5
Repeals
5 Repeals
Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in that Schedule.
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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
The Poisons Standard Feb 2019 (SUSMP 23) is Australia’s national rulebook under the Therapeutic Goods Act that classifies chemicals, medicines and poisons into schedules and sets controls on their sale, labelling, packaging, storage, record‑keeping and advertising.
It affects manufacturers, pharmacists, prescribers, agricultural and industrial suppliers, and consumers by determining who can access a substance, what safety measures are required, and when professional advice or prescriptions are needed.
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Direct links to the current provisions in Poisons Standard February 2019.
5 Repeals
Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in that Schedule.
Schedule 1—Repeals
Note: See section 5.
Poisons Standard October 2018
1 The whole of the instrument
Repeal the instrument
Schedule 2-Standard for the Uniform Scheduling of Medicines and Poisons No. 23
STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS
February 2019
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 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
CONTROL ON MEDICINES AND POISONS
SECTION SIX SALE, SUPPLY, POSSESSION, or USE
SECTION SEVEN/Appendix I PAINT OR TINTERS
APPENDIX A – GENERAL EXEMPTIONS
APPENDIX B – SUBSTANCES CONSIDERED NOT TO REQUIRE CONTROL BY SCHEDULING
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 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
The Poisons Standard February 2019, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons No.23 (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, for example cosmetics.
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:
The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:
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. |
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.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
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POISONS STANDARD FEBRUARY 2019
I, Avi Rebera, as delegate of the Secretary to the Department of Health, make the following Poisons Standard.
Dated 21/12/18
(Signed by)
Avi Rebera
Assistant Secretary
Regulatory Engagement and Planning Branch
Health Products Regulation Group
Department of Health
This instrument is the Poisons Standard February 2019.
This instrument consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 23 (the SUSMP 23).
(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.
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.
This instrument is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989.
5 Repeals
Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in that Schedule.
Schedule 1—Repeals
Note: See section 5.
Poisons Standard October 2018
1 The whole of the instrument
Repeal the instrument
Schedule 2-Standard for the Uniform Scheduling of Medicines and Poisons No. 23
STANDARD FOR THE UNIFORM SCHEDULING OF MEDICINES AND POISONS
No. 23
February 2019
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 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
The Poisons Standard February 2019, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons No.23 (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, for example cosmetics.
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:
The various Commonwealth Acts, legislative instruments and other documents which integrate with the SUSMP include:
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. |
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.
Schedule 10 (previously Appendix C) contains a list of substances or preparations, the sale, supply or use of which should be prohibited because of their known dangerous properties.
Substances in products which have been considered for scheduling, but have been exempted from this Standard, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Schedule entries have been designed to be as simple as possible while retaining readability, legal integrity and as much freedom from ambiguity and contradiction as possible. As a result, they are expressed in a number of ways, though this number has been kept to a minimum. It is necessary to keep this variety of expression in mind when searching or interpreting Schedule entries.
Firstly, poisons are scheduled individually using their approved names wherever practicable although exceptions are necessary in some cases. Some of those are mentioned overleaf. Older group entries are revised and replaced by individual entries as time permits, although in some of these cases a group term has also been retained to deal with any members of the group or class that may have escaped attention but should be scheduled.
Secondly, Schedule entries have been expressed in either positive or negative terms and care must be taken to distinguish between the two different forms of expression. Thus, selenium is in Schedule 6 only when one of the clauses in this Schedule entry applies, while fluorides are in Schedule 6 unless one of the exempting clauses applies.
Where exceptions are included in an entry, these have been emphasised by printing the word “except” in bold type.
Where the Schedule entries for a poison make a specific exclusion or exemption, the requirements of this Standard do not apply to that poison within the constraints of that exclusion or exemption although controls under other legislation, such as pesticide registration, may apply.
Where a Schedule entry for a poison requires a specific statement to be included on a label as a condition for a product to qualify for an exemption (‘reverse scheduling’), then in cases where it is impracticable for a supplier to use the exact wording of such a statement, its wording may be varied provided that the full intent and meaning of the statement is not changed.
Where a poison has been included in more than one Schedule, the principal entry, where practicable, has been included in the most restrictive Schedule with references to the other Schedule(s) involved.
It is important to remember that a Schedule entry includes preparations containing the poison in any concentration and all salts and derivatives of the poison unless it specifically states otherwise. (See Part 1, Interpretation, subparagraph 1(2)).
It is important to note that a substance is not classed as a derivative on the basis of a single, prescriptive set of criteria. Classification of a substance as a derivative of a scheduled poison relies on a balanced consideration of factors to decide if a substance has a similar nature (e.g. structurally, pharmacologically, and toxicologically) to a scheduled poison or is readily converted (either
This is an opening excerpt, not the complete document.