I, Sarah Syme, as delegate of the Secretary of the Department of Health and Aged Care, make the following instrument. Dated 19 January 2024 Sarah Syme Acting Assistant Secretary Regulatory Engagement Branch Health Products Regulation Group Department of Health and Aged Care 이미지에 텍스트가 포함되어 있지 않습니다.
Contents Reader’s guide Introduction i Classification iii Principles of scheduling iv Reading the schedules v Availability of poisons vii Appendices viii Appendix A (General exemptions) viii Appendix B (Substances considered not to require control by scheduling) ix Appendix C (blank) ix Appendix D (Additional controls on possession or supply of poisons included in Schedule 4 or 8) ix Appendix E (First aid instructions for poisons) ix Appendix F (Warning statements and general safety directions for poisons) x Appendix G (Dilute preparations) x Appendix H (Schedule 3 medicines permitted to be advertised) x Appendix I (blank) x Appendix J (Conditions for availability and use of certain poisons included in Schedule 7) x Appendix K (Human medicines required to be labelled with a sedation warning) x Appendix L (Requirements for dispensing labels for medicines) x Appendix M (blank) x Poisons Information Centre telephone numbers for first aid instructions, warning statements and general safety directions for poisons xi Part 1—Preliminary and interpretation 1 1 Name 1 2 Commencement 1 3 Authority 1 4 Repeal and transitional provisions 1 5 Reader’s guide and Index 2 6 Definitions 2 7 References to substances 10 8 References to concentration, strength or quantity of substances 11 9 References to boiling or distillation temperatures 11 10 References to standards 11 Part 2—Controls on substances 12 Division 1—Preliminary 12 11 Application of Part 2 12 12 Preparations containing poisons included in different schedules 12 Division 2—Labels 13 Subdivision A—General 13 13 General requirements 13 14 Immediate wrapper .................................................................................................................. 13 Subdivision B—Primary packs and immediate containers ......................................................... 13 15 Primary packs and immediate containers .............................................................................. 13 16 Signal words .......................................................................................................................... 14 17 Cautionary statement—possession without authority illegal ................................................. 14 18 Cautionary statement—keep out of reach of children ........................................................... 15 19 Cautionary statement—fire and explosion hazard ................................................................. 15 20 Cautionary statement—burns skin and throat ........................................................................ 15 21 Cautionary statements for aqueous solution of paraquat ....................................................... 16 22 Cautionary statement—read safety directions ....................................................................... 16 23 Cautionary statement—flammable ........................................................................................ 17 24 Cautionary statement—for animal treatment only ............................................................... 17 25 Cautionary statement—do not swallow ................................................................................ 17 26 Approved name and quantity, proportion or strength ........................................................... 17 27 Statement—an anticholinesterase compound ........................................................................ 18 28 Directions for use .................................................................................................................. 18 29 Safety directions .................................................................................................................... 19 30 Warning statements ............................................................................................................... 19 31 First aid .................................................................................................................................. 20 32 Name and address of manufacturer or distributor ................................................................. 20 33 Warning statements and sedation warnings for certain medicines for human use ............... 21 Subdivision C—Statements of quantity, proportion or strength .................................................. 21 34 Statements of quantity, proportion or strength ..................................................................... 21 Subdivision D—Exemptions from labelling requirements ......................................................... 22 35 Selected containers and measure packs ................................................................................ 22 36 Ampoules, pre-filled syringes and injection vials ................................................................. 23 37 Transport containers and wrappings .................................................................................... 23 38 Dispensary, industrial, laboratory and manufacturing poisons ............................................ 23 39 Exemptions from label requirements in certain circumstances ............................................ 24 40 Dispensed medicines ............................................................................................................. 24 41 Gas cylinders ......................................................................................................................... 24 42 Paints ..................................................................................................................................... 24 43 Camphor and naphthalene ..................................................................................................... 25 Subdivision E—Prohibitions ........................................................................................................ 25 44 Prohibitions ........................................................................................................................... 25 Division 3—Containers ............................................................................................................... 27 45 General requirements ............................................................................................................ 27 46 Containers for poisons other than poisons included in Schedule 5 ...................................... 27 47 Containers for poisons included in Schedule 5 .................................................................... 27 48 Approved containers ............................................................................................................. 28 49 Child-resistant closures ......................................................................................................... 28 50 Poisons included in Schedule 8 ............................................................................................ 30 51 Exemptions ........................................................................................................................... 30 52 Camphor and naphthalene ..................................................................................................... 31 53 Prohibitions—use of containers for poisons ......................................................................... 31 Division 4—Storage ..................................................................................................................... 32 54 General storage requirements ............................................................................................... 32 Division 5—Disposal ................................................................................................................... 33 55 General disposal requirements ............................................................................................. 33 Division 6—Record keeping 56 General record-keeping requirements .................................................................34 Division 7—Advertising 57 General advertising requirements.......................................................................35 Division 8—Supply, prescribing, possession or use 58 Poisons included in Schedule 2...........................................................................36 59 Poisons included in Schedule 3...........................................................................36 60 Poisons included in Schedule 4...........................................................................37 61 Poisons included in Schedules 5 and 6...............................................................37 62 Poisons included in Schedule 7...........................................................................37 63 Poisons included in Schedule 10.........................................................................38 64 Poisons included in Schedule 4 or 8 and Appendix D.......................................38 65 Hawking...............................................................................................................39 Division 9—Paints and tinters 66 General requirements ..........................................................................................40 67 Definition of first group paint .............................................................................40 68 Definition of second group paint ........................................................................41 Schedule 1—Blank ..................................................................................................42 Schedule 2—Pharmacy medicines ..........................................................................43 Schedule 3—Pharmacist only medicines ...............................................................61 Schedule 4—Prescription only medicines and prescription animal remedies .......70 Schedule 5—Caution .............................................................................................173 Schedule 6—Poisons .............................................................................................207 Schedule 7—Dangerous poisons ..........................................................................261 Schedule 8—Controlled drugs ..............................................................................274 Schedule 9—Prohibited substances ......................................................................279 Schedule 10—Substances of such danger to health as to warrant prohibition of supply and use .......................................................................................................287 Appendix A—General exemptions 1 Exempt preparations and products .....................................................................293 Appendix B—Substances considered not to require control by scheduling 1 Reasons for including substances in the table in clause 3..................................296 2 Areas of use in relation to substances included in the table in clause 3.............296 3 Substances exempt in certain uses......................................................................298 Appendix C—Blank 306 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 ................................................................. 307 2 Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist ......................................................... 307 3 Poisons available only from or on the prescription or order of a medical practitioner approved or authorised under section 19 of the Act ......................... 308 4 Poisons available only from or on the order of a specialist physician ............... 308 5 Poisons for which possession without authority is illegal .................................. 308 6 Poisons available for human use only from or on the prescription or order of a specialist physician ......................................................................................... 309 7 Poisons available for human use only from or on the prescription or order of a dermatologist ................................................................................................... 310 8 Poisons available for initial treatment of a patient only if authorised by certain health practitioners ........................................................................................... 310 9 Poisons which must be stored in a locked container to prevent unauthorised access ............................................................................................................... 310 10 Poisons available only when prescribed or authorised in certain circumstances ............................................................................................................... 311 Appendix E—First aid instructions for poisons 1 Standard statements for first aid instructions .................................................... 312 2 Poisons information centre contact information in statements ......................... 313 3 First aid instructions for poisons ....................................................................... 313 Appendix F—Warning statements and general safety directions for poisons 1 Warning statements ........................................................................................... 324 2 Safety directions—general ................................................................................ 328 3 Poisons information centre contact information in statements ......................... 330 4 Poisons that must be labelled with warning statements and safety directions ............................................................................................................... 330 Appendix G—Dilute preparations 1 Substances exempt at or below certain concentrations .................................... 345 Appendix H—Schedule 3 medicines permitted to be advertised 1 Schedule 3 medicines permitted to be advertised ............................................ 347 Appendix I—Blank 349 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 ...................... 350 Appendix K—Human medicines required to be labelled with a sedation warning 1 Human medicines required to be labelled with a sedation warning .................. 353 Appendix L—Requirements for dispensing labels for medicines 1 General .............................................................................................................. 358 2 Additional warning statements for certain human medicines ........................... 358 Appendix M—Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist 361 Index 362 이미지에는 텍스트가 포함되어 있지 않습니다.
Part 1—Preliminary and interpretation
1 Name
This instrument is the Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024.
This instrument may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons No. 43. 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
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 February 2024. | 1 February 2024 | 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.
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
The Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023 is repealed. Saving—things done under the repealed instrument
If: (a) a thing was done for a particular purpose under the Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023 as in force immediately before that instrument was repealed; and
Part 1 Preliminary and interpretation Section 5 (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.
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
The Reader’s guide is not part of this instrument.
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.
Part 1 Preliminary and interpretation Section 6 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 Therapeutic Vaping Goods) (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 --- Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 Authorised Version F2024L00095 registered 23/01/2024 (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 Therapeutic Vaping Goods) (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
Part 1 Preliminary and interpretation Section 6 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. Section 7 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
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.
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.
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
A poison must not be supplied unless it is labelled in accordance with this Division.
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.
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.
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
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 (b) in bold-face sans serif capital letters of uniform thickness; 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 |
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.
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 must be written: (a) on a separate line or lines immediately below the signal words required by section 16; and (b) in bold-face sans serif capital letters of uniform thickness; and (c) in letters at least four-tenths the height of the letters used for the signal word or 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 must be written: (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 (b) in bold-face sans serif capital letters of uniform thickness; and (c) in letters at least four-tenths the height of the letters used for the signal word or words; 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
If the poison is a dry chlorinating compound containing more than 10% of available chlorine, the cautionary statement: FIRE AND EXPLOSION HAZARD must be written: (a) on a separate line or lines immediately below the cautionary statement “KEEP OUT OF REACH OF CHILDREN” as required by section 18; and (b) in bold-face sans serif capital letters of uniform thickness; and (c) in letters at least four-tenths the height of the letters used for the signal word or words; and (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines.
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 must be written: (a) on a separate line or lines immediately below the cautionary statement "KEEP OUT OF REACH OF CHILDREN" as required by section 18; and (b) in bold-face sans serif capital letters of uniform thickness; 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 must be written: (a) on separate lines immediately below the cautionary statement "KEEP OUT OF REACH OF CHILDREN" as required by section 18; and (b) in bold-face sans serif capital letters of uniform thickness; 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
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 must be written: (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 (b) in bold-face sans serif capital letters of uniform thickness; and (c) in letters at least four-tenths the height of the letters used for the signal word or words; and (d) with nothing, other than a class label as specified in the Australian Dangerous Goods Code, written on the same line or lines.
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: FOR ANIMAL TREATMENT ONLY 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
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.
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 | Column 2 | |------|-------------------|-------------------| | 1 | Alkaline salts | Alkaline salts |
Part 2 Controls on substances
Division 2 Labels Section 27 Appropriate names for poisons | Item | Column 1 Poison | Column 2 Appropriate name | |------|------------------|--------------------------| | 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) |
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
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.
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:
29 Safety directions
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.
This section does not apply to the following: (a) a poison that: (i) is a medicine for human use; and (ii) is labelled in accordance with the required advisory statements for medicine labels; (b) a poison that: (i) is an agricultural chemical or a veterinary chemical; and (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
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.
This section does not apply to the following: (a) a poison that: (i) is a medicine for human use; and (ii) is labelled in accordance with the required advisory statements for medicine labels; (b) a poison that: (i) is an agricultural chemical or a veterinary chemical; and (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. Section 31
31 First aid
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.
This section does not apply to the following: (a) a poison that: (i) is for human internal use; and (ii) is included in Schedule 3, 4 or 8; (b) a poison that: (i) is a medicine for human use; and (ii) is labelled in accordance with the required advisory statements for medicine labels; (c) a poison that: (i) is an agricultural chemical or a veterinary chemical; and (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
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.
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
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
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
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:
Part 2 Controls on substances
Division 2 Labels Section 35 (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.
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: FOR ANIMAL TREATMENT ONLY written in sans serif capital letters.
36 Ampoules, pre-filled syringes and injection vials
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: FOR ANIMAL TREATMENT ONLY written in sans serif capital letters.
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
Part 2 Controls on substances
Division 2 Labels Section 39 (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
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.
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.
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
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.
Part 2 Controls on substances
Division 2 Labels Section 44
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
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*.
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.
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
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).
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
Part 2 Controls on substances
Division 3 Containers Section 48 (ii) printed on a label that complies with subsection (3) that is attached to the container.
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.
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
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 | Poisons that must be closed with a child-resistant closure | Item | Column 1 Poison | Column 2 Nominal capacity of container | |------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------| | 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 |
Part 2 Controls on substances
Division 3 Containers Section 50 Poisons that must be closed with a child-resistant closure | Item | Column 1 Poison | Column 2 Nominal capacity of container | |------|------------------|---------------------------------------| | 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 |
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
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.
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
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.
Section 49 does not apply to a poison prepared, packed and sold solely for dispensary, industrial, laboratory or manufacturing purposes.
The tactile identification or embossing required by 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
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.
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
A poison must not be supplied in a container that is embossed or indelibly marked with the name of another poison.
A container that complies with subsection 46(1) or (3) or section 47 must not be used to supply a poison for internal use.
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.
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.
Part 2 Controls on substances
Division 4 Storage Section 54
Division 4—Storage
54 General storage requirements Poisons included in Schedule 2
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
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
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
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.
Part 2 Controls on substances
Division 6 Record keeping Section 56
Division 6—Record keeping
56 General record-keeping requirements
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.
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
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
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.
Part 2 Controls on substances
Division 8 Supply, prescribing, possession or use Section 58
Division 8—Supply, prescribing, possession or use
58 Poisons included in Schedule 2
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.
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.
Subsection (1) does not apply to the supply of a poison included in Schedule 2 by way of wholesale dealing to: (a) a pharmacist, medical practitioner, dental practitioner or veterinarian; or (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
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.
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.
This section does not apply to the supply of a poison included in Schedule 3 by way of wholesale dealing to: (a) a pharmacist, medical practitioner, dental practitioner or veterinarian; or
60 Poisons included in Schedule 4
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).
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.
Subsection (1) does not apply to the supply of a poison included in Schedule 4 by way of wholesale dealing to: (a) a pharmacist, medical practitioner, dental practitioner or veterinarian; or (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
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.
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).
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
A poison included in Schedule 7 must not be possessed or used for domestic or domestic garden purposes.
Part 2 Controls on substances
Division 8 Supply, prescribing, possession or use Section 63 Supply for domestic or domestic garden purposes prohibited
A poison included in Schedule 7 must not be supplied for domestic or domestic garden purposes. Supply of liquid preparations containing paraquat
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
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
A product sample containing a poison included in Schedule 7 must not be supplied. Supply of poisons included in Appendix J
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
This section applies to a poison included in Schedule 4 or 8. Supply or prescribing
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.
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
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
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.
Part 2 Controls on substances
Division 9 Paints and tinters Section 66
Division 9—Paints and tinters Note: Paints and tinters are poisons that were previously listed in Appendix I.
66 General requirements
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.
An anti-fouling 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.
A paint (other than an anti-fouling 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.
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.
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: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (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; except in preparations for the treatment of children under 2 years of age. 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 (b) for oral use: (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 (b) in preparations for the treatment of tinea pedis. 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: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (b) in a day-night pack containing brompheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. BUDESONIDE in aqueous nasal sprays delivering 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: (a) when included in Schedule 4; or (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: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (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; except in preparations for the treatment of children under 2 years of age. CHOLINE SALICYLATE in preparations for oromucosal use. 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: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (b) in a day-night pack containing dexchlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. DEXTROMETHORPHAN (excluding its stereoisomers) when supplied in a pack containing 600 mg or less of dextromethorphan and with a recommended daily dose of 120 mg or less of dextromethorphan. DIBROMOPROPAMIDINE for ophthalmic use. DICLOFENAC when: (a) in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac; 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: (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (ii) in a day-night pack containing diphenhydramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (b) in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. DUBOISIA LEICHARDTII 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: (a) when included in Schedule 4; or (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: (i) in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and (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 in children 6 years of age and over when: (i) in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and (ii) labelled with a recommended daily dose not exceeding 60 mg of fexofenadine. FLUORIDES for human use: in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or in liquid preparations for topical use containing 1000 mg/kg or less of fluoride ion, in a container with a child-resistant closure: 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 for non-therapeutic use when labelled with warnings to the following effect: Do not swallow; and 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: Do not swallow; and 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: in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when: in a primary pack containing not more than 16 dosage units; and labelled only for the treatment of adults and children over 12 years; or in undivided preparations containing either: 0.25% or less of flurbiprofen per dose; or
10 mg or less of flurbiprofen per dose; except when: in a primary pack containing not more than 15 mL; and 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: when included in Schedule 4; or (b) in preparations containing 500 micrograms or less of folic acid per recommended daily dose. FOLINIC ACID for human therapeutic use except: (a) when included in Schedule 4; or (b) in preparations containing 500 micrograms or less of folinic acid per recommended daily dose. FORMALDEHYDE (excluding its derivatives) for human therapeutic use except: (a) in oral hygiene preparations containing 0.1% 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 (b) for oral use: (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 (b) for oral use: (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. 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 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 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: in liquid preparations that are sold in the manufacturer’s original pack containing 8 g or less of ibuprofen; or in divided immediate release preparations: each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units; and that are labelled not for the treatment of children under 12 years; or in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when: ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and packed in blister or strip packaging or in a container with a child-resistant closure; and in a primary pack containing not more than 25 dosage units; and compliant with the requirements of the required advisory statements for medicine labels; and not labelled for the treatment of children 6 years or under; and 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: in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or 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: when included in Schedule 4; or when labelled with a recommended daily dose of 24 mg or less of iron: in undivided preparations supplied in packs each containing 750 mg or less of iron; or 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 (b) in preparations for the treatment of tinea pedis. 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. OLOPATADINE in preparations for nasal use delivering 600 micrograms or less of olopatadine per dose when the maximum recommended daily dose is no greater than 4,800 micrograms for the treatment of allergic rhinitis or rhinoconjunctivitis for up to 6 months in adults and children 12 years of age and over. 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: (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or Schedule 2 Pharmacy medicines (ii) in a day-night pack containing pheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. PHENOL, or any homologue boiling below 220°C, for human therapeutic use except: (a) when included in Schedule 4; or (b) in preparations for external use containing 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: (a) when included in Schedule 4; or (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:
58 Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (ii) in a day-night pack containing promethazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. PROPAMIDINE for ophthalmic use. PYRANTEL for human therapeutic use. PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10% 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: (a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or (b) in a day-night pack containing triprolidine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper; except in preparations for the treatment of children under 2 years of age. TUAMINOHEPTANE. TYMAZOLINE. XYLOMETAZOLINE. ZINC CHLORIDE for human dermal use except in preparations containing 5% or less of zinc chloride. Schedule 3—Pharmacist only medicines Note: See sections 16 and 31, subsections 54(2) and 57(1) and section 59. ADAPALENE in topical preparations containing 0.1% or less of adapalene for the treatment of acne vulgaris in adults and in children over 12 years of age. ADRENALINE in preparations containing 1% or less of adrenaline except in preparations containing 0.02% or less of adrenaline unless packed and labelled for injection. ALCLOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of alclometasone in packs containing 30 g or less of the preparation. ALIMEMAZINE: (a) in solid oral preparations except when included in Schedule 2; or (b) in liquid oral preparations containing 10 mg or less of alimemazine per 5 mL; except in preparations for the treatment of children under 2 years of age. AMINOPHYLLINE in liquid oral preparations containing 2% or less of aminophylline. AMYL NITRITE when in preparations for human therapeutic use and packaged in containers with child-resistant closures. ASTODRIMER SODIUM except in a condom lubricant. AZATADINE in oral preparations. BILASTINE in divided oral preparations containing 20 mg or less of bilastine for the treatment of adults and adolescents 12 years of age and older. BROMPHENIRAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. BUCLIZINE in oral preparations. BUTOCONAZOLE in preparations for vaginal use. CANNABIDIOL in oral, oromucosal and sublingual preparations included in the Register when: (a) the cannabidiol is either plant derived or, when synthetic, only contains the (-)-CBD enantiomer; and (b) the cannabidiol comprises 98% or more of the total cannabinoid content of the preparation; and (c) any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation. Schedule 3 Pharmacist only medicines preparation and of which tetrahydrocannabinol (THC) can only comprise 1% of the total cannabinoid content; and (d) the maximum recommended daily dose is 150 mg or less of cannabidiol; and (e) packed in blister or strip packaging or in a container fitted with a child-resistant closure; and (f) in packs containing not more than 30 days’ supply; and (g) for persons aged 18 years and over. CELECOXIB in tablets or capsules each containing 200 mg or less of celecoxib, in a primary pack containing not more than 10 dosage units for the short-term treatment of acute pain due to primary dysmenorrhea or musculoskeletal or soft tissue injuries in adults. CHLORAMPHENICOL for ophthalmic use only. CHLORBUTANOL in preparations for human use except: (a) when included in Schedule 2; or (b) in preparations containing 0.5% or less of chlorbutanol. CHLORPHENAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. CICLOPIROX in preparations for dermal use and for application to the nails except: (a) when included in Schedule 2; or (b) in preparations for the treatment of tinea pedis. CIMETIDINE in a primary pack containing not more than 14 days’ supply. CLEMASTINE in preparations for oral use. CLOBETASONE (clobetasone-17-butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of clobetasone in packs containing 30 g or less of the preparation. CLOTRIMAZOLE in preparations for vaginal use. CYCLIZINE in divided preparations for oral use in primary packs containing 6 dosage units or less. CYPROHEPTADINE in oral preparations. DEXCHLORPHENAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. DICLOFENAC in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2. DIHYDROCODEINE when indicated for cough suppression and compounded with one or more other therapeutically active substances: (a) in divided preparations containing 10 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or (b) in undivided preparations containing 0.25% or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine. DIIODOHYDROXYQUINOLINE (iodoquinol) for vaginal use. DIMENHYDRINATE in oral preparations except when included in Schedule 2. DIMETHINDENE in oral preparations. DIPHENHYDRAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1% of the dose of diphenoxylate. DITHRANOL for therapeutic use. DOXYLAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. ECONAZOLE in preparations for vaginal use. ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms. ERYTHRITYL TETRANITRATE for therapeutic use. FAMCICLOVIR for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores). FLAVOXATE. FLUCONAZOLE in single-dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis. FLUORIDES for human topical use. (a) in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or (b) in non-liquid preparations containing 5500 mg/kg or less of fluoride ion except: (i) in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the required advisory statements for medicine labels; or (ii) in preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less; or (iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority. GLUCAGON. GLYCERYL TRINITRATE: (a) in preparations for oral use; or (b) in preparations for rectal use. GLYCOPYRRONIUM except when included in Schedule 4. HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1% or less of hydrocortisone: (a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or (b) for dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and older); or (c) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents: (i) in undivided preparations, in packs of 35 g or less; or (ii) in packs containing 12 or less suppositories; except when included in Schedule 2. HYOSCINE BUTYLBROMIDE in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over. IBUPROFEN when: (a) either: (i) in divided preparations, each containing 400 mg or less of ibuprofen, in a primary pack containing not more than 50 dosage units; or (ii) in a modified release dosage form, each containing 600 mg of ibuprofen, in a primary pack containing not more than 32 dosage units; and (b) labelled: (i) with a recommended daily dose of 1200 mg or less of ibuprofen; and (ii) not for the treatment of children under 12 years; except when: (c) included in Schedule 2; or (d) in preparations for oral use that are labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided preparations, each containing 200 mg or less of ibuprofen, in a pack containing not more than 100 dosage units when: (i) ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and (ii) packed in a blister or strip packaging or in a container with a child-resistant closure; and (iii) in a primary pack containing not more than 25 dosage units; and (iv) compliant with the requirements of the required advisory statements for medicine labels; and (v) not labelled for the treatment of children 6 years or under; and (vi) when combined with phenylephrine—not labelled for the treatment of children under 12 years. INOSITOL NICOTINATE. ISOCONAZOLE in preparations for vaginal use. ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit. KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units. LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2. LEVONORGESTREL for emergency post-coital contraception. MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures. MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose. MALATHION in preparations for human external use except in preparations containing 2% or less of malathion. MANNITYL HEXANITRATE for therapeutic use. MELATONIN in: (a) modified release tablets containing 2 mg or less of melatonin for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing not more than 30 tablets; or (b) immediate release preparations containing 5 mg or less of melatonin for the treatment of jet lag in adults 18 years and over, in a primary pack containing no more than 10 dosage units. MEPYRAMINE in oral preparations. METHDILAZINE in oral preparations. METOCLOPRAMIDE when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units. MICONAZOLE for human use in topical preparations: (a) for the treatment of oral candidiasis; or (b) for vaginal use. MOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.1% or less of mometasone in packs containing 15 g or less. NALOXONE when used for the treatment of opioid overdose. NAPROXEN in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age. NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except: (a) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or (b) nicotinamide. NICOTINYL ALCOHOL except in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit. NYSTATIN in preparations for topical use except when included in Schedule 2. OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2. ORLISTAT in oral preparations for weight-control purposes containing 120 mg or less of orlistat per dosage unit. OXICONAZOLE in preparations for vaginal use. PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2. PARACETAMOL: (a) when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or (b) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or (c) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine and labelled “For dispensing only” and “This pack is not to be supplied to a patient”; or (d) in liquid preparations for oral use except when in Schedule 2. PHENIRAMINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. PODOPHYLLOTOXIN in preparations containing 1% or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2. PODOPHYLLUM EMODI (podophyllin) in preparations containing 20% or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2. PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20% or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2. PROCHLORPERAZINE in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine. PROMETHAZINE in oral preparations except: (a) when included in Schedule 2; or (b) in preparations for the treatment of children under 2 years of age. PSEUDOEPHEDRINE (other than preparations for stimulant, appetite suppression or weight-control purposes) when supplied in a primary pack: (a) in liquid preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its equivalent); or (b) in other preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its equivalent). RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2. RIZATRIPTAN when in divided oral preparations containing 5 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of migraine symptoms. SALBUTAMOL as the only therapeutically active substance: (a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or (b) in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose. SALICYLIC ACID in preparations for dermal use except in preparations containing 40% or less of salicylic acid. SANTONIN. SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures. SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical or surgical procedures. SULFACETAMIDE in preparations for ophthalmic use containing 10% or less of sulfacetamide. SUMATRIPTAN when in divided oral preparations containing 50 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms. TERBUTALINE as the only therapeutically active substance: (a) in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose; or (b) in dry powders for inhalation delivering 500 micrograms or less of terbutaline per dose. THEOPHYLLINE in liquid oral preparations containing 2% or less of theophylline. TIOCONAZOLE in preparations for vaginal use. TRIAMCINOLONE for buccal use in preparations containing 0.1% or less of triamcinolone in a pack of 5 g or less. TRIPROLIDINE in oral preparations except: (a) when included in Schedule 2; or (b) for the treatment of children under 2 years of age. ULIPRISTAL for emergency post-coital contraception. VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose. ZOLMITRIPTAN when in divided oral preparations containing 2.5 mg or less per dosage unit and when sold in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms. Schedule 4—Prescription only medicines and prescription animal remedies Note 1: See sections 16, 28, 31 and 49, subsections 54(2) and 57(1) and section 60. Note 2: Substances marked # are listed in Appendix D. ABACAVIR. ABATACEPT. ABIRATERONE ACETATE. ABCIXIMAB. ABEMACICLIB. ACALABRUTINIB. ACAMPROSATE CALCIUM. ACARBOSE. ACEBUTOLOL. ACEPROMAZINE. ACETANILIDE and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use. ACETARSOL. ACETAZOLAMIDE. ACETOHEXAMIDE. ACETYL ISOVALERYLTYLOSIN. ACETYLCARBROMAL. ACETYLCHOLINE. ACETYLCYSTEINE except: (a) when included in Schedule 2; or (b) in preparations for oral use when labelled with a recommended daily dose of 1 g or less of acetylcysteine. ACETYLDIGITOXIN. Substances marked # are listed in Appendix D. ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE. ACETYLSTROPHANTHIDIN. ACICLOVIR except in preparations containing 5% or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less. ACIPIMOX. # ACITRETIN. ACLIDINIUM BROMIDE. ACOKANTHERA OUABAIO. ACOKANTHERA SCHIMPERI. ACONITUM spp. except: (a) when included in Schedule 2; or (b) in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or (c) in preparations for dermal use in adults containing 0.02% or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids. ACRIVASTINE. ADALIMUMAB. ADAPALENE except when included in Schedule 3. ADEFOVIR. ADENOSINE for human therapeutic use in preparations for injection. ADIPHENINE. ADONIS VERNALIS. ADRAFINIL. ADRENALINE except: (a) when included in Schedule 3; or (b) in preparations containing 0.02% or less of adrenaline unless packed and labelled for injection. ADRENOCORTICAL HORMONES except when separately specified in these Schedules. AFAMELANOTIDE. AFATINIB DIMALEATE. AFLIBERCEPT. AGALSIDASE. AGLEPRISTONE. AGOMELATINE. ALANYLGLUTAMINE. ALATROFLOXACIN MESILATE. ALBENDAZOLE except: (a) when included in Schedule 5 or 6; or (b) in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals. ALCLOFENAC. ALCLOMETASONE except when included in Schedule 3. ALCURONIUM. ALDESLEUKIN. ALDOSTERONE. ALECTINIB. # ALEFACEPT. ALEMTUZUMAB. ALENDRONIC ACID. ALFACALCIDOL. ALFUZOSIN. ALGLUCERASE. ALGLUCOSIDASE. ALIMEMAZINE except when included in Schedule 2 or 3. Substances marked # are listed in Appendix D ALIROCUMAB. ALISKIREN. ALKYL NITRITES except when separately specified in these schedules. ALLERGENS for therapeutic use. ALLOPURINOL. ALLYLESTRENOL. ALOGLIPTIN. ALOSETRON. ALPELISIB. ALPHA1-PROTEINASE INHIBITOR (HUMAN). ALPHADOLONE. ALPHAXALONE. ALPRENOLOL. ALPROSTADIL. ALSEROXYLON. ALTEPLASE. ALTRENOGEST. ALTRETAMINE (hexamethylmelamine). AMANTADINE. AMBENONIUM CHLORIDE. # AMBRISENTAN. AMBUCETAMIDE. AMBUTONIUM BROMIDE. AMCINONIDE. AMIFAMPRIDINE. AMIFOSTINE. AMIKACIN. AMILORIDE. AMINOCAPROIC ACID. AMINOGLUTETHIMIDE. 5-AMINOLEVULINIC ACID. AMINOMETRADINE. AMINOPHENAZONE (amidopyrine) and derivatives for the treatment of animals. AMINOPHYLLINE except when included in Schedule 3. AMINOPTERIN. 4-AMINOPYRIDINE for therapeutic use. AMINOREX. AMINOSALICYLIC ACID. AMIODARONE. AMIPHENAZOLE. AMISOMETRADINE. AMISULPRIDE. AMITRIPTYLINE. AMLODIPINE. AMMI VISNAGA. AMMONIUM BROMIDE for therapeutic use. AMOBARBITAL when packed and labelled for injection. AMODIAQUINE. AMOROLFINE except: (a) when included in Schedule 2; or (b) in preparations for the treatment of tinea pedis. AMOXAPINE. AMOXICILLIN. AMPHOMYCIN. AMPHOTERICIN B. AMPICILLIN. AMPRENAVIR. AMRINONE. AMSACRINE. AMYL NITRITE except when included in Schedule 3. AMYLOCAINE. # ANABOLIC STEROIDAL AGENTS. ANAGRELIDE. ANAKINRA. ANASTROZOLE. ANCESTIM. ANCROD and its immunoglobulin antidote. ANDEXANET ALFA. ANECORTAVE. # ANDROGENIC STEROIDAL AGENTS. # ANDROISOXAZOLE. # ANDROSTANOLONE. # ANDROSTENEDIOL. # ANDROSTENEDIONE. ANGIOTENSIN AMIDE. ANIDULAFUNGIN. ANIRACETAM. ANISTREPLASE. ANTAZOLINE except when included in Schedule 2. ANTIBIOTIC SUBSTANCES except: (a) when separately specified in these Schedules; or (b) nisin. ANTIGENS for human therapeutic use except when separately specified in this Schedule. ANTIHISTAMINES except: (a) when included in Schedule 2 or 3; or (b) when separately specified in this Schedule. ANTIMONY for therapeutic use except when separately specified in these Schedules. ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules. # AOD-9604 (CAS No. 221231-10-3). APALUTAMIDE. APIXABAN. APOCYNUM spp. APOMORPHINE. APRACLONIDINE. APRAMYCIN. APREMILAST. APREPITANT. APROTININ. ARBUTIN (BETA) in oral preparations except herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose. ARECOLINE. ARIPIPRAZOLE. ARMODAFINIL. ARSENIC for human therapeutic use except when separately specified in these Schedules. ARTEMETHER. ARTICAINE. ASCIMINIB. ASENAPINE. ASFOTASE ALFA. ASPARAGINASE. ASPIRIN when: (a) combined with caffeine, paracetamol or salicylamide; or (b) combined with any derivative of the substances mentioned in paragraph (a); or (c) for injection. ASTEMIZOLE. ASUNAPREVIR. # ATAMESTANE. ATAZANAVIR. ATENOLOL. ATEZOLIZUMAB. ATIPAMEZOLE. ATOMOXETINE. ATORVASTATIN. ATOSIBAN. ATOVAQUONE. ATRACURIUM BESILATE. ATROPA BELLADONNA (belladonna) except when included in Schedule 2. ATROPINE except when included in Schedule 2. Substances marked # are listed in Appendix D ATROPINE METHONITRATE. AURANOFIN. AUROTHIOMALATE SODIUM. AVACOPAN. AVATROMBOPAG. AVELUMAB. AVILAMYCIN except: (a) in animal feed premixes containing 15% or less of avilamycin activity; or (b) in animal feeds containing 50 mg/kg or less of avilamycin activity. AVIPTADIL. AXITINIB. AVOPARCIN. AZACITIDINE. AZACYCLOLNOL. AZAPERONE. AZAPROPAZONE. AZARIBINE. AZATADINE except when included in Schedule 3. AZATHIOPRINE. AZELAIC ACID except: (a) when included in Schedule 2; or (b) in preparations containing 1% or less of azelaic acid for non-human use. AZELASTINE except when included in Schedule 2. AZITHROMYCIN. AZLOCILLIN. AZTREONAM. BACAMPICILLIN. BACITRACIN. BACLOFEN. BALOXAVIR MARBOXIL. BALSALAZIDE. BAMBERMYCIN (flavophospholipol) except: (a) when included in Schedule 6; or (b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances. BAMBUTEROL. BAMETHAN. BAMPINE. BARBITURATES except when separately specified in these Schedules. BARICITINIB. BASILIXIMAB. BAZEDOXIFENE. BECAPLERMIN. BECLAMIDE. BECLOMETASONE except when included in Schedule 2. BELATACEPT. BELIMUMAB. BELUMOSUDIL. BELZUTIFAN. BEMEGRIDE. BENACTYZINE. BENAZEPRIL. BENDAMUSTINE. BENDROFLUAZIDE. BENETHAMINE PENICILLIN. BENORYLATE. BENOXAPROFEN. BENPERIDOL. BENRALIZUMAB. BENSERAZIDE. BENZATHINE PENICILLIN. BENZILONIUM. BENZOCAINE except: (a) when included in Schedule 2; or (b) in dermal preparations containing 2% or less of total local anaesthetic substances; or (c) in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit. # BENZODIAZEPINE derivatives except when separately specified in these Schedules. BENZOYL PEROXIDE in preparations for human therapeutic use except: (a) when included in Schedule 2; or (b) in preparations for external use containing 5% or less of benzoyl peroxide. BENZPHETAMINE. BENZTHIAZIDE. BENZATROPINE. BENZYDAMINE except: (a) when included in Schedule 2; or (b) in preparations for dermal use; or (c) in divided topical oral preparations containing 3 mg or less of benzydamine; or (d) in undivided topical oral preparations containing 0.3% or less of benzydamine in a primary pack containing not more than 50 mL. BENZYLPENICILLIN. BEPRIDIL. BERACTANT. BESIFLOXACIN. BETAHISTINE. BETAMETHASONE. BETAXOLOL. BETHANECHOL CHLORIDE. BETHANIDINE. BEVACIZUMAB. BEVANTOLOL. # BEXAROTENE. BEZAFIBRATE. BEZLOTOXUMAB. BICALUTAMIDE. BICTEGRAVIR. BIFONAZOLE except: (a) when included in Schedule 2; or (b) in preparations for dermal use containing 1% or less of bifonazole for the treatment of the scalp; or (c) in preparations for dermal use for the treatment of tinea pedis. BILASTINE except when included in Schedule 3. BIMATOPROST. BINIMETINIB. BIPERIDEN. BISMUTH COMPOUNDS for cosmetic use, except: (a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5% or less; or (b) bismuth oxychloride. BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in dusting powders containing 3% or less of bismuth. BISOPROLOL. BIVALIRUDIN. BLEOMYCIN. BLINATUMOMAB. BOCEPREVIR. # BOLANDIOL. # BOLASTERONE. # BOLAZINE. # BOLDENONE (dehydrotestosterone). # BOLENOL. # BOLMANTALATE. BORON, including boric acid and borax, for human therapeutic use except: (a) in preparations for internal use containing 6 mg or less of boron per recommended daily dose; or (b) in preparations for dermal use containing 0.35% or less of boron, which are not for paediatric or antifungal use; or (c) when present as an excipient. BORTEZOMIB. # BOSENTAN. BOSUTINIB. BOTULINUM TOXINS for human use except when separately specified in these Schedules. BRENTUXIMAB VEDOTIN. BRETYLIUM TOSILATE. BREXPIPRAZOLE. BRIGATINIB. BRIMONIDINE except when included in Schedule 2. BRINZOLAMIDE. BRIVARACETAM. # BROMAZEPAM. BROMIDES, inorganic, for therapeutic use except when separately specified in these Schedules. BROMOCRIPTINE. BROMOFORM for therapeutic use. BROMPHENIRAMINE except when included in Schedule 2 or 3. BROMVALETONE. BRUGMANSIA spp. BUCLIZINE except when included in Schedule 3. BUDESONIDE except when included in Schedule 2. BUFEXAMAC. BUMETANIDE. BUPHENINE. BUPIVACAINE except when included in Schedule 5. BUPROPION. BUSERELIN. BUSPIRONE. BUSULPHAN. BUTACAINE. BUTAMBEN except in dermal preparations containing 2% or less of total local anaesthetic substances. BUTOCONAZOLE except when included in Schedule 3. BUTRACONAZOLE. BUTYLCHLORAL HYDRATE. BUTYL NITRITE. CABAZITAXEL. CABERGOLINE. CABOTEGRAVIR. CABOZANTINIB. CADMIUM COMPOUNDS for human therapeutic use. CAFFEINE for internal therapeutic use except: (a) in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 mg of total caffeine; or (b) in undivided preparations with a concentration of less than 5% of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 mg of total caffeine. CALCIFEDIOL for human internal therapeutic use except in preparations containing 10 micrograms or less of calcifediol per recommended daily dose. CALCIPOTRIOL. CALCITONIN. CALCITONIN SALMON. CALCITRIOL. CALCIUM CARBIMIDE for therapeutic use. CALCIUM HYDROXYLAPATITE in preparations for injection or implantation: (a) for tissue augmentation; or (b) for cosmetic use. CALCIUM POLYSTYRENE SULPHONATE. CALOTROPIS GIGANTEA. CALOTROPIS PROCERA. # CALUSTERONE. CAMPHORATED OIL for therapeutic use. CAMPHOTAMIDE. CANAGLIFLOZIN. CANAKINUMAB. CANDESARTAN CILEXETIL. CANDICIDIN. CANINE TICK ANTI-SERUM. CANNABIDIOL in preparations for therapeutic use or analytical and scientific research where: (a) cannabidiol comprises 98% or more of the total cannabinoid content of the preparation; and (b) any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the preparation; except when: (c) included in Schedule 3; or (d) in hemp seed oil at a concentration of 75 mg/kg or less. CANTHARIDIN. CAPECITABINE. CAPREOMYCIN. CAPTODIAME. CAPTOPRIL. CAPURIDE. CARAMIPHEN. CARBACHOL. CARBAMAZEPINE. CARBARYL for human therapeutic use. CARBAZOCHROME. CARBENICILLIN. CARBENOXOLONE for internal use. CARBETOCIN. CARBIDOPA. CARBIMAZOLE. CARBOCROMEN. CARBOPLATIN. CARBOPROST. CARBROMAL. CARBUTAMIDE. CARBUTEROL. CARFILZOM
1 Exempt preparations and products The following table specifies preparations and products for the purposes of paragraph 11(a). | Exempt preparations and products | |----------------------------------| | **Item** | **Column 1** | | | **Preparation or product** | | 1 | ALGICIDES, BACTERICIDES OR SLIMICIDES for industrial use that are not agricultural chemical products or veterinary chemical products | | 2 | BACTERIAL CULTURE MEDIA containing antibiotics | | 3 | CERAMICS | | 4 | CHEMISTRY SETS for toy and educational use, when complying with the requirements of Australian Standard AS 8124.4-2003, *Safety of toys, Part 4: Experimental sets for chemistry and related activities* | | 5 | COPPER COMPOUNDS in paints | | 6 | DEXTRANS, GELATIN - SUCCINYLATED & ETHERIFIED STARCHES used as plasma substitutes/blood volume expanders | | 7 | ELECTRICAL ACCUMULATORS, BATTERIES, COMPONENTS or LAMPS | | 8 | ELECTRONIC COMPONENTS | | 9 | ENHANCING AGENTS for use in ultrasonic and magnetic resonance imaging | | 10 | EXPLOSIVES | | 11 | FOOD except: | | (a) food additives before incorporation into food; or | | (b) when used as a means of administering a poison for therapeutic use | | 12 | FRITTED GLAZING OR ENAMELLING PREPARATIONS in which the poison is confined as a non-migratory component of glassy solid flakes or granules | | 13 | GLASS (including CRYSTAL WARE) | | 14 | GLAZED POTTERY | | 15 | HUMAN BLOOD PRODUCTS including: | | (a) whole blood; | | (b) blood components including red cells, white cells, platelets and plasma (including cryoprecipitate); and | | (c) the following plasma-derived therapeutic proteins; and their equivalent recombinant alternatives: | | (i) albumin; | | (ii) anticoagulation complex; | | (iii) C1 esterase inhibitors; | | (iv) clotting factors; | | (v) fibrinogen; | | (vi) protein C; | | (vii) prothrombin complex concentrate (PCC); | Clause 1 Exempt preparations and products | Item | Column 1 | |------|----------| | Preparation or product | | (viii) thrombin | | 16 | IN VITRO DIAGNOSTIC AND ANALYTICAL PREPARATIONS containing 0.001% or less of a poison included in Schedules 1 to 8 | | 17 | INTRAOCULAR VISCOELASTIC PRODUCTS | | 18 | LUBRICANTS in preparations that provide a lubricating action between machinery parts, except soluble oils and solvent-deposited lubricating agents | | 19 | MATCHES | | 20 | MEDICAL AND VETERINARY ADHESIVES, GLUES AND CEMENTS | | 21 | MEDICAL DEVICES classified as Class III by the classification rules set out in Schedule 2 to the Therapeutic Goods (Medical Devices) Regulation 2002, except the following: (a) injectable tissue reconstructive, augmentation and restoration materials, including collagen; (b) medical devices which include anticoagulants; (c) artificial tears; (d) urinary catheters; (e) intra-articular fluids | | 22 | MOTOR, HEATING or FURNACE FUELS except the following: (a) when the contrary intention appears in any Schedule; (b) when containing methanol; (c) toy or hobby fuels; or (d) petrol or kerosene when packed in containers having a capacity of 20 L or less | | 23 | NUTRITION REPLACEMENT PREPARATIONS FOR PARENTERAL ADMINISTRATION | | 24 | PAPER except: (a) when prepared for pesticidal use; or (b) when containing a poison included in Schedule 8 or 9 | | 25 | PHOTOGRAPHIC PAPER or FILM | | 26 | PIGMENTS when immobilised in a polymer | | 27 | PORCELAIN | | 28 | PRINTING INKS or INK ADDITIVES except: (a) when containing a pesticide; or (b) preparations containing more than 0.009% of lead calculated on the non-volatile content of the ink or ink additive | | 29 | RADIOGRAPHIC CONTRAST MEDIA (radiopaques) for therapeutic use | | 30 | RADIOISOTOPES for therapeutic use | | 31 | SEEDS treated with seed protectants | | 32 | SINGLE-USE TUBES for the estimation of alcohol content of breath | | 33 | TERMITE BARRIERS consisting of an active ingredient, other than arsenic, approved by the relevant registration authority, and laminated between impervious sheeting | | 34 | TIMBER or WALLBOARD | | 35 | TREATMENT LAYERS OF COATED METAL ARTICLES except articles intended for use in the collection of drinking water when not compliant with the health and safety | Clause 1 Exempt preparations and products | Item | Column 1 Preparation or product | |------|---------------------------------| | | requirements of the Australian Standard AS 4020:2018, *Testing of products for use in contact with drinking water* | | 36 | VITREOUS ENAMELS | | 37 | WRITING CORRECTION PENS which do not allow ingestion of the contents and which contain no scheduled poison other than designated solvents included in Schedule 5 | Clause 1 Appendix B—Substances considered not to require control by scheduling Note: See paragraph 11(b).
1 Reasons for including substances in the table in clause 3 For the purposes of the table in clause 3, the letter specified in column 1 of an item of the following table represents the reason specified in column 2 of the item. | Reasons for including substances in the table in clause 3 | |----------------------------------------------------------| | Item | Column 1 Letter | Column 2 Reason | |------|------------------|---------------------------------| | 1 | a | Low Toxicity | | 2 | b | Use pattern restricts hazard | | 3 | c | Presentation/packaging restricts hazard | | 4 | d | Industrial use only |
2 Areas of use in relation to substances included in the table in clause 3 For the purposes of the table in clause 3, the number specified in column 1 of an item of the following table represents the area, sub-area or sub-sub-area of use specified in column 2, 3 or 4 (as applicable) of the item. | Areas of use in relation to substances included in the table in clause 3 | |-------------------------------------------------------------------------| | Item | Column 1 Number | Column 2 Area | Column 3 Sub-area | Column 4 Sub-sub-area | |------|------------------|---------------------|--------------------------|----------------------------------------| | 1 | 1 | Agriculture | | | | 2 | 1.1 | | Herbicide | | | 3 | 1.2 | | Insecticide | | | 4 | 1.2.1 | | | Insecticide for codling moth | | 5 | 1.2.2 | | | Termiticide | | 6 | 1.3 | | Fungicide | | | 7 | 1.3.1 | | | On seed fungicide | | 8 | 1.4 | | Bird Repellent | | | 9 | 1.5 | | Fertiliser | | | 10 | 1.6 | | Plant Growth Regulator | | | 11 | 1.7 | | Insect Pheromone | | | 12 | 1.8 | | Mushroom Bactericide | | | 13 | 1.9 | | Acaricide | | | 14 | 1.10 | | Biological control agent | | | 15 | 1.11 | | Adjuvant in agricultural products | | Areas of use in relation to substances included in the table in clause 3 Item | Column 1 Number | Column 2 Area | Column 3 Sub-area | Column 4 Sub-sub-area --- | --- | --- | --- | ---
16 | 2 | Veterinary |
17 | 2.1 | For animal use |
18 | 2.2 | Treatment of mastitis in cows |
19 | 2.3 | Coccidiostat |
20 | 2.4 | Feed additive |
21 | 2.5 | Antiseptic |
22 | 2.6 | Scabicide |
23 | 2.7 | Anthelmintic |
24 | 2.8 | Vitamin/Mineral |
25 | 2.9 | Growth Promotant |
26 | 2.10 | Ectoparasiticide |
27 | 3 | Domestic |
28 | 3.1 | Aromatherapy |
29 | 3.2 | Food additive |
30 | 3.3 | Cosmetic |
31 | 3.4 | Human use |
32 | 3.5 | Miticide |
33 | 4 | Industrial |
34 | 4.1 | Water treatment |
35 | 4.2 | Biological control agent |
36 | 5 | Environmental |
37 | 5.1 | Mosquito control |
38 | 6 | Human therapeutic use |
39 | 6.1 | Diagnostic agent |
40 | 6.2 | Medical device |
41 | 6.3 | Antiseptic |
42 | 6.4 | Sunscreen |
43 | 6.5 | External use |
44 | 6.6 | Laxative |
45 | 6.7 | Antiseborrheic |
46 | 6.8 | Cytoprotective |
47 | 6.9 | Vitamin/Mineral |
48 | 6.10 | Eye Drops |
49 | 7 | General |
50 | 7.1 | Any use |
51 | 7.2 | Excipient |
52 | 7.3 | Synergist |
53 | 7.4 | Flux |
54 | 7.5 | Pesticide | Appendix B Substances considered not to require control by scheduling Clause 3 Areas of use in relation to substances included in the table in clause 3 | Item | Column 1 Number | Column 2 Area | Column 3 Sub-area | Column 4 Sub-sub-area | |------|------------------|----------------|--------------------|-----------------------| | 55 | 7.6 | Insect repellent | | | | 56 | 7.7 | Solvent | | | | 57 | 7.8 | Disinfectant | | | | 58 | 7.9 | Preservative | | | | 59 | 7.10 | Antioxidant | | | | 60 | 7.11 | Resin activator/accelerant | | | | 61 | 7.12 | Sweetener artificial | | | | 62 | 7.13 | Food additive | | |
3 Substances exempt in certain uses For the purposes of paragraph 11(b), the following table specifies: (a) substances; and (b) areas, sub-areas and sub-sub-areas of use in relation to those substances. Note: Columns 3 and 4 of the table are included for information only. Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|---------------------------------------------------------|-----------------------------------------------|--------------------------------|----------------------------| | 1 | 4-[4-(ACETYLOXY)PHENYL]-2-BUTANONE | 1.7 | b | Feb 2005 | | 2 | AFIDOPYROPEN | 1.2 | b | Jun 2018 | | 3 | ALCOHOL, DEHYDRATED | 6 | b | Aug 2000 | | 4 | ALUM | 7.1 | a | May 1997 | | 5 | ALUMINIUM AMMONIUM SULFATE | 7.1 | a | May 1997 | | 6 | ALUMINIUM POTASSIUM SULFATE | 7.1 | a | May 1997 | | 7 | ALUMINIUM SILICATE | 7.1 | a | Nov 1974 | | 8 | ALUMINIUM tris (ETHYLPHOSPHONATE) | 1 | a | Aug 1986 | | 9 | AMETOCTRADIN | 1.3 | a | May 2012 | | 10 | AMMONIUM PHOSPHATE | 7.1 | a | Nov 1974 | | 11 | AMMONIUM THIOSULPHATE | 7.1 | a | Nov 1974 | | 12 | AMPROLIUM | 2.3 | a | Jun 1969 | | 13 | AMYL ACETATE | 7.1 | a | Nov 1974 | | 14 | α-AMYLASE derived from Aspergillus niger | 2.4 | a | Feb 2005 | | 15 | AMYL CINNAMALDEHYDE | 3.3 | a, b | Feb 2017 | | 16 | ANDROSTENEDIONE ALBUMEN CONJUGATE WITH DEA DEXTRAN ADJUNCT | 2.1 | a | Jun 2004 | | 17 | ASPARTIC ACID | 6 | a | | Substances exempt in certain uses Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion ---|---|---|---|---
18 | ASULAM | 1 | a | May 1986
19 | AUREOBASIDIUM PULLULANS (strains DSM14940 and DSM14941) | 1.3 | a | Oct 2017
20 | AZIMSULFURON | 1.1 | a | Jun 2003
21 | BACILLUS AMYLOLIQUEFACIENS | 1.3 | a | Jun 2018
22 | BACILLUS SPHAERICUS, STRAIN 2362 | 5.1 | a | Feb 2003
23 | BACILLUS THURINGIENSIS | 5.1 | a | May 1992
24 | BACILLUS THURINGIENSIS (excluding endotoxin) | 2.10 | a | Jun 2003
25 | BACILLUS TOYOI | 2.9 | a | Aug 1980
26 | BACULOVIRUS CYDIA POMONELLA | 1.2 | a | Jun 2006
27 | BENFLURALIN | 1.1 | a | -
28 | BENSULFURON-METHYL | 1 | a | Aug 1987
29 | BENTONITE | 7.1 | a | Jun 2002
30 | BENZYL BENZOATE | 1.2 | a | Aug 1989
31 | BETAINE HYDROCHLORIDE | 7.1 | a | Nov 1974
32 | BIFENAZATE | 1.9 | a | Oct 2002
33 | BISMUTH SUBNITRATE | 2.1 | b, c | Nov 1999
34 | BISTRIFLURON | 1.2.2 | a | Feb 2014
35 | BIURET | 2.4 | a | Nov 1974
36 | BIXLOZONE | 1.1 | a | Feb 2020
37 | BLAD (banda de Lupinus albus doce) | 1.3 | a | Feb 2016
38 | BOSCALID | 1.3 | a | June 2003
39 | BOVINE SOMATOTROPHIN | 2 | a | May 1992
40 | BROMACIL | 1 | a | Aug 1987
41 | BROMOPROPYLATE | 1 | a | Nov 1994
42 | BUPIRIMATE | 1 | a | Nov 1990
43 | BUTAFENACIL | 1 | a | May 2000
44 | BUTOXYPOLYPROPYLENE GLYCOL | 7.7 | a | Nov 1974
45 | n-BUTYL BUTYRATE | 7.1 | a | -
46 | n-BUTYL LACTATE | 7.1 | a | -
47 | CARBOXIN | 1 | a | Aug 1987
48 | CARFENTRAZONE-ETHYL | 1 | a | Aug 1998
49 | CELLULASE derived from Aspergillus niger | 2.4 | a | Feb 2005
50 | CETYL ALCOHOL | 7.1 | a | Nov 1974
51 | CHAMOMILE OIL | 3.1 | a | Feb 2000
52 | CHINA CLAY | 1.2 | a | Sep 2008 Clause 3 Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|--------------------------------------------|-----------------------------------------------|-------------------------------|----------------------------| | 53 | CHLORANTRANILIPROLE | 1.2 | a | Sep 2008 | | 54 | CHLORFLUAZURON | 1.2.2 | a | Oct 2005 | | 55 | CHLORFLURENOL | 1.6 | a | Feb 1974 | | 56 | CHLORIDAZON | 1 | a | May 1988 | | 57 | CHLOROXYLENOLS | 7.8 | a | Feb 1975 | | 58 | CITRONELLA OIL | 7.1 | a | Feb 2000 | | 59 | CLARY SAGE OIL | 7.1 | a | Feb 2000 | | 60 | CLITORIA TERNATEA EXTRACT | 1.2 | a | Feb 2016 | | 61 | CLOPIDOL | 2.3 | d | Nov 1974 | | 62 | COBALT NAPHTHENATE | 7.1 | d | - | | 63 | CROSPOVIDONE | 2 | a | Aug 1996 | | 64 | CULICINOMYCES CLAVOSPORUS | 5.1 | a | Nov 1982 | | 65 | CYCLAMIC ACID | 7.1 | a | Nov 1971 | | 66 | CYCLANILIPROLE | 1.2 | a | Oct 2016 | | 67 | CYCLOBUTRIFLURAM | 1.3, 1.3.1 | a | Oct 2022 | | 68 | CYCLOHEXANE | 7.7 | a | Nov 1974 | | 69 | CYCLOHEXANOL ACETATE | 7.7 | a | - | | 70 | CYPRINID HERPESVIRUS-3 | 1.10 | a | Oct 2018 | | 71 | CYROMAZINE | 2 | a | Nov 1980 | | 72 | DICLAZURIL | 2.3 | a | Nov 2001 | | 73 | DIETHYL CARBONATE | 7.1 | a | - | | 74 | DIFLUFENICAN | 1 | a | Feb 1987 | | 75 | DIKEGULAC-SODIUM | 1.6 | a | Mar 1980 | | 76 | DIMETHYL ETHER | 4 | d | Nov 1988 | | 77 | DIMETICONE | 7.1 | a | - | | 78 | DIPHENYLAMINE | 1 | a | Feb 1988 | | 79 | DIPROPYLENE GLYCOL MONOMETHYL ETHER | 4 | a | Nov 1987 | | 80 | DISODIUM MANGANESE EDTA | 2.1 | a | Feb 2022 | | 81 | DIURON | 1 | a | Nov 1987 | | 82 | DOCUSATE SODIUM (DIOCTYL SODIUM SULFOSUCCINATE) | 7.1 | a | Feb 1970 | | 83 | 2,2-DPA | 1 | a | Nov 1989 | | 84 | DROMETRIZOLE TRISILOXANE | 6.4 | a | Oct 2003 | | 85 | DUDDINGTONIA FLAGRANS, STRAIN IAH 1297 | 2.7 | a | Feb 2018 | | 86 | ESPIRANTEL | 2 | a | Nov 1991 | | 87 | ETHAMETSULFURON-METHYL | 1.1 | a | Nov 2000 | Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|--------------------------------------------|-----------------------------------------------|-------------------------------|----------------------------| | 88 | ETHOPABATE | 2.3 | d | Jun 1969 | | 89 | ETHYL ACETATE | 7.1 | a | Nov 1974 | | 90 | ETHYL ALCOHOL | 7.1 | a | Nov 1974 | | 91 | ETHYLBUTYLACETYL AMINOPROPIONATE | 3.4 | a | Aug 2000 | | 92 | ETHYL BUTYRATE | 7.1 | a | - | | 93 | ETHYL LACTATE | 7.1 | a | - | | 94 | ETOFENPROX | 1.2 | a | Jun 2018 | | 95 | ETOXAZOLE | 1.2 | a | Oct 2003 | | 96 | EUBACTERIUM sp. strain DSM11798 | 2.4 | a | Sep 2013 | | 97 | FENFURAM | 1.3.1 | a | May 1977 | | 98 | FENHEXAMID | 1 | a | Feb 1999 | | 99 | FENOXYCARB | 1 | a | Feb 1988 | | 100 | FLORPYRAUXIFEN-BENZYL | 1, 1.1 | a | Feb 2018 | | 101 | FLORYLPICOXAMID | 1.3 | a | Feb 2021 | | 102 | FLUFENOXURON | 1 | a | Feb 1997 | | 103 | FLUMETSULAM | 1 | a | Feb 1992 | | 104 | FLUOMETURON | 1 | a | Aug 1989 | | 105 | FLUOPICOLIDE | 1.3 | a | Oct 2016 | | 106 | FLUOXAPIPROLIN | 1.3 | a | Feb 2022 | | 107 | FLUTOLANIL | 1.3 | a | Nov 2001 | | 108 | FLUROXYPYR | 1 | a, c | May 1986 | | 109 | FORCHLORFENURON | 1.6 | a | Feb 2005 | | 110 | FULLERS EARTH | 7.1 | a | Nov 1974 | | 111 | FUNGAL PROTEASE derived from Aspergillus niger | 2.4 | a | Feb 2005 | | 112 | GERANIUM OIL | 7.1 | a | Feb 2000 | | 113 | GIBBERELLIC ACID | 1.6 | a | Nov 1974 | | 114 | α-GLUCANASE derived from Aspergillus niger | 2.4 | a | Feb 2005 | | 115 | HALAUXIFEN METHYL | 1, 1.1 | a | Oct 2014 | | 116 | HELIONAL | 7 | a | Feb 2023 | | 117 | HEXAFLUORON | 1 | a | Nov 1988 | | 118 | HEXYL ACETATE | 7.7 | a | - | | 119 | HEXYL CINNAMALDEHYDE | 3.3 | a, b | Feb 2017 | | 120 | HEXYTHIAZOX | 1 | a | Feb 1988 | | 121 | HUMAN OSTEOGENIC PROTEIN-1 (OP-1) | 6.2 | b | Aug 2001 | | 122 | HYDROPRENE | 1 | a | Feb 1988 | Clause 3 Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|---------------------|-----------------------------------------------|-----------------------------|-----------------------------| | 123 | HYDROXYPROPYL CELLULOSE | 7.1 | a | Nov 1982 | | 124 | ICODEXTRIN | 6 | b | Nov 2000 | | 125 | INDOLE-3-ACETIC ACID | 1.6 | b | Feb 1985 | | 126 | IPFLUFENOQUIN | 1.3, 1.3.1 | a | Sep 2022 | | 127 | ISOPRENE ALCOHOL | 7.1 | a | - | | 128 | IPRODIONE | 1 | a | Feb 1997 | | 129 | ISETHIONATE, as mixed ammonium and ethanolamine salts of 2-hydroxyethanesulfonic acid | 1.11 | a, b | Jun 2016 | | 130 | ISOFETAMID | 1.3 | a | Feb 2018 | | 131 | ISOSTEARYL ALCOHOL ETHOXYLATE | 5.1 | a | Nov 1999 | | 132 | KAOLIN | 7.1 | a | Nov 1974 | | 133 | KINETIN | 1.6 | a | Feb 2022 | | 134 | KRESOXIM-METHYL | 1 | a | Aug 1999 | | 135 | KUNZEA OIL | 7.1 | a | Feb 2000 | | 136 | LAURIC ACID | 7.1 | a | Oct 2005 | | 137 | LAURYL ALCOHOL (1-DODECANOL) | 7.1 | a | Nov 1974 | | 138 | LAVANDIN OIL | 7.1 | a | Feb 2000 | | 139 | LAVENDER OIL | 7.1 | a | Feb 2000 | | 140 | LEAD METALLIC | 7.1 | a | - | | 141 | LEPIDOPTEROUS SEX PHEROMONES | 1 | a | Nov 1990 | | 142 | LIMONENE (DIPENTENE) | 7.1 | a | Jun 2002 | | 143 | LINOLEIC ACID | 7.1 | a | Oct 2005 | | 144 | LINSEED FATTY ACIDS | 2.1 | a | Aug 1990 | | 145 | LINURON | 1 | a | Feb 1990 | | 146 | LIQUORICE, DEGLYCYRRHISINISED | 7.1 | a | May 1999 | | 147 | MAGNESIUM HYDROXIDE | 7.1 | a | Jun 2021 | | 148 | MALEIC HYDRAZIDE | 1 | a | Nov 1992 | | 149 | MANGANESE DIOXIDE | 1 | b | May 1999 | | 150 | MEGASPHAERA ELSDENII strain 41125 | 2.4 | a | Sep 2013 | | 151 | MESOSULFURON-METHYL | 1.1 | a | Feb 2002 | | 152 | METARHIZIUM ANISOPLIAE | 4.2 | b | Feb 2000 | | 153 | METARHIZIUM ANISOPLIAE | 1.10 | a | Jun 2003 | | 154 | METCAMIFEN | 1.1 | a | Feb 2020 | | 155 | METHOPRENE | 1 | a | Aug 1987 | | 156 | METHOXYFENOZIDE | 1 | a | Nov 2000 | | 157 | METHYL ACETATE | 7.7 | a | - | | 158 | METHYL BENZOQUATE | 2.3 | d | Nov 1974 | Substances exempt in certain uses Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion ---|---|---|---|---
159 | 1-METHYLCYCLOPROPENE | 1.6 | a | Jun 2003
160 | METHYL p-HYDROXYBENZOATE | 7.9 | a | Nov 1974
161 | METSULFURONMETHYL | 1.1 | a | Nov 1985
162 | MYRISTIC ACID | 7.1 | a | Oct 2005
163 | NAPROPAMIDE | 1 | a | Aug 1987
164 | NAPHTHYL ACETAMIDE | 1.6 | a | Nov 1974
165 | NEROLI OIL | 7.1 | a | Feb 2000
166 | NICARBAZIN | 2.3 | d | Jun 1969
167 | NISIN | 3.2 | a | Jun 2003
168 | NORFLURAZON | 1.1 | a | Nov 1983
169 | NOVALURON | 1 | a | Nov 2000
170 | NUCLEAR POLYHEDROSIS VIRUS of Helicoverpa armigera occlusion bodies | 1.2 | a | Feb 2004
171 | OCTYL ALCOHOLS | 7.1 | a | Nov 1974
172 | OLEIC ACID | 7.1 | a | Oct 2005
173 | ORANGE OIL, SWEET | 7.1 | a | Aug 2000
174 | OXABETRINIL | 1 | a | Feb 1987
175 | OXATHIAPIPROLIN | 1.3 | a | Jun 2016
176 | OXYFLUORFEN | 1 | a | May 2001
177 | PALMAROSA OIL | 7.1 | a | Feb 2000
178 | PALMITIC ACID | 7.1 | a | Oct 2005
179 | PATCHOULI OIL | 7.1 | a | Feb 2000
180 | PECTINASE derived from Aspergillus niger | 2.4 | a | Feb 2005
181 | PEGBOVIGRASTIM | 2.1 | a | Jun 2017
182 | PENCYCURON | 1 | a | Aug 1994
183 | PENTADECANOIC ACID | 7.1 | a | Oct 2005
184 | PEPPERMINT OIL | 7.1 | a | Feb 2000
185 | PHENMEDIPHAM | 1.1 | a | May 1989
186 | D-PHENOTHRIN | 7.5, 1.2 | a | Feb 1982
187 | PHYTASE | 2.4 | a | Feb 1996
188 | PICLORAM | 1 | a | Aug 1987
189 | PICOLINAFEN | 1 | a | May 2000
190 | PIMELIC ACID | 7.1 | a | Oct 2005
191 | PIPERONYL BUTOXIDE | 7.5 | a | Aug 1991
192 | POLOXALENE | 7.1 | a | Nov 1974
193 | POLY DIALKYL DIMETHYL AMMONIUM CHLORIDE (PolyDADMAC) | 4.1 | a | Nov 1997 Clause 3 Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|-----------------------------------------------|-----------------------------------------------|-------------------------------|----------------------------| | 194 | POLYHEDROSIS VIRUS of Helico zea occlusion bodies | 1 | a | Nov 1996 | | 195 | POLY (GNRF) OVALBUMIN | 2 | a | Feb 1990 | | 196 | POLYSORBATE 20 | 1 | a | May 2001 | | 197 | PORCINE SOMATOTROPHIN | 2 | c | Nov 1991 | | 198 | POTASSIUM SORBATE | 1.3 | a | Oct 2004 | | 199 | POTASSIUM BICARBONATE | 1 | a | Jun 2004 | | 200 | PROPYL ACETATES | 7.1 | a | - | | 201 | PROPYLENE GLYCOL | 7.1 | a | Nov 1974 | | 202 | 2-PROPYLENE GLYCOL 1-MONOMETHYL ETHER | 4 | a | Nov 1987 | | 203 | PROTHIOCONAZOLE | 1.3.1 | a | Jun 2005 | | 204 | PSEUDOMONAS FLUORESCENS | 1.8 | a | May 1985 | | 205 | PYDIFLUMETOFEN | 1.3 | a | Feb 2018 | | 206 | PYRIMETHANIL | 1 | a | Feb 1996 | | 207 | PYRIPROXYFEN | 1 | a | Aug 1994 | | 208 | QUASSIA | 6, 2.1 | d | Nov 1974 | | 209 | QUINOXYFEN | 1.3 | a | Nov 2001 | | 210 | RHIZOBIUM RHIZOGENES | 1 | b | Nov 1989 | | 211 | ROSEMARY OIL | 7.1 | a | Feb 2000 | | 212 | SAGE OIL (Spanish) | 7.1 | a | Feb 2000 | | 213 | SANDALWOOD OIL | 7.1 | a | Feb 2000 | | 214 | SEAWEED & UNFRACTIONED SEAWEED EXTRACTS | 1.5 | d | Feb 1985 | | 215 | SILVER OXIDE | 7.14 | b | Jun 2018 | | 216 | SIMAZINE | 1.1 | a | Nov 1987 | | 217 | SODIUM BICARBONATE | 1 | a | Jun 2004 | | 218 | SODIUM PROPIONATE | 1.3 | a | Oct 2004 | | 219 | STERIC ACID | 7.1 | a | Oct 2005 | | 220 | STREPTOMYCES LYDICUS WYEC 108 | 1.3 | a | Oct 2016 | | 221 | SUCRALFATE | 6.8 | a | Aug 1982 | | 222 | SULESOMAB | 6.1 | b | Jun 2002 | | 223 | SULFOSULFURON | 1 | a | Feb 1998 | | 224 | SULPHATED POLYSACCHARIDES | 7.1 | a | - | | 225 | TANNIC ACID | 7.1 | a | Dec 1965 | | 226 | TANNIC ACID/BENZYL ALCOHOL PRODUCT | 7.1 | a | Nov 1993 | | 227 | TERBACIL | 1 | a | Aug 1987 | Substances exempt in certain uses | Item | Column 1 Substance | Column 2 Area, sub-area or sub-sub-area of use | Column 3 Reason for inclusion | Column 4 Date of inclusion | |------|----------------------------------------|-----------------------------------------------|-------------------------------|----------------------------| | 228 | THAUMATIN | 3.2 | a | Nov 1990 | | 229 | THIDIAZURON | 1 | a | Nov 1989 | | 230 | TIAFENACIL | 1 | a | June 2019 | | 231 | TRIASULFURON | 1 | a | Feb 1988 | | 232 | TRICHODERMA HARZIANUM | 1 | a | May 1996 | | 233 | (Z)-9-TRICOSENE | 1 | a | Aug 1991 | | 234 | TRIETHYLENE GLYCOL | 7.1 | a | Nov 1974 | | 235 | TRIFLOXYSULFURON | 1.1 | a | Feb 2002 | | 236 | TRIFLURALIN | 1 | a | Aug 1990 | | 237 | TRIFORINE | 1 | a | Aug 1987 | | 238 | ULOCLADIUM OUDEMANSII | 1.10 | a | Oct 2003 | | 239 | UREA | 7.1 | a | Nov 1974 | | 240 | ¹³C-UREA | 6.1 | a | May 2001 | | 241 | VETIVER OIL | 7.1 | a | Feb 2000 | | 242 | VINYL ETHER | 6 | b | Nov 1987 | | 243 | VITAMIN K | 6.9, 2.8 | a | Jul 1963 | | 244 | XANTHOPHYLL (lutein) | 7.1 | a | Nov 1974 | | 245 | XYLANASE derived from Aspergillus niger | 2.4 | a | Feb 2005 | | 246 | YLANG YLANG OIL | 7.1 | a | Feb 2000 | | 247 | ZINC NAPHTHENATE | 1.3 | a | - | Appendix C—Blank Note 1: Appendix C is intentionally blank. Note 2: Appendix C previously included poisons now included in Schedule 10. Appendix D—Additional controls on possession or supply of poisons included in Schedule 4 or 8 Note: See section 64.
1 Poisons available for human use only from or on the prescription or order of an authorised medical practitioner A poison specified in the following table may be supplied for human use only by, on the prescription or order of, an authorised medical practitioner. | Item | Poison | |------|--------------------------------------------------------------------------------------------| | 1 | CANNABIS for human use | | 2 | CLOMIFENE for human use | | 3 | CLOZAPINE for human use | | 4 | CORIFOLLITROPIN ALFA (recombinant follicle stimulant) for human use | | 5 | CYCLOFENIL for human use | | 6 | DINOPROST for human use | | 7 | DINOPROSTONE for human use | | 8 | FOLLITROPIN ALFA (recombinant human follicle-stimulating hormone) for human use | | 9 | FOLLITROPIN BETA (recombinant human follicle-stimulating hormone) for human use | | 10 | FOLLITROPIN DELTA (recombinant human follicle-stimulating hormone) for human use | | 11 | LUTEINISING HORMONE for human use | | 12 | NABIXIMOLS for human use | | 13 | SODIUM OXYBATE for human use | | 14 | TETRAHYDROCANNABINOLS for human use | | 15 | TERIPARATIDE for human use | | 16 | UROFOLLITROPIN (human follicle-stimulating hormone) for human use |
2 Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist A poison specified in the following table may be supplied for human use: (a) only by, or on the prescription or order of, a specialist physician or a dermatologist; and (b) if the person to whom the poison is to be supplied is a woman of child-bearing age—only if the specialist physician or dermatologist has: (i) ensured that the possibility of pregnancy has been excluded prior to commencement of treatment; and (ii) if the poison is acitretin or etretinate—advised the patient to avoid becoming pregnant during or for a period of 36 months after completion of treatment; and (iii) if the poison is bexarotene, isotretinoin or thalidomide—advised the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment. Appendix D Additional controls on possession or supply of poisons included in Schedule 4 or 8 Clause 3 | Item | Poison | |------|--------| | 1 | ACITRETIN for human use | | 2 | BEXAROTENE for human use | | 3 | ETRETINATE for human use | | 4 | ISOTRETINOIN for human oral use | | 5 | THALIDOMIDE for human use |
3 Poisons available only from or on the prescription or order of a medical practitioner approved or authorised under section 19 of the Act A poison specified in the following table may be supplied only by, or on the prescription or order of, a medical practitioner for whom an approval or authority under section 19 of the Act that covers the poison is in force. | Item | Poison | |------|--------| | 1 | DRONABINOL (delta-9-tetrahydrocannabinol) |
4 Poisons available only from or on the order of a specialist physician A poison specified in the following table may be supplied: (a) only by, or on the prescription or order of, a specialist physician; and (b) if the person to whom the poison is to be supplied is a woman of child-bearing age—only if the specialist physician has: (i) ensured that the possibility of pregnancy has been excluded prior to commencement of treatment; and (ii) advised the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment. | Item | Poison | |------|--------| | 1 | LENALIDOMIDE | | 2 | POMALIDOMIDE | | 3 | RIOCIGUAT for human use | | 4 | TRETINOIN for human oral use |
5 Poisons for which possession without authority is illegal The following table specifies poisons that must not be possessed by a person without authority (for example, possession other than in accordance with a legal prescription). | Item | Poison | |------|--------| | 1 | ANABOLIC STEROIDAL AGENTS, including those separately specified in Schedule 4 | | 2 | ANDROGENIC STEROIDAL AGENTS, including those separately specified in Schedule 4 | | 3 | AOD-9604 (CAS No. 221231-10-3) | Clause 6 | Item | Poison | |------|--------| | 4 | BENZODIAZEPINE DERIVATIVES, including those separately specified in Schedule 4 and Schedule 8 | | 5 | CJC-1295 (CAS No. 863288-34-0) | | 6 | DARBEPOETIN | | 7 | DEXTROPROPOXYPHENE | | 8 | N, α-DIMETHYL-3,4-(METHYLENEDIOXY)PHENYLETHYLAMINE *(MDMA) | | 9 | EPHEDRINE | | 10 | EPOETINS | | 11 | ERYTHROPOIETIN | | 12 | ERYTHROPOIETINS except when separately specified in this Appendix | | 13 | FIBROBLAST GROWTH FACTORS | | 14 | FOLLISTATIN | | 15 | GLUTETHIMIDE | | 16 | GROWTH HORMONE RELEASING HORMONES (GHRHs) including those separately specified in Schedule 4 | | 17 | GROWTH HORMONE RELEASING PEPTIDES (GHRPs) including those separately specified in Schedule 4 | | 18 | GROWTH HORMONE RELEASING PEPTIDE-6 (GHRP-6) | | 19 | GROWTH HORMONE SECRETAGOGUES including those separately specified in Schedule 4 | | 20 | HEXARELIN | | 21 | IBUTAMOREN | | 22 | INSULIN-LIKE GROWTH FACTORS | | 23 | IPAMORELIN | | 24 | NICOTINE | | 25 | PERAMPANEL for human use | | 26 | PHENTERMINE | | 27 | PRALMORELIN (GROWTH HORMONE RELEASING PEPTIDE-2) (GHRP-2) | | 28 | PSILOCYBINE | | 29 | SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARM), including those separately specified in Schedule 4 | | 30 | SOMATROPIN (human growth hormone) | | 31 | STENABOLIC (SR9009) and other synthetic REV-ERB agonists | | 32 | TB-500 | | 33 | THYMOSIN BETA 4 (THYMOSIN β4) | | 34 | TIANEPTINE | | 35 | VADAUSTAT |
6 Poisons available for human use only from or on the prescription or order of a specialist physician A poison specified in the following table may be supplied for human use: (a) only by, or on the prescription or order of, a specialist physician; and Clause 7 (b) if the person to whom the poison is to be supplied is a woman of child-bearing age—only if the specialist physician has: (i) ensured that the possibility of pregnancy has been excluded prior to commencement of treatment; and (ii) advised the patient to avoid becoming pregnant during and for a period of 3 months after completion of treatment. | Item | Poison | |------|---------------------------------| | 1 | AMBRISENTAN for human use | | 2 | BOSENTAN for human use | | 3 | ENZALUTAMIDE for human use | | 4 | MACITENTAN for human use | | 5 | SITAXENTAN for human use |
7 Poisons available for human use only from or on the prescription or order of a dermatologist A poison specified in the following table may be supplied for human use only by, or on the prescription or order of, a dermatologist. | Item | Poison | |------|---------------------------------| | 1 | ALEFACEPT for human use |
8 Poisons available for initial treatment of a patient only if authorised by certain health practitioners HYDROXYCHLOROQUINE may be supplied, for human use, for the initial treatment of a patient only if that treatment is authorised by: (a) a medical practitioner registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law as a specialist in any of the following specialties or fields of specialty practice: (i) dermatology; (ii) emergency medicine; (iii) intensive care medicine; (iv) paediatrics and child health; (v) physician; or (b) a dental practitioner registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law as a specialist in the specialty of oral medicine.
9 Poisons which must be stored in a locked container to prevent unauthorised access The following table specifies poisons that must be stored in a locked container to prevent unauthorised access. Item | Poison ---|---
1 | PENTOBARBITAL in injectable preparations
10 Poisons available only when prescribed or authorised in certain circumstances N, α-DIMETHYL-3,4-(METHYLENEDIOXY)PHENYLETHYLAMINE *(MDMA) in preparations for human use may be supplied only for the treatment of post-traumatic stress disorder: (a) if MDMA is prescribed, or its supply is authorised, by a medical practitioner: (i) registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law as a specialist psychiatrist; and (ii) for whom an authority under subsection 19(5) of the Act that covers MDMA is in force; or (b) for use in a clinical trial that is approved by, or notified to, the Secretary under the Act. PSILOCYBINE in preparations for human use may be supplied only for the treatment of treatment-resistant depression: (a) if psilocybine is prescribed, or its supply is authorised, by a medical practitioner: (i) registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law as a specialist psychiatrist; and (ii) for whom an authority under subsection 19(5) of the Act that covers psilocybine is in force; or (b) for use in a clinical trial that is approved by, or notified to, the Secretary under the Act. Clause 1 Appendix E—First aid instructions for poisons Note: See section 31.
1 Standard statements for first aid instructions For the purposes of the table in clause 3, the statement code specified in column 2 of an item of the following table represents: (a) the statement specified in column 3 of the item; or (b) a different statement that has the same intent as the statement specified in column 3 of the item. Standard statements for first aid instructions | Item | Column 1 Category | Column 2 Statement code | Column 3 Statement | |------|--------------------|-------------------------|--------------------| | 1 | Basic | A | For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once). | | 2 | Basic | Z | First aid is not generally required. If in doubt, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor. | | 3 | General | G1 | Urgent hospital treatment is likely to be needed. (Note - the words “at once” to be added to instruction A). | | 4 | General | G2 | If swallowed, give activated charcoal if instructed. (Note - the words “at once” to be added to instruction A). | | 5 | General | G3 | If swallowed, do NOT induce vomiting. | | 6 | General | G4 | Immediately give a glass of water. | | 7 | General | G5 | Avoid giving milk or oils. | | 8 | General | G6 | If sprayed in mouth, rinse mouth with water. | | 9 | Eyes | E1 | If in eyes wash out immediately with water. | | 10 | Eyes | E2 | If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes. | | 11 | Respiratory system| R1 | If inhaled, remove from contaminated area. Apply artificial respiration if not breathing. | | 12 | Respiratory system| R2 | If swallowed or inhaled, remove from contaminated area. Apply artificial respiration if not breathing. Do not give direct mouth-to-mouth resuscitation. To protect rescuer, use air-viva, oxy-viva or one-way mask. Resuscitate in a well-ventilated area. | | 13 | Skin | S1 | If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water. | | 14 | Skin | S2 | If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water. Continue flushing with water until advised to stop by a Poisons Information Centre (e.g. | Clause 2 Standard statements for first aid instructions | Item | Column 1 Category | Column 2 Statement code | Column 3 Statement | |------|--------------------|-------------------------|--------------------| | 15 | Skin | S3 | If on skin, remove any contaminated clothing, wash skin thoroughly with soap and water, then methylated spirit if available. Contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor. | | 16 | Skin | S4 | If on skin, immediately remove any contaminated clothing, wash skin with methylated spirit or PEG (polyethylene glycol) 300 or 400 if available, then flush under running water until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor. | | 17 | Skin | S5 | If skin contact occurs, immediately remove contaminated clothing. Flush skin under running water for 15 minutes. Then apply calcium gluconate gel. Contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766). | | 18 | Special Purpose | SP1 | If swallowed, splashed on skin or in eyes, or inhaled, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor at once. Remove any contaminated clothing and wash skin thoroughly. If swallowed, activated charcoal may be advised. Give atropine if instructed. |
2 Poisons information centre contact information in statements A statement required for a poison that includes a reference to a Poisons Information Centre must include: (a) the telephone number that is appropriate to the country or countries in which the poison is to be supplied; and (b) immediately following the reference to a Poisons Information Centre: (i) the national telephone number for the Poisons Information Centre in Australia (13 11 26); or (ii) the telephone number for another poisons information centre: (A) that is attended by adequately trained staff for 24 hour emergency poisons information; and (B) calls to which are logged and submitted for incorporation into the official collection of poisoning data. Note: For subparagraph (b)(ii), in 2022 the Poisons Information Centre telephone number in New Zealand was 0800 764 766.
3 First aid instructions for poisons
For the purposes of subsection 31(1), and subject to subclause (2), the statement represented by each statement code specified in column 2 of an item of the following table is required for the poison specified in column 1 of the item.
A statement required for a poison must: Appendix E First aid instructions for poisons Clause 3 (a) be modified for its use in relation to that poison as appropriate for the poison (for example if the poison is combined with other substances (whether toxic or non-toxic) or is in a particular physical form or presentation); and (b) if the statement refers to a Poisons Information Centre—comply with clause 2. Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 1 | ACETIC ACID | A, G3, E2, S1 | | 2 | ACETIC ANHYDRIDE | A, G3, E2, S1 | | 3 | ACETONE | A, G3 | | 4 | ACROLEIN | A, G1, G2, G3, E2, R2, S2 | | 5 | ALKALINE SALTS | A, G3, E2, S1 | | 6 | ALKYL NITRITES | A | | 7 | AMIDOPROPYL BETAINES—in cosmetic wash-off preparations when included in Schedule 6 | E1 | | 8 | AMIDOPROPYL BETAINES—in other preparations when included in Schedule 6 | E1, S1 | | 9 | AMINES for use as curing agents | A, G3, E1, S1 | | 10 | 2-AMINO-6-CHLORO-4-NITROPHENOL | A, E1 | | 11 | 4-AMINO-m-CRESOL | A, E1 | | 12 | 2-AMINO-5-ETHYLPHENOL | A | | 13 | 4-AMINO-2-HYDROXYTOLUENE | A, E1 | | 14 | 4-AMINO-3-NITROPHENOL | A | | 15 | 2,2'-[(4-AMINO-3-NITROPHENYL)IMINO]BISETHANOL | E1 | | 16 | m-AMINOPHENOL | A, S1 | | 17 | p-AMINOPHENOL | A, S1 | | 18 | 4-AMINOPYRIDINE | A, G1, G2, E1, S1 | | 19 | AMMONIA—5% or less | A | | 20 | AMMONIA—above 5% | A, G3, E1, R1, S1 | | 21 | AMMONIUM COCOYL ISETHIONATE | E1 | | 22 | AMMONIUM PERSULFATE | A, G3, E2 | | 23 | AMMONIUM THIOCYANATE | A | | 24 | AMYL NITRITE | A | | 25 | ANHYDRIDES, organic acid, for use as curing agents for epoxy resins | A, G3, E1, S1 | | 26 | ANILINE | A, E2, R1, S1 | | 27 | ANISE OIL | A, G3 | | 28 | ANTIMONY CHLORIDE | A, E2, S2 | | 29 | ANTIMONY COMPOUNDS, except antimony chloride | A | | 30 | ARBUTIN when included in Schedule 6 | A, G2, G3, E2, R2, S1 | Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 31 | AZADIRACHTA INDICA (neem) including its extracts and derivatives when included in Schedule 6 | A, E1 | | 32 | AZO DYES (derivatives by diazotisation) | A | | 33 | BARIUM SALTS, except barium sulfate | A | | 34 | BASIC RED 76 | A | | 35 | BASIL OIL | A, G3 | | 36 | BAY OIL | A, G3 | | 37 | BENZALKONIUM CHLORIDE—when included in Schedule 5 | A, G3, E2 | | 38 | BENZALKONIUM CHLORIDE—when included in Schedule 6 | A, G3, E2, S1 | | 39 | BENZENE | A, G3, E1, R1, S1 | | 40 | 1,2-BENZENEDIOL (Catechol) | A, E1, S1 | | 41 | BENZOYL PEROXIDE—above 20% | A, E2, S1 | | 42 | BENZOYL PEROXIDE—above 10% up to 20% | A, E1 | | 43 | BENZOYL PEROXIDE—10% or less | A | | 44 | BERGAMOT OIL | A, G3 | | 45 | BIFLUORIDES (including ammonium, potassium and sodium salts)—when included in Schedule 5 | A | | 46 | BIFLUORIDES (including ammonium, potassium and sodium salts)—when included in Schedule 6 or 7 | A, G3, E2, S5 | | 47 | 1,3-BIS(2,4-DIAMINOPHENOXY)PROPANE | E1, S1 | | 48 | BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETICONE COPOLYMER | A, E1 | | 49 | BORAX | A | | 50 | BORIC ACID | A | | 51 | BORON TRIFLUORIDE—when included in Schedule 5 | A | | 52 | BORON TRIFLUORIDE—when included in Schedule 6 or 7 | A, G3, E2, S5 | | 53 | BROMOFORM | A, G3, E2, R1, S2 | | 54 | BRUCINE | A, G1, G2, G3, R2 | | 55 | 2-BUTOXYETHANOL and its acetates | A, E2, S1 | | 56 | n-BUTYL ALCOHOL | A, E1, S1 | | 57 | BUTYL NITRITE | A | | 58 | CADMIUM COMPOUNDS | A | | 59 | CAJUPUT OIL | A, G3 | | 60 | CAMPHOR | A, G1, G3, G5 | | 61 | CARBAMIDE PEROXIDE—more than 9% up to 60% | A, G3, E2, S1 | | 62 | CARBAMIDE PEROXIDE—more than 60% | A, G1, G3, G4, E2, S1 | | 63 | CARBON DISULFIDE | A, G3, E2, R1, S2 | | 64 | CARBON TETRACHLORIDE | A, G3, E1, R1, S1 | | 65 | CASSIA OIL | A, G3 | Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|-------------------------------------------------------------------------------------------------------------|--------------------------------| | 66 | CHLORINATING COMPOUNDS, except when separately specified—containing above 4% and below 10% of available chlorine | A, G3, E1, S1 | | 67 | CHLORINATING COMPOUNDS, except when separately specified—containing 10% or more of available chlorine | A, G3, E2, S1 | | 68 | CHLORIDE (gas) | A, E1, R1 | | 69 | CHLOROACETAMIDE | A | | 70 | CHLOROCRESOL | A, G3, E2, S2 | | 71 | 2-CHLORO-6-(ETHYLAMINO)-4-NITROPHENOL | A, S1 | | 72 | CHLOROFORM | A, G3, E1, R1, S1 | | 73 | CHROMATES | A, G3, E2, S1 | | 74 | CHROMIUM TRIOXIDE | A, G3, E2, S1 | | 75 | CHRYSOIDINE BASE | A, S1, E1 | | 76 | CINEOLE | A, G1, G3 | | 77 | CINNAMON BARK OIL | A, G3 | | 78 | CINNAMON LEAF OIL | A, G3 | | 79 | CLIMBAZOLE | A | | 80 | CLOVE OIL | A, G1, G3, E2 | | 81 | COCOYL GLYCINATE | E1 | | 82 | COPPER SULFATE | A, G3, E2, S1 | | 83 | CREOSOTE | A, G3, E2, S1 | | 84 | CRESOLS | A, G3, E2, S3 | | 85 | CRESOLS in pressurised spray packs | A, G6, E1, S1 | | 86 | CYANIDES | A, G1, E1, R2 | | 87 | CYANOACRYLIC ACID ESTERS | A | | 88 | CYANURIC ACID | A | | 89 | CYCLOHEXANONE PEROXIDE | A, G3, E2, S1 | | 90 | CYCLOSILAZANES, DI-ME, ME HYDROGEN, POLYMERS WITH DI-ME, ME HYDROGEN SILAZANES, REACTION PRODUCTS WITH | A, E2, S1 | | | 3-(TRIETHOXYSILYL)-1-PROPANAMINE (CAS 475645-84-2) | | | 91 | CYCTEAMINE | E1 | | 92 | 1-DEOXY-1-(METHYLAMINO)-d-GLUCITOL N-COCO ACYL DERIVATIVES | E1 | | 93 | 2,4-DIAMINOPHENOXYETHANOL | A, E2, S1 | | 94 | o-DICHLOROBENZENE | A, G3, E1, S1 | | 95 | para-DICHLOROBENZENE (PDB) | A | | 96 | DICHLOROETHYL ETHER | A, G3, E1, R1, S1 | | 97 | DICHLOROISOCYANURATES | A, G3, E1, S1 | | 98 | DICHLOROMETHANE (methylene chloride) | A, G3, G5, E1, R1, S1 | First aid instructions for poisons Appendix E Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 99 | DICHLOROMETHANE (methylene chloride)—in pressurised spray packs | A, G6, S1 | | 100 | DICHROMATES | A, G1, G3, E2, S1 | | 101 | DIDECYLDIMETHYLAMMONIUM SALTS | A, G3 | | 102 | DIESEL (distillate) | A, G3 | | 103 | DIETHANOLAMINE—when included in Schedule 5 | A, G3 | | 104 | DIETHANOLAMINE—when included in Schedule 6 | A, G3, E2, S1 | | 105 | DIETHYLENE GLYCOL MONOBUTYL ETHER | A, E1, S1 | | 106 | 5,6-DIHYDROXYINDOLINE | E1 | | 107 | DIMETHYLFORMAMIDE—less than 75% | A | | 108 | DIMETHYLFORMAMIDE—75% or more | A, E1, R1, S1 | | 109 | 4,4-DIMETHYL-1-CYCLOHEXENE-1-PROPANAL | A, E2 | | 110 | 3,7-DIMETHYL-2,6-OCTADIEN-1-OL | A, E1, S1 | | 111 | DIMETHYL SULFOXIDE | A, G3, E1, S1 | | 112 | DINITROCRESOLS | A, G1, E1, S1 | | 113 | DINITROPHENOLS | A, G1, E1, S1 | | 114 | DIOXANE | A, G3, E1, R1, S1 | | 115 | DISPERSE YELLOW 3 | A, S1 | | 116 | DISTILLATE | A, G3 | | 117 | N-(N-DODECYL)-2-PYRROLIDONE—when included in Schedule 5 | A, G3, E1 | | 118 | N-(N-DODECYL)-2-PYRROLIDONE—when included in Schedule 6 | A, G3, E2, S1 | | 119 | EPOXY RESINS liquid | A, G3, E2, S1 | | 120 | Essential oils containing CAMPHOR as natural component unless otherwise specified | A, G3 | | 121 | ETHER | A, G3, E1, R1 | | 122 | ETHYL BROMIDE | A, E2, S1, R1 | | 123 | ETHYLENE GLYCOL | A | | 124 | ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates, except when separately specified | A, G3, E2, S1 | | 125 | ETHYLENE OXIDE | A, E2, R1 | | 126 | ETHYLHEXANEDIOL | A, E2 | | 127 | 2-ETHYLHEXANOIC ACID | A | | 128 | EUCALYPTUS OIL | A, G1, G3 | | 129 | EUGENOL | A, G1, G3, E2 | | 130 | FENNEL OIL | A, G3 | | 131 | FLUORIDES except when separately specified—when included in Schedule 5 | A | | 132 | FLUORIDES except when separately specified—when included in Schedule 6 | A, G1, G3, E2, S1 | Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 133 | FORMALDEHYDE (see also paraformaldehyde) | A, G3, E2, R1, S1 | | 134 | FORMIC ACID | A, G3, E2, S1 | | 135 | FURFURAL | A, E1, S1 | | 136 | GLUTARAL—below 5% | A, G3, E1 | | 137 | GLUTARAL—5% or more | A, G3, E2, S1 | | 138 | GLYCOLIC ACID | A, G3, E2 | | 139 | GUANIDINE when included in Schedule 6 | A, G3, E2, S1 | | 140 | HC VIOLET 1 | E1 | | 141 | HEXACHLOROPHENE when included in Schedule 6 | A | | 142 | HEXYLOXYETHANOL | A, G3, E2, S1 | | 143 | HYDRAZINE | A, G1, G3, E2, R1, S1 | | 144 | HYDROCARBONS, liquid | A, G3 | | 145 | HYDROCHLORIC ACID | A, G3, E2, S1 | | 146 | HYDROCHLORIC ACID—when included in Schedule 5 | A, G3 | | 147 | HYDROFLUORIC ACID and admixtures that generate hydrofluoric acid—when included in Schedule 5 | A | | 148 | HYDROFLUORIC ACID and admixtures that generate hydrofluoric acid—when included in Schedule 6 or 7 | A, G3, E2, S5 | | 149 | HYDROGEN PEROXIDE—more than 3% up to 20% | A, G3, E2, S1 | | 150 | HYDROGEN PEROXIDE—more than 20% | A, G1, G3, G4, E2, S1 | | 151 | HYDROQUINONE—when included in Schedule 2 | A | | 152 | HYDROQUINONE—when included in Schedule 4 or 6 | A, G2, G3, E2, R2, S1 | | 153 | HYDROSILICOFLUORIC ACID—when included in Schedule 5 | A | | 154 | HYDROSILICOFLUORIC ACID—when included in Schedule 6 or 7 | A, G3, E2, S5 | | 155 | 2-HYDROXYETHYL METHACRYLATE | A, E1, S1 | | 156 | HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE | E1, S1 | | 157 | IODINE (excluding salts, derivatives and iodophors)—2.5% or more for human external use | A, E2 | | 158 | IODINE (excluding salts, derivatives and iodophors)—2.5% or more for other uses | A, E2, S1 | | 159 | IODINE (excluding salts, derivatives and iodophors)—below 2.5% | A | | 160 | IODOPHORS | A | | 161 | ISOAMYL NITRITE | A | | 162 | ISOBUTYL NITRITE | A | | 163 | ISOCYANATES, free organic | A, E2, S1 | | 164 | ISOEUGENOL | A, E1, S1 | | 165 | ISOPHORONE | A, G3, E2, S1 | | 166 | KEROSENE | A, G3 | First aid instructions for poisons Appendix E Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 167 | LAURETH CARBOXYLIC ACIDS—leave-on or wash-off preparations above 5% | E1 | | 168 | LAURETH CARBOXYLIC ACIDS—other preparations above 5% | E1, S1 | | 169 | LAURYL ISOQUINOLINIUM BROMIDE | A, E1 | | 170 | LEAD COMPOUNDS—in hair cosmetics | A | | 171 | LEAD COMPOUNDS—in other preparations | A, S1 | | 172 | LEMON OIL | A, G3 | | 173 | LEPTOSPERMUM SCOPARIUM OIL (manuka oil) | A, G1, G3 | | 174 | LIME OIL | A, G3 | | 175 | MAGNESIUM CHLORATE | A | | 176 | MALATHION at 20% or less | A | | 177 | MARJORAM OIL | A, G3 | | 178 | MELALEUCA OIL | A, G1, G3 | | 179 | MERCAPTOACETIC ACID | A, E1 | | 180 | MERCURIC CHLORIDE—for external therapeutic use | A | | 181 | MERCURIC CHLORIDE—for other uses | A, G1, G3, E2, R2, S1 | | 182 | MERCURIC IODIDE | A, G1, G3, E2, R2, S1 | | 183 | MERCURIC NITRATE | A, G1, G3, E2, R2, S1 | | 184 | MERCURIC OXIDE | A, G1, G3 | | 185 | MERCURIC POTASSIUM IODIDE | A, G1, G3, E2, R2, S1 | | 186 | MERCURIC THIOCYANATE | A, G1, G3, E2, R2, S1 | | 187 | MERCUROCHROME | A | | 188 | MERCUROUS CHLORIDE | A | | 189 | MERCURY—metallic | A | | 190 | MERCURY—organic compounds | A, S1 | | 191 | MERCURY—organic compounds in preparations for human external use | A | | 192 | METALDEHYDE | A, E1, S1 | | 193 | METHANOL—above 10% | A, G3 | | 194 | METHANOL—10% or less | A | | 195 | METHYLATED SPIRIT(S) | A, G3 | | 196 | METHYLATED SPIRIT(S)—when packed and labelled as a “biofuel” suitable for use in “spirit burners” | A, G3 | | 197 | METHYL ETHYL KETONE | A, G3 | | 198 | METHYL ETHYL KETONE OXIME | A, E1, S1 | | 199 | METHYL ETHYL KETONE PEROXIDE | A, G3, E2, S1 | | 200 | METHYL EUGENOL | A | | 201 | METHYL ISOAMYL KETONE | A, G3 | | 202 | METHYL ISOBUTYL KETONE | A, G3 | Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|---------------------------------------------------------------|--------------------------| | 203 | N-METHYL-2-PYRROLIDONE—when included in Schedule 5 | A, G3, E1 | | 204 | N-METHYL-2-PYRROLIDONE—when included in Schedule 6 | A, G3, E2 | | 205 | 2-METHYLRESORCINOL | A, E1 | | 206 | METHYL SALICYLATE LIQUID when included in Schedule 5 or 6 | A, G3, E1 | | 207 | MONOETHANOLAMINE—when included in Schedule 5 | A, G3, E1 | | 208 | MONOETHANOLAMINE—when included in Schedule 6 | A, G3, E2, S1 | | 209 | 1,5-NAPHTHALENEDIOL | A, E1, S1 | | 210 | 2,7-NAPHTHALENEDIOL | A, E1, S1 | | 211 | NAPHTHALENE | A, G1, G3 | | 212 | 1-NAPHTHOL | A, E1, S1 | | 213 | NITRIC ACID | A, G3, E2, S1 | | 214 | NITROBENZENE | A, G3, E1, S1 | | 215 | 3-NITRO-p-HYDROXYETHYLAMINOPHENOL | E1 | | 216 | NITROPHENOL | A, G3, E2, S1 | | 217 | NITROPRUSSIDES—in aerosols | A, G6, R1 | | 218 | NITROPRUSSIDES—in other preparations | A, G3 | | 219 | NITROUS OXIDE | A | | 220 | NONOXYNOL 9 | A, E2 | | 221 | NUTMEG OIL | A, G3 | | 222 | OCTHILINONE | A, G3, E2, S1 | | 223 | OCTYL NITRITE | A | | 224 | N-(N-OCTYL)-2-PYRROLIDONE—when included in Schedule 5 | A, G3, E1 | | 225 | N-(N-OCTYL)-2-PYRROLIDONE—when included in Schedule 6 | A, G3, E2 | | 226 | ORANGE OIL (bitter) | A, G3 | | 227 | OXALIC ACID | A, G3, E2, S1 | | 228 | PARAFORMALDEHYDE | A, G3, E2, R1, S1 | | 229 | PENNYROYAL OIL | A, G3 | | 230 | PERACETIC ACID—when included in Schedule 5 | A, G3, E1, S1 | | 231 | PERACETIC ACID—when included in Schedule 6 | A, G3, E2, S1 | | 232 | PETROL | A, G3, R1 | | 233 | 2-PHENOXYETHANOL | A, E1 | | 234 | PHENOL when included in Schedule 6 | A, E1 | | 235 | PHENOLS—25% and less | A, G3, E2, S3 | | 236 | PHENOLS—above 25% | A, G3, E2, S4 | | 237 | PHENOLS—in pressurised spray packs | A, E1 | | 238 | PHENOXYMETHYL OXIRANE | A, E1 | Poisons that must be labelled with first aid instructions Item | Column 1 | Column 2 ---|---|--- Poison | Statement code
239 | PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives—in hair dyes | A, E1
240 | PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives—in preparations other than hair dyes | A, G1, G3, E1, S1
241 | PHENYL METHYL KETONE as such, or in preparations of similar viscosity | A, G3, E1
242 | PHENYL METHYL PYRAZOLONE | A, S1
243 | N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE -2,5-DIMETHANAMINE | A, E2, S1
244 | N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE -2,6-DIMETHANAMINE | A, E2, S1
245 | o-PHENYLPHENOL | A, G3, E2, S1
246 | o-PHENYLPHENOL—in pressurised spray packs | A, G6, E2, S1
247 | PHOSPHONIC ACID | A, G3, E2, S1
248 | PHOSPHONIC ACID—neutralised to pH 6 (approx) | A
249 | PHOSPHONIC ACID—in spray packs | A, E2, S1
250 | PHOSPHORIC ACID | A, G3, E2, S1
251 | PHOSPHORUS, YELLOW | A, G1, G3, E2, R2, S2
252 | o-PHTHALALDEHYDE—when included in Schedule 5 | A, E1
253 | o-PHTHALALDEHYDE—when included in Schedule 6 | A, G3, E2, S1
254 | PICRAMIC ACID including its salts (excluding other derivatives) | A, E1
255 | PICRIC ACID | A, G1, G3, E2, R1, S1
256 | POLIHEXANIDE | E1
257 | POLYETHANOXY (15) TALLOW AMINE | A, E2, S1
258 | POLY(OXY-1,2-ETHANEDIYL), A -[2-[(2-HYDROXYETHYL)AMINO]-2-OXOETHYL]- A-HYDROXY-MONO-C13-15-ALKYL ETHERS | A, E1
259 | POTASSIUM BROMATE | A
260 | POTASSIUM CHLORATE | A
261 | POTASSIUM CYANATE | A, E1, S1
262 | POTASSIUM HYDROXIDE | A, G3, E2, S1
263 | POTASSIUM METABISULPHITE | A
264 | POTASSIUM NITRITE—when included in Schedule 7 | A, G1, G3
265 | POTASSIUM NITRITE—when included in Schedule 5 or 6 | A, G3
266 | POTASSIUM PEROXOMONOSULFATE TRIPLE SALT—when included in Schedule 5 | A, G3, E1
267 | POTASSIUM PEROXOMONOSULFATE TRIPLE SALT—when included in Schedule 6 | A, G3, E2, S1
268 | POTASSIUM PERSULFATE | A, G3, E2
269 | POTASSIUM SULFIDE | A, G3, E2, S1 Appendix E First aid instructions for poisons Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 Poison | Column 2 Statement code | |------|------------------|-------------------------| | 270 | PROPIONIC ACID | A, G3, E1, S1 | | 271 | n-PROPYL ALCOHOL | A, E1 | | 272 | D-PULEGONE | A, G3 | | 273 | PYRITHIONE ZINC | A, E1 | | 274 | QUATERNARY AMMONIUM COMPOUNDS except when separately specified—above 20% | A, G3, E2 | | 275 | QUATERNARY AMMONIUM COMPOUNDS except when separately specified—20% and below | A, E2 | | 276 | QUATERNARY AMMONIUM COMPOUNDS except when separately specified—in pressurised spray packs | A, E2, G6 | | 277 | QUINOLINE | A, E1, S1 | | 278 | RESORCINOL | A, E2, S1 | | 279 | SAFROLE | A, G1, G3 | | 280 | SAGE OIL (Dalmatian) | A, G3 | | 281 | SASSAFRAS OIL | A, G1, G3 | | 282 | SELENIUM COMPOUNDS | A, G1, E1, S1 | | 283 | SILICOFLUORIDES—when included in Schedule 5 | A | | 284 | SILICOFLUORIDES—when included in Schedule 6 | A, G1, G3, E2, S1 | | 285 | SILVER SALTS | A, E2 | | 286 | SODIUM ALUMINATE | A, G3, E2, S1 | | 287 | SODIUM BROMATE | A, G1 | | 288 | SODIUM CHLORATE | A | | 289 | SODIUM DIACETATE | A, G3, E2, S1 | | 290 | SODIUM DICHLOROISOCYANURATE | A, G3, E1, S1 | | 291 | SODIUM DODECYLBENZENE SULFONATE | A, G3, E2, S1 | | 292 | SODIUM HYDROGEN SULFATE | A, G3, E1, S1 | | 293 | SODIUMHYDROSULFITE | A, G3, E2, S1 | | 294 | SODIUM HYDROXIDE | A, G3, E2, S1 | | 295 | SODIUM LAURETH-6 CARBOXYLATE | A | | 296 | LAURYL SULFATE SALTS—leave-on or wash-off preparations above 5% | E1 | | 297 | LAURYL SULFATE SALTS—other preparations above 5% | E1, S1 | | 298 | SODIUM METABISULPHITE | A, G3 | | 299 | SODIUM NITRITE—when included in Schedule 7 | A, G1, G3 | | 300 | SODIUM NITRITE—when included in Schedule 5 or 6 | A, G3 | | 301 | SODIUM PERCARBONATE—when included in Schedule 5 | A, G3, S1 | | 302 | SODIUM PERCARBONATE—when included in Schedule 6 | A, G3, E2, S1 | | 303 | SODIUM PERSULFATE | A, G3, E2 | | 304 | SODIUM STANNATE | A, E1 | | 305 | SODIUM SULFIDE | A, G3, E2, S1 | Clause 3 Poisons that must be labelled with first aid instructions | Item | Column 1 | Column 2 | |------|----------|----------| | | Poison | Statement code | | 306 | SODIUM TRICHLOROACETATE | A | | 307 | STRYCHNINE | A, G1, G2, G3, R2 | | 308 | STYRENE | A, G3, S1, E1 | | 309 | SULCOFURON | A | | 310 | SULFAMIC ACID | A, G3, E2, S1 | | 311 | SULFURIC ACID | A, G3, E2, S1 | | 312 | TERPENES, chlorinated | A, G3 | | 313 | TETRACHLOROETHANE | A, G3, E1, R1, S1 | | 314 | TETRACHLOROETHYLENE | A, G3, E2, R1, S1 | | 315 | THIOUREA | A | | 316 | THUJONE | A, G3 | | 317 | THYME OIL | A, G3 | | 318 | o-TOLIDINE | A | | 319 | TOLUENE—above 75% | A, G3, E1, R1, S1 | | 320 | TOLUENE—75% and below | A, G3 | | 321 | TOLUENE—in pressurised spray packs | A | | 322 | TOLUENEDIAMINES—in hair dyes | A, E1 | | 323 | TOLUENEDIAMINES—in other preparations | A, G1, G3, E1, S1 | | 324 | TRICHLOROACETIC ACID | A, G3, E2, S1 | | 325 | TRICHLOROACETIC ACID ALKALI SALTS | A | | 326 | 1,1,1-TRICHLOROETHANE | A, G3, E1, R1, S1 | | 327 | TRICHLOROETHYLENE | A, G3, E1, R1, S1 | | 328 | TRICHLOROISOCYANURIC ACID | A, G3, E1, S1 | | 329 | TRIETHYL PHOSPHATE | A, E1 | | 330 | TRIFLUOROMETHANESULFONIC ACID | A, G3, E2 | | 331 | TRIISOPROPANOLAMINE LAURYL ETHER SULFATE | A, E1, S1 | | 332 | TROLAMINE | A, G3, E1, S1 | | 333 | TURPENTINE (mineral) | A, G3 | | 334 | TURPENTINE OIL (vegetable) | A, G3, E2 | | 335 | VINYL ACETATE MONOMER | A, R1 | | 336 | WHITE SPIRIT | A, G3 | | 337 | XYLENE—above 75% | A, G3, E1, R1, S1 | | 338 | XYLENE—75% and below | A, G3 | | 339 | XYLENE—in pressurised spray packs | A, G6, E1, S1 | | 340 | XYLENOLS in pressurised spray packs | A, E1 | | 341 | ZINC CHLORIDE | A, G3, E2, S1 | | 342 | ZINC SULFATE | A, G3, E2, S1 | Clause 1 Appendix F—Warning statements and general safety directions for poisons Note: See sections 29 and 30, subsection 33(2) and section 42.
1 Warning statements For the purposes of the table in clause 4 of this Appendix and the table in clause 2 of Appendix L, the item number of an item of the following table represents the warning statement specified in column 1 of the item. Note: See section 30. Warning statements | Item | Column 1 Warning statement | |------|-----------------------------| | 1 | Highly corrosive. | | 2 | Corrosive. | | 3 | Corrosive liquid. | | 4 | Strongly alkaline. | | 5 | Irritant. | | 6 | May cause cancer. | | 7 | WARNING – Causes birth defects. | | 8 | WARNING – May be fatal to children. | | 9 | Can be fatal to children if sucked or swallowed. | | 10 | May produce severe burns. | | 11 | WARNING – Vapour may be harmful. | | 12 | Vapour is harmful to health on prolonged exposure. | | 13 | May be fatal if inhaled, swallowed or absorbed through skin. | | 14 | Dust will irritate and burn eyes, nose and skin. | | 15 | Liquid will cause burns. | | 16 | Forms dangerous gas near radiators or naked flames. | | 17 | Contact with eyes even for short periods can cause blindness. | | 18 | Product will irritate the eyes, nose, throat and skin. | | 19 | WARNING – Skin contact may be dangerous. Take every precaution to avoid contact – wash off after spillage and after use. | | 20 | May give off dangerous gas if mixed with other products. | | 21 | WARNING – This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye. | | 22 | Highly reactive oxidising chlorine compound. | | 23 | May cause fire or explosion. | | 24 | For external washing only. Rinse skin thoroughly after use. | | 25 | Do not use on broken skin. Wash hands thoroughly after use. | Warning statements and general safety directions for poisons Appendix F Clause 1 Warning statements | Item | Column 1 Warning statement | |------|-----------------------------| | 26 | (Powder) (and) (concentrated solutions) are dangerous if swallowed. | | 27 | Not for therapeutic use. | | 28 | (Over) (Repeated) exposure may cause sensitisation. | | 29 | If congestion persists, consult your doctor or pharmacist. | | 30 | WARNING – Do not use on face or on anal or genital areas. | | 31 | WARNING – Do not use on face or on anal or genital areas except on doctor’s advice. | | 32 | This preparation should be part of an overall treatment plan regularly assessed with your doctor. | | 33 | Do not take for periods longer than four weeks except on medical advice. | | 34 | WARNING – This medication may be dangerous when used in large amounts or for a long time (period). | | 35 | CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful. or CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged or excessive use without medical supervision could be harmful. | | 36 | For use under medical supervision only. | | 37 | Consult a doctor before giving this medication to children or teenagers with chicken pox, influenza or fever. | | 38 | CAUTION – Do not use for children under 2 years unless a doctor has told you to. | | 39 | This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol. | | 40 | This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery. | | 41 | Do not give to children under 12 years of age. Do not use beyond 48 hours or in pregnancy or lactation except on doctor’s advice. | | 42 | WARNING – Overuse may stain the skin or mouth. | | 43 | Use of this product is not necessary in areas supplied with fluoridated water. | | 44 | WARNING – May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time. | | 45 | WARNING – If a pigmented spot or mole has recently become darker, changed colour, become enlarged or itchy, or bleeds, do not use this product, see your doctor immediately. Do not use on children. Do not use near the eyes. Mild irritation may occur; stop use if it becomes severe. If fading is not evident in three months, seek doctor’s advice. | | 46 | WARNING – Contains (name of substance) which causes birth defects in laboratory animals. Women of child bearing age should avoid contact with (name of substance). | | 47 | WARNING – This product contains (name of substance) which causes birth defects in certain laboratory animals. Women of child bearing age are advised not to mix, load or spray this product. They should keep out of crops being sprayed. | | 48 | WARNING – This product forms cheyatexin which causes birth defects in certain laboratory animals. Women of child bearing age are advised not to mix, load or spray this product. They should keep out of crops being sprayed. | Clause 1 Warning statements | Item | Column 1 Warning statement | |------|-----------------------------| | 49 | WARNING – Do not mix with other medication except on veterinarian’s advice. | | 50 | Unless adequately fired, utensils glazed with this preparation must not be used as containers for food or beverages; to do so may cause lead poisoning. | | 51 | Irritant to skin, eyes, mucous membranes and upper respiratory tract. | | 52 | Breathing vapour or spray mist is harmful and may cause an asthma-like reaction. | | 53 | CAUTION – (Name of substance) should not be used by pregnant women. | | 54 | Seek medical advice before first course of treatment. | | 55 | Keep from eyes, lips, mouth and sensitive areas of the neck. If excessive swelling, irritation, redness or peeling occurs, discontinue use. If these persist, consult a physician. Avoid excessive exposure to sunlight and other sources of ultra violet light. | | 56 | WARNING – Can cause elevated blood pressure and interact adversely with other medication. | | 57 | Not to be applied to infants under 12 months of age unless on doctor’s advice. | | 58 | Highly reactive oxidising bromine and chlorine compound. | | 59 | May cause allergy. | | 60 | Do not mix with detergents or other chemicals. | | 61 | WARNING - Can react with other medicines. Ask your doctor or pharmacist before taking. | | 62 | Do not use if pregnant. | | 63 | See a doctor if you are pregnant or diabetic. | | 64 | See a doctor (or) (dentist) if no better after (Insert number of days as per approved Product Information) days. | | 65 | If getting better, keep using for (Insert number of days as per approved Product Information) days. | | 66 | See a doctor if problem returns. | | 67 | Do not use if pregnant or likely to become pregnant. | | 68 | If symptoms persist beyond 5 days consult a doctor (or) (dentist). | | 69 | If symptoms recur within two weeks of completing the course, consult a doctor. | | 70 | Use only under medical supervision if you are taking other medicines. | | 71 | Do not use during the last three months of pregnancy. | | 72 | Do not use in the eyes. | | 73 | Do not use for acne. | | 74 | Do not use under waterproof bandages unless a doctor has told you to. | | 75 | Do not use for more than 7 days unless a doctor has told you to. | | 76 | Do not become pregnant during use or within (Insert number of months as per approved Product Information) month(s) of stopping treatment. | | 77 | WARNING - May cause birth defects. | | 78 | Attacks skin and eyes. | | 79 | Will irritate eyes. | | 80 | WARNING: Do not attempt to refill burner while it is in use or still warm; it could lead to serious burn injury. | Warning statements and general safety directions for poisons Appendix F Clause 1 Warning statements | Item | Column 1 | |------|-----------| | | Warning statement | | 81 | (Intentionally blank) | | 82 | (Intentionally blank) | | 83 | This paint is dangerous to health, even when dry. For industrial use only. Do not use on toys or furniture. Do not use on, in or around the home. | | 84 | Breathing the vapour is dangerous. Provide adequate ventilation during application. Do not use in the presence of a naked flame. Do not smoke. | | 85 | This paint contains lead and is dangerous to health, even when dry. For industrial use only. Do not use on toys or furniture. Do not use for painting any building or fixed structure. Do not use where contact with food or drinking water is possible. | | 86 | This tinter contains lead. Do not add to any paint which is for application to any toy, furniture, building (interior or exterior), fixed structure or to anything which may contact food or drinking water. | | 87 | (Insert brand name) remains in the body for many months after treatment has stopped. Do not become pregnant or father a child before consulting your doctor. | | 88 | This product is not recommended for dyeing eyelashes or eyebrows. To do so may be injurious to the eye. | | 89 | Application to skin may increase sensitivity to sunlight. | | 90 | This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol. | | 91 | CAUTION – Total iodine intake may exceed recommended level when taking this preparation. | | 92 | WARNING – Contains iodine - do not take when pregnant except on physician’s advice. | | 93 | Causes severe burns, which are not likely to be immediately painful or visible. | | 94 | WARNING – Contains nitrite. Substitution for table or cooking salt may be dangerous, particularly for young children. | | 95 | CAUTION – Do not use for children under 12 years unless a doctor has told you to. | | 96 | CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. If symptoms persist or recur within two weeks, consult a doctor. | | 97 | Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to by a doctor. | | 98 | Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor. | | 99 | If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage. | Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 327 Appendix F Warning statements and general safety directions for poisons Clause 2 Warning statements | Item | Column 1 | Warning statement | |------|----------|-------------------| | 100 | Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist. | | 101 | Don’t use [this product/name of the product]: - If you have a stomach ulcer. - In the last 3 months of pregnancy. [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.] - If you are allergic to (name of substance) or anti-inflammatory medicines. | | 102 | Unless a doctor has told you to, don’t use [this product/name of the product]: - For more than a few days at a time. - With other medicines containing aspirin or other anti-inflammatory medicines. - If you have asthma. - In children under 12 years of age. - In children 12-16 years of age with or recovering from chicken pox, influenza or fever. - If you are pregnant. | | 103 | See a doctor before taking [this product/name of the product] for thinning the blood or for your heart. [This statement may be omitted in products for inhibition of platelet aggregation or with additional active ingredients.] | | 104 | Unless a doctor has told you to, don’t use [this product/name of the product]: - For more than a few days at a time. - With other medicines containing (name of substance) or other anti-inflammatory medicines. - If you have asthma. - If you are pregnant. [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.] | | 105 | Do not use on the bedding or clothing of infants or in the bedrooms of children 3 years of age or less. | | 106 | Contains formaldehyde. | | 107 | Not recommended for children under twelve years of age. | | 108 | Breathing of solder fumes is harmful and may cause asthma or sensitisation. | | 109 | See your healthcare provider if you consider that you may be at risk of a Sexually Transmitted Infection (STI). | | 110 | See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed. | | 111 | Do not use if breastfeeding or planning to breastfeed. | | 112 | WARNING – May cause irreversible nerve damage if inhaled. |
2 Safety directions—general For the purposes of the table in clause 4, the item number of an item of the following table represents the safety direction specified in column 1 of the item. Note: See section 29.
328 Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 Safety directions Item | Column 1 Safety direction
1 Avoid contact with eyes.
2 Attacks eyes - protect eyes when using.
3 Wear eye protection when mixing or using.
4 Avoid contact with skin.
5 Wear protective gloves when mixing or using.
6 Wash hands after use.
7 Wash hands thoroughly after use.
8 Avoid breathing dust (or) vapour (or) spray mist.
9 Use only in well ventilated area.
10 Ensure adequate ventilation when using.
11 No smoking.
12 Do not allow product to come into contact with other chemicals, especially acids.
13 Do not allow product to come into contact with combustible materials such as paper, fabric, sawdust or kerosene.
14 Do not allow to get damp.
15 Store under cover in a dry, clean, cool, well ventilated place away from sunlight.
16 Store and transport in an upright container.
17 Do not mix with other chemicals.
18 Do not mix with different types of chlorinating chemicals.
19 Use clean containers for dispensing.
20 Mix with water only.
21 Do not add water to product - add product to water, but in case of fire drench with water.
22 In case of spillage flush with large quantities of water.
23 Keep away from heat, sparks and naked flames.
24 Avoid contact of the crystals or strong solutions with the eyes, mouth, nose and other mucous membranes.
25 Avoid contact with food.
26 Avoid contact with clothing.
27 Wear a positive-pressure air-supplied full-face respirator whilst spraying and until spray mist has been effectively dispersed.
28 Do not mix with hot water.
29 Obtain a supply of calcium gluconate gel.
30 (Intentionally blank)
31 Do not use on broken skin.
32 Do not use under occlusive dressing.
33 Mix strictly according to instructions.
34 May cause fire if it comes into contact with other chemicals, paper or other flammable materials.
35 Wash gloves thoroughly, immediately after use.
36 Protect cuticles with grease or oil. Clause 3 Safety directions | Item | Column 1 | Safety direction | |------|----------|------------------| | 37 | Avoid breathing solder fumes. | | 38 | Do not intentionally inhale contents. |
3 Poisons information centre contact information in statements A statement required for a poison that includes a reference to a Poisons Information Centre must include: (a) the telephone number that is appropriate to the country or countries in which the poison is to be supplied; and (b) immediately following the reference to a Poisons Information Centre: (i) the national telephone number for the Poisons Information Centre in Australia (13 11 26); or (ii) the telephone number for another poisons information centre: (A) that is attended by adequately trained staff for 24 hour emergency poisons information; and (B) calls to which are logged and submitted for incorporation into the official collection of poisoning data. Note: For subparagraph (b)(ii), in 2022 the Poisons Information Centre telephone number in New Zealand was 0800 764 766.
4 Poisons that must be labelled with warning statements and safety directions
For the purposes of subsections 29(1) and 30(1), and subject to subclauses (2) and (3), the following are required for a poison specified in column 1 of an item of the following table: (a) the warning statement represented by each item number specified in column 2 of the item; (b) the safety direction represented by each item number specified in column 3 of the item.
A warning statement or safety direction required for a poison must: (a) be completed or modified for its use in relation to that poison if the statement or direction indicates that such completion is required or such modification is appropriate; and (b) if the statement includes a reference to a Poisons Information Centre—comply with clause 3. Note: For paragraph (a), for example: (a) a statement or direction may require completion by including the name of the poison; and (b) a statement or direction may indicate that modification is appropriate by including different options for the text, or by stating that certain text is not needed in certain circumstances.
If more than one statement or direction is required for a poison, the statements and directions may be combined to form simple sentences (if appropriate). Poisons that must be labelled with warning statements and safety directions Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number ---|---|---|---
1 | ACETIC ACID in concentrations of 80% or more except when included in Schedule 2 | 2 | 1, 4, 8
2 | ACETIC ANHYDRIDE | 2 | 1, 4, 8
3 | ACETONE in concentrations greater than 75% | | 1, 4, 8
4 | ACITRETIN—for oral use | 7, 62, 76 |
5 | ACITRETIN—for topical use | 62, 77 |
6 | ADAPALENE for topical use | 62, 77 |
7 | ALCLOMETASONE when included in Schedule 3 | 38, 72, 73, 74, 75 |
8 | ALKALINE SALTS | 4 | 1, 4
9 | AMBRISENTAN | 7, 62, 76 |
10 | AMINES used as curing agents for epoxy resins | | 1, 3, 4, 5, 8
11 | 2-AMINO-6-CHLORO-4-NITROPHENOL | 28 |
12 | 4-AMINO-m-CRESOL | 28 |
13 | 2-AMINO-5-ETHYLPHENOL | 21 |
14 | 4-AMINO-2-HYDROXYTOLUENE | 28 |
15 | 4-AMINO-3-NITROPHENOL | 28 |
16 | 2,2'-[(4-AMINO-3-NITROPHENYL)IMINO] BISETHANOL | 28 |
17 | m-AMINOPHENOL | 28 | 4, 8
18 | p-AMINOPHENOL | 28 |
19 | AMMONIA/AMMONIUM HYDROXIDE in concentrations greater than 20% ammonia except in smelling salts | 4 | 1, 4, 8
20 | AMMONIUM PERSULFATE | 5, 21, 25 | 1, 5, 23, 33, 34
21 | ANHYDRIDES, organic acid, for use as curing agents for epoxy resins | | 1, 3, 4, 5, 8
22 | ANILINE | 13 | 1, 4, 8
23 | ANTIHISTAMINES not separately specified in this Appendix except the following: (a) dermal, ocular, parenteral and paediatric preparations; (b) oral preparations of astemizole, azelastine, bilastine, cetirizine, desloratadine, fexofenadine, loratadine, or terfenadine; (c) nasal preparations of azelastine or olopatadine; (d) preparations for the treatment of animals | 39 or 40 |
24 | ARBUTIN when included in Schedule 6 | 45 | 1, 4
25 | AROMATIC EXTRACT OILS | | 1, 3, 4, 5, 6
26 | ASPIRIN—for inhibition of platelet aggregation | 36 | Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|---------------------------------------|---------------------------------------| | 27 | ASPIRIN—in sustained release preparations containing 650 mg or more of aspirin | 36 | - | | 28 | ASPIRIN—in other preparations | 101, 102, 103 | - | | 29 | ASTEMIZOLE | 61 | - | | 30 | ASTODRIMER SODIUM—for the treatment and relief of bacterial vaginosis | 63, 64, 69, 75, 109, 110 | - | | 31 | ASTODRIMER SODIUM—for the prevention of recurrent bacterial vaginosis | 63, 75, 109, 110 | - | | 32 | AZADIRACHTA INDICA including its extracts and derivatives when included in Schedule 6 | 67 | - | | 33 | AZOCYCLOTIN | 48 | - | | 34 | AZO DYES (derivatives by diazotisation) | 6 | 5 | | 35 | BASIC RED 76 | - | 5 | | 36 | BENOMYL | 46 | - | | 37 | BENZENE | 12 | 1, 4, 9 | | 38 | 1,2-BENZENEDIOL (Catechol) | 51, 59 | 1, 4, 8 | | 39 | BENZOYL PEROXIDE—when included in Schedule 2 | 55 | - | | 40 | BENZOYL PEROXIDE—when included in Schedule 5 | - | 1, 4, 8 | | 41 | BERGAMOT OIL | 89 | - | | 42 | BERYLLIUM | - | 1, 4, 8 | | 43 | BEXAROTENE—for human use | 7, 62, 76 | - | | 44 | BEXAROTENE—for topical use | 62, 77 | - | | 45 | BIFLUORIDES (including ammonium, potassium and sodium salts)—when included in Schedule 5 | - | 1, 4 | | 46 | BIFLUORIDES (including ammonium, potassium and sodium salts)—when included in Schedule 6 or 7 | 1, 17, 93 | 1, 3, 4, 5, 8, 29, 35 | | 47 | 1,3-BIS(2,4-DIAMINOPHENOXY)PROPANE | 28, 79 | 1 | | 48 | BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETICONE COPOLYMER | - | 1 | | 49 | BITHIONOL for the treatment of animals | - | 1, 4, 8 | | 50 | BORIC ACID when used in Schedule 5 | 25, 26 | - | | 51 | BORON TRIFLUORIDE (including mixtures that generate boron trifluoride)—when included in Schedule 5 | 2 | 1, 4 | | 52 | BORON TRIFLUORIDE (including mixtures that generate boron trifluoride)—when included in Schedule 6 or 7 | 1, 17, 93 | 1, 3, 4, 5, 8, 29, 35 | | 53 | BOSENTAN | 7, 62, 76 | - | | 54 | BROMOFORM | - | 1, 4, 8 | | 55 | 2-BUTOXY-2'-THIOCYANOETHYL ETHER | - | 1, 4, 8 | | 56 | 2-BUTOXYETHANOL and its acetates | - | 1, 4, 8 | Poisons that must be labelled with warning statements and safety directions Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number ---|---|---|---
57 | n-BUTYL ALCOHOL | 5 | 2, 4, 8
58 | CAMPHOR—in block, ball, disc, pellet or flake form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents | 9 |
59 | CAMPHOR—in other forms | 9 | 1
60 | CANNABIDIOL when included in Schedule 3 | 67, 111 |
61 | CARBAMIDE PEROXIDE—more than 9% up to 30% | 5 | 1
62 | CARBAMIDE PEROXIDE—more than 30% up to 60% | 5 | 2
63 | CARBAMIDE PEROXIDE—more than 60% | 2 | 2, 4
64 | CARBON DISULFIDE | 12 | 1, 4, 8, 9, 23
65 | CARBON TETRACHLORIDE | 12 | 1, 4, 8, 9
66 | CASSIA OIL | | 4
67 | CHLORINATING COMPOUNDS—in household cleaning or bleaching preparations | 20 |
68 | CHLORINATING COMPOUNDS—in preparations containing less than 10% of available chlorine | 11 | 1, 4, 10
69 | CHLORINATING COMPOUNDS—in liquid preparations containing 10% or more of available chlorine | 3, 18 | 1, 4, 6, 8, 10, 15, 16, 17, 18, 19, 20, 22, 26
70 | CHLORINATING COMPOUNDS—in dry preparations containing 10% or more of available chlorine | 10, 18, 22, 23 | 1, 4, 8, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 26
71 | CHLORINATING COMPOUNDS—in dry preparations containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code | 10, 18, 22 | 1, 4, 8, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 26
72 | CHLORINATING COMPOUNDS—in compressed block or tablets containing 10% or more of available chlorine except in preparations for use in toilet cisterns only, containing 15 g or less of trichloroisocyanuric acid | 10, 22, 23 | 12, 13, 14, 15, 17, 18, 19, 21
73 | CHLORINATING COMPOUNDS—in other compressed blocks or tablets containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code except in preparations for use in toilet cisterns only, containing 15 g or less of trichloroisocyanuric acid | 10, 22 | 12, 13, 14, 15, 17, 18, 19, 21
74 | CHLOROACETAMIDE | 28 | 4
75 | 2-CHLORO-6-(ETHYLAMINO)-4-NITROPHENOL | 28 | 4 Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|----------------------------------------|---------------------------------------| | 76 | CHLOROFORM when included in Schedule 6 | 1, 4, 8 | | 77 | alpha-CHLOROHYDRIN | 13, 51 | 1, 4, 8, 9 | | 78 | CHROMATES (including dichromates) of alkali metals or ammonia | 1, 4, 8 | | 79 | CHROMIUM TRIOXIDE | 2, 14, 15, 23 | 1, 4, 8, 13 | | 80 | CIMETIDINE when included in Schedule 3 | 70, 96 | | 81 | CINNAMON BARK OIL | 4 | | 82 | CLOBETASONE when included in Schedule 3 | 72, 73, 74, 75, 95 | | 83 | CLOTRIMAZOLE in vaginal preparations when included in Schedule 3 | 54, 63, 64, 66 | | 84 | CLOVE OIL | 1 | | 85 | CYANIDES when included in Schedule 7 | 13 | 4, 8 | | 86 | CYANURIC ACID | 1, 4, 8 | | 87 | CYCLOHEXANONE PEROXIDE | 1, 4, 8 | | 88 | CYCLOSILAZANES, DI-ME, ME HYDROGEN, POLYMERS WITH DI-ME, ME HYDROGEN SILAZANES, REACTION PRODUCTS WITH 3-(TRIETHOXYSILYL)-1-PROPANAMINE (CAS 475645-84-2) | 2, 10, 78 | 1, 4, 5, 35 | | 89 | CYCTEAMINE | 1 | | 90 | 1-DEOXY-1-(METHYLAMINO)-D-GLUCITOL N-COCO ACYL DERIVATIVES | 79 | 1 | | 91 | 4,4-DIAMINODIPHENYLMETHANE (methylene dianiline) | 1, 4, 8 | | 92 | 2,4-DIAMINOPHENOXYETHANOL | 28, 79 | 1, 4 | | 93 | o-DICHLOROBENZENE | 1, 4, 8 | | 94 | para-DICHLOROBENZENE | 1, 4 | | 95 | DICHLOROETHYLENE | 1, 4, 8 | | 96 | DICHLOEOETHYL ETHER | 1, 4, 8 | | 97 | DICHLOROISOCYANURATES—in household cleaning or bleaching preparations | 20 | | 98 | DICHLOROISOCYANURATES—in preparations containing less than 10% of available chlorine | 11 | 1, 4, 10 | | 99 | DICHLOROISOCYANURATES—in liquid preparations containing 10% or more of available chlorine | 3, 18 | 1, 4, 6, 8, 10, 15, 16, 17, 18, 19, 20, 22, 26 | | 100 | DICHLOROISOCYANURATES—in dry preparations containing 10% or more of available chlorine | 10, 18, 22, 23 | 1, 4, 8, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 26 | Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|----------------------------------------|---------------------------------------| | 101 | DICHLOROISOCYANURATES—in dry preparations containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code | 10, 18, 22 | 1, 4, 8, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 26 | | 102 | DICHLOROISOCYANURATES—in anti-bacterial tablets containing 2.5 g or less of sodium dichloroisocyanurate | 60 | - | | 103 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine except in preparations containing 21 g or less of sodium dichloroisocyanurate for use in toilet cisterns only | 10, 22, 23 | 12, 13, 14, 15, 17, 18, 19, 21 | | 104 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code except in preparations containing 21 g or less of sodium dichloroisocyanurate for use in toilet cisterns only | 10, 22 | 12, 13, 14, 15, 17, 18, 19, 21 | | 105 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine in preparations containing 5 g or less of sodium dichloroisocyanurate for use in toilet bowls only—during storage | 10, 22, 23 | 12, 13, 14, 15, 17, 18, 21 | | 106 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine in preparations containing 5 g or less of sodium dichloroisocyanurate for use in toilet bowls only—during use | 5 | 1, 4, 7, 12 | | 107 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code in preparations containing 5 g or less of sodium dichloroisocyanurate for use in toilet bowls only—during storage | 10, 22 | 12, 13, 14, 15, 17, 18, 21 | | 108 | DICHLOROISOCYANURATES—in other compressed blocks or tablets containing 10% or more of available chlorine certified by a relevant State or Territory authority as not being a Dangerous Good of Class 5, Division 5.1: Oxidising substances, as specified in the Australian Dangerous Goods Code in preparations containing 5 g or less of sodium dichloroisocyanurate for use in toilet bowls only—during use | 5 | 1, 4, 7, 12 | Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|---------------------------------------|---------------------------------------| | 109 | DICHLOROMETHANE (methylene chloride)—in paint or lacquer removers | 12, 16 | 1, 4, 8, 11 | | 110 | DICHLOROMETHANE (methylene chloride)—other than in paint or lacquer removers | 1, 4, 8, 25 | | 111 | DICLOFENAC | 101, 104 | | | 112 | DIENESTROL | 67 | | | 113 | DIETHANOLAMINE—when included in Schedule 5 | 5 | 1, 4 | | 114 | DIETHANOLAMINE—when included in Schedule 6 | 2, 11, 18 | 1, 4, 8 | | 115 | DIETHYLTOLUAMIDE for human use | 44 | | | 116 | DIETHYLENE GLYCOL MONOBUTYL ETHER | 5 | 1, 4, 8, 9 | | 117 | 5,6-DIHYDROXYINDOLINE | 21, 28 | | | 118 | 2,6-DIMETHOXY-3,5-PYRIDINEDIAMINE | 28 | | | 119 | DIMETHYLFORMAMIDE | | 1, 4, 8 | | 120 | 4,4-DIMETHYL-1-CYCLOHEXENE-1-PROPANAL | 5, 28 | 1, 2 | | 121 | 3,7-DIMETHYL-2,6-OCTADIEN-1-OL | 5 | 1, 4 | | 122 | DIMETHYL SULFATE | 2 | 1, 4, 8 | | 123 | DIMETHYL SULFOXIDE—when not packed and labelled for therapeutic use | 27 | 1, 4, 5, 8 | | 124 | DIMETHYL SULFOXIDE—when packed and labelled for the treatment of animals | 49 | 1, 4, 5, 8 | | 125 | DINITROCRESOLS (and their homologues) except when for therapeutic use | | 1, 4, 8 | | 126 | DINITROPHENOLS (and their homologues) except when for therapeutic use | | 1, 4, 8 | | 127 | DINOCAP | 47 | | | 128 | DIOXANE | | 1, 4, 8 | | 129 | DIPHENOXYLATE when included in Schedule 3 | 39 or 40, 41 | | | 130 | DISPERSE YELLOW 3 | 28 | 4 | | 131 | ECONAZOLE in vaginal preparations when included in Schedule 3 | 54, 63, 64, 66 | | | 132 | ENZALUTAMIDE | 7, 67, 87 | | | 133 | EPHEDRINE in nasal preparations for topical use | 29 | | | 134 | EPICHLOROHYDRIN | 2 | 1, 4, 8 | | 135 | EPOXY RESINS, liquid | | 1, 3, 4, 5, 8 | | 136 | ETHER when included in Schedule 5 or 6 | | 1, 4, 8 | | 137 | 2-ETHOXYETHANOL | 77 | 1, 4, 8 | | 138 | ETHOXYETHYLMERCURIC CHLORIDE | | 1, 4 | | 139 | ETHYL BROMIDE | | 1, 4, 8 | | 140 | ETHYLENE CHLOROHYDRIN | | 1, 4, 8 | Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|-----------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------| | 141 | ETHYLENE GLYCOL MONOALKYL ETHERS and their acetates except when separately specified | | 1, 4, 8 | | 142 | ETHYLENE OXIDE | | 1, 4, 8 | | 143 | ETHYLHEXANEDIOL | 79 | 1 | | 144 | 2-ETHYLHEXANOIC ACID | 53 | | | 145 | ETHYLMERCURIC CHLORIDE | | 1, 4 | | 146 | ETHYL METHACRYLATE | 28 | 4, 9, 23 | | 147 | ETRETINATE | 7, 62, 76 | | | 148 | EUGENOL | | 1 | | 149 | FAMOTIDINE when included in Schedule 2 | 96 | | | 150 | FENTEROL in metered aerosols | 32 | | | 151 | FLUCONAZOLE in oral preparations when included in Schedule 3 | 64 | | | 152 | FLUORIDES (including silicofluorides) when included in Schedule 5 or 6 except when separately specified | | 1, 4 | | 153 | FORMALDEHYDE—in nail hardener cosmetics | 106 | 1, 4, 8, 36 | | 154 | FORMALDEHYDE—in other preparations | 106 | 1, 4, 8 | | 155 | FORMIC ACID | | 1, 4, 8 | | 156 | FURFURAL | 5 | 1, 4 | | 157 | Glazing preparations containing LEAD COMPOUNDS | 50 | | | 158 | GLUTARAL except when included in Schedule 2—25% or less | 5, 59 | 1, 4, 5 | | 159 | GLUTARAL except when included in Schedule 2—more than 25% | 3, 59 | 1, 4, 5, 8 | | 160 | GLYCOLIC ACID | 79 | 1, 5, 6, 31 | | 161 | HC VIOLET 1 | 28 | | | 162 | HEXACHLOROPHENE in preparations for skin cleansing purposes containing 3% or less of hexachlorophene | 24 | | | 163 | HEXYLOXYETHANOL | 2 | 1, 4, 8 | | 164 | HYDRAZINE | | 1, 4, 8 | | 165 | HYDROCHLORIC ACID—30% or less of HCl | | 1, 4 | | 166 | HYDROCHLORIC ACID—more than 30% of HCl | | 1, 4, 8 | | 167 | HYDROCORTISONE—for dermal use when included in Schedule 2 or 3 | 38, 72, 73, 74, 75 | | | 168 | HYDROCORTISONE—for topical rectal use when included in Schedule 2 or 3 | 38, 75 | | | 169 | HYDROCYANIC ACID when included in Schedule 7 | 13 | 4, 8 | | 170 | HYDROFLUORIC ACID (including mixtures that generate hydrofluoric acid)—when included in Schedule 5 | 2 | 1, 4 | Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|-----------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------| | 171 | HYDROFLUORIC ACID (including mixtures that generate hydrofluoric acid)—when included in Schedule 6 or 7 | 1, 17, 93 | 1, 3, 4, 5, 8, 29, 35 | | 172 | HYDROGEN PEROXIDE—more than 3% up to 10% | 5 | 1 | | 173 | HYDROGEN PEROXIDE—more than 10% up to 20% | 5 | 2 | | 174 | HYDROGEN PEROXIDE—more than 20% | 2 | 2, 4 | | 175 | HYDROQUINONE—when included in Schedule 2 | 45 | | | 176 | HYDROQUINONE—except when included in Schedule 2 or 4 | | 1, 4 | | 177 | HYDROSILICOFLUORIC ACID (including mixtures that generate hydrosilicofluoric acid)—when included in Schedule 5 | 2 | 1, 4 | | 178 | HYDROSILICOFLUORIC ACID (including mixtures that generate hydrosilicofluoric acid)—when included in Schedule 6 or 7 | 1, 17, 93 | 1, 3, 4, 5, 8, 29, 35 | | 179 | 2-HYDROXYETHYL METHACRYLATE | 28 | 4 | | 180 | HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE | 28 | | | 181 | IBUPROFEN | 101, 104 | | | 182 | IODINE—more than 20% | | 1, 4, 8 | | 183 | IODINE—in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose | 91, 92 | | | 184 | IPRATROPIUM BROMIDE in metered aerosols | 32 | | | 185 | ISOCYANATES (free organic)—when in paint | 28, 52 | 1, 5, 8, 10, 27 | | 186 | ISOCYANATES (free organic)—other than in paint | 28, 52 | 1, 4, 8 | | 187 | ISOEUGENOL | 19, 28, 79 | 1, 4 | | 188 | ISOPRENALINE in metered aerosols | 32 | | | 189 | ISOTRETINOIN—for human oral use | 7, 62, 76 | | | 190 | ISOTRETINOIN—for topical use | 62, 77 | | | 191 | LEAD COMPOUNDS—in hair cosmetics | 25 | | | 192 | LEAD COMPOUNDS—when included in Schedule 6 preparations that are not hair cosmetics | | 1, 4, 8 | | 193 | LEFLUNOMIDE | 7, 62, 87 | | | 194 | LEMON OIL | 89 | | | 195 | LENALIDOMIDE | 7, 62, 76 | | | 196 | LEVOCABASTINE—in eye or nasal preparations containing 0.5 mg/mL or less of levocabastine | 62 | | | 197 | LEVOCABASTINE—in other preparations | 62 and either 39 or 40 | | | 198 | LIME OIL | 89 | | Poisons that must be labelled with warning statements and safety directions Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number ---|---|---|---
199 | LOPERAMIDE when included in Schedule 2 | 41 |
200 | MAGNESIUM CHLORATE | 1, 4 |
201 | MEFENAMIC ACID | 101, 104 |
202 | MERCAPTOACETIC ACID | 5, 28 | 1, 31
203 | MERCURIC THIOCYANATE | 1, 4 |
204 | METACRESOLSULPHONIC ACID and formaldehyde condensation product for the treatment of animals | 1, 4 |
205 | METHANOL except in methylated spirit | 1, 4, 8 |
206 | METHOXAMINE in nasal preparations for topical use | 29 |
207 | 2-METHOXYETHANOL | 77 | 1, 4, 8
208 | METHYLATED SPIRIT(S) when packed and labelled as a “biofuel” suitable for use in “spirit burners” | 80 |
209 | p-METHYLAMINOPHENOL | 28 |
210 | METHYL CHLORIDE | 1, 4, 8 |
211 | METHYL ETHYL KETONE | 5 | 1, 4, 8
212 | METHYL ETHYL KETONE OXIME | 5, 28 | 1, 4
213 | METHYL ETHYL KETONE PEROXIDE | 2 | 2, 3, 4, 6
214 | METHYL ISOAMYL KETONE | 1, 4, 8 |
215 | METHYL ISOBUTYL KETONE | 1, 4, 8 |
216 | METHYL ISOTHIOCYANATE | 5, 12 | 1, 4, 8
217 | METHYL METHACRYLATE | 28 | 4, 9, 23
218 | METHYLCHLOROISOTHIAZOLINONE | 28 |
219 | METHYLDIBROMO GLUTARONITRILE | 28 | 1, 4, 7
220 | METHYLENE BISTHIOCYANATE | 1, 4 |
221 | METHYLEUGENOL | 1, 6 |
222 | METHYLISOTHIAZOLINONE | 28 |
223 | METHYLNORBORNYLPYRIDINE | 59 |
224 | 2-METHYLRESORCINOL | 1 |
225 | 1-(BETA-METHYL SULPHONAMIDOETHYL)-2-AMINO-3,N,N-DIETHYLAMINOBENZENE | 1, 4, 8 |
226 | MICONAZOLE in vaginal preparations when included in Schedule 3 | 54, 63, 64, 66 |
227 | MISOPROSTOL | 53 |
228 | MONOETHANOLAMINE when included in Schedule 5 | 5 | 1, 4
229 | MONOETHANOLAMINE when included in Schedule 6 | 2, 11, 18 | 1, 4, 8
230 | NAPHAZOLINE in nasal preparations for topical use | 29 |
231 | NAPHTHALENE—in block, ball, disc, pellet or flake form, enclosed in a device which, in normal use, prevents removal or ingestion of its contents | 9, 105 | Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|----------------------------------------|---------------------------------------| | 232 | NAPHTHALENE—in other forms | 9, 105 | 1 | | 233 | 1,5-NAPHTHALENEDIOL | 28 | 1 | | 234 | 2,7-NAPHTHALENEDIOL | 28 | 1, 3 | | 235 | 1-NAPHTHOL | 28 | 1 | | 236 | NAPROXEN | 101, 104 | - | | 237 | NICOTINE except when in tobacco | - | 1, 4 | | 238 | NITRIC ACID—75% or less HNO₃ | 2 | 1, 4 | | 239 | NITRIC ACID—more than 75% HNO₃ | 2 | 1, 4, 8 | | 240 | NITROBENZENE | - | 1, 4, 8 | | 241 | 3-NITRO-p-HYDROXYETHYLAMINOPHENOL | 28 | - | | 242 | NITROPHENOLS | - | 1, 4 | | 243 | NITROPRUSSIDES in aerosols | 84 | 8 | | 244 | NITROUS OXIDE | 112 | 38 | | 245 | NIZATIDINE when included in Schedule 2 | 96 | - | | 246 | NORADRENALINE in metered aerosols | 32 | - | | 247 | NYSTATIN in vaginal preparations when included in Schedule 3 | 54, 63, 64, 65, 66 | - | | 248 | ORANGE OIL (bitter) | 89 | - | | 249 | ORCIPRENALINE in metered aerosols | 32 | - | | 250 | OXALATES, metallic | - | 4, 8 | | 251 | OXALIC ACID | 2 | 4, 8 | | 252 | OXYMETAZOLINE in nasal preparations for topical use | 29 | - | | 253 | OXYQUINOLINE (including salts and derivatives) when prepared for internal use | 33 | - | | 254 | PAINT—first group paints | 83 | - | | 255 | PAINT—second group paints | 84 | - | | 256 | PALOVAROTENE | 7, 62, 76, 111 | - | | 257 | PARACETAMOL | 97 and/or 98, 99, 100 | - | | 258 | PENTACHLOROPHENOL | - | 1, 4, 8 | | 259 | PERACETIC ACID | 2 | 1, 4, 8 | | 260 | PERMANGANATES | 2 | 24 | | 261 | 2-PHENOXYETHANOL | 5 | 1 | | 262 | PHENOL and any other homologue of phenol | - | 1, 4 | | 263 | PHENOL when included in Schedule 6 | 3, 51 | 2, 4, 8 | | 264 | PHENOLS | - | 5 | | 265 | PHENOXYMETHYL OXIRANE | 12, 28, 51 | 1, 3, 4, 5, 7, 8, 9 | Poisons that must be labelled with warning statements and safety directions Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number --- | --- | --- | ---
266 | PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives—in hair dyes | 21 |
267 | PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives—in preparations other than hair dyes | 28 | 1, 4, 8
268 | PHENYL METHYL PYRAZOLONE | 28 | 4
269 | PHENYLEPHRINE in nasal preparations for topical use | 29 |
270 | POMALIDOMIDE | 7, 62, 76 |
271 | N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,5-DIMETHANAMINE | 5, 28 | 1, 4, 5, 10
272 | o-PHENYLPHENOL except when in antiseptics | | 1, 4
273 | PHENYLPROPANOLAMINE | 56 |
274 | PHENYTOIN in pastes for the treatment of horses | 9 |
275 | PHOSPHONIC ACID | | 1, 4
276 | PHOSPHORIC ACID | | 1, 4
277 | PHOSPHORUS (yellow) | 2 | 1, 4
278 | o-PHTHALALDEHYDE—when included in Schedule 5 | 51, 52, 59 | 1, 4, 5, 8, 10
279 | o-PHTHALALDEHYDE—when included in Schedule 6 | 51, 52, 59 | 2, 4, 5, 8, 10
280 | PICRAMIC ACID including its salts (excluding other derivatives) | 28 | 5
281 | PICRIC ACID (more than 20%) | | 1, 4
282 | PODOPHYLLIN—in preparations specifically for use on anal or genital area | 36 |
283 | PODOPHYLLIN—in other liquid preparations when included in Schedule 2 or 3 | 31 |
284 | PODOPHYLLIN—in other solid or semi-solid preparations when included in Schedule 2 | 30 |
285 | PODOPHYLLOTOXIN—in preparations specifically for use on anal or genital area | 36 |
286 | PODOPHYLLOTOXIN—in other liquid preparations when included in Schedule 2 or 3 | 31 |
287 | PODOPHYLLOTOXIN—in other solid or semi-solid preparations when included in Schedule 2 | 30 |
288 | POLIHEXANIDE | 28 | 1, 4, 8
289 | POLYETHANOXY (15) TALLOW AMINE | | 1, 4
290 | POLYOXY-1,2-ETHANEDIYL), A-[2-[(2-HYDROXYETHYL)AMINO]-2-OXOETHYL]-A-HYDROXY-MONO-C13-ALKYL ETHERS | 5, 88 | 1, 5
291 | POTASSIUM HYDROXIDE—in preparations containing 0.5% or less of potassium hydroxide | 5 | 1, 4, 6 Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|------------------|---------------------------------------|---------------------------------------| | 292 | POTASSIUM HYDROXIDE—in solid preparations containing more than 0.5% of potassium hydroxide | 2, 10, 78 | 3, 5, 28 | | 293 | POTASSIUM HYDROXIDE—in liquid preparations containing more than 0.5% of potassium hydroxide | 2, 10, 78 | 3, 5 | | 294 | POTASSIUM PERSULFATE | 5, 21, 25 | 1, 5, 23, 33, 34 | | 295 | POTASSIUM SULFIDE | 2 | 1, 4 | | 296 | PROPIONIC ACID when included in Schedule 6 | 2 | 1, 4 | | 297 | n-PROPYL ALCOHOL | 5 | 1, 9 | | 298 | QUININE | 28 | | | 299 | QUINOLINE | 79 | 1, 4 | | 300 | RANITIDINE when included in Schedule 2 | 96 | | | 301 | RESORCINOL | 19, 28, 79 | 1, 3, 4 | | 302 | ROSIN | 108 | 37 | | 303 | SAFROLE—in preparations for therapeutic use | 1 | | | 304 | SAFROLE—other than for therapeutic use | 1, 4 | | | 305 | SALBUTAMOL in metered aerosols or in dry powder formulations | 32 | | | 306 | SALICYLAMIDE | 34 or 35 | | | 307 | SASSAFRAS OIL—in preparations for therapeutic use | 1 | | | 308 | SASSAFRAS OIL—other than for therapeutic use | 1, 4 | | | 309 | SELENIUM COMPOUNDS except when for therapeutic use (human or animal) | 1, 4, 8 | | | 310 | SILVER in smoking deterrents | 42 | | | 311 | SITAXENTAN | 7, 62, 76 | | | 312 | SODIUM ALUMINATE | 2 | 1, 4 | | 313 | SODIUM CHLORATE | 1 | 1, 4 | | 314 | SODIUM DODECYLBENZENE SULFONATE | 79 | 1 | | 315 | SODIUM FLUORIDE in preparations for human ingestion when included in Schedule 2 | 43 | | | 316 | SODIUM HYDROGEN SULFATE | 1, 4, 8 | | | 317 | SODIUM HYDROSULFITE (more than 50%) | 5, 26 | 1, 4, 8 | | 318 | SODIUM HYDROXIDE—in preparations containing 0.5% or less of sodium hydroxide | 5 | 1, 4, 6 | | 319 | SODIUM HYDROXIDE—in solid preparations containing more than 0.5% of sodium hydroxide | 2, 10, 78 | 3, 5, 28 | | 320 | SODIUM HYDROXIDE—in liquid preparations containing more than 0.5% of sodium hydroxide | 2, 10, 78 | 3, 5 | | 321 | SODIUM LAURETH-6 CARBOXYLATE | 79 | 1 | | 322 | SODIUM METABISULPHITE (more than 50%) | 5, 26 | 1, 4 | | 323 | SODIUM NITRITE in pickling or curing salts | 94 | | Poisons that must be labelled with warning statements and safety directions Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number ---|---|---|---
324 | SODIUM PERSULFATE | 5, 21, 25 | 1, 5, 23, 33, 34
325 | SODIUM SULFIDE | 2 | 1, 4
326 | STYRENE | 1, 4, 8 |
327 | SULFAMIC ACID | 2 | 1, 4
328 | SULFURIC ACID | 2 | 1, 4
329 | SYMPHYTUM SPP. (Comfrey) when included in Schedule 5 | | 31, 32
330 | TAZAROTENE for topical use | 77, 62 |
331 | TERBUTALINE in metered aerosols or in dry powder formulations | 32 |
332 | TERFENADINE | | 61
333 | TERIFLUNOMIDE | 7, 62, 87 |
334 | TERPENES, chlorinated | | 1, 4, 8
335 | TETRACHLOROETHANE | 12 | 8
336 | TETRACHLOROETHYLENE when included in Schedule 5 or 6 | 12, 16 | 1, 4, 8, 11
337 | TETRYZOLINE in nasal preparations for topical use | | 29
338 | THALIDOMIDE | 7, 62, 76 |
339 | THIOUREA | | 1, 4
340 | TOLUENE | | 1, 4, 8
341 | TOLUENEDIAMINES—in hair dyes | 21 |
342 | TOLUENEDIAMINES—in preparations other than hair dyes | | 1, 4, 8
343 | TRAMAZOLINE in nasal preparations for topical use | | 29
344 | TRETINOIN—for human oral use | 7, 62, 76 |
345 | TRETINOIN—for topical use | 62, 77 |
346 | TRIAMCINOLONE when in topical preparations for the treatment of mouth ulcers | 64 or 68 |
347 | TRICHLOROACETIC ACID except when for therapeutic use | 2 | 1, 4
348 | 1,1,1-TRICHLOROETHANE | | 8, 9
349 | TRICHLOROETHYLENE except when for therapeutic use | 12 | 1, 4, 5, 8, 9
350 | TRICHLOROPHENOL | | 1, 4, 8
351 | TRIETHYL PHOSPHATE | | 1, 4, 8
352 | TRIFLUOROMETHANESULFONIC ACID—more than 10% | 1, 17 | 1, 4, 8
353 | TRIFLUOROMETHANESULFONIC ACID—10% or less | | 1, 4, 8 Clause 4 Poisons that must be labelled with warning statements and safety directions | Item | Column 1 Poison | Column 2 Warning statement item number | Column 3 Safety direction item number | |------|-----------------------------------------------------|----------------------------------------|---------------------------------------| | 354 | TRIISOPROPANOLAMINE LAURYL ETHER SULFATE | | 1, 4, 6 | | 355 | 3,6,9-TRIOXAUNDECANEDIOIC ACID | 5 | 1 | | 356 | TROLAMINE | 5 | 1, 4 | | 357 | TYMAZOLINE in nasal preparations for topical use | 29 | | | 358 | VINCLOZOLIN | 46 | | | 359 | VINYL ACETATE MONOMER | 11 | 8, 9 | | 360 | XYLENE | | 1, 4, 8 | | 361 | XYLOMETAZOLINE in nasal preparations for topical use| 29 | | | 362 | ZINC CHLORIDE | | 1, 4 | | 363 | ZINC LACTATE | 107 | | | 364 | ZINC SULFATE when included in Schedule 6 | | 1, 4 | Appendix G—Dilute preparations Note: See paragraph 11(c).
1 Substances exempt at or below certain concentrations For the purposes of paragraph 11(c), the following table specifies: (a) substances; and (b) concentrations in relation to those substances. Substances and concentrations | Item | Column 1 Substance | Column 2 Concentration (quantity per litre or kilogram) | |------|--------------------------------------------|---------------------------------------------------------| | 1 | ACETYLCHOLINE | 1 mg | | 2 | ALDOSTERONE | 10 micrograms | | 3 | ANTIMONY COMPOUNDS | 1 mg | | 4 | APOMORPHINE | 1 mg | | 5 | ARSENIC | 1 mg | | 6 | ATROPA BELLADONNA (belladonna) | 300 micrograms | | 7 | ATROPINE | 300 micrograms | | 8 | CANTHARIDIN | 10 micrograms | | 9 | CHLORINE | 5 mg | | 10 | CROTON TIGLIUM (croton oil) | 1 mg | | 11 | DIOXANE | 100 mg | | 12 | EPIDERMAL GROWTH FACTOR | 2 mg | | 13 | ERYSIMUM spp. | 1 mg | | 14 | ESTRADIOL | 10 micrograms | | 15 | ESTRONE | 100 micrograms | | 16 | FOLLICLE-STIMULATING HORMONE | 100 micrograms | | 17 | GELSEMIUM SEMPERVIRENS | 1 mg | | 18 | GLUCAGON | 100 micrograms | | 19 | GLYCERYL TRINITRATE | 100 micrograms | | 20 | GROWTH HORMONE | 10 micrograms | | 21 | HALOPERIDOL | 1 mg | | 22 | HYDROCYANIC ACID | 1 microgram | | 23 | HYOSCINE | 300 micrograms | | 24 | HYOSCYAMINE | 300 micrograms | | 25 | HYOSCYAMUS NIGER | 300 micrograms | | 26 | HYPOTHALAMIC RELEASING FACTORS | 10 micrograms | | 27 | INDOMETACIN | 1 mg | | 28 | MERCURY | 1 mg | | 29 | METHYLMERCURY | 300 micrograms | Appendix G Dilute preparations Clause 1 Substances and concentrations | Item | Column 1 Substance | Column 2 Concentration (quantity per litre or kilogram) | |------|----------------------------------------|---------------------------------------------------------| | 30 | NAPHTHALENE | 1 mg | | 31 | NERIUM OLEANDER | 1 mg | | 32 | OXYTOCIN | 1 microgram | | 33 | PHOSPHORUS | 1 mg | | 34 | PODOPHYLLUM RESIN (podophyllin) | 1 mg | | 35 | PROGESTERONE | 1 mg | | 36 | PROPRANOLOL | 1 mg | | 37 | SELENIUM | 100 micrograms | | 38 | STROPHANTHUS spp. | 1 mg | | 39 | STRYCHNINE | 1 mg | | 40 | TESTOSTERONE | 1 mg | | 41 | THYROXINE | 10 micrograms | Appendix H—Schedule 3 medicines permitted to be advertised Note: See paragraph 57(1)(a).
1 Schedule 3 medicines permitted to be advertised The following table specifies poisons for the purposes of paragraph 57(1)(a). Schedule 3 medicines permitted to be advertised | Item | Column 1 | | Poison |------|--------------------------------------------- | 1 | ADAPALENE | 2 | ADRENALINE | 3 | ASTODRIMER SODIUM—for the treatment and relief of bacterial vaginosis and for the prevention of recurrent bacterial vaginosis | 4 | BILASTINE | 5 | BUTOCONAZOLE | 6 | CELECOXIB | 7 | CICLOPIROX | 8 | CLOBETASONE | 9 | CLOTRIMAZOLE | 10 | DICLOFENAC | 11 | DIMENHYDRINATE—for the prevention and relief of motion sickness | 12 | DIPHENOXYLATE | 13 | ECONAZOLE | 14 | ELETRIPTAN | 15 | ESOMEPRAZOLE | 16 | FAMCICLOVIR | 17 | FLUCONAZOLE | 18 | FLUORIDES | 19 | GLUCAGON | 20 | GLYCERYL TRINITRATE | 21 | HYDROCORTISONE | 22 | HYOSCINE BUTYLBROMIDE | 23 | IBUPROFEN | 24 | ISOCONAZOLE | 25 | KETOPROFEN | 26 | LANSOPRAZOLE | 27 | LEVONORGESTREL | 28 | MELATONIN | 29 | MICONAZOLE | 30 | NALOXONE Clause 1 Schedule 3 medicines permitted to be advertised | Item | Column 1 | |------|----------| | | Poison | | 31 | NAPROXEN | | 32 | NYSTATIN | | 33 | OMEPRAZOLE | | 34 | OXICONAZOLE | | 35 | PANTOPRAZOLE | | 36 | PARACETAMOL | | 37 | PODOPHYLLOTOXIN | | 38 | PODOPHYLLUM EMODI (podophyllin) | | 39 | PODOPHYLLUM PELTATUM (podophyllin) | | 40 | RABEPRAZOLE | | 41 | RIZATRIPTAN | | 42 | SALICYLIC ACID | | 43 | SUMATRIPTAN | | 44 | TIOCONAZOLE | | 45 | TRIAMCINOLONE | | 46 | ULIPRISTAL—for emergency post-coital contraception | | 47 | VITAMIN D | | 48 | ZOLMITRIPTAN | Appendix I—Blank Note 1: Appendix I is intentionally blank. Note 2: Appendix I previously included poisons now dealt with in Division 9 of Part 2. Appendix J—Conditions for availability and use of certain poisons included in Schedule 7 Note: See subsection 62(6).
1 Conditions for supply of certain poisons included in Schedule 7 For the purposes of subsection 62(6), a poison included in Schedule 7 that is specified in column 1 of an item of the following table may be supplied: (a) only to a person who is appropriately authorised or licensed under the law of the jurisdiction where the person will receive the poison; and (b) if “a” appears in column 2 of the item—only for analytical or research purposes; and (c) if “p” appears in column 2 of the item—only to a person who is authorised or licensed, under the law of the jurisdiction where the person will receive the poison, to possess and use the poison. Conditions for supply of certain poisons included in Schedule 7 | Item | Column 1 | Column 2 | |------|----------|----------| | | Poison | Condition| | 1 | ABAMECTIN | | | 2 | ACIBENZOLAR-S-METHYL | | | 3 | ACROLEIN | | | 4 | ACRYLONITRILE | | | 5 | ALACHLOR | a | | 6 | ALLYL ALCOHOL | | | 7 | 4-AMINOPROPIOPHENONE | p | | 8 | 4-AMINOPYRIDINE | | | 9 | ARPRINOCID | a | | 10 | ARSENIC | p | | 11 | AZOCYCLotin | a | | 12 | BENZENE | | | 13 | BIFLUORIDE | | | 14 | BORON TRIFLUORIDE | | | 15 | BRODIFACOUM | | | 16 | BROMADIOLONE | | | 17 | BROMINE | | | 18 | BRUCINE | | | 19 | CALCIFEROL | | | 20 | CARBADOX | | | 21 | CARBON TETRACHLORIDE | | | 22 | CARBONYL SULFIDE | | | 23 | CHLORDECONE | a | Clause 1 Conditions for supply of certain poisons included in Schedule 7 | Item | Column 1 Poison | Column 2 Condition | |------|-----------------------------------------------|---------------------| | 24 | CHLORDIMEFORM | a | | 25 | CHLORINE | | | 26 | CHLOROMETHIURON | a | | 27 | CHLOROPICRIN | | | 28 | 4-CHLORO-o-TOLUIDINE | a | | 29 | COLECALCIFEROL | | | 30 | COUMATETRALYL | | | 31 | CYANOGEN | | | 32 | CYHEXATIN | a | | 33 | 4,4-DIAMINODIPHENYLMETHANE | | | 34 | 1,2-DIBROMO-3-CHLOROPROPANE | a | | 35 | 1,3-DICHLOROPROPENE | | | 36 | DIFENACOUM | | | 37 | 4-DIMETHYLAMINOAZOBENZENE | a | | 38 | DINITROCRESOLS | a | | 39 | DINITROPHENOLS | a | | 40 | DINOSEB | a | | 41 | EPICHLOROHYDRIN | | | 42 | EPIDERMAL GROWTH FACTOR | | | 43 | ETACONAZOLE | a | | 44 | ETHYLENE DIBROMIDE | a | | 45 | ETHYLENE OXIDE | | | 46 | FLUOROACETAMIDE | p | | 47 | FLUOROACETIC ACID | p | | 48 | FOLPET | | | 49 | HALOFUGINONE | | | 50 | HALOGENATED DIBENZODIOXINS AND DIBENZOFURANS | a | | 51 | HCB | a | | 52 | HYDROCYANIC ACID AND CYANIDES | p | | 53 | HYDROFLUORIC ACID | | | 54 | HYDROSILICOFLUORIC ACID | | | 55 | IODOMETHANE | | | 56 | MADURAMICIN | | | 57 | MERCURY | | | 58 | METHACRIFOS | | | 59 | METHOXYETHYLMERCURIC ACETATE | a | | 60 | METHOXYETHYLMERCURIC CHLORIDE | | | 61 | METHYL BROMIDE | | | 62 | 4,4'-METHYLENEBIS[2-CHLOROANILINE] | | Clause 1 Conditions for supply of certain poisons included in Schedule 7 | Item | Column 1 Poison | Column 2 Condition | |------|-----------------------------------------------------|--------------------| | 63 | MIREX | a | | 64 | MOLINATE | | | 65 | NICOTINE except when in tobacco | | | 66 | NITROFEN | a | | 67 | PHENYLMERCURIC ACETATE | | | 68 | PHOSPHIDE, metallic | | | 69 | PHOSPHINE | | | 70 | PROPYLENE OXIDE | | | 71 | PYRIMURON | a | | 72 | STRYCHNINE | p | | 73 | SULCOFURON | a | | 74 | TETRACHLOROETHANE | | | 75 | 2,2',6,6'-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE | | | 76 | THALLIUM | p | | 77 | o-TOLIDINE | | | 78 | VINYL CHLORIDE | | Appendix K—Human medicines required to be labelled with a sedation warning Note: See subsection 33(2).
1 Human medicines required to be labelled with a sedation warning The following table specifies poisons for the purposes of subsection 33(2). Human medicines required to be labelled with a sedation warning | Item | Column 1 | |------|----------| | 1 | ALIMEMAZINE | | 2 | ALPRAZOLAM | | 3 | AMISULPRIDE | | 4 | AMITRIPTYLINE | | 5 | AMOBARBITAL | | 6 | ARIPIPRAZOLE | | 7 | ASENAPINE | | 8 | AZATADINE | | 9 | BACLOFEN | | 10 | BENZATROPINE | | 11 | BREXPIPRAZOLE | | 12 | BRIVARACETAM | | 13 | BROMAZEPAM | | 14 | BROMPHENIRAMINE | | 15 | BUCLIZINE | | 16 | BUPRENORPHINE | | 17 | BUTOBARBITAL | | 18 | CANNABIS except cannabidiol when included in Schedule 3 or 4 | | 19 | CETIRIZINE | | 20 | CHLORAL HYDRATE | | 21 | CHLORDIAZEPOXIDE | | 22 | CHLORMETHIAZOLE | | 23 | CHLORPHENAMINE | | 24 | CHLORPROMAZINE | | 25 | CLEMASTINE | | 26 | CLOMIPRAMINE | | 27 | CLONAZEPAM | | 28 | CLONIDINE | | 29 | CLORAZEPATE | | 30 | CLOZAPINE | Clause 1 Human medicines required to be labelled with a sedation warning | Item | Column 1 | |------|----------| | 31 | CODEINE | | 32 | CYCLIZINE | | 33 | CYCLOBARBITAL | | 34 | CYCLOSERINE | | 35 | CYPROHEPTADINE | | 36 | DANTROLENE | | 37 | DESIPRAMINE | | 38 | DEUTETRABENAZINE | | 39 | DEXCHLORPHENAMINE | | 40 | DEXTROMORAMIDE | | 41 | DEXTROPROPOXYPHENE | | 42 | DIAZEPAM | | 43 | DIFELIKEFALIN | | 44 | DIFENOXIN | | 45 | DIHYDROCODEINE | | 46 | DIMENHYDRINATE | | 47 | DIMETHINDENE | | 48 | DIPHENHYDRAMINE | | 49 | DIPHENOXYLATE | | 50 | DIPHENYLPYRALINE | | 51 | DOSULEPIN | | 52 | DOXEPIN | | 53 | DOXYLAMINE | | 54 | DRONABINOL (delta-9-TETRAHYDROCANNABINOL) | | 55 | DROPERIDOL | | 56 | DULOXETINE | | 57 | ESKETAMINE | | 58 | ETHYLMORPHINE | | 59 | FENFLURAMINE | | 60 | FENTANYL | | 61 | FLUNITRAZEPAM | | 62 | FLUPENTIXOL | | 63 | FLUPHENAZINE | | 64 | FLURAZEPAM | | 65 | GABAPENTIN | | 66 | GEMCITABINE | | 67 | GLUTETHIMIDE | | 68 | GUANFACINE | | 69 | HALOPERIDOL | Clause 1 Human medicines required to be labelled with a sedation warning | Item | Column 1 | |------|----------| | 70 | HYDROCODONE | | 71 | HYDROMORPHONE | | 72 | HYDROXYZINE | | 73 | IMIPRAMINE | | 74 | LAMOTRIGINE | | 75 | LEMBOREXANT | | 76 | LEVETIRACETAM | | 77 | LEVOCABASTINE | | 78 | LEVOCETIRIZINE | | 79 | LORAZEPAM | | 80 | LURASIDONE | | 81 | MAZINDOL | | 82 | MEBHYDROLIN | | 83 | MECLOZINE | | 84 | MEDAZEPAM | | 85 | MEPROBAMATE | | 86 | MEPYRAMINE | | 87 | MERCAPTAMINE | | 88 | METHADONE | | 89 | METHDILAZINE | | 90 | METHOCARBAMOL | | 91 | METHYLPHENOBARBITAL | | 92 | MIANSERIN | | 93 | MIDAZOLAM | | 94 | MIRTAZAPINE | | 95 | MORPHINE | | 96 | NABIXIMOLS | | 97 | NALBUPHINE | | 98 | NITRAZEPAM | | 99 | NORMETHADONE | | 100 | NORTRIPTYLINE | | 101 | OLANZAPINE | | 102 | OPIUM in any form except the alkaloids noscapine and papaverine | | 103 | OXAZEPAM | | 104 | OXYCODONE | | 105 | PALIPERIDONE | | 106 | PAPAVERETUM | | 107 | PENTAZOCINE | | 108 | PENTOBARBITAL | Clause 1 Human medicines required to be labelled with a sedation warning | Item | Column 1 | |------|----------| | 109 | PERAMPANEL | | 110 | PERICIAZINE | | 111 | PERPHENAZINE | | 112 | PETHIDINE | | 113 | PHENELZINE | | 114 | PHENIRAMINE | | 115 | PHENOBARBITAL | | 116 | PHENOPERIDINE | | 117 | PHENYLTOLOXAMINE | | 118 | PHOLCODINE | | 119 | PIMOZIDE | | 120 | PIZOTIFEN | | 121 | PRAZEPAM | | 122 | PREGABALIN | | 123 | PROCHLORPERAZINE | | 124 | PROMAZINE | | 125 | PROMETHAZINE | | 126 | PROTRIPTYLINE | | 127 | QUETIAPINE | | 128 | RETIGABINE | | 129 | RISPERIDONE | | 130 | ROTIGOTINE | | 131 | RUFINAMIDE | | 132 | RUPATADINE | | 133 | SAFINAMIDE | | 134 | SECBUTOBARBITAL | | 135 | SECOBARBITAL | | 136 | SELETRACETAM | | 137 | SODIUM OXYBATE | | 138 | STIRIPENTOL | | 139 | SUVOREXANT | | 140 | TAPENTADOL | | 141 | TEMAZEPAM | | 142 | TETRAHYDROCANNABINOLS except cannabidiol when included in Schedule 3 or 4 | | 143 | THENYLDIAMINE | | 144 | THIETHYLPERAZINE | | 145 | THIOPROPAZATE | | 146 | THIORIDAZINE | | 147 | THIOTHIXENE | Clause 1 Human medicines required to be labelled with a sedation warning | Item | Column 1 | |------|----------| | | Poison | | 148 | TRABECTEDIN | | 149 | TRAMADOL | | 150 | TRANYLCYPROMINE | | 151 | TRIFLUOPERAZINE | | 152 | TRIMIPRAMINE | | 153 | TRIPROLIDINE | | 154 | ZIPRASIDONE | | 155 | ZOLPIDEM | | 156 | ZONISAMIDE | | 157 | ZOPICLONE | Appendix L Requirements for dispensing labels for medicines Clause 1 Appendix L—Requirements for dispensing labels for medicines Note: See subsection 33(1) and paragraph 40(b).
1 General
This clause sets out requirements for the purposes of paragraph 40(b).
All details, words and other required information on a label on a container of a substance for therapeutic use must be in the English language in letters at least 1.5 mm in height.
All symbols, numbers and words on a label must be in durable characters.
The label on a container of a substance for therapeutic use must contain the following details: (a) the name, address and telephone number of the dispenser supplying the substance; (b) the approved name of the substance and/or its proprietary name (unless it is a preparation compounded in accordance with the dispenser’s own formula); (c) adequate directions for use; (d) the strength and form of the substance; (e) the total quantity of the goods in the container; (f) the words “KEEP OUT OF REACH OF CHILDREN” in red on a white background; (g) if the substance is intended for external use only, the word “POISON”, or the words “FOR EXTERNAL USE ONLY”, in red on a white background; (h) if the substance is a medicine for human use, the name of the person for whom it was dispensed; and (i) if the substance is a veterinary chemical, the species of animal, the name of the animal’s owner and the words “FOR ANIMAL TREATMENT ONLY”.
The label on a container of a medicine for human use, or a veterinary chemical, that is supplied on prescription must also include: (a) the prescription reference number; and (b) the date on which the prescription was supplied (unless that date is clear from the prescription reference number); and (c) the directions for use set out in the prescription.
2 Additional warning statements for certain human medicines
For the purposes of subsection 33(1), and subject to subclause (2), the warning statement represented by each item number specified in column 2 of an item of the following table is required for the poison specified in column 1 of the item. Note: For the warning statements represented by the item numbers, see clause 1 of Appendix F.
358 Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024
If more than one statement or direction is required for a poison, the statements and directions may be combined to form simple sentences (if appropriate). Additional warning statements for certain human medicines | Item | Column 1 | Column 2 | |------|----------|----------| | Poison | Warning statement item number | | 1 | ACITRETIN—for oral use | 7, 62, 76 | | 2 | ACITRETIN—for topical use | 62, 77 | | 3 | ADAPALENE—for oral use | 7, 62, 76 | | 4 | ADAPALENE—for topical use | 62, 77 | | 5 | AMBRISENTAN | 7, 62, 76 | | 6 | BELUMOSUDIL | 62, 77 | | 7 | BEXAROTENE—for oral use | 7, 62, 76 | | 8 | BEXAROTENE—for topical use | 62, 77 | | 9 | BOSENTAN | 7, 62, 76 | | 10 | DIENESTROL | 67 | | 11 | ETRETINATE—for oral use | 7, 62, 76 | | 12 | ETRETINATE—for topical use | 62, 77 | | 13 | ENZALUTAMIDE | 7, 67, 87 | | 14 | FARICIMAB | 76 | | 15 | FINERENONE | 67, 111 | | 16 | FINGOLIMOD | 76 | | 17 | ISAVUCONAZOLE | 53 | | 18 | ISOTRETINOIN—for oral use | 7, 62, 76 | | 19 | ISOTRETINOIN—for topical use | 62, 77 | | 20 | LEFLUNOMIDE | 7, 62, 87 | | 21 | LENALIDOMIDE—for oral use | 7, 62, 76 | | 22 | LENALIDOMIDE—for topical use | 62, 77 | | 23 | LEVOCABASTINE | 62 | | 24 | MACITENTAN | 7, 62, 76 | | 25 | MISOPROSTOL | 53 | | 26 | PALOVARETENE | 7, 62, 76, 111 | | 27 | PLITIDEPSIN | 7, 62, 63, 76, 87 | | 28 | POMALIDOMIDE | 7, 62, 76 | | 29 | PONESIMOD | 76 | | 30 | RIOCIGUAT | 7, 62, 76 | | 31 | RUFINAMIDE | 62, 76, 77 | | 32 | SAFINAMIDE | 62, 76, 77 | | 33 | SELINEXOR | 62 and 77 | | 34 | SELUMETINIB | 76 | | 35 | SITAXENTAN | 7, 62, 76 | | 36 | TERIFLUNOMIDE | 7, 62, 87 | | 37 | THALIDOMIDE—for oral use | 7, 62, 76 | Clause 2 Additional warning statements for certain human medicines | Item | Column 1 | Column 2 | |------|---------------------------------------|------------------------------------| | | Poison | Warning statement item number | | 38 | THALIDOMIDE—for topical use | 62, 77 | | 39 | TIRZEPATIDE | 67 | | 40 | TRASTUZUMAB DERUXTECAN | 62, 77 | | 41 | TRETINOIN—for oral use | 7, 62, 76 | | 42 | TRETINOIN—for topical use | 62, 77 | Appendix M—Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist Note: Appendix M is intentionally blank. It is reserved for future use. Index A ABACAVIR Schedule 4 ABAMECTIN Schedule 7 Schedule 6 Schedule 5 Appendix J, clause 1 ABATACEPT Schedule 4 ABCIXIMAB Schedule 4 ABEMACICLIB Schedule 4 ABIRATERONE ACETATE Schedule 4 ABRUS PRECATORIUS cross reference: JEQUIRITY Schedule 10 ABSCISIC ACID Schedule 5 ACALABRUTINIB Schedule 4 ACAMPROSATE CALCIUM Schedule 4 ACARBOSE Schedule 4 ACEBUTOLOL Schedule 4 ACEPHATE Schedule 6 ACEPROMAZINE Schedule 4 ACEQUINOCYL Schedule 5 ACETAMIPRID Schedule 6 ACETANILIDE cross reference: ALKYL ACETANILIDES Schedule 4 ACETARSOL Schedule 4 ACETAZOLAMIDE Schedule 4 ACETIC ACID Schedule 6 Schedule 5 Schedule 2 Appendix E, clause 3 Appendix F, clause 4 ACETIC ANHYDRIDE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 ACETOHEXAMIDE Schedule 4 ACETONE cross reference: DESIGNATED SOLVENT Schedule 5 Appendix E, clause 3 Appendix F, clause 4 ACETORPHINE cross reference: CAS No. 25333-77-1 Schedule 9 ACETYL-ALPHA-METHYLFENTANYL cross reference: CAS No. 101860-00-8 Schedule 9 ACETYLCARBROMAL Schedule 4 ACETYLCHOLINE Schedule 4 Appendix G, clause 1 ACETYLCYSTEINE Schedule 4 Schedule 2 Index ACETYLDIGITOXIN Schedule 4 ACETYLDIHYDROCODEINE Schedule 8 ACETYL ISOVALERYLTYLOSIN Schedule 4 ACETYLMETHADOL Schedule 8 ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE ACETYLMORPHINES Schedule 8 4-[4-(ACETYLOXY)PHENYL]-2-BUTANONE Appendix B, clause 3 ACETYLSTROPHANTHIDIN Schedule 4 ACIBENZOLAR-S-METHYL Schedule 7 Appendix J, clause 1 ACICLOVIR Schedule 4 ACIFLUORFEN Schedule 6 ACINITRAZOLE Schedule 6 ACIPIMOX Schedule 4 ACITRETIN Schedule 4 Appendix D, clause 2 Appendix F, clause 4 Appendix L, clause 2 ACLIDINIUM BROMIDE Schedule 4 ACLONIFEN Schedule 6 ACOKANTHERA OUABAIO Schedule 4 ACOKANTHERA SCHIMPERI Schedule 4 ACONITUM spp. Schedule 4 Schedule 2 ACORUS CALAMUS cross reference: CALAMUS Schedule 10 ACRIFLAVINE cross reference: ACRIFLAVINIUM CHLORIDE ACRIFLAVINIUM CHLORIDE Schedule 7 Schedule 5 ACRIVASTINE Schedule 4 ACROLEIN Schedule 7 Appendix E, clause 3 Appendix F, clause 4 ACRYLONITRILE Schedule 7 Appendix J, clause 1 ADALIMUMAB Schedule 4 ADAPALENE Schedule 4 Schedule 3 Appendix F, clause 4 Appendix H, clause 1 Appendix L, clause 2 ADEFOVIR Schedule 4 ADENOSINE Schedule 4 ADIPHENINE Schedule 4 ADONIS VERNALIS Schedule 4 ADRAFINIL Schedule 4 Index ADRENALINE Schedule 4 Schedule 3 Appendix H, clause 1 ADRENOCORTICAL HORMONES Schedule 4 AFAMELANOTIDE cross reference: MELANOCYTE STIMULATING HORMONE, MELANOTAN I Schedule 4 AFATINIB DIMALEATE Schedule 4 AFIDOPYROPEN Appendix B, clause 3 AFLIBERCEPT Schedule 4 AFOXOLANER Schedule 5 AGALSIDASE Schedule 4 AGLEPRISTONE Schedule 4 AGOMELATINE Schedule 4 AKLOMIDE Schedule 5 ALACHLOR Schedule 7 Appendix J, clause 1 ALANYLGLUTAMINE Schedule 4 ALATROFLOXACIN MESILATE cross reference: ALATROFLOXACIN MESYLATE Schedule 4 ALBENDAZOLE Schedule 6 Schedule 5 Schedule 4 ALCLOFENAC Schedule 4 ALCLOMETASONE Schedule 4 Schedule 3 Appendix F, clause 4 ALCOHOL, DEHYDRATED Appendix B, clause 3 ALCURONIUM Schedule 4 ALDESLEUKIN Schedule 4 ALDICARB Schedule 7 ALDOSTERONE Schedule 4 Appendix G, clause 1 ALDOXYCARB Schedule 7 ALDRIN Schedule 6 ALECTINIB Schedule 4 ALEFACEPT Schedule 4 Appendix D, clause 7 ALEMTUZUMAB Schedule 4 ALENDRONIC ACID Schedule 4 ALFACALCIDOL Schedule 4 ALFENTANIL Schedule 8 ALFUZOSIN Schedule 4 ALGICIDES Appendix A, clause 1 ALGLUCERASE Schedule 4 ALGLUCOSIDASE Schedule 4 ALIMEMAZINE cross reference: TRIMEPRAZINE Schedule 4 Schedule 3 Schedule 2 Appendix K, clause 1 ALIROCUMAB Schedule 4 ALISKIREN Schedule 4 ALKALINE SALTS cross reference: LYE WATER, POTASSIUM CARBONATE, POTASSIUM PHOSPHATE, POTASSIUM SALTS, POTASSIUM SILICATE, SODIUM CARBONATE, SODIUM SALTS, SODIUM SILICATE(S) Schedule 10 Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 ALKOXYAMPHETAMINES cross reference: ALKOXYAMPHETAMINES Schedule 9 ALKOXYLATED FATTY ALKYLAMINE POLYMER Schedule 6 Schedule 5 ALKOXYPHENYLETHYLAMINES Schedule 9 ALKYLAMINES WITH STIMULANT PROPERTIES cross reference: 1,3-DIMETHYLBUTYLAMINE, DMBA, OCTODRINE, 1-AMINOISOHEPTANE, DMHA, 1,5-DIMETHYLHEXYLAMINE, 4-METHYLHEXANE-2-AMINE, 1,3-DIMETHYLAMYLAMINE, DMAA, 4-AMINO-2-METHYLPENTANE CITRATE (AMP CITRATE), 1,4-DIMETHYLPENTYLAMINE, DMPA, 1,4-DIMETHYLAMYLAMINE, DMAA. Schedule 10 ALKYL NITRITES Schedule 4 Appendix E, clause 3 ALKYLTHIOAMPHETAMINES cross reference: ALKYLTHIOAMPHETAMINES Schedule 9 ALLERGENS Schedule 4 ALLETHRIN Schedule 6 Schedule 5 ALLOPURINOL Schedule 4 ALLOXYDIM Schedule 5 ALLYL ALCOHOL Schedule 7 Appendix J, clause 1 ALLYL CYCLOHEXANEACETATE (CAS No. 4728-82-9) Schedule 6 ALLYL CYCLOHEXANEPROPIONATE (CAS No. 2705-87-5) Schedule 6 ALLYL ESTERS (excluding derivatives) Schedule 6 ALLYLESTRENOL cross reference: ALLYLOESTRENOL Schedule 4 ALLYL HEPTANOATE/ALLYL HEPTYLATE (CAS No. 142-19-8) Schedule 6 ALLYL HEXANOATE (CAS No. 123-68-2) Schedule 6 ALLYL ISOVALERATE (CAS No. 2835-39-4) Schedule 6 ALLYL NONANOATE (CAS No. 7493-72-3) Schedule 6 ALLYL OCTANOATE (CAS No. 4230-97-1) Schedule 6 ALLYLOESTRENOL cross reference: ALLYLESTRENOL ALLYL PHENYLACETATE (CAS No. 1797-74-6) Schedule 6 ALLYLPRODINE cross reference: CAS No. 25384-17-2 Schedule 9 ALLYL TRIMETHYLHEXANOATE (CAS No. 68132-80-9) Schedule 6 ALOGLIPTIN Schedule 4 ALOSETRON Schedule 4 ALOXIPRIN Schedule 2 ALPELISIB Schedule 4 ALPHACETYLMETHADOL Schedule 8 ALPHA-CHLOROHYDRIN Schedule 6 Appendix F, clause 4 ALPHA-CYPERMETHRIN Schedule 7 Schedule 6 Schedule 5 ALPHADOLONE Schedule 4 ALPHAMEPRODINE cross reference: CAS No. 468-51-9 Schedule 9 ALPHAMETHADOL cross reference: CAS No. 17199-54-1 Schedule 9 ALPHA-METHYLFENTANYL cross reference: CAS No. 79704-88-4 Schedule 9 ALPHA-METHYLTHIOFENTANYL cross reference: CAS No. 103963-66-2 Schedule 9 ALPHAPRODINE Schedule 8 ALPHA-PYRROLIDINOVALEROPHENONE *(ALPHA-PVP)* cross reference: CAS No. 14530-33-7 Schedule 9 ALPHA1-PROTEINASE INHIBITOR (HUMAN) Schedule 4 ALPHAXALONE Schedule 4 ALPRAZOLAM Schedule 8 Appendix D, clause 5 (Benzodiazepine derivatives) Appendix K, clause 1 ALPRENOLOL Schedule 4 ALPROSTADIL Schedule 4 ALSEROXYLON Schedule 4 ALTEPLASE Schedule 4 ALTRENOGEST Schedule 4 ALTRETAMINE cross reference: HEXAMETHYLMELAMINE Schedule 4 ALUM Appendix B, clause 3 ALUMINIUM AMMONIUM SULFATE Appendix B, clause 3 ALUMINIUM POTASSIUM SULFATE Appendix B, clause 3 ALUMINIUM SILICATE Appendix B, clause 3 ALUMINIUM tris (ETHYLPHOSPHONATE) Appendix B, clause 3 AMANTADINE Schedule 4 AMBENONIUM CHLORIDE Schedule 4 AMBRISENTAN Schedule 4 Appendix D, clause 6 Index Appendix F, clause 4 Appendix L, clause 2 AMBUCETAMIDE Schedule 4 AMBUTONIUM BROMIDE Schedule 4 AMCINONIDE Schedule 4 AMETOCTRADIN Appendix B, clause 3 AMETRYN Schedule 5 AMICARBAZONE Schedule 6 AMIDITHION Schedule 6 AMIDOPROPYL BETAINES Schedule 6 Appendix E, clause 3 AMIFAMPRIDINE Schedule 4 AMIFOSTINE Schedule 4 AMIKACIN Schedule 4 AMILORIDE Schedule 4 AMINACRINE cross reference: AMINOACRIDINE AMINES cross reference: CURING AGENTS FOR EPOXY RESINS Schedule 5 Appendix E, clause 3 Appendix F, clause 4 AMINOACRIDINE cross reference: AMINACRINE Schedule 7 Schedule 5 AMINOCAPROIC ACID Schedule 4 AMINOCARB Schedule 7 Schedule 6 2-AMINO-6-CHLORO-4-NITROPHENOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 4-AMINO-m-CRESOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 5-AMINO-o-CRESOL cross reference: 4-AMINO-2-HYDROXYTOLUENE AMINOCYCLOPYRACHLOR Schedule 5 2-AMINO-1-(2,5-DIMETHOXY-4-METHYL)PHENYLPROPANE cross reference: DOM, STP (CAS No. 15588-95-1), DOM HYDROCHLORIDE (CAS No. 15589-00-1) Schedule 9 AMINOETHOXYVINYLGLYCINE Schedule 6 2-AMINO-5-ETHYLPHENOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 AMINOGLUTETHIMIDE Schedule 4 4-AMINO-2-HYDROXYTOLUENE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 5-AMINOLEVULINIC ACID Schedule 4 1-AMINOMETHANAMIDE DIHYDROGEN TETRAOXOSULFATE Schedule 6 2-[(4-AMINO-2-METHYL-5-NITROPHENYL)AMINO]-ETHANOL cross reference: HC VIOLET 1 2-AMINO-5-METHYLPHENOL cross reference: CAS No. 2835-98-5 Schedule 10 Schedule 7 AMINOMETRADINE Schedule 4 4-AMINO-3-NITROPHENOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 2,2'-[(4-AMINO-3-NITROPHENYL)IMINO]BISETHANOL cross reference: HC RED 13 Schedule 6 Appendix E, clause 3 Appendix F, clause 4 AMINOPHENAZONE cross reference: AMIDOPYRINE (CAS No. 58-15-1), AMINOPHENAZONE HYDROCHLORIDE (CAS No. 6170-29-2) Schedule 10 Schedule 4 m-AMINOPHENOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 p-AMINOPHENOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 AMINOPHYLLINE Schedule 4 Schedule 3 4-AMINOPROPIOPHENONE cross reference: PARA-AMINOPROPIOPHENONE (PAPP) Schedule 7 Appendix J, clause 1 5-(2-AMINOPROPYL)INDAN cross reference: CAS No. 13396-94-6 Schedule 9 AMINOPTERIN Schedule 4 AMINOPYRALID Schedule 6 Schedule 5 4-AMINOPYRIDINE cross reference: FAMPRIDINE Schedule 7 Schedule 4 Appendix E, clause 3 Appendix J, clause 1 AMINOREX Schedule 4 AMINOSALICYLIC ACID Schedule 4 AMIODARONE Schedule 4 AMIPHENAZOLE Schedule 4 AMISOMETRADINE Schedule 4 AMISULBROM Schedule 5 AMISULPRIDE Schedule 4 Appendix K, clause 1 AMITON Schedule 7 AMITRAZ Schedule 6 AMITRIPTYLINE Schedule 4 Appendix K, clause 1 AMITROLE Schedule 5 AMLODIPINE Schedule 4 AMMI VISNAGA Schedule 4 Index AMMONIA cross reference: AMMONIUM HYDROXIDE, CHROMATES Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 AMMONIUM BROMIDE Schedule 4 AMMONIUM COCOYL ISETHIONATE Schedule 6 Appendix E, clause 3 AMMONIUM PERSULFATE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 AMMONIUM PHOSPHATE Appendix B, clause 3 AMMONIUM THIOCYANATE Schedule 5 Appendix E, clause 3 AMMONIUM THIOSULPHATE Appendix B, clause 3 AMOBARBITAL Schedule 8 Schedule 4 Appendix K, clause 1 AMODIAQUINE Schedule 4 AMOROLFINE Schedule 4 Schedule 2 AMOXAPINE Schedule 4 AMOXICILLIN Schedule 4 AMOXYCILLIN cross reference: AMOXICILLIN AMFETAMINE cross reference: AMPHETAMINE Schedule 8 AMPHOMYCIN Schedule 4 AMPHOTERICIN cross reference: AMPHOTERICIN B AMPHOTERICIN B Schedule 4 AMPICILLIN Schedule 4 AMPRENAVIR Schedule 4 AMPROLIUM Appendix B, clause 3 AMRINONE Schedule 4 AMSACRINE Schedule 4 AMYGDALIN cross reference: CAS No. 29883-15-6, APRICOT KERNELS Schedule 10 AMYL ACETATE Appendix B, clause 3 AMYL NITRITE Schedule 4 Schedule 3 Appendix E, clause 3 α-AMYLASE derived from Aspergillus niger Appendix B, clause 3 AMYL CINNAMALDEHYDE Appendix B, clause 3 AMYLOBARBITAL cross reference: AMOBARBITAL AMYLOBARBITONE cross reference: AMOBARBITAL AMYLOCAINE Schedule 4 ANABOLIC STEROIDAL AGENTS cross reference: ANDROSTERONE, STEROIDAL AGENTS Schedule 4 Appendix D, clause 5 ANAGRELIDE Schedule 4 ANAKINRA Schedule 4 ANASTROZOLE Schedule 4 ANCESTIM Schedule 4 ANCHUSA OFFICINALIS Schedule 10 ANCROD Schedule 4 ANDEXANET ALFA Schedule 4 ANDROGENIC STEROIDAL AGENTS cross reference: STEROIDAL AGENTS Schedule 4 Appendix D, clause 5 ANDROISOXAZOLE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) ANDROSTANOLONE Schedule 4 ANDROSTENEDIOL Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) ANDROSTENEDIONE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) ANDROSTENEDIONE ALBUMEN Appendix B, clause 3 ANECORTAVE Schedule 4 ANGIOTENSIN AMIDE Schedule 4 ANHYDRIDES, ORGANIC ACID cross reference: CURING AGENTS FOR EPOXY RESINS Schedule 5 Appendix E, clause 3 Appendix F, clause 4 ANIDULAFUNGIN Schedule 4 ANILERIDINE Schedule 8 ANILINE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 ANIRACETAM cross reference: RACETAMS Schedule 4 ANISE OIL Schedule 5 Appendix E, clause 3, Part 4 o-ANISIDINE cross reference: CAS No. 90-04-0, o-ANISIDINE HYDROCHLORIDE (CAS No. 134-29-2) Schedule 10 ANISTREPLASE Schedule 4 ANTAZOLINE Schedule 4 Schedule 2 ANTIBIOTIC SUBSTANCES cross reference: NISIN Schedule 4 ANTIGENS Schedule 4 ANTIHISTAMINES cross reference: ASTEMIZOLE, AZELASTINE, BILASTINE, CETIRIZINE, DESLORATADINE, FEXOFENADINE, LORATADINE, OLOPATADINE, TERFENADINE Schedule 4 Appendix F, clause 4 ANTIMONY cross reference: ANTIMONY COMPOUNDS, ANTIMONY CHLORIDE, ANTIMONY TITANATE Schedule 6 Schedule 4 Appendix E, clause 3 Appendix G, clause 1 Index ANTISERA cross reference: IMMUNOSERA Schedule 4 AOD-9604 (CAS No. 221231-10-3) Schedule 4 Appendix D, clause 5 APALUTAMIDE Schedule 4 APIXABAN Schedule 4 APOCYNUM spp. Schedule 4 APOMORPHINE Schedule 4 Appendix G, clause 1 APRACLONIDINE Schedule 4 APRAMYCIN Schedule 4 APREMILAST Schedule 4 APREPITANT Schedule 4 APRICOT KERNELS cross reference: AMYGDALIN, HYDROCYANIC ACID APRONAL cross reference: ALLYLISOPROPYLACETYLUREA (CAS No. 528-92-7) Schedule 10 APROTININ Schedule 4 ARBUTIN (ALPHA) cross reference: ARBUTIN (BETA); ARBUTIN (DEOXY OR OTHER DERIVATIVES) Schedule 6 Appendix E, clause 3 Appendix F, clause 4 ARBUTIN (BETA) cross reference: ARBUTIN (ALPHA); ARBUTIN (DEOXY OR OTHER DERIVATIVES) Schedule 6 Schedule 4 Appendix E, clause 3 Appendix F, clause 4 ARBUTIN (DEOXY OR OTHER DERIVATIVES) cross reference: ARBUTIN (ALPHA); ARBUTIN (BETA) Schedule 6 Appendix E, clause 3 Appendix F, clause 4 ARECOLINE Schedule 4 ARIPIPRAZOLE Schedule 4 Appendix K, clause 1 ARISTOLOCHIA spp. Schedule 10 ARISTOLOCHIC ACID(S) cross reference: ASARUM spp, BRAGANTIA (CAS No. 313-67-7) Schedule 10 ARPRINOCID Schedule 7 Appendix J, clause 1 ARMODAFINIL Schedule 4 ARSENIC cross reference: ARSENIC TRIOXIDE, CACODYLIC ACID, TERMITE BARRIERS, COPPER-CHROME-ARSENIC, SELENIUM ARSENIDE, THIACETARSAMIDE Schedule 7 Schedule 6 Schedule 4 Appendix G, clause 1 Appendix J, clause 1 ARTEMETHER Schedule 4 ARTICAINE Schedule 4 ASARUM spp Schedule 10 ASCIMINIB Schedule 4 ASENAPINE Schedule 4 Appendix K, clause 1 Index ASFOTASE ALFA Schedule 4 ASPARAGINASE cross reference: CRISANTASPASE Schedule 4 ASPARTIC ACID Appendix B, clause 3 ASPIRIN cross reference: CAFFEINE, PARACETAMOL, SALICYLAMIDE Schedule 6 Schedule 5 Schedule 4 Schedule 2 Appendix F, clause 4 ASTEMIZOLE Schedule 4 Appendix F, clause 4 ASTODRIMER SODIUM Schedule 3 Appendix F, clause 4 Appendix H, clause 1 ASULAM Appendix B, clause 3 ASUNAPREVIR Schedule 4 ATAMESTANE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) ATAZANAVIR Schedule 4 ATENOLOL Schedule 4 ATEZOLIZUMAB Schedule 4 ATIPAMEZOLE Schedule 4 ATOMOXETINE Schedule 4 ATORVASTATIN Schedule 4 ATOSIBAN Schedule 4 ATOVAQUONE Schedule 4 ATRACURIUM BESILATE cross reference: ATRACURIUM BESYLATE Schedule 4 ATRAZINE Schedule 5 ATROPA BELLADONNA cross reference: BELLADONNA Schedule 4 Schedule 2 Appendix G, clause 1 ATROPINE Schedule 4 Schedule 2 Appendix G, clause 1 ATROPINE METHONITRATE Schedule 4 AURANOFIN Schedule 4 AUREOBASIDIUM PULLULANS (Strains DSM14940 and DSM14941) Appendix B AUROTHIOMALATE SODIUM Schedule 4 AVACOPAN Schedule 4 AVATROMBOPAG Schedule 4 AVELUMAB Schedule 4 AVILAMYCIN Schedule 4 AVIPTADIL Schedule 4 AVOPARCIN Schedule 4 AXITINIB Schedule 4 AZACITIDINE Schedule 4 AZACONAZOLE Schedule 6 AZACYCLOLOL Schedule 4 AZADIRACHTA INDICA cross reference: DEBITTERISED NEEM SEED OIL, NEEM Schedule 10 Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 AZADIRACHTA INDICA EXTRACTS Schedule 5 AZAFENIDIN Schedule 7 AZAMETHIPHOS Schedule 6 AZAPERONE Schedule 4 AZAPROPAZONE Schedule 4 AZARIBINE Schedule 4 AZATADINE Appendix K, clause 1 AZATADINE Schedule 4 Schedule 3 AZATHIOPRINE Schedule 4 AZELAIC ACID Schedule 4 Schedule 2 AZELASTINE Schedule 4 Schedule 2 AZIMSULFURON Appendix B, clause 3 AZINPHOS-ETHYL Schedule 7 AZINPHOS-METHYL Schedule 7 AZITHROMYCIN Schedule 4 AZLOCILLIN Schedule 4 AZOBENZENE Schedule 6 AZOCYCLOTIN Schedule 7 Appendix F, clause 4 Appendix J, clause 1 AZO DYES (derivatives by diazotisation) Schedule 7 Appendix E, clause 3 Appendix F, clause 4 AZOXYSTROBIN Schedule 5 AZTREONAM Schedule 4 B BACAMPICILLIN Schedule 4 BACILLUS AMYLOLIQUEFACIENS cross reference: BACILLUS SUBTILIS, STRAIN QST 713; BACILLUS AMYLOLIQUEFACIENS, STRAIN QST 713; BACILLUS AMYLOLIQUEFACIENS, STRAIN MBI 600 Appendix B, clause 3 BACILLUS SPHAERICUS, STRAIN 2362 Appendix B, clause 3 BACILLUS SUBTILIS, STRAIN QST 713 cross reference: BACILLUS AMYLOLIQUEFACIENS, STRAIN QST 713 BACILLUS THURINGIENSIS cross reference: ENDOTOXIN Appendix B, clause 3 BACILLUS THURINGIENSIS DELTA ENDOTOXIN Schedule 5 BACILLUS TOYOI Appendix B, clause 3 BACITRACIN Schedule 4 BACLOFEN Schedule 4 Appendix K, clause 1 BACTERIAL CULTURE MEDIA cross reference: ANTIBIOTIC SUBSTANCES Appendix A, clause 1 BACTERICIDES Appendix A, clause 1 BACULOVIRUS CYDIA POMONELLA Appendix B, clause 3 BALOXAVIR MARBOXIL Schedule 4 BALSALAZIDE Schedule 4 BAMBERMYCIN cross reference: FLAVOPHOSPHOLIPOL Schedule 6 Schedule 4 BAMBUTEROL Schedule 4 BAMETHAN Schedule 4 BAMIPINE Schedule 4 BARBITURATES Schedule 4 BARICITINIB Schedule 4 BARIUM SALTS cross reference: BARIUM METABORATE, BARIUM SULFATE Schedule 6 Appendix E, clause 3 BARIUM SILICOFLUORIDE Schedule 5 BASIC BLUE 26 Schedule 10 Schedule 6 BASIC ORANGE 31 cross reference: 2-[(4-AMINOPHENYL)AZO]-1,3-DIMETHYL-1H-IMIDAZOLIUM, CHLORIDE (CAS No. 97404-02-9) Schedule 10 Schedule 6 BASIC RED 76 (CAS No. 68391-30-0) cross reference: [7-HYDROXY-8-[(2-METHOXYPHENYL)AZO]-2-NAPHTHYL]TRIMETHYLAMMONIUM CHLORIDE (CAS No. 68391-30-0) Schedule 7 Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BASIL OIL cross reference: METHYL CHAVICOL Schedule 5 Appendix E, clause 3 BASILIXIMAB Schedule 4 BATTERIES Appendix A, clause 1 Index BAY OIL Schedule 6 Appendix E, clause 3 BAZEDOXIFENE Schedule 4 BEAUVERIA BASSIANA Schedule 6 Schedule 5 BECAPLERMIN Schedule 4 BECLAMIDE Schedule 4 BECLOMETASONE cross reference: BECLOMETHASONE Schedule 4 Schedule 2 BECLOMETHASONE cross reference: BECLOMETASONE BELATACEPT Schedule 4 BELIMUMAB Schedule 4 BELUMOSUDIL Schedule 4 Appendix L, clause 2 BELZUTIFAN Schedule 4 BEMEGRIDE Schedule 4 BENACTYZINE Schedule 4 BENALAXYL Schedule 5 BENAZEPRIL Schedule 4 BENDAMUSTINE Schedule 4 BENDIOCARB cross reference: DENATONIUM BENZOATE Schedule 7 Schedule 6 Schedule 5 BENDROFLUAZIDE Schedule 4 BENETHAMINE PENICILLIN Schedule 4 BENFLURALIN Appendix B, clause 3 BENOMYL Schedule 7 Appendix F, clause 4 BENORYLATE Schedule 4 BENOXAPROFEN Schedule 4 BENPERIDOL Schedule 4 BENQUINOX Schedule 6 BENRALIZUMAB Schedule 4 BENSERAZIDE Schedule 4 BENSULFURON-METHYL Appendix B, clause 3 BENSULIDE Schedule 6 BENTAZONE Schedule 5 BENTONITE Appendix B, clause 3 BENZALKONIUM CHLORIDE Schedule 6 Schedule 5 Appendix E, clause 3 BENZATHINE PENICILLIN Schedule 4 BENZENE cross reference: LIQUID HYDROCARBONS Schedule 7 Appendix E, clause 3 Appendix F, clause 4 Appendix J, clause 1 1,2-BENZENEDIAMINE cross reference: CAS No. 95-54-5, 1,2-BENZENEDIAMINE DIHYDROCHLORIDE (CAS No. 615-28-1) Schedule 10 1,3-BENZENEDIAMINE cross reference: CAS No. 108-45-2 Schedule 10 1,2-BENZENEDIOL cross reference: CATECHOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BENZETHIDINE cross reference: CAS No. 3691-78-9 Schedule 9 BENZHEXOL cross reference: TRIHEXYPHENIDYL BENZIDINE-CONGENER (3,3'-disubstituted) AZO DYES Schedule 7 BENZIDINE-BASED AZO DYES Schedule 7 BENZILONIUM Schedule 4 BENZOCAINE Schedule 4 Schedule 2 BENZODIAZEPINE DERIVATIVES Schedule 4 Appendix D, clause 5 BENZOFENAP Schedule 5 BENZOVINDIFLU PYR Schedule 6 BENZOYL PEROXIDE Schedule 5 Schedule 4 Schedule 2 Appendix E, clause 3 Appendix F, clause 4 BENZOYLINDOLES Schedule 9 BENZPHETAMINE Schedule 4 BENZTHIAZIDE Schedule 4 BENZATROPINE cross reference: BENZITROPINE Schedule 4 Appendix K, clause 1 BENZYDAMINE Schedule 4 Schedule 2 6-BENZYLADENINE Schedule 6 BENZYL BENZOATE Appendix B, clause 3 BENZYLMORPHINE Schedule 8 BENZYLPENICILLIN Schedule 4 BENZYLPIPERAZINE cross reference: BZP (CAS No. 2759-28-6), BENZYLPIPERAZINE TARTRATE (CAS No. 10510-56-2), BENZYLPIPERAZINE DIHYDROCHLORIDE (CAS No. 5321-63-1) Schedule 9 BEPHENIUM SALTS Schedule 2 BEPRIDIL Schedule 4 BERACTANT Schedule 4 Index BERGAMOT OIL Schedule 5 Appendix E, clause 3 Appendix F, clause 4 BERYLLIUM Schedule 6 Appendix F, clause 4 BESIFLOXACIN Schedule 4 BETACETYLMETHADOL cross reference: CAS No. 17199-59-6 Schedule 9 BETACYFLUTHRIN Schedule 7 Schedule 6 Schedule 5 BETA-CYPERMETHRIN Schedule 6 BETA-PHENYL-GAMMA-AMINOBUTYRIC ACID cross reference: PHENIBUT BETAHISTINE Schedule 4 BETA-HYDROXY-3-METHYLFENTANYL cross reference: CAS No. 78995-14-9 Schedule 9 BETA-HYDROXYFENTANYL cross reference: CAS No. 78995-10-5 Schedule 9 BETAINE HYDROCHLORIDE Appendix B, clause 3 BETAMEPRODINE cross reference: CAS No. 468-50-8 Schedule 9 BETAMETHADOL cross reference: CAS No. 17199-55-2 Schedule 9 BETAMETHASONE Schedule 4 1-(BETA-METHYL SULPHONAMIDOETHYL)-2-AMINO-3 Appendix F, clause 4 BETAPRODINE cross reference: CAS No. 468-59-7 Schedule 9 BETAXOLOL Schedule 4 BETHANECHOL CHLORIDE Schedule 4 BETHANIDINE Schedule 4 BEVACIZUMAB Schedule 4 BEVANTOLOL Schedule 4 BEXAROTENE Schedule 4 Appendix D, clause 2 Appendix F, clause 4 Appendix L, clause 2 BEZAFIBRATE Schedule 4 BEZITRAMIDE Schedule 8 BEZLOTOXUMAB Schedule 4 BHC Schedule 6 BICALUTAMIDE Schedule 4 BICTEGRAVIR Schedule 4 BICYCLOPYRONE Schedule 6 Schedule 5 BIFENAZATE Appendix B, clause 3 BIFENTHRIN Schedule 7 Schedule 6 Index BIFLUORIDES cross reference: AMMONIUM BIFLUORIDE, AMMONIUM SALTS, POTASSIUM SALTS, SODIUM SALTS Schedule 7 Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 Appendix J, clause 1 BIFONAZOLE Schedule 4 Schedule 2 BILASTINE Schedule 4 Schedule 3 Appendix H, clause 1 BIMATOPROST Schedule 4 BINIMETINIB Schedule 4 BIOALLETHRIN Schedule 6 Schedule 5 BIORESMETHRIN Schedule 5 BIPERIDEN Schedule 4 1,3-BIS(2,4-DIAMINOPHENOXY)PROPANE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BIS-ISOBUTYL PEG/PPG-20/35/AMODIMETICONE COPOLYMER Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BISMUTH COMPOUNDS cross reference: BISMUTH CITRATE, BISMUTH FORMIC IODIDE, BISMUTH OXYCHLORIDE, BISMUTH SUBIODIDE Schedule 4 BISMUTH SUBNITRATE Appendix B, clause 3 BISOPROLOL Schedule 4 N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,5-DIMETHANAMINE cross reference: N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,6-DIMETHANAMINE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,6-DIMETHANAMINE cross reference: N,N-BIS(PHENYLMETHYLENE)-BICYCLO-(2.2.1)HEPTANE-2,6-DIMETHANAMINE Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BISPYRIBAC Schedule 5 BISTRIFLURON Appendix B, clause 3 BITHIONOL cross reference: CAS No. 97-18-7 Schedule 10 Schedule 6 Appendix F, clause 4 BIURET Appendix B, clause 3 BIVALIRUDIN Schedule 4 BIXAFEN Schedule 5 BIXLOZONE Appendix B, clause 3 BLAD (banda de Lupinus albus doce) Appendix B, clause 3 BLEOMYCIN Schedule 4 BLINATUMOMAB Schedule 4 BOCEPREVIR Schedule 4 BOLANDIOL Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BOLASTERONE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BOLAZINE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BOLDENONE cross reference: DEHYDROTESTOSTERONE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BOLENOL Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BOLMANTALATE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) BORAGO OFFICINALIS cross reference: BORAGE Schedule 10 BORIC ACID cross reference: BORAX, SODIUM BORATE, POTASSIUM BORATE, MEA-BORATE, MIPA-BORATE Schedule 5 Schedule 4 Appendix E, clause 3 Appendix F, clause 4 BORON cross reference: BORATES, BORAX, BORIC ACID, BORON COMPOUNDS Schedule 4 BORON TRIFLUORIDE Schedule 7 Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 Appendix J, clause 1 BORTEZOMIB Schedule 4 BOSCALID Appendix B, clause 3 BOSENTAN Schedule 4 Appendix D, clause 6 Appendix F, clause 4 Appendix L, clause 2 BOSUTINIB Schedule 4 BOTULINUM TOXINS Schedule 4 BOVINE SOMATOTROPHIN Appendix B, clause 3 BRAGANTIA spp Schedule 10 BRENTUXIMAB VEDOTIN Schedule 4 BRETYLIUM TOSILATE Schedule 4 BRETYLIUM TOSYLATE cross reference: BRETYLIUM TOSILATE BREXPIPRAZOLE Schedule 4 Appendix K, clause 1 BRIGATINIB Schedule 4 BRIMONIDINE Schedule 4 Schedule 2 BRINZOLAMIDE Schedule 4 BRIVARACETAM cross reference: RACETAMS Schedule 4 Appendix K, clause 1 BRODIFACOUM Schedule 7 Schedule 6 Appendix J, clause 1 BROFLANILIDE Schedule 6 Schedule 5 Index BROMACIL Appendix B, clause 3 BROMADIOLONE Schedule 7 Schedule 6 Appendix J, clause 1 BROMAZEPAM Schedule 4 Appendix D, clause 5 (Benzodiazepine derivatives) Appendix K, clause 1 BROMETHALIN Schedule 7 Schedule 6 BROMHEXINE Schedule 2 BROMIDES Schedule 4 BROMINE Schedule 7 Appendix J, clause 1 1-(8-BROMOBENZO[1,2-B;4,5-B]DIFURAN-4-YL)-2-AMINOPROPANE cross reference: BROMO-DRAGONFLY (CAS No. 502759-67-3) Schedule 9 BROMOCRIPTINE Schedule 4 4-BROMO-2,5-DIMETHOXYPHENETHYLAMINE cross reference: BDMPEA (CAS No. 66142-81-2) Schedule 9 BROMOFORM Schedule 6 Schedule 4 Appendix E, clause 3 Appendix F, clause 4 BROMOPHOS Schedule 6 BROMOPHOS-ETHYL Schedule 6 BROMOPROPYLATE Appendix B, clause 3 BROMOXYNIL Schedule 6 BROMPHENIRAMINE Schedule 4 Schedule 3 Schedule 2 Appendix K, clause 1 BROMUCONAZOLE Schedule 6 Schedule 5 BROMVALETONE Schedule 4 BROTIANIDE Schedule 6 BRUCINE Schedule 7 Appendix E, clause 3 Appendix J, clause 1 BRUGMANSIA spp. Schedule 4 BUCLIZINE Schedule 4 Schedule 3 Appendix K, clause 1 BUCLOSAMIDE cross reference: CAS No. 575-74-6 Schedule 10 BUDESONIDE Schedule 4 Schedule 2 BUFEXAMAC Schedule 4 BUFOTENINE cross reference: CAS No. 487-93-4 Schedule 9 BUMETANIDE Schedule 4 BUNAMIDINE Schedule 6 BUNIODYL SODIUM cross reference: CAS No. 1923-76-8, BUNIODYL BASE (CAS No. 1233-53-0) Schedule 10 BUPHENINE Schedule 4 BUPIRIMATE Appendix B, clause 3 BUPIVACAINE Schedule 5 Schedule 4 BUPRENORPHINE Schedule 8 Appendix K, clause 1 BUPROFEZIN Schedule 5 BUPROPION cross reference: AMFEBUTAMONE Schedule 4 BUSERELIN Schedule 4 BUSPIRONE Schedule 4 BUSULPHAN Schedule 4 BUTACAINE Schedule 4 BUTACARB Schedule 6 BUTAFENACIL Appendix B, clause 3 BUTAMBEN cross reference: BUTYL AMINOBENZOATE Schedule 4 1,4-BUTANEDIOL cross reference: CAS No. 110-63-4 Schedule 10 BUTHIDAZOLE Schedule 5 BUTOBARBITAL Schedule 8 Appendix K, clause 1 BUTOBARBITONE cross reference: BUTOBARBITAL BUTOCONAZOLE Schedule 4 Schedule 3 Appendix H, clause 1 BUTONITAZENE cross reference: CAS No. 95810-54-1 Schedule 9 BUTORPHANOL Schedule 8 BUTOXYCARBOXIM Schedule 6 Schedule 5 2-BUTOXYETHANOL Schedule 6 Appendix E, clause 3 Appendix F, clause 4 BUTOXYPOLYPROPYLENE GLYCOL Appendix B, clause 3 2-BUTOXY-2'-THIOCYANODIETHYL ETHER Schedule 6 Appendix F, clause 4 BUTRACONAZOLE Schedule 4 BUTRALIN Schedule 5 BUTROXYDIM Schedule 5 n-BUTYL ALCOHOL Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 Index BUTYL AMINOBENZOATE cross reference BUTAMBEN BUTYL BENZYL PHTHALATE cross reference: CAS No. 85-68-7 Schedule 10 n-BUTYL BUTYRATE Appendix B, clause 3 n-BUTYL LACTATE Appendix B, clause 3 BUTYL NITRITE Schedule 4 Appendix E, clause 3 BUTYLCHLORAL HYDRATE Schedule 4 BUTYRIC ACID Schedule 6 C CABAZITAXEL Schedule 4 CABERGOLINE Schedule 4 CABOTEGRAVIR Schedule 4 CABOZANTINIB Schedule 4 CACALIA spp. Schedule 10 CACODYLIC ACID Schedule 7 Schedule 6 CADMIUM COMPOUNDS cross reference: CADMIUM, CADMIUM ACETATE, CADMIUM CHLORIDE, CADMIUM NITRATE Schedule 6 Schedule 4 Appendix E, clause 3 CADUSAFOS Schedule 7 Schedule 6 CAFFEINE cross reference: PARACETAMOL, ASPIRIN, SALICYLAMIDE Schedule 6 Schedule 4 CAJUPUT OIL Schedule 6 Appendix E, clause 3 CALCIFEDIOL Schedule 4 CALCIFEROL Schedule 7 Schedule 6 Appendix J, clause 1 CALCIPOTRIOL Schedule 4 CALCITONIN SALMON Schedule 4 Index CALCITRIOL Schedule 4 CALCIUM CARBIMIDE Schedule 4 CALCIUM HYDROXYLAPATITE Schedule 4 CALCIUM POLYSTYRENE SULPHONATE Schedule 4 CALOTROPIS GIGANTEA Schedule 4 CALOTROPIS PROCERA Schedule 4 CALUSTERONE Schedule 4 Appendix D, clause 5 (Anabolic and/or androgenic steroidal agents) CAMBENDAZOLE Schedule 6 CAMPHOR cross reference: ESSENTIAL OILS, LAVANDIN OIL, ROSEMARY OIL, SHUI OIL Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 CAMPHORATED OIL Schedule 4 CAMPHOTAMIDE Schedule 4 CANAGLIFLOZIN Schedule 4 CANAKINUMAB Schedule 4 CANDESARTAN CILEXETIL Schedule 4 CANDICIDIN Schedule 4 CANINE TICK ANTI-SERUM Schedule 4 CANNABICHROMENE cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABIDIOL cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS Schedule 4 Schedule 3 Appendix F, clause 4 CANNABIDIOLIC ACID cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABIDIVAROL cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABIGEROL cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABINOIDS cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABINOL cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS CANNABIS cross reference: CANNABIS SATIVA, HEMP, HEMP SEED OIL, TETRAHYDROCANNABINOLS Schedule 9 Schedule 8 Appendix D, clause 1 Appendix K, clause 1 CANTHARIDIN Schedule 4 Appendix G, clause 1 CAPECITABINE Schedule 4 CAPREOMYCIN Schedule 4 CAPTAFOL Schedule 7 Appendix J, clause 1 CAPTAN Schedule 6 CAPTODIAME Schedule 4 CAPTOPRIL Schedule 4 CAPURIDE Schedule 4 CARAMIPHEN Schedule 4 CARBACHOL Schedule 4 CARBADOX Schedule 7 Appendix J, clause 1 CARBAMAZEPINE Schedule 4 CARBAMIDE PEROXIDE cross reference: CAS No. 124-43-6 Schedule 10 Schedule 6 Schedule 5 Appendix E, clause 3 Appendix F, clause 4 CARBARYL Schedule 6 Schedule 5 Schedule 4 CARBAZOCHROME Schedule 4 CARBENDAZIM Schedule 7 CARBENICILLIN Schedule 4 CARBENOXOLONE Schedule 4 CARBETAMIDE Schedule 6 CARBETAPENTANE Schedule 2 CARBETOCIN Schedule 4 CARBIDOPA Schedule 4 CARBIMAZOLE Schedule 4 CARBOCISTEINE Schedule 2 CARBOCROMEN Schedule 4 CARBOFURAN Schedule 7 CARBON DISULFIDE Schedule 6 Appendix E, clause 3 CARBON TETRACHLORIDE Schedule 7 Appendix E, clause 3 Appendix F, clause 4 Appendix J, clause 1 CARBONYL SULFIDE Schedule 7 Appendix J, clause 1 CARBOPHENOTHION Schedule 7 CARBOPLATIN Schedule 4 CARBOPROST Schedule 4 CARBOSULFAN Schedule 7 CARBOXIN Appendix B, clause 3 CARBROMAL Schedule 4 CARBUTAMIDE Schedule 4 CARBUTEROL Schedule 4 CARDARINE cross reference: CAS No. 317318-70-0 Schedule 10 CARFENTANYL Schedule 8 CARFENTRAZONE-ETHYL Appendix B, clause 3 CARFILZOMIB Schedule 4 CARGLUMIC ACID Schedule 4 CARINDACILLIN Schedule 4 CARIPRAZINE Schedule 4 CARISOPRODOL Schedule 4 CARMUSTINE Schedule 4 CARNIDAZOLE Schedule 4 CARPROFEN Schedule 4 CARVEDILOL Schedule 4 CASIRIVIMAB Schedule 4 CASPOFUNGIN Schedule 4 CASSIA OIL Schedule 5 Appendix E, clause 3 Appendix F, clause 4 CASTOR OIL, MONOMALEATE Schedule 6 CATHINE Schedule 4 CATHINONES cross reference: SYNTHETIC CATHINONE