Notice of final decision to amend (or not amend) the current Poisons Standard - ACMS #44, ACCS #38, Joint ACMS-ACCS #36

This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulations 42ZCZS and 42ZCZX, this notice publishes:

• the decisions made by a delegate^[1] of the Secretary of the Department of Health and Aged Care (the Delegate) pursuant to regulations 42CZR, 42ZCZU AND 42ZCZW
• the reasons for those final decisions and
• the date of effect of those decisions.
• Defined terms
• In this notice the following defined terms are used in addition to those above:
• the Therapeutic Goods Act 1989 (Cth) (the Act)
• the Scheduling Policy Framework 2018 (the SPF)
• the Scheduling handbook, Guidance for amending the Poisons Standard (the Handbook) and
• the Therapeutic Goods Administration (the TGA).

Note: additional terms are also defined for individual decisions.

Final decisions and reasons

We aim to provide documents in an accessible format. If you're having problems using this document, please contact medicines.scheduling@health.gov.au.

Contents

• Notice of final decisions to amend (or not amend) the current Poisons Standard
• Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #44, March 2024)
  • Cytisine
  • Dextromethorphan
  • Ethylmorphine
• Final decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #38, March 2024)
  • Niclosamide
• Final decisions on proposed amendments referred to the Advisory Committees on Medicines and Chemicals Scheduling in joint session (ACMS-ACCS #36, March 2024)
  • Oxytetracycline
  • Tranexamic acid
• Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZU
  • Dimethylacetamide
  • Epyrifenacil
  • Metarylpicoxamid
  • Vatinoxan hydrochloride
  • Homobrassinolide
     
• Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZW
  • Prescription only (Schedule 4) substances contained within research-only kits in very small amounts
  • Azelaic acid
• Decisions to amend the current Poisons Standard under section 52D(2) of the Act
  • Thiafentanil
  • Phenidines
  • Carbendazim
• Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)
  • Vutrisiran
  • Ritlecitinib
  • Odevixibat
  • Pinaverium bromide
  • Lumasiran
  • Capivasertib
  • Vorasidenib
  • Fruquintinib
  • Iptacopan
  • Danicopan
  • Sotatercept

^[1] For the purposes of s 52D of the Therapeutic Goods Act 1989 (Cth).