Poisons Standard June 2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00749 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard June 2015

 

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 June 2015) in substitution for the previous Poisons Standard.  The previous Poisons Standard that is being substituted is the Poisons Standard 2015 (which was registered on the Federal Register of Legislative Instruments on 10 February 2015).

 

The Poisons Standard June 2015 also incorporates a number of new changes to the Poisons Standard 2015.  These amendments involve changes to existing entries, and the inclusion of a small 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 https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

 

Public comment was invited on those matters referred to the March 2015 ACMS, the November 2013, March, July and November 2014 and the March 2015 ACCS meetings and the November 2014 joint meeting of the ACMS and the ACCS, which related to proposals to amend the Poisons Standard in relation to the following substances:

 

  • Diethylene glycol monobutyl ether - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 17 October 2013, and closed on 14 November 2013;
  • Mercaptoacetic acid - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 17 October 2013, and closed on 14 November 2013;
  • 3,7-Dimethyl-2,6-octadienal isomers (citral, geranial and neral) - 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;
  • Diethylene glycol monomethyl ether - 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;
  • AOD-9604 (CAS No. 221231-10-3) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • CJC-1295 (CAS No. 863288-34-0) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Pralmorelin ((Growth hormone releasing peptide-2) (GHRP-2) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Growth hormone releasing peptide-6 (GHRP-6) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Growth hormone releasing hormones *(GHRHs) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Growth hormone releasing peptide *(GHRPs) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Growth hormone secretagogues *(GHSs) - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Hexarelin - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Ipamorelin - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Benzydamine - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Pantoprazole - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Cyclizine - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Pomalidomide - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Enzalutamide - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • Cannabidiol - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 20 October 2014, and closed on 17 November 2014;
  • 1,2-Benzendicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) - 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;
  • 1,2-benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP) - 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;
  • Alkoxyethanols (C1-C2) and their acetates - 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;
  • Benzidine-congener based dyes - 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;
  • C. I. Acid black 29 - 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;
  • Fenpyrazamine - 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;
  • Fluopyram - 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;
  • Methyl ethyl ketone oxime - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 14 August 2014, and closed on 11 September 2014;
  • 1,4-benzenediamine, 2-nitro-  - 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;
  • 2-Cyclohexylphenol - 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;
  • Gamma butyrolactone - 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;
  • Oxalic acid (soluble oxalates) - 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;
  • Lemongrass oil - 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;
  • Polihexanide - 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; and
  • Phenylenediamines - 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.

 

Further public comment was subsequently invited on the delegates’ interim decisions on: 27 February 2014 (with a closing date of 13 March 2014); 29 May 2014 (with a closing date of 12 June 2014); 27 June 2014 (with a closing date of 11 July 2014); 18 September 2014 (with a closing date of 2 October 2014); 14 November 2014 (with a closing date of 28 November 2014); and 5 February 2015 (with a closing date of 19 February 2015).

 

The delegates’ final decisions in relation to these matters were published on the TGA website on: 14 April 2014; 7 August 2014; 28 October 2014; 17 and 24 December 2014; 19 and 27 March 2015; and 21 April 2015.

 

Other amendments set out in this instrument added a number of new substances to the Poisons Standard for the first time, including apremilast, dasabuvir, ombitasvir, paritaprevir and ulipristal.

 

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 June 2015 also includes a small number of editorial amendments in accordance with the recommendations of the Australian Health Ministers’ Advisory Council (AHMAC) Out of Session item 645 titled Uniform controls on Poisons on 7 August 2015.

 

These decisions 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.

 

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 June 2015.

 

 

Overview

The Therapeutic Goods Act 1989 (TG Act) was enacted to provide a system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. It aims to establish a framework for States and Territories to adopt a uniform approach to the control, availability, and safe handling of poisons. The Therapeutic Goods Administration (TGA) administers the TG Act, which includes the Poisons Standard, a document that classifies substances into different schedules, indicating the degree of control recommended over their availability to the public. This Standard serves as a basis for regulatory controls under State and Territory legislation and the TG Act itself, ensuring public health and safety by restricting access to substances deemed hazardous. The Act allows for amendments to the Poisons Standard by the Secretary to the Department of Health or a delegate, often following advice from expert committees like the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. The Poisons Standard June 2015 updates and replaces the previous version, incorporating new substances and changes based on expert advice and public consultation, aiming to enhance the regulation of substances to mitigate risks associated with their misuse or abuse.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) applies to the regulation of therapeutic goods used in or exported from Australia, ensuring their quality, safety, efficacy, and timely availability. The Act also provides a framework for the control of poisons across the nation, promoting safe handling and accessibility. The Therapeutic Goods Administration (TGA) administers the TG Act, with responsibility for maintaining and updating the Poisons Standard, which classifies substances into schedules based on the degree of control recommended to be exercised over their availability to the public. The Act applies to a broad range of entities including individuals, businesses, and manufacturers involved in the production, supply, and distribution of therapeutic goods. The Poisons Standard is adopted by State and Territory legislation for regulatory purposes, allowing restrictions on the supply of scheduled substances in accordance with the degree of risk and control recommended for public health and safety. The scheduling of substances under the Poisons Standard is guided by expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, which provide advice to the Secretary of the Department of Health or their delegate. The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003, though it is not subject to disallowance or scrutiny under the Human Rights (Parliamentary Scrutiny) Act 2011. This instrument, which includes the Poisons Standard June 2015, commenced on 1 June 2015.

Key Provisions

The main sections of the Poisons Standard June 2015, as an amendment to the Therapeutic Goods Act 1989 (TG Act), pertain to the scheduling of various substances based on their potential risks and the level of control required for their availability to the public. These schedules range from Schedule 1 to Schedule 10/Appendix C, each denoting different levels of restriction on the substances' distribution and use. The Poisons Standard June 2015 introduces changes to existing entries and includes new substances, such as apremilast, dasabuvir, ombitasvir, paritaprevir, and ulipristal, into the schedules for the first time. These changes and additions are made based on recommendations from the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), in line with the Scheduling Policy Framework (SPF). The Act imposes obligations on entities and individuals to comply with the schedules outlined in the Poisons Standard. For example, entities must ensure that any advertisements for substances categorised in certain schedules, such as Schedule 4 or 8 for prescription medicines, or Schedule 3 and not in Appendix H for over-the-counter medicines, are not published. Similarly, substances in Schedule 9 or Schedule 10/Appendix C are prohibited from being advertised to consumers. Compliance with these advertising restrictions is crucial to safeguard public health and prevent misuse or abuse of scheduled substances. Breaches of the Poisons Standard can result in both civil and criminal consequences. Under the TG Act, civil penalties can be imposed for non-compliance, including fines that may vary depending on the severity of the breach. For criminal offences related to the unauthorised supply or advertising of scheduled substances, individuals can face fines and imprisonment. The maximum penalties are not specified in the explanatory statement but generally align with the severity of the offence and the potential harm caused by the breach. The Act ensures that these consequences are in place to deter non-compliance and protect public health and safety.

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