Schedule 1—Standard for the Uniform Scheduling of Medicines and Poisons No. 31
STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS
October 2020
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 SchedulingSecretariat (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 October 2020, which, under section 4 above contains the Standard for the Uniform Scheduling of Medicines and Poisons No. 31 (“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 2019 – 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.