Source: http://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/legislation/controlled+substances+legislation/controlled+substances+poisons+regulations+2011+amendments
Timestamp: 2018-09-25 09:22:41
Document Index: 697259485

Matched Legal Cases: ['art 5', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 5', 'art 3']

Controlled Substances (Poisons) Regulations 2011 amendments :: SA Health
Changes to the Controlled Substances Act 1984 and the Controlled Substances (Poisons) Regulations 2011 come into effect on 1 April 2017
Contribute to nationally consistent regulation of Schedule 5, 6 and 7 poisons by implementing a national agreement to refer to national uniform controls published in the Standard for the Uniform Scheduling of Medicines and Poisons. These amendments relate to:
retail storage of poisons - r27(b) and r27(c)
packaging, transport and disposal of poisons - r26(1)(b), r29(a), r47(2) and r47(3)
record-keeping for Schedule 7 poisons - s16(4), r15(2) and r49(1)(a)
product samples containing poisons - r47(1)
certain paints and tinters containing poisons - new rPart 5A
Clarify requirements relating to:
the regulation of prescription drugs administered to animals - s18(1d) (c)
the Minister’s powers to prohibit certain activities (s57(1)(c))
For complete details of the requirements under the Controlled Substances legislation refer to the South Australian Legislation website.
Amendments to Controlled Substances legislation
Controlled Substances Act 1984:
16(4) - Sale of certain poisons (record-keeping for Schedule 7 poisons)
18(1d) (c) - Regulation of prescription drugs (administration to an animal when licensed)
57 (1) (c) - Power of the Minister to prohibit certain activities
Controlled Substances (Poisons) Regulations 2011:
15(2) - Sale of certain poisons (record-keeping for Schedule 7 poisons)
26(1)(b) - Packaging and labelling of poisons
27(b) - Storage of poisons (retail storage of Schedule 6 poisons)
27(c) - Storage of poisons (retail storage of Schedule 7 poisons)
29(a) - Transport of poisons
47(1) - Offences relating to the sale or supply of poisons (product samples)
47(2) - Offences relating to the sale or supply of poisons (food and beverage containers)
47(3) - Offences relating to the sale or supply of poisons (camphor and naphthalene)
48 - Offence to dispose of a poison
49(1)(a) - Keeping of records etc. (record-keeping for Schedule 7 poisons)
5A - Special provisions relating to certain paints and tinters
Changes to the Controlled Substances Act 1984
Section 16(4) - Sale of certain poisons
The information a person who sells Schedule 7 poisons must keep is prescribed by the regulations.
This change consolidates all record-keeping requirements for retailers of Schedule 7 poisons previously located in the Act and the Poisons Regulations in one place in the Poisons Regulations making them easier to find.
It also enables South Australia to take account of a national agreement endorsed by the Council of Australian Governments (COAG) Health Council on behalf of COAG to achieve nationally consistent regulation of poisons to reduce regulatory burden on businesses.
In an associated change to the Poisons Regulations reference to the national uniform control over record-keeping has economic benefits for South Australian businesses by harmonising requirements. This change also reduce the amount of information retailers are required to record by removing the requirement to record the purpose of purchase which was unique to South Australia. Other requirements retained under the Controlled Substances Act 1984 and the national uniform control maintain regulatory oversight of the supply chain necessary for these dangerous poisons (for example, requirement for retailers to satisfactorily determine the purpose for which a poison is required before proceeding with the sale, and to record other information about the purchaser and the context of poison use).
Section 18(1d) (c) - Regulation of prescription drugs
The permissions specifying the exceptions that permit a person to administer a prescription drug (not being a drug of dependence) to an animal are amended to refer to administration of a prescription drug (not being a drug of dependence) to an animal by a person who is licensed to do so by the Minister.
Prior to the Controlled Substances (Therapeutic Goods and Other Matters) Amendment Act 2011 coming into operation on 1 July 2011, section 18 made reference to a person being permitted to administer a Schedule 4 prescription drug to an animal if licensed to do so by the Minister for Mental Health and Substance Abuse . This minor technical change reinstates reference to a person being permitted to administer a Schedule 4 drug to an animal if licensed to do so by the Minister. The change has no effect on existing licences.
Section 57 (1) (c) - Power of the Minister to prohibit certain activities
The activities the Minister may consider when forming the opinion to issue a Prohibition Order against a person is amended to clarify that sale of a prescription drug in an irresponsible manner is included.
The terms ‘supply’ and ‘sell’ are not used interchangeably in the Controlled Substances Act 1984, and when pharmacists dispense medicines on prescription they are selling rather than supplying prescription drugs.
This minor technical change includes the term ‘sell’ as well as ‘supply’ in this Section to clarify that the Minister for Mental Health and Substance Abuse has the power to issue a prohibition order against a person who dispensed medicines on prescription in an irresponsible manner to prevent that person from doing this again in the future.
Changes to the Controlled Substances (Poisons) Regulations 2011
Regulation 15(2) - Sale of certain poisons
The additional matters a person who sells Schedule 7 poisons must record are replaced by reference to a requirement set out in the Uniform Poisons Standard that requires keeping records of a nationally agreed set of information pertaining to the sale of Schedule 7 poisons.
This change enables South Australia to implement a national agreement to achieve nationally consistent record-keeping requirements for retailers who sell Schedule 7 poisons.
The information that is to be recorded by a person who sells or supplies Schedule 7 poisons is now consistent with the national uniform control by referring to Part 2 Section 5.1 (1) of the Uniform Poisons Standard that requires a person who sells or supplies Schedule 7 poisons to keep a record of:
Name and address of seller or supplier and purchaser; and
Date of order and supply; and
Approved name or trade name that identifies the poison to be supplied or sold; and
Quantity supplied or sold; and
Proof of purchaser authorisation must be recorded in jurisdictions where an authorisation is required for purchase
This change reduces the amount of information retailers are required to record by removing the uniquely South Australian requirement to record the purchaser’s occupation. Other requirements retained under the Controlled Substances Act 1984 and the national uniform control maintain necessary regulatory oversight of the supply chain for these dangerous poisons.
Regulation 26(1)(b) - Packaging and labelling of poisons
The additional requirements relating to the packaging and containers of Schedule 5, 6 and 7 poisons that duplicate those set out in the Uniform Poisons Standard and are already adopted by reference in the Poisons Regulations are removed.
The requirements for packaging and containers for Schedule 2, 3, 4 and 8 poisons are unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent packaging requirements for Schedule 5, 6 and 7 poisons by removing duplicated regulation.
The package or container for all poisons are required to comply with the requirements published in section 2 of Part 2 of the Uniform Poisons Standard, and previously also required to comply with additional requirements relating to the strength, permeability, and closure of the package or container.
While these additional requirements relating to Schedule 5, 6 and 7 poisons are consistent with section 2 of Part 2 of the Uniform Poisons Standard, they have been removed to ensure national uniformity through adoption of the poisons controls published in the Uniform Poisons Standard.
Section 2 of Part 2 of the Uniform Poisons Standard requires compliance with at least the general requirements of the Australian Standard AS2216-1997 Packaging for poisonous substances that states:
The container shall be robust enough to withstand damage resulting in leakage during handling, storage and transport (strength and impermeability).
Under normal conditions the container shall show no visible deterioration during the life of the product.
The container shall have barrier properties which shall prevent alteration of contents or transfer of contents through the wall (impervious).
The container, closure and any other sealant shall not chemically react with the contents and the contents shall not physically interact to cause deterioration in the performance of the container (incapable of chemical reaction).
The container shall be capable of being securely closed and except where intended for single use only, shall be capable of being securely reclosed to prevent leakage during ordinary risks of handling, storage and transport (securely and readily closed and reclosed).
The provisions of the Uniform Poisons Standard that require compliance with at least the ‘General Requirements’ of the Australian Standard AS2216-1997 Packaging for poisonous substances duplicated the previous additional packaging requirements in the Poisons Regulations.
Regulation 27(b) - storage of poisons
Storage of poisons: the requirements relating to the storage of Schedule 5 and 6 poisons in retail premises (including the exception for Schedule 6 hair-colouring preparations) are replaced by reference to the requirement set out in the Uniform Poisons Standard that requires retail storage of Schedule 6 poisons to preclude access by children.
The requirements for the storage of Schedule 2 poisons in retail premises are unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent retail storage requirements for Schedule 5 and 6 poisons by removing the requirement for the storage of Schedule 5 poisons in retail premises and providing retailers with the opportunity to choose compliant storage options for Schedule 6 poisons.
This change removes the requirement for Schedule 5 poisons sold in retail premises to be stored in a part of the premises to which the public is not permitted access or stored higher than 1.2m above floor level etc.
The requirement for the storage of Schedule 6 poisons in retail premises is replaced by a new regulation 27 (d) that is now consistent with the national uniform control by referring to section 3.1 (1) of Part 2 of the Uniform Poisons Standard that requires:
A person who sells or supplies Schedule 6 poisons by way of retail sale must keep those poisons in such a way as to prevent access by children.
A guidance document National guideline for retail storage of Schedule 6 and Schedule 7 poisons | Therapeutic Goods Administration (TGA) is available to assist retailers to choose storage options that are deemed to comply with the national uniform control.
Regulation 27(c) - Storage of poisons
The requirement relating to the storage of Schedule 7 poisons in retail premises is replaced by reference to the requirement set out in the Uniform Poisons Standard that allows for strictly supervised purchaser access to Schedule 7 poisons for the purposes of product selection.
The requirements for the storage of Schedule 3 and 4 poisons in retail premises are unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent retail storage requirements for Schedule 7 poisons by providing retailers with the opportunity to offer supervised access to products to purchasers.
This change replaces the requirement for the storage of Schedule 7 poisons in retail premises by a new regulation 27 (d) that is now consistent with the national uniform control by referring to section 3.1(2) of Part 2 of the Uniform Poisons Standard:
A person who sells or supplies Schedule 7 poisons must not keep those poisons for retail sale in any areas or in any area or in any manner that allows physical access by any person unless they are:
A guidance document (National guideline for retail storage of Schedule 6 and Schedule 7 poisons | Therapeutic Goods Administration (TGA)) is available to assist retailers to choose storage options that are deemed to comply with the national uniform control.
Regulation 29(a) - Transport of poisons
The requirement relating to the joint transport of Schedule 5, 6 and 7 poisons with food to mitigate risk of contamination that duplicates similar requirements under food industry regulation are removed.
The requirement relating to transport of Schedule 2, 3, 4 and 8 poisons with food is unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent storage requirements for Schedule 5, 6 and 7 poisons by removing duplicated regulation.
This change removes additional requirements for storage of poisons during transport that require poisons transported in a vehicle in which any food or component of food is also being transported to be effectively separated from the part of the vehicle containing the food. These requirements are considered to duplicate similar provisions under food industry regulation that ensure food safety.
Regulation 47(1) - Offences relating to the sale or supply of poisons
The prohibition on selling or supplying a poison in any residential premises or from door to door or in a public place (for example, hawking) is replaced by reference to a requirement set out in the Uniform Poisons Standard that permits some restricted sale and supply of Schedule 5 and 6 poisons when packed as product samples.
The prohibition on distribution in this manner of Schedule 2, 3, 4, 7 and 8 poisons and Schedule 5 and 6 poisons (other than product samples) is unchanged.
This change enables South Australia to implement a national agreement to enable nationally consistent distribution of Schedule 5 and 6 poisons packed as product samples for marketing purposes.
This change replaces the prohibition on selling or supplying Schedule 5 and 6 poisons when packed as product samples by a new regulation 47 (2) that is consistent with the national uniform control by referring to section 6.1 of Part 2 of the Uniform Poisons Standard that requires:
A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in any manner unless the recipient has the opportunity to refuse at the time of sale or supply
A person must not sell or supply or distribute free a product sample containing a Schedule 5 or Schedule 6 poison in an unsolicited manner for example via the post / mailbox or attached to any other product
A person must not sell or supply a Schedule 5 or Schedule 6 poison product sample in a manner that does not promote disposal in accordance with section four;
The change also adopts the national definition of product sample published in the Uniform Poisons Standard in a new regulation 47 (3) where a poison is a product sample if:
it is supplied directly to the consumer free of charge, or at a nominal charge, as a mechanism to promote the sale of the product; and
it is supplied in a small pack produced specifically for the purposes of promotion, or packaged in a normal commercial pack that in other circumstances a consumer would need to purchase.
The prohibition on sale or supply of any Schedule 7 poison and Schedule 5 and 6 poisons (other than product samples) in any residential premises or from door to door or in a public place is unchanged.
Regulation 47(2) - Offences relating to the sale or supply of poisons
The additional requirement that prohibits a person from selling or supplying a Schedule 5, 6 or 7 poison in a container that is similar to or normally used for food or beverages that duplicates a requirement set out in the Uniform Poisons Standard and is already adopted by reference in the Poisons Regulations is removed.
Packages and containers for all poisons are required to comply with the requirements published in section 2 of Part 2 of the Uniform Poisons Standard, and previously also required to comply with an additional requirement about being or resembling a food or beverage container.
While this additional requirement is consistent with section 2 of Part 2 of the Uniform Poisons Standard, it has been removed with respect to Schedule 5, 6 and 7 poisons in a new regulation 47 (4) to ensure national uniformity through adoption of the poisons controls published in the Uniform Poisons Standard.
Section 2.8 (3) of Part 2 of the Uniform Poisons Standard requires that:
A person must not sell any poison in a container that is not readily distinguishable from a container in which food, alcohol, other beverage or condiment is sold.
Regulation 47(3) - Offences relating to the sale or supply of poisons
The additional requirement relating to the packaging of camphor and naphthalene products that duplicates the requirement set out in the Uniform Poisons Standard and is already adopted by reference in the Poisons Regulations is removed.
The package or container for all poisons are required to comply with the requirements published in section 2 of Part 2 of the Uniform Poisons Standard, and previously also required to comply with an additional requirement for camphor or naphthalene in block, ball, disc or pellet form for domestic use that requires these substances to be enclosed in a device that restricts removal or ingestion.
While this additional requirement relating to camphor and naphthalene is consistent with section 2 of Part 2 of the Uniform Poisons Standard, it has been removed to ensure national uniformity through adoption of the poisons controls published in the Uniform Poisons Standard.
Section 2.7 (2) of Part 2 of the Uniform Poisons Standard requires that:
Regulation 48 - Offence to dispose of a poison
The requirement that relates to the disposal of Schedule 5, 6 and 7 poisons is replaced by reference to a requirement set out in the Uniform Poisons Standard that requires the safe disposal of Schedule 5, 6 and 7 poisons.
The requirements for safe disposal of Schedule 2, 3, 4 and 8 poisons and the safe use of Schedule 5, 6 and 7 poisons are unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent disposal requirements for Schedule 5, 6 and 7 poisons. It mirrors the previous requirement for safe disposal.
The requirement for the disposal of Schedule 5, 6 and 7 poisons has been replaced by a new regulation 48 (a) that refers to section 4.1 of Part 2 of the Uniform Poisons Standard that requires:
A person must not dispose of or cause to be disposed of a Schedule 5, Schedule 6 or Schedule 7 poison in any place or manner that constitutes or is likely to constitute a risk to public health or safety
While the previous requirement is consistent with the national uniform control it has been replaced to ensure national uniformity through adoption of the poisons controls published in the Uniform Poisons Standard.
Regulation 49(1)(a) - Keeping of records
The requirement relating to the retention period for records of Schedule 7 poisons sales is replaced by a requirement set out in the Uniform Poisons Standard that requires records to be kept for five years.
The requirement for retention of records for two years in any other circumstances, as required by the Poisons Regulations, is unchanged.
This change enables South Australia to implement a national agreement to achieve nationally consistent record-keeping requirements for retailers who sell Schedule 7 poisons by extending the time period that these records must be kept from 2 years to 5 years.
The requirement for a person to keep records pertaining to Schedule 7 poison sales transactions at the registered business address in South Australia for 2 years from the day on which the entry was made has been replaced by a new regulation 48 (a) that is now consistent with Australian taxation requirements and the national uniform control in section 5.1 (2) of Part 2 of the Uniform Poisons Standard that requires
Records for the sale or supply of Schedule 7 poisons must be kept for a minimum of five years.
Regulation 5A - Special provisions relating to certain paints and tinters
Provisions and offences are inserted that give effect to and provide offences relating to the prohibitions set out in the Uniform Poisons Standard that regulate manufacture, sale, supply or use of certain paints for certain purposes.
This change enables South Australia to implement a national agreement to achieve nationally consistent requirements for the manufacture, sale, supply and use of paints containing certain scheduled poisons by including offences that give effect to provisions published in the national Uniform Paint Standard.
The content of Appendix I: Uniform Poisons Standard of the Uniform Poisons Standard has been moved to section 7 of Part 2 of the Standard. It contains requirements that protect public health in circumstances where the use of paint is considered to pose potential risk such as roof surfaces used to collect or store potable water, furniture, domestic structures, food premises and toys or the paint component is of high concern for example, Lead.
While Appendix I is not struck out in the definition of the Uniform Poisons Standard in the Poisons Regulations, previously there were no provisions that enabled enforcement of the national uniform control over paints and tinters specified in the Uniform Poisons Standard.
This change provides a new Part 5A—Special provisions relating to certain paints and tinters that is consistent with the national uniform control in Section Seven/Appendix I of the Uniform Poisons Standard by stating:
A person must not manufacture, sell, supply or use a First Group Paint for application to:
any premises used for the manufacture, processing, preparation, packing or serving of products intended for human or animal consumption.
A person must not manufacture, sell, supply or use a paint or tinter containing more than 0.1% Lead (the proportion of Lead for the purposes of this section is calculated as a percentage of the element present in the non-volatile content of the paint).
A person must not manufacture, sell, supply or use a paint for application to toys unless the paint complies with the specification for coating materials contained in Australian/New Zealand Standard AS/NZS ISO 8124.3:2012 entitled Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD).
A person must not manufacture, sell, supply, or use a paint or tinter containing a pesticide except a fungicide, algaecide, bactericide or antifouling agent.
The Controlled Substances (Poisons) Regulations 2011