The Poisons Standard (the SUSMP)

1 February 2016

The Poisons Standard is a Legislative Instrument for the purposes of the Legislative Instruments Act 2003. The Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories. The Poisons Standard also includes model provisions about containers and labels, a list of products recommended to be exempt from these provisions, and recommendations about other controls on drugs and poisons.

The Poisons Standard has been presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia.

The Poisons Standard is the legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Electronic version of the SUSMP

The SUSMP is available in electronic form, free of charge, on the ComLaw website at the Federal Register of Legislative Instruments (FRLI). The FRLI is a repository and authoritative source of Commonwealth legislative instruments, explanatory statements and compilations of legislative instruments in electronic form.

Please note that on FRLI the SUSMP goes by its legal title, the Poisons Standard. Additionally, rather than referring to the edition number, the publication will be named according to the year of publication (i.e. the year it is published on FRLI). For example, SUSMP No.7 is known as Poisons Standard June 2015 on FRLI.

Please note that the SUSMP No.9 and all future editions of the Poisons Standard will only be available online.

The SUSMP

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP):

  • is a record of decisions regarding the classification of medicines and chemicals into Schedules for inclusion in relevant legislation of the states and territories;
  • includes model provisions about containers and labels, and recommendations about other controls on medicines and chemicals; and
  • is registered on the Federal Register of Legislative Instruments as the Poisons Standard.

Recent changes

SUSMP No.10 is the current edition. It 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 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 Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS). 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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, including an amendment to the scheduling of di-iodohydroxyquinoline.