Section 2 - Therapeutic Goods (Poisons Standard—February 2025) Instrument 2025 - Poisons available for human use only from or on the prescription or order of a specialist physician or a dermatologist

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

9 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

Reader’s guide

Introduction

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

This instrument serves 2 key purposes.

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

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

The requirements for labelling and containers in this instrument are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.

Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in this instrument as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time. Note, however that this exemption does not extend to controls on supply of these poisons.

This instrument is presented with a view to promoting uniform:

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

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

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

Classification

Poisons are classified according to the Schedules in which they are included. The following is a general description of the Schedules. For the legal definitions, however, it is necessary to check with each relevant State or Territory authority.

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.

Principles of scheduling

Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.

This instrument lists poisons in 10 Schedules according to the degree of control recommended to be exercised over their availability to the public.

Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 with progression through these Schedules signifying increasingly restrictive regulatory controls.

For some medicines and agricultural, domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly stricter container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7. Products for domestic use must not include poisons listed in Schedule 7.

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

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