3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
Note
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3.3 Final decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)
Final decision in relation to pentobarbital
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to pentobarbital as follows:
| 9. | Poisons which must be stored in a locked container to prevent unauthorised access |
| PENTOBARBITAL in injectable preparations. |
Materials considered
In making this final decision, the Delegate considered the following material:
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- The scheduling proposal to amend the current Poisons Standard with respect to pentobarbital;
- The 11 public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Joint meeting of the Advisory Committees on Medicines and Chemicals Scheduling (Joint ACMS-ACCS#24);
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018);
- The Scheduling handbook: Guidance for amending the Poisons Standard;
- The National Coronial Information System (NCIS) report on pentobarbital-related deaths in Australia 2000 - 2017 (pdf,791kb)*; and
- Specialist advice on veterinary medicine from two veterinary surgeons.
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the current Poisons Standard to clarify the storage requirements for Schedule 4 injectable pentobarbital through the provision of a new Appendix D listing. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and I have noted that no public submissions were received before the second closing date in response to the call for further submissions published on 10 June 2020 under regulation 42ZCZP of the Regulations.
Date of effect of the decision
1 October 2020