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Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024
No longer in force
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Administered by
Department of Health and Aged Care
This item is authorised by the following title:
Therapeutic Goods Act 1989
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F2024L00589
30 May 2024
-
30 September 2024
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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
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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
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Part 2—Controls on substances
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Division 1—Preliminary
11 Application of Part 2
12 Preparations containing poisons included in different schedules
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Division 2—Labels
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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
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Appendix A—General exemptions
1 Exempt preparations and products
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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
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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 Poisons 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
10 Poisons available only when prescribed or authorised in certain circumstances
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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
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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
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Appendix G—Dilute preparations
1 Substances exempt at or below certain concentrations
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Appendix H—Schedule 3 medicines permitted to be advertised
1 Schedule 3 medicines permitted to be advertised
Appendix I—Blank
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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
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Appendix K—Human medicines required to be labelled with a sedation warning
1 Human medicines required to be labelled with a sedation warning
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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