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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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1.7 Melanotan II

Part A - Final decisions on matters referred to an expert advisory committee (November 2017)

1. Advisory Committee on Medicines Scheduling (ACMS #22)

1.7 Melanotan II

Delegate's final decision
Final decision:

The delegate's final decision is to include melanotan II in Schedule 4 as follows:

Schedule 4 - New Entry

MELANOTAN II.

Index - New Entry

MELANOTAN II
cross reference: α-MELANOCYTE STIMULATING HORMONE

Schedule 4

Implementation date: 1 June 2018
Reasons:

The delegate notes the public submission on the interim decision. As a Schedule 4 substance, there will still be the requirement for a medical practitioner to prescribe melanotan II. Any inappropriate prescribing by a medical practitioner would be regulated by the Medical Board of Australia.

The delegate has confirmed that the final decision and reasons for the final decision for melanotan II are identical to the interim decision.

Public submissions on the interim decision

One (1) public submission was received that opposed the delegate's interim decision and wanted melanotan II to go into Schedule 10.

The main points opposed are:
  • Due to no benefits and well established public health risks including medication error, toxic effects, infection and false information around skin cancer protection with regards to sunless skin tanning increasing melanoma risk, melanotan II meets the criteria for Schedule 10.
  • Schedule 4 is inappropriate as it would not provide the appropriate public access in consideration of its public health risks and will have no impact on current internet sales.
  • Recent cases of overdose and poor injecting practices from online purchases highlight the current inappropriate public access, which will continue if it is listed as a Schedule 4 medicine and its continued availability through online pharmacies.
Interim decision

The interim decision for melanotan II was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.7. Melanotan II.

Scheduling proposal

The pre-meeting scheduling proposal for melanotan II was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.

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