Preamble
The purpose of scheduling is to classify substances into groups (Schedules) according to the degree of risk 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 are very important factors to be considered, scheduling decisions also take into account many other criteria such as the purpose of use, safety in use and labelling and packaging mechanisms to mitigate safety concerns.
The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) contains the decisions of the Secretary of the Department of Health regarding the classification of poisons into Schedules. The scheduling of poisons is implemented through relevant State and Territory legislation. The SUSMP also includes requirements for labelling, containers, storage, disposal, record-keeping, possession, distribution of product samples and any other relevant controls.
Schedule 6 poisons are 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 poisons are substances with a high potential for causing harm at low exposures 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.
This guideline is published under the authority of the Australian Health Minister's Advisory Council and is 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 a nationally uniform approach to retail storage that meets the expectations of consumers, regulators and other 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 6 poisons that is commensurate with the risk of accidental ingestion by a child; and
- practical interpretation of the mandatory requirements for the retail storage of Schedule 7 poisons that are commensurate with the risk of accidental or intentional ingestion, 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 the purposes of this guideline:
- Retail storage is defined as the keeping of Schedule 6 poisons and Schedule 7 poisons in any 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 or product samples.
Note:
- hawking or the distribution of product samples of Schedule 7 poisons is prohibited
- this interpretation does not replace or alter any requirements under the relevant jurisdictions’ 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 to the Schedule 6 poison and accidentally ingest a sufficient quantity which could result in serious injury and/or permanent damage.
- Limiting the likelihood of such ingestion through barriers to a child readily gaining access to or delaying a child from opening the product, this guideline should also serve to provide limited general exposure to the poison and potentially improve the products' integrity in the transport and storage prior to retail sale.
- To address the higher risk profile of Schedule 7 poisons, access controls should ensure that only people permitted to purchase should have access to these products.
- The supervised access provision of the control also ensures that Schedule 7 poisons are not available for self-selection so purchasers have access to advice from the owner of the retail establishment or an employee of a retail supplier about these products.
- In limiting access to Schedule 7 poisons, this control also mitigates security risks for business 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 those poisons 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 of accidental ingestion by a child by providing a barrier and/or delay to opening the product as per the risk management considerations set out above.
The following measures do not replace the packaging controls on Schedule 6 poisons set out in Part 2 of the SUSMP (e.g. products that are required by law to have a child-resistant closure). They are intended to guide 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 6 products 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 as defined in Part 1 Interpretation of the SUSMP; or
- the product is stored in containers with the capacity of 5 litres or more or a weight inclusive of its contents of 5 kilograms or more; or
- the area is directly supervised or within direct line of sight of a manned service counter where 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 such measures 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 welded plastic 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/or sealed, 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 limit access/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 limit access, 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 limit access, or
- reduced flow formulations and presented with another barrier feature to limit access, or
- presented in a pack with a small orifice with another barrier feature to limit access.
Note
- This list is not intended to be exhaustive and does not preclude product or packaging 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 an Australian Standard.
- These barrier features are only considered to preclude access to children if they are intact and engaged so that they function as intended by the manufacturer.
Practical interpretation of the mandatory requirements for retail storage of Schedule 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 retail sale in any area or in any manner that allows physical access by any person unless they are:
- 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 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 enclosure1 (e.g. a cage), or
- a secured bulk storage container e.g. an Intermediate Bulk Container that has a security seal
- with a volume or weight capacity that precludes manual removal without equipment/vehicles; and
- is located on a property kept secured to prevent unauthorised vehicular or walk-in access when the premises are unmanned.
Footnotes
- secured in place on the premises and enclosed on all sides with a single locked entry point