Poisons Standard February 2016

Administered by Department of Health, Disability and Ageing

Legislation au F2016L00036 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard February 2016

 

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

 

Subsection 52D(2) of the TG Act authorises the Secretary to the Department of Health, or a delegate of the Secretary, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) or to prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.

 

Part 6-3 of the TG Act provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.

 

The TG Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (the ACMS) (section 52B) and the Advisory Committee on Chemicals Scheduling (the ACCS) (section 52C), which provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions.

 

The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.

 

The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes. This enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk associated with them and the degree of control recommended to be exercised over their availability, in the interest of public health and safety.

 

The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act.

 

For example, the TG Act and regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Schedule 10/Appendix C of the Poisons Standard is also prohibited.

 

The purpose of this instrument is to prepare a new Poisons Standard (cited as the Poisons Standard February 2016) in substitution for the previous Poisons Standard.  The previous Poisons Standard that is being substituted is the Poisons Standard October 2015 (which commenced on 1 October 2015).

 

The Poisons Standard February 2016 incorporates a number of new changes to the Poisons Standard October 2015.  These amendments principally involve changes to existing entries, and the inclusion of a number of specified substances in the Poisons Standard for the first time.

 

A number of these changes were made following the provision of advice from the ACCS and the ACMS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee. 

 

The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an expert advisory committee for advice.  A copy of the SPF is available from https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

 

Public comment was invited on those matters referred to the November 2014, March 2015 and August 2015 ACCS meetings, the August 2015 ACMS meeting and the March 2014, July 2014 and August 2015 joint meetings of both the ACMS and the ACCS.  These meetings related to proposals to amend the Poisons Standard in relation to the following substances:

 

  • Lauryl sulfates - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 30 January 2014, and closed on 20 February 2014.
  • 2-ethylhexanoic acid and its derivatives - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 January 2015, and closed on 27 February 2015.
  • Bicyclopyrone - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 28 May 2015, and closed on 25 June 2015.
  • Clitoria ternatea extract - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 28 May 2015, and closed on 25 June 2015.
  • Momfluorothrin - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 28 May 2015, and closed on 25 June 2015.
  • Carcinogenic amines (azo dyes) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 28 May 2015, and closed on 25 June 2015.
  • Naloxone - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 2 April 2015, and closed on 7 May 2015.
  • Hydrocortisone - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 2 April 2015, and closed on 7 May 2015.
  • 2-Hydroxyethyl methacrylate - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 11 June 2015, and closed on 9 July 2015.
  • Esomeprazole - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 2 April 2015, and closed on 7 May 2015.
  • Proton pump inhibitors - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 11 June 2015, and closed on 9 July 2015.
  • Levocetirizine - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 11 June 2015, and closed on 9 July 2015.
  • Zinc lactate - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 May 2014, and closed on 26 June 2014.
  • Formaldehyde donors - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 25 September 2014, and closed on 23 October 2014.
  • Methylated spirits - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 25 September 2014, and closed on 23 October 2014.
  • Amidopropyl betaines - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 January 2015, and closed on 27 February 2015.
  • Ammonium cocoyl isethionate - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 January 2015, and closed on 27 February 2015.

 

Further public comment was subsequently invited on the delegates’ interim decisions on these items either on 27 June 2014 with a closing date of 11 July 2014, 30 September 2014 with a closing date of 14 October 2014, 5 February 2015 with a closing date of 19 February 2015, 4 June 2015 with a closing date of 18 June 2015 or 1 October 2015, with a closing date of 15 October 2015.

 

The delegates’ final decisions in relation to these matters were published on the TGA website on 28 October 2014, 21 April 2015, 23 July 2015 and 19 November 2015, with the delegate deciding that these decisions should be implemented from 1 October 2015 for lauryl sulfates, and from 1 February 2016 in the case of each of the other substances mentioned above.

 

Other amendments set out in this instrument added a number of new substances to the Poisons Standard for the first time, including BLAD (banda de Lupinus albus doce), bixafen, armodafinil, asfotase alfa, nintedanib, sacubitril and tofactinib, and changes to the entry in the Poisons Standard for afoxolaner and milbemycin oxime.

 

These decisions were delegate-only decisions that were not open to public consultation, as they were considered (in accordance with the SPF) to be sufficiently straightforward as to not require public consultation. For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substance.

 

The Poisons Standard February 2016 also includes a number of editorial amendments, including an amendment to the scheduling of di-iodohydroxyquinoline. This decision was not open to public consultation, as it was considered, in accordance with the SPF, to be sufficiently straightforward as to not require public consultation.

 

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA). However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

 

As this instrument is not disallowable, subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 does not require that the instrument be accompanied by a statement of compatibility with the human rights recognised under that Act.

 

The instrument commences on 1 February 2016.

 

 

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to establish and maintain a system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. It also provides a framework for the States and Territories to adopt a uniform approach to control the availability, accessibility, and safe handling of poisons. The Therapeutic Goods Administration is responsible for administering the Act. One of the key components of the Act is the Poisons Standard, which lists substances in schedules based on the degree of control recommended for their availability to the public, aimed at minimising risks of poisoning and misuse. The Act authorises the Secretary to the Department of Health to amend or replace the Poisons Standard, with advice from expert committees on medicines and chemicals scheduling. The Poisons Standard February 2016 instrument updates the previous Poisons Standard, incorporating new changes and amendments, including the addition of new substances and adjustments to existing entries, based on advice from the relevant committees and public consultation where appropriate. This instrument does not require disallowance or a human rights compatibility statement and commenced on 1 February 2016.

Scope and Application

The Therapeutic Goods Act 1989 provides for the regulation of therapeutic goods used in or exported from Australia, focusing on ensuring quality, safety, efficacy, and timely availability. The Act establishes the Therapeutic Goods Administration (TGA) as the administering authority and includes the Poisons Standard, which classifies substances into various schedules indicating the degree of control over their availability to the public. The Act applies to substances, products, and entities involved in the manufacture, supply, advertising, and distribution of therapeutic goods within Australia. The Poisons Standard operates on a Commonwealth level but is also referenced by State and Territory legislation for enforcing local restrictions on the supply of scheduled substances. The Act does not explicitly state exclusions but the scheduling process considers the degree of risk and public health implications. The Poisons Standard February 2016 replaces the previous standard and incorporates new changes, including the classification of new substances and amendments to existing entries, based on advice from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. Public consultations were held for certain substances before the final decisions were made. This legislative instrument is not subject to disallowance under the Legislative Instruments Act 2003 and commenced on 1 February 2016.

Key Provisions

The Therapeutic Goods Act 1989 (TG Act) sets up a system for controlling the quality, safety, efficacy, and availability of therapeutic goods in Australia. The Act also provides a framework for the states and territories to regulate the availability, accessibility, and safe handling of poisons. The Therapeutic Goods Administration (TGA) administers the Act. Section 52D(2) of the TG Act allows the Secretary to the Department of Health, or a delegate, to amend the Poisons Standard, which classifies substances into schedules according to the degree of control recommended over their availability. The Poisons Standard is referenced by state and territory legislation to regulate the supply of scheduled substances, aiming to protect public health and safety by minimising poisoning and misuse risks. The Poisons Standard February 2016, replacing the October 2015 version, incorporates new changes, including adjustments to existing entries and the introduction of new substances. These changes were partly based on advice from the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). Public consultations were held for certain substances, such as lauryl sulfates and carcinogenic amines, to gather feedback before the final decisions were made. The instrument includes new substances like bixafen and sacubitril, which were added based on delegate-only decisions deemed straightforward enough not to require public consultation. Editorial amendments, such as the scheduling of di-iodohydroxyquinoline, were also made, and these decisions were similarly considered straightforward. The Poisons Standard is a legislative instrument under the Legislative Instruments Act 2003 and is not subject to disallowance or scrutiny for compatibility with human rights. The instrument comes into effect on 1 February 2016. The Act imposes obligations on the parties involved, particularly the TGA, to administer the Act effectively and ensure compliance with the Poisons Standard. The Secretary, or a delegate, must consult with expert advisory committees, such as the ACMS and ACCS, when proposing amendments to the Poisons Standard. The committees provide advice and recommendations on scheduling decisions. Public consultations are also required for certain amendments to gather input from stakeholders. The Act prohibits the advertising of certain substances, such as prescription medicines in Schedules 4 or 8, and over-the-counter medicines in Schedule 3 but not in Appendix H, to protect public health. Advertising of substances in Schedules 9 or 10/Appendix C is also prohibited. Breaching the provisions of the Therapeutic Goods Act 1989 and the Poisons Standard can lead to significant consequences. Offences may include unauthorised supply or possession of scheduled substances, advertising prohibited substances, or non-compliance with advertising restrictions. The penalties for these offences can vary widely depending on the severity and nature of the breach. For instance, the Act may impose fines, imprisonment, or both. The exact penalties are stipulated in the regulations and can be severe, reflecting the importance of adhering to the safety and regulatory standards set by the Act and the Poisons Standard. Non-compliance with advertising restrictions can also result in penalties, including fines and potential criminal charges. These provisions underscore the critical role of adherence to the Act and the Standard in safeguarding public health and safety.

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