Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, November 2016

Scheduling medicines and poisons

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2 February 2017

3 Summary of delegate's interim decisions

Part A - Interim decisions on matters referred to an expert advisory committee (November 2016)

3. Advisory Committee on Medicines Scheduling (ACMS #19)

Summary of delegate's interim decisions
Substance Interim decision
Vitamin D

Schedule 3 - Current entry

VITAMIN D for human therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.

Appendix H - New Entry

VITAMIN D

The proposed implementation date is 1 June 2017.

Melatonin The delegate's interim decision is that the current scheduling for melatonin remains appropriate.
Paracetamol compounded with caffeine

Schedule 2 - Amend Entry

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  6. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

The proposed implementation date is 1 June 2017.

Vardenafil The delegate's interim decision is that the current scheduling of vardenafil remains appropriate.
Cetirizine hydrochloride

Schedule 4 - Amend Entry

CETIRIZINE HYDROCHLORIDE except:

  1. when included in Schedule 2 ; or
  2. in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 10 mg of cetirizine hydrochloride.

Schedule 2 - Amend Entry

CETIRIZINE HYDROCHLORIDE in preparations for oral use except in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age an over when:

  1. in a primary pack containing not more than 10 days' supply; and
  2. labelled with a recommended daily dose not exceeding 10 mg of cetirizine hydrochloride.

The proposed implementation date is 1 June 2017.

Tianeptine

Schedule 4 - New Entry

TIANEPTINE.

Appendix D item 5 - New Entry

TIANEPTINE.

The proposed implementation date is 1 June 2017.

Olaparib

Schedule 4 - New Entry

OLAPARIB.

The proposed implementation date is 1 June 2017.

Ceritinib

Schedule 4 - New Entry

CERITINIB.

The proposed implementation date is 1 June 2017.

Panobinostat lactate

Schedule 4 - New Entry

BRIVARACETAM.

Appendix K - New Entry

BRIVARACETAM.

The proposed implementation date is 1 June 2017.

Brivaracetam

Schedule 4 - New Entry

BRIVARACETAM.

Appendix K - New Entry

BRIVARACETAM.

The proposed implementation date is 1 June 2017.

Guanfacine hydrochloride

Schedule 4 - New Entry

GUANFACINE.

Appendix K - New Entry

GUANFACINE.

The proposed implementation date is 1 June 2017.

Follitropin delta

Schedule 4 - New Entry

#FOLLITROPIN DELTA.

Appendix D, Item 1 - New Entry

FOLLITROPIN DELTA (recombinant human follicle-stimulating hormone) for human use.

Index - New Entry

FOLLITROPIN DELTA
cross reference: FOLLICLE-STIMULATING HORMONE, RECOMBINANT HUMAN

Schedule 4
Appendix D, Item 1

The proposed implementation date is 1 June 2017.

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