Australian Government

Federal Register of Legislation

Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023

No longer in force

Administered by

Department of Health and Aged Care

This item is authorised by the following title:

Therapeutic Goods Act 1989

Latest version

F2023L00617

26 May 2023 - 30 June 2023

For transitional provisions relating to the repeal of this standard, see subsections 4(2) and (3) of the TTherapeutic Goods (Poisons Standard—July 2023) Instrument 2023.

Table of contents

Reader’s guide
- Introduction
- Classification
- Principles of scheduling
- Reading the schedules
- Availability of poisons
- Appendices
- Appendix A (General exemptions)
- Appendix B (Substances considered not to require control by scheduling)
- Appendix C (blank)
- Appendix D (Additional controls on possession or supply of poisons included in Schedule 4 or 8)
- Appendix E (First aid instructions for poisons)
- Appendix F (Warning statements and general safety directions for poisons)
- Appendix G (Dilute preparations)
- Appendix H (Schedule 3 medicines permitted to be advertised)
- Appendix I (blank)
- Appendix J (Conditions for availability and use of certain poisons included in Schedule 7)
- Appendix K (Human medicines required to be labelled with a sedation warning)
- Appendix L (Requirements for dispensing labels for medicines)
- Appendix M (blank)
- Poisons Information Centre telephone numbers for first aid instructions, warning statements and general safety directions for poisons
Part 1—Preliminary and interpretation
- 1 Name
- 2 Commencement
- 3 Authority
- 4 Repeal and transitional provisions
- 5 Reader’s guide and Index
- 6 Definitions
- 7 References to substances
- 8 References to concentration, strength or quantity of substances
- 9 References to boiling or distillation temperatures
- 10 References to standards
Part 2—Controls on substances
- Division 1—Preliminary
  - 11 Application of Part 2
  - 12 Preparations containing poisons included in different schedules
- Division 2—Labels
  - Subdivision A—General
    - 13 General requirements
    - 14 Immediate wrapper
  - Subdivision B—Primary packs and immediate containers
  - 15 Primary packs and immediate containers
  - 16 Signal words
  - 17 Cautionary statement—possession without authority illegal
  - 18 Cautionary statement—keep out of reach of children
  - 19 Cautionary statement—fire and explosion hazard
  - 20 Cautionary statement—burns skin and throat
  - 21 Cautionary statements for aqueous solution of paraquat
  - 22 Cautionary statement—read safety directions
  - 23 Cautionary statement—flammable
  - 24 Cautionary statement—for animal treatment only
  - 25 Cautionary statement—do not swallow
  - 26 Approved name and quantity, proportion or strength
  - 27 Statement—an anticholinesterase compound
  - 28 Directions for use
  - 29 Safety directions
  - 30 Warning statements
  - 31 First aid
  - 32 Name and address of manufacturer or distributor
  - 33 Warning statements and sedation warnings for certain medicines for human use
  - Subdivision C—Statements of quantity, proportion or strength
  - 34 Statements of quantity, proportion or strength
  - Subdivision D—Exemptions from labelling requirements
  - 35 Selected containers and measure packs
  - 36 Ampoules, pre filled syringes and injection vials
  - 37 Transport containers and wrappings
  - 38 Dispensary, industrial, laboratory and manufacturing poisons
  - 39 Exemptions from label requirements in certain circumstances
  - 40 Dispensed medicines
  - 41 Gas cylinders
  - 42 Paints
  - 43 Camphor and naphthalene
  - Subdivision E—Prohibitions
  - 44 Prohibitions
- Division 3—Containers
- 45 General requirements
- 46 Containers for poisons other than poisons included in Schedule 5
- 47 Containers for poisons included in Schedule 5
- 48 Approved containers
- 49 Child resistant closures
- 50 Poisons included in Schedule 8
- 51 Exemptions
- 52 Camphor and naphthalene
- 53 Prohibitions—use of containers for poisons
- Division 4—Storage
- 54 General storage requirements
- Division 5—Disposal
- 55 General disposal requirements
- Division 6—Record keeping
- 56 General record keeping requirements
- Division 7—Advertising
- 57 General advertising requirements
- Division 8—Supply, prescribing, possession or use
- 58 Poisons included in Schedule 2
- 59 Poisons included in Schedule 3
- 60 Poisons included in Schedule 4
- 61 Poisons included in Schedules 5 and 6
- 62 Poisons included in Schedule 7
- 63 Poisons included in Schedule 10
- 64 Poisons included in Schedule 4 or 8 and Appendix D
- 65 Hawking
- Division 9—Paints and tinters
- 66 General requirements
- 67 Definition of first group paint
- 68 Definition of second group paint
Schedule 1—Blank
Schedule 2—Pharmacy medicines
Schedule 3—Pharmacist only medicines
Schedule 4—Prescription only medicines and prescription animal remedies
Schedule 5—Caution
Schedule 6—Poisons
Schedule 7—Dangerous poisons
Schedule 8—Controlled drugs
Schedule 9—Prohibited substances
Schedule 10—Substances of such danger to health as to warrant prohibition of supply and use
Appendix A—General exemptions
- 1 Exempt preparations and products
Appendix B—Substances considered not to require control by scheduling
- 1 Reasons for including substances in the table in clause 3
- 2 Areas of use in relation to substances included in the table in clause 3
- 3 Substances exempt in certain uses
Appendix C—Blank
Appendix D—Additional controls on possession or supply of poisons included in Schedule 4 or 8
- 1 Poisons available for human use only from or on the prescription or order of an authorised medical practitioner
- 2 Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist
- 3 Poisons available only from or on the prescription or order of a medical practitioner approved or authorised under section 19 of the Act
- 4 Poisons available only from or on the order of a specialist physician
- 5 Poisons for which possession without authority is illegal
- 6 Poisons available for human use only from or on the prescription or order of a specialist physician
- 7 Poisons available for human use only from or on the prescription or order of a dermatologist
- 8 Poison available for initial treatment of a patient only if authorised by certain health practitioners
- 9 Poisons which must be stored in a locked container to prevent unauthorised access
Appendix E—First aid instructions for poisons
- 1 Standard statements for first aid instructions
- 2 Poisons information centre contact information in statements
- 3 First aid instructions for poisons
Appendix F—Warning statements and general safety directions for poisons
- 1 Warning statements
- 2 Safety directions—general
- 3 Poisons information centre contact information in statements
- 4 Poisons that must be labelled with warning statements and safety directions
Appendix G—Dilute preparations
- 1 Substances exempt at or below certain concentrations
Appendix H—Schedule 3 medicines permitted to be advertised
- 1 Schedule 3 medicines permitted to be advertised
Appendix I—Blank
Appendix J—Conditions for availability and use of certain poisons included in Schedule 7
- 1 Conditions for supply of certain poisons included in Schedule 7
Appendix K—Human medicines required to be labelled with a sedation warning
- 1 Human medicines required to be labelled with a sedation warning
Appendix L—Requirements for dispensing labels for medicines
- 1 General
- 2 Additional warning statements for certain human medicines
Appendix M—Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist
Index