You are here

Scheduling delegate's final decisions: ACMS, November 2015

Scheduling medicines and poisons

18 November 2015

Book pagination

Part B - Final decisions on matters not referred to an expert advisory committee (3)

3. Editorial amendments

3.1 Di-iodohydroxyquinoline

Scheduling proposal

The medicines scheduling delegate has initiated an editorial amendment to clarify the scheduling of di-iodohydroxyquinoline by reinstating the Schedule 10/Appendix C entry for di-iodohydroxyquinoline for human internal use, which was removed from the SUSMP in 2009.

Schedule 10 - Editorial amendment

DI-IODOHYDROQYQUINOLINE (iodoquinol) for human internal use.

Scheduling status

Di-iodohydroqyquinoline (iodoquinol) is currently listed in Schedules 3 and 4.

Schedule 4

DI-IODOHYDROXYQUINOLONE (iodoquinol) except:

  1. when included in Schedule 3; or
  2. for human internal use.
Schedule 3

DI-IODOHYDROXYQUINOLONE (iodoquinol) for vaginal use.

Clioquinol is currently listed in Schedule 4 and 10/Appendix C

Schedule 10/Appendix C

CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when in Schedule 4 or when being used solely for experimental purposes in humans and where such use:

  1. is in accordance with:
    1. an approval granted under paragraph 19(1)(b) of the Therapeutic Goods Act 1989, including any conditions specified in the notice of approval; and
    2. any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(1A) of the Therapeutic Goods Act 1989; and
    3. any conditions specified in the Therapeutic Goods Regulations 1990 for the purposes of subsection 19(4A) of the Therapeutic Goods Act 1989; or
  2. is in accordance with the requirements of item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990.
Schedule 4

CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human topical use except when separately specified in this Schedule.

Scheduling history
National Drugs and Poisons Scheduling Committee - February 1999

Recommendation No. 82 of the Trans-Tasman Harmonisation Working Party was that the Schedule 4 entry for di-iodohydroxyquinoline be amended to exclude for oral use and create an Appendix C entry.

National Drugs and Poisons Scheduling Committee – June 2009

The Committee decided that the entry for di-iodohydroxyquinoline (iodoquinol) for human internal use be removed from Appendix C as it was appropriately captured by the Appendix C entry for clioquinol and other halogenated derivatives of 8- hydroxyquionoline. Further, the Committee agreed to cross-reference diiodohydroxyquinoline with the clioquinol Appendix C entry in the SUSDP index.

Delegate's consideration

The delegate considered the following in regards to this editorial amendment:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989.
  • Scheduling factors13.
Delegate's final decision

The delegate's final decision is that di-iodohydroxyquinoline for human internal use is reinstated in Schedule 10/Appendix C.

The implementation date is 1 February 2016.

Reasons for the decision are:

  • Although di-iodohydroxyquinoline is covered by the Schedule 10 /Appendix C entry for Clioquinol there is potential confusion as di-iodohydroxyquinoline is specifically listed in Schedules 3 and 4.
  • This decision clarifies the status of di-iodohydroxyquinoline as also being covered by Schedule 10/Appendix C.
Schedule entry
Schedule 10 - Editorial amendment

DI-IODOHYDROQYQUINOLINE (iodoquinol) for human internal use.


Footnotes

Book pagination