1 Final decisions made pursuant to regulation 42ZCZR - proposals referred to the November 209 Advisory Committee on Medicines Schedule (ACMS #28)
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1.7. Final decision in relation to Hyoscine butylbromide
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to hyoscine butylbromide as follows:
Schedule 4 - New Entry
Schedule 3 - New Entry
HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.
Schedule 2 - Amend Entry
HYOSCINE (excluding hyoscine butylbromide):
for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
for oral use:
in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.
Appendix H - New Entry
Index - Amend Entry
Reasons for the final decision (including findings on material questions of fact)
I confirm the reasons for my final decision to amend the Poisons Standard in relation to hyoscine butylbromide by creating new Schedule 3, Schedule 4 and Appendix H entries and removing the reference to hyoscine butylbromide in the Schedule 2 entry for hyoscine, are as detailed in my interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and have noted that no public submissions were received before the second closing date in response to the call for further submissions published on 6 February 2020 under regulation 42ZCZP of the Regulations.
Summary of public submissions on the interim decision
No public submissions were received in response to the interim decision.
Date of effect of the decision
1 June 2020
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.