This content is current only at the time of printing. This document was printed on 20 December 2021. A current copy is located at http://www.ipagescanada.com/node/94206
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Scheduled drugs and poisons
About the Poisons Standard
The intent of the Poisons Standard is to promote uniform scheduling of substances. This includes scheduled poisons and uniform labelling and packaging requirements throughout Australia.
The Poisons Standard lists poisons in 10?Schedules according to the degree of control recommended to be exercised over their availability to the public. The purpose of classification is to group substances into Schedules that require similar regulatory controls over their availability.
Poisons are not scheduled based on 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 considers many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.
Requirements for agvet scheduled poisons
The Poisons Standard sets the level of control on the availability of poisons, implemented through state and territory legislation. While there are requirements for labelling and containers in the Poisons Standard, these are intended to integrate with, relevantly, the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code) and the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (Agvet Code Regulations).
The agvet legislation includes specific labelling requirements for chemical products, including scheduled poisons, whether these are included as the active constituent in the product or as an excipient.
For example, the agvet legislation requires that:
- a label must include appropriate ‘signal words’ if required by the Poisons Standard (regulation 8AE of the Agvet Code Regulations), such as ‘prescription animal remedy’ for products that are Schedule 4 poisons
- if a product contains a constituent that is classified as a poison in the current Poisons Standard, the label must also contain the appropriate signal words required by the Poisons Standard (regulation 17 of the Agvet Code Regulations).?
The approved label for a registered product will include the appropriate signal words, as well as the other requirements to ensure the label meets the labelling criteria as outlined in the Agvet Code (section 5D of the Agvet Code).
Labelling requirements for excluded nutritional or digestive products
The Agvet Code Regulations set out specific labelling requirements for excluded nutritional or digestive (END) products, including those that contain a scheduled poison (clause 7 of Schedule 3AA to the Agvet Code Regulations). If the current Poisons Standard requires signal words in relation to the supply of the substance or mixture, the label must contain the signal words, first aid instructions for the substance or mixture and poisons information centre contact details.
Ensuring compliance with the legislation
Part of the APVMA’s role is to monitor and enforce?compliance?in the marketplace with the regulatory requirements relating to agvet chemical products and to help manufacturers, importers and suppliers of agvet chemicals to be aware of and understand these regulatory requirements.
The APVMA works closely with state and territory governments to ensure there is effective coordination and communication of monitoring and compliance efforts. The APVMA also works with the Australian Border Force to intercept illegal imports of agvet chemicals.
Compliance and enforcement outcomes?are published on the APVMA website.
The APVMA recognises the value of information provided by the community and facilitates online and free call reporting of suspected non-compliance.?More information about how to?report suspected non-compliance?is available online.