’ supply; and

 (b) labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

CHLOPHEDIANOL.

CHLORBUTANOL for human use in topical preparations containing 5% or less of chlorbutanol except in preparations containing 0.5% or less of chlorbutanol.

CHLOROFORM in preparations for therapeutic use except:

 (b) in preparations containing 0.5% or less of chloroform.

CHLORPHENAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (b) in a day‑night pack containing chlorphenamine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

CICLOPIROX:

 (a) in preparations for dermal use containing 2% or less of ciclopirox except in preparations for the treatment of tinea pedis; or

 (b) in preparations for application to the nails containing 8% or less of ciclopirox.

CINCHOCAINE in preparations for topical use other than eye drops, containing 0.5% or less of total local anaesthetic substances.

CINNAMEDRINE.

CLOTRIMAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

CREOSOTE derived from wood other than beechwood for human therapeutic use, except in preparations containing 10% or less of creosote derived from wood other than beechwood.

DATURA spp. for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids, or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids;

 except when separately specified in these Schedules.

DATURA STRAMONIUM (stramonium) for oral use when:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids;

 except for smoking or burning.

DATURA TATULA (stramonium) for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids;

 except for smoking or burning.

DELPHINIUM STAPHISAGRIA except in preparations containing 0.2% or less of Delphinium staphisagria.

DESLORATADINE in preparations for oral use.

DEXCHLORPHENAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (b) in a day‑night pack containing dexchlorphenamine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

DEXTROMETHORPHAN (excluding its stereoisomers) when supplied in a pack containing 600 mg or less of dextromethorphan and with a recommended daily dose of 120 mg or less of dextromethorphan.

DIBROMOPROPAMIDINE for ophthalmic use.

DICLOFENAC when:

 (a) in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac; or

 (b) in preparations for dermal use containing 4% or less of diclofenac except in preparations for dermal use containing 2% or less of diclofenac or for the treatment of solar keratosis; or

 (c) in transdermal preparations for topical use containing 140 mg or less of diclofenac.

DIMENHYDRINATE in primary packs of 10 doses or less for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

DIPHENHYDRAMINE in oral preparations:

 (a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or

 (b) when combined with one or more other therapeutically active substances when:

 (ii) in a day‑night pack containing diphenhydramine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:

 (b) in a day‑night pack containing doxylamine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

DUBOISIA LEICHHARDTII for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

DUBOISIA MYOPOROIDES for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ECONAZOLE for human use in dermal preparations except in preparations for the treatment of tinea pedis.

ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days’ supply.

ETAFEDRINE.

ETHER for therapeutic use except:

 (b) in preparations containing 10% or less of ether.

ETHYLMORPHINE when:

 (a) compounded with one or more other therapeutically active substances:

 (i) in divided preparations containing 10 mg or less of ethylmorphine per dosage unit; or

 (ii) in undivided preparations containing 0.25% or less of ethylmorphine; and

 (b) labelled with a recommended dose not exceeding 15 mg of ethylmorphine.

ETOFENAMATE in preparations for external use.

FAMOTIDINE when sold in the manufacturer’s original pack containing not more than 14 days’ supply.

FELBINAC in preparations for external use.

FEXOFENADINE in preparations for oral use except in divided preparations:

 (a) for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

 (ii) labelled with a recommended daily dose not exceeding 120 mg of fexofenadine; or

 (b) for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

 (i) in a primary pack containing 10 dosage units or less and not more than 10 days’ supply; and

 (ii) labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or

 (c) for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:

 (ii) labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.

FLUORIDES for human use:

 (a) in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or

 (b) in liquid preparations for topical use containing 1000 mg/kg or less of fluoride ion, in a container with a child‑resistant closure:

 (i) for therapeutic use when compliant with the requirements of the required advisory statements for medicine labels except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride when fitted with a child‑resistant closure and compliant with the requirements of required advisory statements for medicine labels; or

 (ii) for non‑therapeutic use when labelled with warnings to the following effect:

 (A) Do not swallow; and

 (B) Do not use [this product/insert name of product] in children 6 years of age or less;

  except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child‑resistant closure and labelled with warnings to the following effect:

 (C) Do not swallow; and

 (D) Do not use [this product/insert name of product] in children 6 years of age or less;

 except in preparations containing 15 mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority.

FLURBIPROFEN in preparations for topical oral use when:

 (a) in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when:

 (i) in a primary pack containing not more than 16 dosage units; and

 (ii) labelled only for the treatment of adults and children over 12 years; or

 (b) in undivided preparations containing either:

 (i) 0.25% or less of flurbiprofen per dose; or

 (ii) 10 mg or less of flurbiprofen per dose;

 (iii) in a primary pack containing not more than 15 mL; and

 (iv) labelled only for the treatment of adults 18 years and over.

FLUTICASONE PROPIONATE (excluding derivatives) in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

FOLIC ACID for human therapeutic use except:

 (b) in preparations containing 500 micrograms or less of folic acid per recommended daily dose.

FOLINIC ACID for human therapeutic use except:

 (b) in preparations containing 500 micrograms or less of folinic acid per recommended daily dose.

FORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

 (a) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or

 (b) in other preparations containing 0.2% or less of free formaldehyde.

GELSEMIUM SEMPERVIRENS.

GLUTARAL for human therapeutic use.

GUAIFENESIN in a modified release dosage form of 1200 mg or less of guaifenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.

HEXACHLOROPHENE in preparations for human use containing 3% or less of hexachlorophene except:

 (a) in preparations for use on infants, as specified in Schedule 4; or

 (b) in preparations for cosmetic use, as specified in Schedule 6; or

 (c) in other preparations containing 0.75% or less of hexachlorophene.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use:

 (a) for dermal use in preparations containing 0.5% or less of hydrocortisone, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or

 (b) for dermal use in preparations containing 1% or less of hydrocortisone, in packs containing 15 g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent:

 (i) for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and

 (ii) not labelled for the treatment of children under 12 years of age; or

 (c) for rectal use in preparations containing 0.5% or less of hydrocortisone, when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

 (i) in undivided preparations in packs of 35 g or less; or

 (ii) in packs containing 12 or less suppositories.

HYDROQUINONE (excluding monobenzone and alkyl ethers of hydroquinone included in Schedule 4) in preparations for human external therapeutic or cosmetic use containing 2% or less of hydroquinone except:

 (a) in hair preparations containing 0.3% or less of hydroquinone; or

 (b) in cosmetic nail preparations containing 0.02% or less of hydroquinone.

HYOSCINE:

 (a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or

 (i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

HYOSCYAMINE:

 (a) for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or

 (i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less total solanaceous alkaloids.

HYOSCYAMUS NIGER for oral use:

 (a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

 (b) in divided preparations containing 0.3 mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids;

 except in a pack containing 0.03 mg or less of total solanaceous alkaloids.

IBUPROFEN in preparations for oral use that are labelled with a recommended daily dose of 1200 mg or less of ibuprofen, when:

 (a) in liquid preparations that are sold in the manufacturer’s original pack containing 8 g or less of ibuprofen; or

 (b) in divided immediate release preparations:

 (i) each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units; and

 (ii) that are labelled not for the treatment of children under 12 years; or

 (c) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:

 (i) ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and

 (ii) packed in blister or strip packaging or in a container with a child-resistant closure; and

 (v) not labelled for the treatment of children 6 years or under; and

 (vi) if combined with phenylephrine—not labelled for the treatment of children under 12 years.

INDANAZOLINE.

INDOMETACIN in preparations for external use containing 1% or less of indometacin.

IODINE:

 (a) in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or

 (b) in preparations for human external therapeutic use containing more than 2.5% of available iodine (excluding salts, derivatives or iodophors);

 except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

IPRATROPIUM in preparations for nasal use.

IRON COMPOUNDS (excluding iron oxides when present as an excipient, in divided preparations containing 10 mg or less of total iron oxides per dosage unit or in undivided preparations containing 1% or less of total iron oxides) for human internal use except:

 (b) when labelled with a recommended daily dose of 24 mg or less of iron:

 (i) in undivided preparations supplied in packs each containing 750 mg or less of iron; or

 (ii) in divided preparations:

 (A) containing more than 5 mg of iron per dosage unit in packs each containing 750 mg or less of iron; or

 (B) containing 5 mg or less of iron per dosage unit.

ISOCONAZOLE for human use in dermal preparations.

ISOPROPAMIDE in preparations for dermal use containing 2% or less of isopropamide.

KETOCONAZOLE in preparations for dermal use except:

 (a) in preparations containing 1% or less of ketoconazole for the treatment of the scalp; or

KETOTIFEN for ophthalmic use in preparations containing 0.025% or less of ketotifen.

LANSOPRAZOLE in oral preparations 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 7 days’ supply.

LEVOCABASTINE in topical eye or nasal preparations.

LEVOCETIRIZINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:

 (a) in a primary pack containing not more than 5 days’ supply; and

 (b) labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

LIDOCAINE in preparations for topical use other than eye drops:

 (a) containing 10% or less of total local anaesthetic substances, except:

 (i) in dermal preparations containing 2% or less of total local anaesthetic substances; or

 (ii) in aqueous sprays for oromucosal use containing 0.6% or less of total local anaesthetic substances; or

 (b) in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LINDANE in preparations for human external therapeutic use containing 2% or less of lindane.

LITHIUM in preparations for dermal use containing 1% or less of lithium except:

 (a) when present as an excipient at 0.25% or less of lithium; or

 (b) in preparations containing 0.01% or less of lithium.

LOBELIA INFLATA except for smoking or burning.

LOBELINE except in preparations for smoking or burning.

LODOXAMIDE in preparations for ophthalmic use.

LOPERAMIDE in divided preparations for oral use in packs of 20 dosage units or less except in preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.

LORATADINE in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis when:

 (a) in a primary pack containing 10 dosage units or less when labelled for adults and children 6 years and over; and

 (b) labelled with a recommended daily dose not exceeding 10 mg of loratadine.

MACROGOLS in preparations for oral use as a liquid concentrate for laxative use.

MEBENDAZOLE for human therapeutic use.

MECLOZINE in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

MEFENAMIC ACID in divided preparations for oral use in packs of 30 or less dosage units for the treatment of dysmenorrhoea.

MEPYRAMINE for dermal use.

MERCUROCHROME in preparations for external use containing 2% or less of mercurochrome except when included in Schedule 6.

MERCURY for external use in preparations containing 0.5% or less of mercury.

METHOXAMINE in preparations for external use except in preparations containing 1% or less of methoxamine.

METHOXYPHENAMINE.

METHYLEPHEDRINE.

MICONAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

MINOXIDIL in preparations for dermal use containing 5% or less of minoxidil.

MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

NAPHAZOLINE.

NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.

NICLOSAMIDE for human therapeutic use.

NIZATIDINE when sold in the manufacturer’s original pack containing not more than 14 days’ supply.

NOSCAPINE.

NYSTATIN in dermal preparations.

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 7 days’ supply.

OXETACAINE (oxethazaine) in preparations for internal use.

OXICONAZOLE for dermal use except in preparations for the treatment of tinea pedis.

OXYMETAZOLINE.

OXYQUINOLINE and its non‑halogenated derivatives for human therapeutic use, except in preparations for external use containing 1% or less of such substances.

PAPAVERINE except when included in Schedule 4.

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 7 days’ supply.

PARACETAMOL for therapeutic use:

 (a) in liquid preparations for oral use containing a maximum of 10 g of paracetamol per container; or

 (b) when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or

 (c) in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or

 (d) in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled “For dispensing only” and “This pack is not to be supplied to a patient”; or

 (e) in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or

 (f) in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled “For dispensing only” and “This pack is not to be supplied to a patient”; or

 (g) in other preparations except:

 (i) when included in Schedule 3 or 4; or

 (ii) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

 (A) enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;

 (B) compliant with the requirements of the required advisory statements for medicine labels;

 (C) not labelled for the treatment of children 6 years of age or less; and

 (D) not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or

 (iii) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

 (A) packed in blister or strip packaging or in a container with a child‑resistant closure;

 (B) in a primary pack containing not more than 20 tablets or capsules;

 (C) compliant with the requirements of the required advisory statements for medicine labels;

 (D) not labelled for the treatment of children 6 years of age or less; and

 (E) not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

 (a) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or

 (b) in other preparations containing 0.2% or less of free formaldehyde.

PHEDRAZINE.

PHENAZONE for human external use.

PHENIRAMINE:

 (a) in eye drops; or

 (b) when combined with one or more other therapeutically active substances in oral preparations when:

 (ii) in a day‑night pack containing pheniramine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:

 (b) in preparations for external use containing 1% or less of phenol and in preparations for external use containing 3% or less of cresols and xylenols and other homologues of phenol.

PHENYLEPHRINE except:

 (b) in oral preparations containing 50 mg or less of phenylephrine per recommended daily dose in packs containing 250 mg or less of phenylephrine; or

 (c) in topical eye or nasal preparations containing 1% or less of phenylephrine.

PHOLCODINE:

 (a) in liquid preparations containing 0.5% or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine; or

 (b) when compounded with one or more other therapeutically active substances in divided preparations containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine.

PIPERAZINE for human therapeutic use.

PODOPHYLLOTOXIN in preparations containing 0.5% or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM EMODI (podophyllin) in preparations containing 10% or less of podophyllin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 10% or less of podophyllin for human use for the treatment of warts other than anogenital warts.

POTASSIUM CHLORATE for therapeutic use except in preparations containing 10% or less of potassium chlorate.

PRILOCAINE in preparations for dermal use containing 10% or less of total local anaesthetic substances.

PROCYCLIDINE in preparations containing 5% or less of procyclidine for dermal use.

PROMETHAZINE in oral preparations:

 (a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or

 (b) when combined with one or more other therapeutically active substances when:

 (ii) in a day‑night pack containing promethazine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

PROPAMIDINE for ophthalmic use.

PYRANTEL for human therapeutic use.

PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10% of such substances.

PYRITHIONE ZINC for human therapeutic use, except in preparations for the treatment of the scalp containing 2% or less of pyrithione zinc when compliant with the requirements of the required advisory statements for medicine labels.

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 7 days’ supply.

RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days’ supply except:

 (a) in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units; or

 (b) in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 dosage units.

SALICYLAMIDE except when included in Schedule 4.

SELENIUM in preparations for human therapeutic use except:

 (a) for topical use containing 3.5% or less of selenium sulfide;

 (b) when included in Schedule 4; or

 (c) for oral use with a recommended daily dose of 150 micrograms or less.

SILVER for therapeutic use except:

 (a) in solutions for human oral use containing 0.3% or less of silver when compliant with the requirements of the required advisory statements for medicine labels; or

 (b) in other preparations containing 1% or less of silver.

SODIUM CROMOGLYCATE in preparations for nasal or ophthalmic use.

SODIUM NITRITE for therapeutic use (excluding when present as an excipient).

SQUILL except in preparations containing 1% or less of squill.

SULCONAZOLE in preparations for dermal use.

TERBINAFINE for dermal use except in preparations for the treatment of tinea pedis.

TETRACAINE in preparations for topical use other than eye drops, containing 10% or less of total local anaesthetic substances except in dermal preparations containing 2% or less of total local anaesthetic substances.

TETRACHLOROETHYLENE for human therapeutic use.

TETRYZOLINE.

THIABENDAZOLE for human therapeutic use.

TIOCONAZOLE in preparations for dermal use except in preparations for the treatment of tinea pedis.

TRAMAZOLINE.

TRIAMCINOLONE in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:

 (b) in a day‑night pack containing triprolidine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;

TUAMINOHEPTANE.

TYMAZOLINE.

XYLOMETAZOLINE.

ZINC CHLORIDE for human dermal use except in preparations containing 5% or less of zinc chloride.