2  Commencement

 (1) 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 2022. 1 February 2022

Note: This table relates only to the provisions of this instrument as originally made.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.

 (2) 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  Current Poisons Standard

  Schedule 1 to this instrument contains the Standard for the Uniform Scheduling of Medicines and Poisons No. 35, otherwise known as the current Poisons Standard.

5  Repeals and transitional provisions

  Repeal

 (1) The Poisons Standard October 2021 is repealed.

  Things done under the repealed instrument

 (2) If:

 (a) a thing was done for a particular purpose under the Poisons Standard October 2021 as in force immediately before that instrument was repealed; and

 (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.

 (3) 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.

Schedule 1—Standard for the Uniform Scheduling of Medicines and Poisons No. 35

STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS

February 2022

Reasons for scheduling delegates’ final decisions can be accessed from the TGA website, at https://www.tga.gov.au/reasons-scheduling-delegates-final-decisions

Further inquiries in relation to this document should be directed to:

The Secretary Chemicals and Medicines Scheduling Secretariat (MD122) Scheduling and Committee Governance Therapeutic Goods Administration PO Box 100 WODEN ACT 2606  

or by email to

Medicines.Scheduling@health.gov.au

Chemicals.Scheduling@health.gov.au

Media Liaison Unit Australian Government Department of Health

Table of Contents

Table of Contents

INTRODUCTION

PART 1

INTERPRETATION

PART 2

CONTROL ON MEDICINES AND POISONS

SECTION ONE LABELS

SECTION TWO CONTAINERS

SECTION THREE STORAGE

SECTION FOUR DISPOSAL

SECTION FIVE RECORD KEEPING

SECTION SIX SALE, SUPPLY, POSSESSION, or USE

SECTION SEVEN/Appendix I PAINT OR TINTERS

PART 3

MISCELLANEOUS REGULATIONS

SECTION ONE ADVERTISING

SECTION TWO SALE OR SUPPLY

SECTION THREE STORAGE

PART 4

THE SCHEDULES

SCHEDULE 1

SCHEDULE 2

SCHEDULE 3

SCHEDULE 4

SCHEDULE 5

SCHEDULE 6

SCHEDULE 7

SCHEDULE 8

SCHEDULE 9

SCHEDULE 10

PART 5

THE APPENDICES

APPENDIX A – GENERAL EXEMPTIONS

APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING

APPENDIX C (see SCHEDULE 10)

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 POISONS PERMITTED TO BE ADVERTISED

APPENDIX I

APPENDIX J – SCHEDULE 7 POISONS REQUIRING ADDITIONAL CONTROLS ON AVAILABILITY AND USE

APPENDIX K – DRUGS REQUIRED TO BE LABELLED WITH A SEDATION WARNING

APPENDIX L – REQUIREMENTS FOR DISPENSING LABELS FOR HUMAN AND VETERINARY MEDICINES

APPENDIX M – ADDITIONAL CONTROLS OR SUPPLY REQUIREMENTS FOR POISONS INCLUDED IN SCHEDULE 3 TO ALLOW THEM TO BE PROVIDED BY A PHARMACIST

INDEX

INTRODUCTION

The Poisons Standard February 2022, which, under section 4 above contains the Standard for the Uniform Scheduling of Medicines and Poisons No. 35 (“the Standard” or “the SUSMP”), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (“SPF”) of the Australian Health Ministers' Advisory Council. Further information on the scheduling amendments and the SPF can be accessed at www.tga.gov.au. Refer to Part 1, Interpretation, on page 2 below for definitions of specific terms used in this document including “medicine” and “poison” (noting that the definition of poison includes medicine).

The SUSMP serves two key purposes.

Firstly, the SUSMP contains the decisions of the Secretary of the Department of Health 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, the SUSMP includes provisions for labelling, containers, storage, disposal, record-keeping, sale, 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 the SUSMP 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 the SUSMP 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.

The SUSMP is presented with a view to promoting uniform:

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

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

• the Agricultural and Veterinary Chemicals Code Act 1994;
• the Agricultural and Veterinary Chemicals Code Regulations 1995;
• the Therapeutic Goods Act 1989;
• the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (Compilation No. 2);
• the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (Compilation No. 1);
• the Therapeutic Goods Order No. 95 – Child-resistant packaging requirements for medicines 2017 (TGO 95);
• the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 – Schedule 1 Required Advisory Statements for Medicine Labels (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 1 | This Schedule is intentionally blank. | | Schedule 2 | Pharmacy Medicine – 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 Medicine – 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 Medicine, or Prescription Animal Remedy – 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 | Poison – 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 Poison – 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 Drug – 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 Substance – Substances which may be abused or misused, the manufacture, possession, sale 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 sale, 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 Standard lists poisons in ten 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.

Schedule 9 contains substances that should be available only for teaching, training, medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State and Territory health authorities. Although appearing as a Schedule in this Standard, the method by which it is implemented in the States and Territories may vary.