Schedule Sch 10 - Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023 - (previously Appendix C) contains a list of substances or preparations, the supply or use of which should be prohibited because of their known dangerous properties. | Zoe
Sch 10(previously Appendix C) contains a list of substances or preparations, the supply or use of which should be prohibited because of their known dangerous properties.
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Schedule 10 (previously Appendix C) contains a list of substances or preparations, the 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 instrument, may be listed in either Appendix A (general exemptions) or Appendix B (substances considered not to require control by scheduling).
Reading the schedules
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 below. 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 2 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 instrument 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 section 7).
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 physically or chemically) to a scheduled poison. However, a substance is only considered a derivative of a scheduled poison if it is not individually listed elsewhere in the Schedules, or captured by a more restrictive group or class entry. Additionally, some entries specifically exclude derivatives. Once a substance is determined to be a derivative of a scheduled poison, the same scheduling requirements as the scheduled poison, including limits on access, supply and availability, will apply.
Finally, when using this instrument to determine the scheduling status of a poison, it may be necessary to search each relevant Schedule as well as Appendices A, B and the Index. In this process, if the poison is not found under its “approved name” it may be shown under a group term such as:
| Group | Example |
| the parent acid of salts | “oxalic acid” to find sodium oxalate |
| the radical of a salt | “chromates” to find potassium chromate |
| the element | “arsenic” to find arsenic trioxide |
| a chemical group with similar toxicological or pharmacological activity | “hydrocarbons, liquid” to find kerosene |
| a pharmacological group | “anabolic steroidal agents” to find “androsterone” |
Availability of poisons
The purpose of classification is to group substances into Schedules that require similar regulatory controls over their availability.
These Schedules have been developed over a long period and contain poisons that may be obsolete for various reasons. Also, as part of the move to harmonise the Australian and New Zealand classifications, many substances have been added to the Schedules for that purpose, irrespective of their availability in either country.
Inclusion of a poison in a Schedule indicates the degree of control required if it is marketed. It does not:
indicate that the poison is available; or
indicate that it is has been approved or is efficacious for any use that may be specified in a Schedule; or
negate any obligation for registration of therapeutic goods, or agricultural or veterinary chemical product containing that poison.
Appendices
Some substances in certain circumstances are also subject to exemptions or additional restrictions as described in the Appendices of this instrument. The table below summarises the purpose of each of the Appendices and the controls imposed on substances included in them.
Appendix
Title
Purpose/controls imposed
Appendix A
General exemptions
List of preparations and products exempted from this instrument.
Appendix B
Substances considered not to require control by scheduling
List of poisons exempted from scheduling.
Appendix C
Appendix is intentionally left blank
See Schedule 10.
Appendix D
Additional controls on possession or supply of poisons included in Schedule 4 or 8
List of poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply.
Appendix E
First aid instructions for poisons
First aid instructions for poisons (other than agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).
Appendix F
Warning statements and general safety directions for poisons
Warning statements and general safety directions for poisons (other than human medicines, agricultural and veterinary chemicals and chemicals packed and sold solely for industrial, dispensary, manufacturing or laboratory use).
Appendix G
Dilute preparations
Concentration cut‑offs for specified poisons, below which the requirements of this instrument do not apply
Appendix H
Schedule 3 medicines permitted to be advertised
List of medicines included in Schedule 3 that are permitted to be advertised to the public.
Appendix I
Appendix is intentionally left blank
Appendix J
Conditions for availability and use of Schedule 7 poisons
List of poisons included in Schedule 7 where additional specified conditions apply to their availability and use.
Appendix K
Human medicines required to be labelled with a sedation warning
List of poisons in medicines for human use required to be labelled with a warning regarding their sedation potential.
Appendix L
Requirements for dispensing labels for medicines
Requirements applying to labels attached to medicines at the time of dispensing.
Appendix M
Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist<br>Appendix is intentionally left blank and is reserved for future use.
Appendix A (General exemptions)
Appendix A lists preparations and products that are exempted from this instrument.
Appendix B (Substances considered not to require control by scheduling)
Substances for which the available information suggests that inclusion in the Poisons Schedules is not necessary, or not the most appropriate means of controlling the risk to public health, have been considered at various times.
Inclusion in Appendix B indicates that a decision has been taken not to include substances anywhere in the Schedules, either for a specific purpose, or generally. It is an inclusive, but not an exhaustive, list (that is, there may be substances not included in the Schedules, and not included in Appendix B, which may be hazardous or non‑hazardous, but have not been considered in relation to the need for scheduling).
Substances may be included in Appendix B because they have intrinsically low toxicity, or where other factors suggest that the potential public health risk would be minimal. Factors which are considered when determining an Appendix B entry include:
the toxicology profile was adequately characterised and not consistent with inclusion in any of the Schedules;
the use, purpose or product presentation minimised any hazard to the public such as to not require scheduling; or
the public access was limited such that scheduling was inappropriate or unnecessary.
The list of substances included in Appendix B was developed from scheduling files and historical records. For transparency, where the reason for entry and/or purpose or use for the substance was apparent in the consideration, this has been included in the columns “Reason for Entry” and “Area of Use”.
Inclusion in Appendix B will not prevent reconsideration of the scheduling of a substance where adverse information becomes available about the Appendix B entry for that substance.
Applications are considered for scheduling. Applications for inclusion in Appendix B will not be accepted.
Appendix C (blank)
Appendix C is intentionally blank.
Appendix D (Additional controls on possession or supply of poisons included in Schedule 4 or 8)
Appendix D lists poisons included in Schedule 4 or 8 where additional specified controls apply on possession or supply.
Appendix E (First aid instructions for poisons)
Under poisons legislation, scheduled substances and their preparations are required to be labelled with appropriate directions for first aid attention in case of poisoning. It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the first aid instructions included on the label of a poison are appropriate for a specific product. Standard statements have been prepared as a guide for health authorities and manufacturers in drafting suitable first aid directions for this purpose. Standard statements specified in Appendix E may be varied provided that the intent is not changed.
The directions listed for any particular substance may require modification to take into account combination of that substance with other substances, both toxic and non‑toxic, in a formulation, as well as the physical form and presentation of the product. Any such modification should be concise and readily understood.
The First Aid Instructions include action to be taken in case of eye contamination from substances recognised as causing direct poisoning via the eye, causing severe eye damage or requiring prolonged flushing to free the absorbed substance from the eye tissue. However, it is recognised that many other substances or preparations will require a statement of varying nature depending on the detailed formulation. While the necessity to flush the eyes in case of accident will be so self‑evident as not to justify label space in many instances, a statement such as “If in eyes rinse well with water” may be appropriate.
Appendix F (Warning statements and general safety directions for poisons)
It is the responsibility of the manufacturer, packer and supplier of a drug or poison to ensure that the purchaser or user of a product is given sufficient information to be able to use it correctly and safely.
Under poisons legislation, scheduled substances, which may be harmful to the user, must be labelled with appropriate warning statements and/or safety directions. The selection of warning statements and safety directions will depend on the formulation of the product, and the use for which it is sold or supplied. Warning statements and safety directions have been prepared as a guide for this purpose.
The wording of warning statements and safety directions specified in Appendix F may be varied provided that the intent is not changed. Additional statements also may be added to ensure that the user of a product is sufficiently advised of its harmful nature and how to avoid any deleterious effects.
Appendix G (Dilute preparations)
Appendix G lists concentration cut‑offs for specified substances, below which the requirements of this instrument do not apply.
Appendix H (Schedule 3 medicines permitted to be advertised)
Appendix H lists medicines included in Schedule 3 that are permitted to be advertised to the public.
Appendix I (blank)
Appendix I is intentionally blank.
Appendix J (Conditions for availability and use of certain poisons included in Schedule 7)
All poisons included in Appendix J are not to be available except to authorised or licensed persons.
The use of a poison may be restricted for a particular purpose. Controls recommended for the Schedule 7 poisons included in Appendix J may be implemented through poisons controls or other State or Territory legislation.
Appendix K (Human medicines required to be labelled with a sedation warning)
Medicines for human use that contain a poison included in Appendix K are required to be labelled with a warning regarding their sedation potential.
Appendix L (Requirements for dispensing labels for medicines)
Appendix L sets out the requirements for labels attached to medicines at the time of dispensing.
Appendix M (blank)
Appendix M is intentionally blank and is reserved for future use.
Poisons Information Centre telephone numbers for first aid instructions, warning statements and general safety directions for poisons
Companies should use the Poisons Information Centre telephone number(s) (Australia 13 11 26; New Zealand 0800 764 766) appropriate to the country(ies) of sale for the product.
Companies wishing to use a poisons information centre telephone number other than the national telephone numbers for Australia and New Zealand must meet the following criteria:
the poisons information service whose number is used must be attended by adequately trained staff for 24 hour emergency poisons information; and
calls must be logged and submitted for incorporation into the official collection of poisoning data.
Part 1—Preliminary and interpretation
1 Name
(1) This instrument is the Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023.
(2) This instrument may also be cited as the Standard for the Uniform Scheduling of Medicines and Poisons No. 42.
Note: This instrument is the current Poisons Standard for the purposes of the Act until a document is prepared in substitution for it (see sections 52A and 52D of the Act).
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
The whole of this instrument 1 October 2023. 1 October 2023
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.