Poisons Standard 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01343 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard 2014

 

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 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 2014) in substitution for the previous Poisons Standard.  The previous Poisons Standard that is being substituted is the Poisons Standard 2013 (which was registered on the Federal Register of Legislative Instruments on 22 August 2013), together with the three subsequent amendments that have been made to the Poisons Standard 2013: Poisons Standard Amendment No. 2 of 2013, Poisons Standard Amendment No. 1 of 2014 and Poisons Standard Amendment No. 2 of 2014.  

 

As such, the Poisons Standard 2014 is principally a consolidation of the Poisons Standard 2013 and its three amendments.

 

However, the Poisons Standard 2014 also incorporates a small number of changes to the Poisons Standard 2013 which have not previously been included in any of the amendments to the Poisons Standard 2013 mentioned above.

 

These amendments 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 ACMS and the ACCS, 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 http://www.tga.gov.au/industry/scheduling-spf.htm.

 

Public comment was invited on those matters referred to the ACMS, the ACCS and a joint meeting of the ACMS and the ACCS, which related to proposals to amend the Poisons Standard in relation to the following substances:

 

  • Naproxen - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 21 November 2013, and closed on 19 December 2013;
  • Perampanel - 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;
  • Sodium oxybate - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 21 November 2013, and closed on 19 December 2013;
  • Dibutyl Phthalate - 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;
  • Ethanol, 2-phenoxy - 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;
  • 1,3,5,7-Tetraazatricyclo [3.3.1.13] decane - 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; and
  • Lambda-cyhalothrin- 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.

 

Public submissions in relation to these substances were taken into consideration at the meetings of the ACCS, the ACMS and a joint meeting of the ACMS and the ACCS, in March 2014. Further public comment was subsequently invited on the delegates’ interim decisions on 27 June 2014, with a closing date of 12 July 2014. The delegates’ final decisions in relation to these matters were published on the TGA website on 3 July and 7 August 2014.

 

Other amendments set out in this instrument added a number of new substances to the Poisons Standard for the first time, including halauxifen methyl, imeptoin, insulin glargine, nalmefene and propoxur.

 

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 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 the day after registration on the Federal Register of Legislative Instruments.

 

 

Overview

The Therapeutic Goods Act 1989 (TG Act) was enacted to establish a regulatory framework for therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This legislation provides for the control of poisons and scheduled substances, aiming to minimise risks of poisoning and misuse. The Act empowers the Therapeutic Goods Administration (TGA) to administer its provisions and mandates the creation of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling to advise on scheduling matters. The Poisons Standard, updated in 2014, consolidates previous standards and amendments, incorporating new substances and changes based on expert advice and public consultation. This legislative instrument is not subject to disallowance under the Legislative Instruments Act 2003 and does not require a statement of compatibility with human rights under the Human Rights (Parliamentary Scrutiny) Act 2011. It comes into effect the day after registration on the Federal Register of Legislative Instruments.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) governs the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia, and it establishes a uniform framework for the control of poisons across the states and territories. The Therapeutic Goods Administration (TGA) administers this Act, and it includes provisions for the scheduling of substances to regulate their availability and mitigate risks of poisoning or misuse. The Act establishes two advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, which provide advice on scheduling decisions. The Poisons Standard, a legislative instrument under the TG Act, classifies substances into schedules based on the degree of control needed to ensure public health and safety. This Standard is referenced in state and territory legislation to enforce restrictions on the supply of scheduled substances. The Poisons Standard 2014 consolidates and updates the previous Poisons Standard 2013 and its amendments, incorporating changes recommended by the advisory committees and public consultations, and introducing new substances to the schedule. Certain decisions do not require public consultation if they are deemed straightforward. The Poisons Standard 2014 is a legislative instrument under the Legislative Instruments Act 2003 and commences the day after its registration on the Federal Register of Legislative Instruments.

Key Provisions

The main operative sections of the Poisons Standard 2014 include the classification of substances into various schedules, which indicate the degree of control recommended for their availability to the public. These schedules range from Schedule 1 (unrestricted) to Schedule 9 (prohibited). The Standard also details the substances included in each schedule, providing a comprehensive list for regulatory purposes (section 52D(2)). The standard establishes the legal framework for restricting the supply of certain substances based on their potential risk and impact on public health and safety. The Poisons Standard imposes several obligations on parties and entities involved in the handling, supply, and advertising of scheduled substances. Manufacturers, suppliers, and retailers must comply with the restrictions on the supply of substances according to their schedule classification. For instance, substances in Schedule 4 or 8 cannot be advertised to consumers as prescription medicines, and substances in Schedule 9 or Appendix C are entirely prohibited from advertising (section 52D(2)). Furthermore, entities must ensure that their practices align with the provisions outlined in the Standard to avoid legal repercussions. Breaches of the Poisons Standard can result in significant penalties and legal consequences. The Therapeutic Goods Act 1989 provides for civil and criminal penalties for non-compliance. For example, advertising restricted substances in violation of the Standard can result in fines up to $220,000 for individuals and $1,100,000 for corporations. Additionally, supplying scheduled substances in breach of the Standard can lead to fines and potential imprisonment. The severity of penalties underscores the importance of adhering to the Standard to maintain public health and safety standards.

Legal classification tags

Area of Law
Regulatory Standards
Instrument
Regulation
Concepts
Regulatory Standards
Offence Provisions
Reporting & Disclosure Obligations
Catchwords
Poisons Standard
Schedules

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.