Section 2 - Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 - Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist

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

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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

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 363

Reader’s guide

Introduction

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

Schedule	Title	Description
Schedule 1	Blank	This Schedule is intentionally blank.
Schedule 2	Pharmacy medicines	Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.
Schedule 3	Pharmacist only medicines	Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.
Schedule 4	Prescription only medicines and prescription animal remedies	Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.
Schedule 5	Caution	Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.
Schedule 6	Poisons	Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Schedule 7	Dangerous poisons	Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.
Schedule 8	Controlled drugs	Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.
Schedule 9	Prohibited substances	Substances which may be abused or misused, the manufacture, possession, supply or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.
Schedule 10 (previously Appendix C)	Substances of such danger to health as to warrant prohibition of supply and use	Substances which are prohibited for the purpose or purposes listed for each poison.

Schedule

Title

Description

Schedule 1

Blank

This Schedule is intentionally blank.

Schedule 2

Pharmacy medicines

Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

Schedule 3

Pharmacist only medicines

Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

Schedule 4

Prescription only medicines and prescription animal remedies

Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

Schedule 5

Caution

Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.

Schedule 6

Poisons

Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.

Schedule 7

Dangerous poisons

Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.

Schedule 8

Controlled drugs

Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

Schedule 9

Prohibited substances

Substances which may be abused or misused, the manufacture, possession, supply or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.

Schedule 10 (previously Appendix C)

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

Substances which are prohibited for the purpose or purposes listed for each poison.