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

2 Summary of delegate's interim decisions

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

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #14)

Summary of delegate's interim decisions
Substance Interim decision
Nicotine The delegates' interim decision is that the current scheduling of nicotine remains appropriate.
Pentobarbital (pentobarbitone) The delegates' interim decision is that the current scheduling of pentobarbital remains appropriate.
Cannabis, tetrahydrocannabinols and cannabidiol

Schedule 9 - Amend Entry

# CANNABIS (including seeds, extracts, resins, and the plant and any part of the plant when packed or prepared), except:

  1. when separately specified in these Schedules; or
  2. processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinols, and hemp fibre products manufactured from such fibre; or
  3. in hemp seed oil for purposes other than human use containing 50 mg/kg or less of total cannabinoids, including 20 mg/kg or less of tetrahydrocannabinols, when labelled with either of the following warning statements:
    1. Not for internal use; or
    2. Not to be taken.

Schedule 8 - Amend Entry

# CANNABIS (including seeds, extracts, resins and the plant, and any part of the plant) when prepared or packed for human therapeutic use, when:

  1. cultivated or produced, or in products manufactured[1], in accordance with the Narcotic Drugs Act 1967 and/or
  2. for use in products manufactured in accordance with the Narcotic Drugs Act 1967 and/or
  3. imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or
  4. in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989,
  5. except when:
    1. it is a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or
    2. separately specified in Schedule 4; or
    3. separately specified in the NABIXIMOLS entry in this Schedule.

Schedule 9 - Amend Entry

# TETRAHYDROCANNABINOLS and their alkyl homologues, except:

  1. when included in Schedule 4 or Schedule 8; or
  2. processed hemp fibre containing 0.1 per cent or less of tetrahydrocannabinols, and hemp fibre products manufactured from such fibre; or
  3. in hemp seed oil for purposes other than human use containing 50 mg/kg or less of total cannabinoids, including 20 mg/kg or less of tetrahydrocannabinols when labelled with either of the following warning statements:
    1. Not for internal use; or
    2. Not to be taken.

Schedule 8 - Amend Entry

# TETRAHYDROCANNABINOLS when extracted from cannabis for human therapeutic use, when:

  1. included in products manufactured in accordance with the Narcotic Drugs Act 1967; and/or
  2. imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or
  3. in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989,
  4. except when:
    1. it is in a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or
    2. separately specified in the NABIXIMOLS entry in this Schedule.

Schedule 4 - Amend Entry

CANNABIDIOL in preparations for therapeutic use containing 2 per cent or less of total other cannabinoids found in cannabis.

APPENDIX D, ITEM 1 - Current entries

CANNABIS for human use.

TETRAHYDROCANNABINOLS for human use.

APPENDIX K - Current entries

CANNABIS

TETRAHYDROCANNABINOLS

Implementation date of 1 June 2017.

Epidermal Growth Factor The delegates' interim decision is that the current scheduling of epidermal growth factor remains appropriate.
Fennel Oil

FENNEL OIL except:

  1. in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;
  2. in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

    KEEP OUT OF REACH OF CHILDREN; or

  3. in preparations containing 5 per cent or less of methyl chavicol.

Appendix E, Part 2

FENNEL OIL

Standard Statements: A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).), G3 (If swallowed, do NOT induce vomiting)

Part 2, Section 2.4 Child-resistant closures

Column 1, Name of the poison: Fennel oil when included in Schedule 5.

Column 2, Nominal capacity: 200 millilitres or less.

Implementation date of 1 June 2017.

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