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Scheduling handbook: Guidance for amending the Poisons Standard

Endorsed by AHMAC December 2017

18 January 2018

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Version 1.0, January 2018

About the scheduling handbook

The handbook provides guidance for stakeholders on how the Poisons Standard is amended and provides details of the processes that underpin the scheduling policy. Read this handbook in conjunction with the Scheduling policy framework for medicines and chemicals.

The Scheduling policy framework and Scheduling handbook support the broader public health policy frameworks in Australia for both the quality use of human medicines and the safe use of chemicals.

The Australian Health Ministers' Advisory Council (AHMAC) has responsibility for the policy principles for scheduling and other poisons regulatory controls, as set out in the Scheduling policy.

Scheduling decisions are made under the Therapeutic Goods Act 1989 (CTH) and Therapeutic Goods Regulation. The Commonwealth (through the Therapeutic Goods Administration of the Department of Health) also provides and funds the Secretariats for Medicines and Chemicals scheduling. This handbook is to support the activities of the Secretariats, in particular those interacting with the Secretariats such as applicants for the scheduling or re-scheduling of substances.

Principles of scheduling

The quality use of (human) medicines framework incorporates the selection of appropriate therapeutic management options, appropriate choice of medicines (where a medicine is considered necessary) and safe use. Scheduling classification supports this framework by determining the need for particular health professionals to be involved in the supply of medicinal substances to promote their safe and quality use. Labelling of products using specific phrases, called signal headings, emphasises this need for intervention by particular health professionals.

Scheduling also supports safer use of agricultural, veterinary and domestic chemical products through labelling with specific alert phrases aligned to the risk associated with the substance, or signal headings emphasising the need for intervention by particular professionals, where required. Where necessary the scheduling of certain veterinary medicines reinforces the need for intervention by a veterinary practitioner to promote safe use. The Poisons Standard also establishes the required packaging and necessary label information for the safe use of domestic chemical products.

The Poisons Standard

The Poisons Standard is considered to be a Legislative Instrument for the purposes of the Legislation Act 2003(CTH). It must be registered and published on the FRL website in electronic form. In order to ensure certainty in the continuing application of state and territory laws, the Poisons Standard is not a disallowable instrument.

Scheduling decisions are legislative in character, so the lawfulness of the Secretary's decision is not reviewable under the Therapeutic Goods Act 1989, in the Commonwealth Administrative Appeals Tribunal or in the Federal Court.

For general information about the Poisons Standard, see An introduction to the Poisons Standard.

Parts 1, 2 and 3

Part 1 provides definitions and interpretation of terms relevant to the Poisons Standard and the scheduling process.

Parts 2 and 3 provide a description of the nature of controls, including access, labelling, packaging, supply etc., recommended to be implemented by states and territories for scheduled substances.

The schedules

The schedules are in Part 4 of the Poisons Standard and comprise lists of substances, referred to as entries. These entries are subject to the conditions and requirements for that schedule, which are set out in Parts 2, 3 and 4 of the Poisons Standard. Details of factors for determining the relevant schedule are set out in the Scheduling policy.

Reference to a substance in a schedule or an appendix of the Poisons Standard:

  • includes those descriptions covered in subsection 1(2)(a) to (g) in Part 1 of the Poisons Standard
  • does not include those descriptions covered in subsection 1(2)(h) to (k) in Part 1 of the Poisons Standard

The schedules reflect the level of risk mitigation to be applied to reduce the assessed risk to public health to an acceptable level for each substance.

Substances are classified into schedules as follows:

  • Schedule 1 is currently not in use.
  • Schedules 2, 3, 4, and 8 include medicinal substances intended for human therapeutic use and have increasingly restrictive regulatory controls on their availability in the order stated. Schedules 4 and 8 also include veterinary medicines.
  • Schedules 5, 6 and 7 include poisons (including veterinary chemicals), with increasing regulatory controls on their availability. Veterinary medicines available without prescription are generally included in Schedules 5 and 6. Controls over poisons in Schedules 5 and 6 are through packaging and labelling.
  • Schedule 9 includes substances that have a high propensity for dependency and abuse. These substances should be available only for prescribed purposes such as analysis, and medical or scientific research, including clinical trials, conducted with the approval of Commonwealth and/or State/Territory health authorities. Otherwise, the possession, use, sale or supply of substances in Schedule 9 is generally prohibited.
  • Schedule 10 includes poisons, other than those that cause dependence, of such danger to health as to warrant prohibition of sale, supply and use.

The numbering of Schedules 2, 3, 4, and 8 signifies an increasing level of professional healthcare intervention combined with increasingly stricter restrictions on availability. For Schedules 5, 6 and 7 the numbering signifies increasingly stricter container and labelling requirements. Unscheduled substances can also be made available on general sale.

Appendices

The appendices of the Poisons Standard support the schedules by detailing substances that do not require scheduling, require additional labelling or access, or other information that isn't captured in the schedules.

The appendices are:

  • Appendix A - General exemptions
  • Appendix B - Substances considered not to require control by scheduling
  • Appendix C - Superseded by Schedule 10
  • Appendix D - Additional controls on possession or supply of poisons included in Schedules 4 or 8
  • Appendix E - First aid instructions for poisons
  • Appendix F - Warning statements and general safety directions for poisons
  • Appendix G - Dilute preparations
  • Appendix H - Schedule 3 medicines permitted to be advertised
  • Appendix I - Superseded by Part 2 Section 7
  • Appendix J - Schedule 7 poisons requiring additional controls on availability and use
  • Appendix K - Medicines required to be labelled with a sedation warning
  • Appendix L - Requirements for dispensing labels for human and veterinary medicines
  • Appendix M - Additional requirements for Schedule 3 medicines

Details of factors to be considered for the appendices are set out in the Scheduling Policy Framework.

How are the schedules implemented

Controls on substances through scheduling are given legal effect through relevant State and Territory legislation. Hence, implementation of these controls may differ depending on the State/Territory.

Specific jurisdictions may also impose additional restrictions on access to a substance and/or labelling and packaging.

Licences and applications for access to scheduled substances are administered through the jurisdictions and other regulatory agencies (i.e. the TGA or the APVMA).

More information on State and Territory implementation (including contact details) is available at: State/Territory scheduling information.

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