This Act has been repealed and is no longer in force. It is retained for historical reference.
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Commonwealth
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legislative instrument
Plain English Summary
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The Poisons Standard 2014 (SUSMP) is Australia’s national rulebook for classifying medicines, chemicals and other hazardous substances into regulatory Schedules that determine legal availability and controls. It sets uniform labelling, packaging, storage and supply requirements to protect public health.
It affects manufacturers/importers (labelling, safety directions, child‑resistant packaging), pharmacists and prescribers (access and supply controls), retailers and consumers, and ensures consistent restrictions and exemptions across states and territories.
Zoe can write the in-depth analysis on top of the summary above: how it works, who it affects and what each part actually does.
Current sections
Direct links to the current provisions in Poisons Standard 2014.
11
Sch 1
Standard for the Uniform Scheduling of Medicines and Poisons No. 5
Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
STANDARD FOR THE UNIFORM SCHEDULING OF
MEDICINES AND POISONS
October 2014
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in July 2014. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further inquiries should be directed to:
The Secretary<br>Chemicals Scheduling Secretariat (MDP88)<br>Office of Chemical Safety<br>Department of Health<br>GPO Box 9848<br>CANBERRA ACT 2601<br> <br>or by email to Chemicals.Scheduling@health.gov.au<br>
The Secretary<br>Medicines Scheduling Secretariat (MD122) Communications and Secretariat Therapeutic Goods Administration PO Box 100 WODEN ACT 2606<br> <br>or by email to Medicines.Scheduling@tga.gov.au<br>
The Poisons Standard 2014, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. 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 model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. 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 Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. 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
Therapeutic Goods Order 69 – General requirements for labels for medicines
Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
the 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.
Sch 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 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.
Sch 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 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.
Sch 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 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.
Sch 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 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.
Sch 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 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.
Sch 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 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.
Sch 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 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.
More sections below
Source text: opening excerpt
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
I, ANTHONY GILL, a delegate of the Secretary to the Department of Health for the purposes of paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act) and acting in accordance with the Secretary’s power under that paragraph of the Act, prepare this new Poisons Standard, in substitution for the current Poisons Standard.
(Signed by)
ANTHONY GILL
Delegate of the Secretary to the Department of Health
Dated this 8th of October 2014
Citation
This instrument is the Poisons Standard 2014.
The New Poisons Standard
The Poisons Standard 2014 consists of the Standard for the Uniform Scheduling of Medicines and Poisons No. 5 (the SUSMP5) as set out in Schedule 1.
Commencement
The Poisons Standard 2014 commences on the day after registration.
Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons No. 5
Schedule Sch 5Caution – 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.
The amendments listed in this document are a result of decisions made by the Secretary of the Department of Health or the Secretary’s Delegate in July 2014. The basis of these amendments can be found in the ‘Reasons for scheduling delegate’s final decisions’, which can be accessed from the TGA website at http://www.tga.gov.au/industry/scheduling-decisions-final.htm.
Further inquiries should be directed to:
The Secretary<br>Chemicals Scheduling Secretariat (MDP88)<br>Office of Chemical Safety<br>Department of Health<br>GPO Box 9848<br>CANBERRA ACT 2601<br> <br>or by email to Chemicals.Scheduling@health.gov.au<br>
The Secretary<br>Medicines Scheduling Secretariat (MD122) Communications and Secretariat Therapeutic Goods Administration PO Box 100 WODEN ACT 2606<br> <br>or by email to Medicines.Scheduling@tga.gov.au<br>
The Poisons Standard 2014, which, under section 2 above consists of the Standard for the Uniform Scheduling of Medicines and Poisons (the Standard, or the SUSMP), is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989, and is a compilation of the decisions made under section 52D of the same Act. The SUSMP should be read in conjunction with the Scheduling Policy Framework (SPF) of the National Coordinating Committee on Therapeutic Goods. 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 model provisions for labelling, containers, storage and possession of poisons in general, which are intended to be adopted for use in each jurisdiction of Australia, according to local requirements and local law. Appropriate labelling and container requirements for products, other than therapeutic goods and agricultural and veterinary chemicals, are imposed through adoption of Parts 1, 2 and 3 of the SUSMP into State or Territory legislation. 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 Safe Work Australia's National Code of Practice for the Labelling of Workplace Substances [NOHSC: 2012(1994)]. 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
Therapeutic Goods Order 69 – General requirements for labels for medicines
Therapeutic Goods Order 80 – Child-Resistant Packaging Requirements for Medicines
the 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.
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 nine 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.
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).
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. It is recommended that the provisions of this Appendix be put into effect through inclusion of the substances in appropriate State and Territory legislation.
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 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
This is an opening excerpt, not the complete document.