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

Scheduling medicines and poisons

15 September 2016

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Summary

Part A - Interim decisions on scheduling proposals referred to an advisory committee (July 2016)

1. Advisory Committee on Medicines Scheduling (ACMS#18)

Summary of delegate's interim decisions
Substance Interim decision
Ulipristal

Schedule 4 - Amend Entry

ULIPRISTAL except when included in Schedule 3.

Schedule 3 - New Entry

ULIPRISTAL for emergency post-coital contraception.

Proposed implementation date: 1 February 2017

Fexofenadine

Schedule 4 - Amend Entry

FEXOFENADINE 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 20 dosage units or less and not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

Schedule 2 - Amend Entry

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

  1. in a primary pack containing 20 dosage units or less and not more than 10 days' supply; and
  2. labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

Proposed implementation date: 1 February 2017

2,4-Dinitrophenol

Schedule 10 - New Entry

2,4-DINITROPHENOL for human use.

Schedule 7 - Amend Entry

DINITROPHENOLS except when included in Schedule 4, 6 or 10.

Proposed implementation date: 1 February 2017

N,N-Dimethyltryptamine

The current scheduling remains appropriate for N,N-dimethyltryptamine.

Piper methysticum (kava)

The current scheduling remains appropriate for piper methysticum (kava).

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