Poisons Standard February 2016

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.