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

Scheduling medicines and poisons

12 May 2016

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3 Summary

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

3. Advisory Committee on Medicines Scheduling (ACMS#17)

Summary of delegate's interim decisions
Substance Interim decision
Cannabis The Delegate's interim decision on Cannabis and Tetrahydrocannabinol has been published separately.
Codeine The Delegate's decision relating to scheduling of codeine will be made after June 2016.
Benzodiazepines

Schedule 9 - New entries

DICYCLAZEPAM

PYRAZOLAM

CLONAZOLAM

DESCHLOROETIZOLAM

FLUBROMAZEPAM

NIFOXIPAM

MECLONAZEPAM

Proposed implementation date: 1 October 2016.

Ketoprofen The current scheduling remains appropriate
Naproxen The current scheduling remains appropriate
Paracetamol

Schedule 2 – Amend entry

PARACETAMOL for therapeutic use:

  1. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules except 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 containing not more than 20 tablets or capsules;
    3. compliant with RASML requirements;
    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 phenylephrine and/or guaiphenesin; or
  2. 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 words to that effect); or
  3. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules except in 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 containing not more than 10 such powders or sachets of granules;
    2. compliant with RASML requirements;
    3. not labelled for the treatment of children 6 years or age or less; and
    4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
  4. 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 words to that effect); or
  5. in other preparations except when included in Schedule 3 or Schedule 4.

Schedule 4 – Amend entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any of their derivatives except when separately specified in the Schedules; or
  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 when included 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; or
  8. for injection.

Proposed 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.

Proposed implementation date: 1 October 2016.

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