Scheduled Substances

Overview

Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison required to protect public health and safety.

For more information, visit the Therapeutic Goods Administration website and check the Poisons Standard.

Key Principles

  1. Facility Managers (or equivalent) are responsible for gaining and/or renewing regulatory approvals (e.g., permits and licences) for all S2, S3, S4 substances for their facility.
  2. Users of S8 and S9 substances are responsible for gaining and/or renewing regulatory approvals they may use in the course of their work.
  3. The Safety and Wellbeing Team will maintain a University-wide S7 approval.
  4. Compliance with all permit or licence conditions is mandatory.
  5. Facility Managers are aware of all approvals applicable to their Facility and are aware of any new permit applications being sought.
  6. Facility Managers and the Research Division will provide guidance on the processes involved in applying for approvals.
  7. Permits and licences for scheduled substances must be stored centrally in Service Now. It is the responsibility of the permit/licence holder to upload their documentation.
  1. All purchasing must be done by an approved buyer and use the natural account code for scheduled substances.
  2. A project or chemical risk assessment must be completed by the end user and approved prior to purchase.
  3. The buyer is responsible for the chain of custody of the scheduled substance from delivery to use.
  4. Every area must have a documented process, based on risk, for receiving scheduled substances.
  1. All containers, including those of any decanted or synthesised substances, must be appropriately labelled.
  2. A manifest of all substances must be kept and maintained by the Facility Manager or equivalent within ChemWatch. This requirement is in addition to maintaining a drug register for S8 substances.
  3. An annual stocktake of the manifest must be completed.
  4. All new safes must have swipe card access or electronic PIN access (with the ability for the PIN to be changed by an appropriate person, such as the Facility Manager).
  1. All areas where S8 and S9 substances are stored must be secured with swipe card access.
  2. Scheduled substances must be secured in line with licence or permit conditions.
  3. Access lists must be reviewed and updated annually.
  4. Access is only to be provided for staff and students who have completed the appropriate facility induction and training.
  5. Facility managers must keep a record of who has access to the PIN for drug safes.
  1. All staff and students must undertake identified training requirements prior to commencing work. The Laboratory and Workshop Induction unit in MyLO contains a Red Level module on Scheduled Substances, which provides an appropriate level of information for users commencing work with scheduled substances.
  2. Staff and students who require lab access must complete the MyLO lab induction prior to gaining access and refresh their training every 2 years.
  3. Training materials must be reviewed by Safety and Wellbeing and Facility Managers annually to ensure they are fit for purpose.
  1. All scheduled substances which have been identified as waste must be disposed of according to licence, permit or regulatory conditions.
  1. Any loss of a scheduled substance must be immediately reported to the Facility Manager. This includes the inability to reconcile a manifest during an annual stocktake.
  2. Facility Managers are responsible for notifying Pharmaceutical Services Branch of any loss of an S2, S3, S4, S7, S8 or S9 substance.