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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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2 Summary

Part A - Final decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#17)

Summary of delegate's final decisions
Substance Final Decision
Benzodiazepine derivatives

Schedule 9 - New Entries

DICYCLAZEPAM.

PYRAZOLAM.

CLONAZOLAM.

DESCHLOROETIZOLAM.

FLUBROMAZEPAM.

NIFOXIPAM.

MECLONAZEPAM.

Implementation date: 1 October 2016.

Ketoprofen Current scheduling remains appropriate.
Naproxen Current scheduling remains appropriate.
Paracetamol

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 phenylephrine and/or guaiphenesin 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 RASML.
      3. not labelled for the treatment of children 6 years of age or less.
      4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin 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 that contains not more than 20 tablets or capsules.
      3. compliant with the requirements of the RASML.
      4. not labelled for the treatment of children 6 years of age or less.
      5. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.

Schedule 3 - Current Entry

PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.

Schedule 4 - Amend entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in the Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection.

Current Appendix F entries for paracetamol remain appropriate.

Implementation date: 1 October 2016.

Loratadine

Schedule 2 - Amend Entry

LORATADINE 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 10 dosage units or less; and
  2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Schedule 4 - Amend Entry

LORATADINE 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 10 dosage units or less; and
    2. labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Implementation date: 1 October 2016.

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