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Final decisions amending, or not amending, the current Poisons Standard, April 2018
Scheduling medicines and poisons
Part A - Final decisions on matters referred to an expert advisory committee (November 2017)
1. Advisory Committee on Medicines Scheduling (ACMS #22)
Delegate's final decision
The delegate's final decision is to include ibutamoren in Schedule 4 with an Appendix D (Part 5) entry as follows:
Schedule 4 - New Entry
Appendix D, Part 5 - New Entry
Index - New Entry
cross reference: MK-677, Nutrobal
Appendix D, Part 5
Implementation date: 1 June 2018
As no new evidence has been received to alter the interim decision for ibutamoren, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.
Public submissions on the interim decision
No public submissions were received.
The interim decision for ibutamoren was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.4. Ibutamoren.
The pre-meeting scheduling proposal for ibutamoren 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.