National guideline for retail storage of Schedule 6 andSchedule 7 poisons

11 September 2015

On this page: Preamble | Objective | Scope | Risk management considerations | Guidance for retail storage of Schedule 6 poisons |Practical interpretation of the mandatory requirements for retail storage of Schedule 7 poisons

Preamble

The purpose of scheduling is to classify substances into groups (Schedules) according to the degree ofrisk that require similar levels of regulatory control to protect public health and safety.

Substances are not classified on the basis of a universal scale of toxicity or hazard. Although these arevery important factors to be considered, scheduling decisions also take into account many other criteriasuch as the purpose of use, safety in use and labelling and packaging mechanisms to mitigate safetyconcerns.

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) contains the decisions ofthe Secretary of the Department of Health regarding the classification of poisons into Schedules. Thescheduling of poisons is implemented through relevant State and Territory legislation. The SUSMP alsoincludes requirements for labelling, containers, storage, disposal, record-keeping, possession, distributionof product samples and any other relevant controls.

Schedule 6 poisons are substances with a moderate potential for causing harm, the extent of which can bereduced through the use of distinctive packaging with strong warnings and safety directions on the label.

Schedule 7 poisons are substances with a high potential for causing harm at low exposures which requirespecial precautions during manufacture, handling or use. These poisons should be available only tospecialised or authorised users who have the skills necessary to handle them safely. Special regulationsrestricting their availability, possession, storage or use may apply.

This guideline is published under the authority of the Australian Health Minister's Advisory Council andis to be read in conjunction with the relevant provisions of the SUSMP and the relevant jurisdictions’drugs/medicines and poisons legislation.

This guideline aligns with the hierarchy of controls over poisons in the SUSMP and provides for anationally uniform approach to retail storage that meets the expectations of consumers, regulators andother stakeholders while retaining flexibility for business where possible.

Objective

The objective of this guideline is to provide:

guidance on achieving a consistent safety standard for the retail storage of Schedule 6poisons that is commensurate with the risk of accidental ingestion by a child; and

practical interpretation of the mandatory requirements for the retail storage ofSchedule 7 poisons that are commensurate with the risk of accidental or intentionalingestion, exposure to or misuse of these highly toxic poisons.

Scope

The scope of this guideline is limited to the retail storage of Schedule 6 and Schedule 7 poisons. For thepurposes of this guideline:

Retail storage is defined as the keeping of Schedule 6 poisons and Schedule 7 poisons inany location including vehicles, where they are displayed or offered for retail sale, and;

Retail sale includes hawking, peddling or supplying or distributing for free products orproduct samples.

Note:

hawking or the distribution of product samples of Schedule 7 poisons isprohibited

this interpretation does not replace or alter any requirements under the relevantjurisdictions’ Dangerous Goods legislation.

Risk management considerations

The following considerations have been taken into account in the development of this guideline:

The ease and/or likelihood of children with sufficient time and motivation to gain access tothe Schedule 6 poison and accidentally ingest a sufficient quantity which could result inserious injury and/or permanent damage.

Limiting the likelihood of such ingestion through barriers to a child readily gaining accessto or delaying a child from opening the product, this guideline should also serve to providelimited general exposure to the poison and potentially improve the products' integrity inthe transport and storage prior to retail sale.

To address the higher risk profile of Schedule 7 poisons, access controls should ensurethat only people permitted to purchase should have access to these products.

The supervised access provision of the control also ensures that Schedule 7 poisons arenot available for self-selection so purchasers have access to advice from the owner of theretail establishment or an employee of a retail supplier about these products.

In limiting access to Schedule 7 poisons, this control also mitigates security risks forbusiness associated with selling and supplying these highly toxic poisons.

Guidance for retail storage of Schedule 6 poisons

The control on storage of Schedule 6 poisons as set out in Part 2 of the SUSMP states that:

'A person who sells or supplies Schedule 6 poisons by way of retail sale must keep thosepoisons in such a way as to prevent access by children'.

Flexible retail storage is possible where the product's storage and/or packaging limits the likelihood ofaccidental ingestion by a child by providing a barrier and/or delay to opening the product as per the riskmanagement considerations set out above.

The following measures do not replace the packaging controls on Schedule 6 poisons set out in Part 2 ofthe SUSMP (e.g. products that are required by law to have a child-resistant closure). They are intended toguide the interpretation and practical application of the measures in the SUSMP.

A retailer or supplier (e.g. sample distributor), when displaying, presenting or offering Schedule 6products are stored at least 1.2 metres above the floor and at least 1.2 metres away from any step,stairway, ramp or escalator to which the public has access; or

the product is presented with a child-resistant closure and/or child-resistant packaging asdefined in Part 1 Interpretation of the SUSMP; or

the product is stored in containers with the capacity of 5 litres or more or a weightinclusive of its contents of 5 kilograms or more; or

the area is directly supervised or within direct line of sight of a manned service counterwhere staff are able to supervise the storage area when consumers are present ; or

the product packaging or presentation limits or delays access by a child. Examples of suchmeasures are:

Composite packs e.g. an outer box that contains one or more inner packs, or

Blister or strip packaging, or

Heat-sealed or glued clam shell packaging, or

Sealed cartons, or

Aerosol packs, or

Non-access packaging presentations e.g. insect bait stations (enclosed in a weldedplastic labyrinth), or

Shrink-wrapped containers and/or closure, or

Liquid preparations that are presented as a dab on or a roller, or

Powder and/or solids that are in containers that are foil and/or paper wrapped and/orsealed, or

Products that use tamper-evident packaging including:

Film wrappers

Bubble packs

Heat-shrink bands or wrappers

Pouches, sachets and form-fill seal packs

Container mouth inner seals

Tape seals

Breakable caps

Tear-away caps

Sealed metal tubes

Sealed plastic/laminate tubes

or

Liquid or gel preparations (other than above) that are

trigger packs and presented with another barrier feature to limitaccess/exposure, or

very viscous and presented with another barrier feature to limit access, or

presented in a pack with a small orifice with another barrier feature to limitaccess, or

presented with a restricted flow insert.

or

Powders and/or solid preparations (other than above) that are:

presented as shaker packs and presented with another barrier feature to limitaccess, or

reduced flow formulations and presented with another barrier feature to limitaccess, or

presented in a pack with a small orifice with another barrier feature to limitaccess.

Note

This list is not intended to be exhaustive and does not preclude product orpackaging innovations that aim to achieve the same outcome

These barrier features are not deemed to be child-resistant packaging or child-resistant closures as defined in the SUSMP and are not assessed against anAustralian Standard.

These barrier features are only considered to preclude access to children if theyare intact and engaged so that they function as intended by the manufacturer.

Practical interpretation of the mandatory requirements for retail storage ofSchedule 7 poisons

The control on storage of Schedule 7 poisons as set out in Part 2 of the SUSMP states that:

A person who sells or supplies Schedule 7 poisons must not keep those poisons for retailsale in any area or in any manner that allows physical access by any person unless theyare:

the owner of the retail establishment; or

an employee of the owner; or

legally permitted to purchase the substance and are under the supervision of the

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owner or an employee of the owner.

Storage features that are deemed to comply or satisfy this control are:

a locked purpose-built interior enclosure (e.g. a cage, small cupboard, or metal chest), or

a locked storage room, or

a locked dedicated building or shed, or

a locked purpose-built exterior enclosure (e.g. a cage), or

a secured bulk storage container e.g. an Intermediate Bulk Container that has a securityseal

with a volume or weight capacity that precludes manual removal withoutequipment/vehicles; and

is located on a property kept secured to prevent unauthorised vehicular or walk-inaccess when the premises are unmanned.

Footnotes

1. secured in place on the premises and enclosed on all sides with a single locked entry point

regulatory guidanceFriday, 11 September 2015

https://www.tga.gov.au/node/709300 (//www.tga.gov.au/publication/national-guideline-retail-storage-schedule-6-and-schedule-7-poisons)

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