The Therapeutic Goods Administration (TGA) has made interim decisions to amend the Poisons Standard for Cytisine, Dextromethorphan, and Dihydrocodeine.

  • Cytisine: It is proposed for new entries in Schedules 3 and 4, with an implementation date of 01-Oct-2024.
  • Dextromethorphan: It was not recommended for rescheduling.
  • Dihydrocodeine: Known for its antitussive properties, it is proposed for amendments in Schedules 8, 4, and 3, with an implementation date of 01-Jun-2025.

These decisions are based on considerations such as risks and benefits, toxicity, potential for abuse, and other public health matters. The TGA’s interim decisions are made after considering public submissions and the advice of the Advisory Committee on Medicines Scheduling (ACMS) or the Advisory Committee on Chemicals Scheduling (ACCS).

The committee’s decisions are based on subsection 52E(1) of the Act, which includes factors such as:

  • Risks and benefits
  • Purposes of use
  • Toxicity
  • Dosage
  • Formulation
  • Labeling
  • Packaging
  • Presentation
  • Potential for abuse
  • Other public health matters

Source: https://www.tga.gov.au/sites/default/files/2024-07/public_notice_of_interim_decisions_-_acms44_accs38_joint_acms-accs36_-_march_2024.pdfhttps://www.tga.gov.au/resources/publication/scheduling-decisions-interim/notice-interim-decisions-proposed-amendments-poisons-standard-acms-44-accs-38-and-joint-acms-accs-36-march-2024

Region: Australia

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