Poisons Standard March 2016

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, establishes a regulatory framework for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. This Act provides the basis for a uniform system of access controls for goods containing scheduled substances, ensuring that the public’s health and safety are protected from the risks of poisoning and misuse. The Act also facilitates a coordinated approach for the States and Territories to manage the availability and safe handling of poisons. The Therapeutic Goods Administration is responsible for administering the Act and its related schedules, which classify substances according to the degree of control required for their availability to the public. The Poisons Standard, updated in March 2016, rectifies an inadvertent omission from the previous February 2016 version, specifically re-inserting an entry for methylated spirit(s) in Schedule 5, thereby reinstating the necessary regulatory controls for these products. This legislative instrument is not subject to disallowance under the Legislative Instruments Act 2003 and, accordingly, does not require a compatibility statement under the Human Rights (Parliamentary Scrutiny) Act 2011.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) applies to the control of therapeutic goods in Australia, including their quality, safety, efficacy, and timely availability, and extends to goods used within Australia or exported from Australia. The Act also governs the regulation of poisons to ensure safe handling, availability, and accessibility across the nation. The Therapeutic Goods Administration (TGA) administers the Act, with the Secretary to the Department of Health or a delegate having the authority to amend the Poisons Standard, which schedules substances based on the level of control required for public safety. The Poisons Standard is integral to state and territory legislation for regulatory purposes, establishing controls on the supply of scheduled substances. The Act applies to all persons, entities, and industries dealing with therapeutic goods and scheduled substances within Australia. The Act's reach is national, with the Poisons Standard being referenced under state and territory legislation for local regulatory enforcement. The Act does not apply to substances that are exempt or not classified under the Poisons Standard. The Act allows for the extension or restriction of its application through subordinate instruments, which are not subject to disallowance under the Legislative Instruments Act 2003. The instrument in question, the Poisons Standard March 2016, corrects an inadvertent omission from the previous standard and comes into effect on 1 March 2016.

Key Provisions

The main operative sections of the Poisons Standard March 2016 involve the amendment of the previous Poisons Standard February 2016, specifically by reinstating an entry for methylated spirit(s) in Schedule 5 (subsection 52D(2) of the Therapeutic Goods Act 1989). This change ensures that methylated spirit(s) products, which are ethanol denatured with certain chemicals, are appropriately regulated when not in preparations, admixtures, or large containers over 5 litres. The new Poisons Standard corrects an inadvertent omission in the previous version, thereby applying the necessary controls such as labelling and packaging to products currently on the market and those being introduced. The obligations imposed by the Act include the responsibility of the Secretary to the Department of Health, or their delegate, to ensure the Poisons Standard accurately reflects the scheduling of substances to control their availability and accessibility, thereby protecting public health and safety. This role involves the creation of expert advisory committees such as the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, which provide expert advice on scheduling decisions (sections 52B and 52C). Furthermore, the Act mandates that the Poisons Standard be referenced under State and Territory legislation to enforce restrictions on the supply of scheduled substances according to their risk profiles. The Act also imposes various restrictions on advertising prescription and over-the-counter medicines, as well as substances in Schedule 9 or Schedule 10/Appendix C of the Poisons Standard, to prevent misleading or inappropriate advertising that could endanger public health. The Therapeutic Goods Administration oversees the implementation and enforcement of these provisions. Any breaches of the Act's advertising prohibitions may result in civil or criminal penalties, including fines and imprisonment, although the specific penalties are determined by the courts based on the severity and circumstances of the breach. The consequences for non-compliance with the Poisons Standard and the Therapeutic Goods Act include substantial penalties. For example, advertising prescription medicines in Schedule 4 or 8, or over-the-counter medicines in Schedule 3 not included in Appendix H, could result in civil penalties of up to $220,000 for individuals and $1,100,000 for bodies corporate, as well as potential criminal penalties that could lead to imprisonment. Similarly, advertising substances in Schedule 9 or Schedule 10/Appendix C could result in fines of up to $1,100,000 and imprisonment for up to 5 years for individuals, and higher fines for bodies corporate. These penalties underscore the importance of adhering to the regulatory requirements outlined in the Act and the Poisons Standard.