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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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1.2 Cannabidiol, cannabis and tetrahydrocannabinols

Part A: Amendments to the Poisons Standard referred to an expert advisory committee

1. Advisory Committee on Medicines Scheduling (ACMS #23)

1.2 Cannabidiol, cannabis and tetrahydrocannabinols

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the Schedule 4 entry for cannabidiol, and the Schedule 8 and Appendix K entries for tetrahydrocannabinols and cannabis in the Poisons Standard to read as follows:

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

Schedule 4 - Amend Entry

CANNABIDIOL in preparations for therapeutic use where:

  1. cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
  2. any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprisetotal 2 per cent or less of the total cannabinoid content of the preparation.

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,

    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. in hemp seed oil, containing 50 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; or
    3. separately specified in the NABIXIMOLS entry in this Schedule; or
    4. captured by the CANNABIDIOL entry in Schedule 4.

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,

    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; or
    3. captured by the CANNABIDIOL entry in Schedule 4; or
    4. in hemp seed oil for purposes other than internal human therapeutic use containing 50 mg/kg or less of cannabinoids.

Appendix K - Amend Entries

CANNABIS except cannabidiol when included in Schedule 4.

TETRAHYDROCANNABINOLS except cannabidiol when included in Schedule 4.

Implementation date: 1 October 2018
Reasons:

The delegate has confirmed that the reasons for the final decision are identical to the interim decision. Additional reasons for the final decision are the following:

  1. References to cannabidiol as an alkaloid hashave been deleted as this is incorrect.
  2. Wording in the Schedule 4 entry for cannabidiol have been amended for clarity.
  3. The wWording in the Schedule 8 entries for entries for tetrahydrocannabinols and cannabis making reference to the Schedule 4 cannabidiol entry hashave been amended for clarity.
  4. References to hemp seed oil have been deleted in the Schedule 8 entries for tetrahydrocannabinols and for cannabis because hemp seed oil is adequately controlled by the Schedule 9 entry for tetrahydrocannabinols and for cannabis.
Public submissions on the interim decision

No public submissions were received before the second closing date in response to an invitation published on 7 June 2018 under regulation 42ZCKP of the Regulations.

Interim decision

The interim decision for cannabidiol, cannabis and tetrahydrocannabinols was published on the TGA website on 7 June 2018 at Publication of interim decisions amending, or not amending, the current Poisons Standard, June 2018 - 1.2 Cannabidiol, cannabis and tetrahydrocannabinols.

Scheduling proposal

The pre-meeting scheduling proposal for cannabidiol, cannabis and tetrahydrocannabinols was published on the TGA website on 21 December 2017 at Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018.


Footnotes

  1. 'Cultivation', 'production' and 'manufacture' have the same meaning as in the Narcotic Drugs Act 1967

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