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Consultation: Proposed amendments to the Poisons Standard - Joint ACMS/ACCS meetings, June 2020

24 April 2020

This consultation closed on 22 May 2020.

Scheduling amendments referred to expert advisory committee

This consultation is for a delegate initiated proposal to amend the scheduling for cannabidiol. Both the proposal below (item 2.5) and the application to amend the scheduling of cannabidiol outlined in the Public Notice of 17 April 2020 (item 2.2) will be referred to the June 2020 Joint ACMS/ACCS meeting.

The due date for both cannabidiol consultations is close of business 22 May 2020. The due date for consultation on all other scheduling proposals published on 17 April 2020 remains close of business 18 May 2020. See How to respond.

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard or decides to amend the Poisons Standard on his or her own initiative and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the June 2020 meeting of the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #25).

Submissions must be received by close of business 22 May 2020.

Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #25

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.

2.5 Cannabidiol

CAS Number

13956-29-1

Alternative names

CBD; 2-(6-Isopropenyl-3-methyl-2-cyclohexen-1-yl)-5-pentyl-1,3-benzenediol

Applicant

N/A - initiated by the Delegate of the Secretary of the Commonwealth Department of Health

Current scheduling

Cannabis

Schedule 9

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. when in hemp seed oil for purposes other than internal human use containing 50 mg/kg or less of 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

# 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.

Appendix D, Item 1 (Poisons available only from or on the prescription or order of an authorised medical practitioner)

CANNABIS for human use.

Appendix K

CANNABIS except cannabidiol when included in Schedule 4

Index

CANNABIS
cross reference: CANNABIS SATIVA, HEMP, HEMP SEED OIL, TETRAHYDROCANNABINOLS

Schedule 9
Schedule 8
Appendix D, Item 1
Appendix K

Cannabidiol

Schedule 4

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 comprise 2 per cent or less of the total cannabinoid content of the preparation.

Index

CANNABIDIOL
cross reference: NABIXIMOLS, CANNABIS, TETRAHYDROCANNABINOLS

Schedule 4

Proposed scheduling

Cannabis

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[2], 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 Schedule 3.

Appendix D, Item 1 (Poisons available only from or on the prescription or order of an authorised medical practitioner)

CANNABIS for human use.

Appendix K

CANNABIS except cannabidiol when included in Schedule 4

Index

CANNABIS
cross reference: CANNABIS SATIVA, HEMP, HEMP SEED OIL, TETRAHYDROCANNABINOLS

Schedule 9
Schedule 8
Appendix D, Item 1
Appendix K

Cannabidiol

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 comprise 2 per cent or less of the total cannabinoid content of the preparation;

except when included in Schedule 3.

Schedule 3 - New Entry

CANNABIDIOL in preparations for therapeutic use when:

a. the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer; and

b. the maximum recommended daily dose is 60 mg or less of cannabidiol; and

c. in packs containing not more than 30 days' supply; and

d. cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and

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

f. for adults aged 18 years and over.

Key uses/expected use

Medicines

Reasons for the proposal

  • The current proposal is to create a new Schedule 3 (Pharmacist Only Medicine) entry for cannabidiol (CBD) at doses up to 60 mg/day or less. A safety review conducted by the TGA has established that low doses of CBD may have possible clinical utility when used via the oral route in the management of some conditions that do not require medical practitioner oversight. See the report at Review on the safety of low dose cannabidiol.
  • The evidence in the report establishes that CBD has an acceptable safety and tolerability profile at the proposed dose.
  • Given that the safety profile is based on cannabidiol having low affinity for the CB1 and CB2 receptors, and thus is not exhibiting psychoactive effects, the proposed Schedule 3 entry should be limited to plant derived CBD as it is present only as (-) CBD or synthetic cannabidiol only containing the (-) CBD enantiomer.
  • The proposed Schedule 3 entry has been restricted to adults aged 18 and over as there is little evidence to establish the safe use of low dose CBD in children.
  • In Australia, CBD is currently a Schedule 4 substance and therefore only available with a prescription. The access controls on CBD in Australia are notably more restrictive than comparable regulators. CBD is available as an over the counter product (for products without medicinal claims) in the UK and some US states.
  • It is proposed that down-scheduling to Schedule 3 is more appropriate than Schedule 2, as pharmacist advice is necessary to mitigate safety risks associated with CBD's high potential for drug-drug interactions when used concomitantly with many other commonly prescribed drugs that are metabolised via CYP pathways.
  • The consumer can identify the ailments or symptoms that may be treated by the medicine but counselling and verification by a pharmacist is required before use to identify potential drug-drug interactions.
  • Schedule 3 requires that both Product Information and Consumer Medicine Information is available to reinforce and/or expand on the safe use of CBD.
  • Schedule 3 provides an appropriate level of health professional advice while increasing accessibility of CBD.
  • The proposed dosage of CBD is within the wide range of dosages seen in overseas CBD products for retail sale.

Australian regulations

International regulations

  • In a letter dated 24 Jan 2019 from the Director General of the WHO to the Secretary General of the United Nations, on the basis of the 12 to 16 November 2018 reviews conducted by the WHO's Expert Committee on Drug Dependence (ECDD) on cannabis and cannabis related substances (including CBD), the WHO recommended that preparations containing predominantly CBD with not more than 0.2% THC should not be placed under international drug control (WHO 2019)[10]:
    "To give effect to the recommendation of the fortieth meeting of the ECDD that preparations considered to be pure cannabidiol (CBD) should not be scheduled within the International Drug Control Conventions by adding a footnote to the entry for cannabis and cannabis resin in Schedule I of the Single Convention on Narcotic Drugs (1961) to read "Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control""
  • In New Zealand cannabinol is classified as a prescription only medicine, where the tetrahydrocannabinols (THCs) and specified substances within the product must not exceed 2 percent of the total CBD, tetrahydrocannabinol (THC) and other specified substances. If a product contains CBD but does not meet the definition of a CBD product, it is a 'controlled drug' and is subject to the regulatory requirements of the Misuse of Drugs Act.
  • In the United States (U.S) the FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy. It is currently illegal to market CBD by adding it to a food or labelling it as a dietary supplement. Some CBD products are being marketed with unproven medical claims and are of unknown quality. In 2018, the Farm Bill legalized the production and sale of hemp and its extracts. Hemp derived CBD containing less than 0.3 percent THC, is exempted under federal law, however some states still have legal restrictions on the possession of CBD.
  • In Canada, there is one approved product containing a CBD/THC combination, available as a prescription medicine. Phytocannabinoids are regulated under the Cannabis Act. Under the Cannabis Act, CBD products remain strictly regulated and are only legal when sold in compliance with the Act and its regulations. The provinces and territories are responsible for determining how cannabis is distributed and sold within their jurisdictions. CBD and products containing CBD, such as cannabis oil, may only be sold by a provincially or territorially-authorized cannabis retailer or a federally-licensed seller of cannabis for medical purposes.
  • The European Union guides all member states that hemp should not exceed a THC limit of 0.2%. In January 2019, European Union's Novel Food regime, led to the classification of all extracted cannabinoids as "novel". Novel Food is defined as food that had not been used for human consumption to a significant degree in the European Union before 15th May 1997. According to this new classification, CBD products require pre-market authorisation
  • In the United Kingdom (U.K), CBD in its pure form is not classed as a controlled drug. The limit on THC content is set at 1mg of THC per container limit. The UK Food Standards Agency has set a deadline on 21 March 2021 for companies marketing CBD extracts as foods or foods supplements, to submit Novel Food approval applications.

How to respond

Submissions must:

  • be relevant to the proposed amendment;
  • address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
  • submitted by the closing date of 22 May 2020 to medicines.scheduling@health.gov.au for substances referred to the ACMS or Joint ACMS-ACCS (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);
  • include whether or not you support the amendment/s; and
  • be accompanied by a completed TGA Consultation submission coversheet.

Submissions might also include:

  • Suggested improvements; and/or
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 9 September 2020.

Privacy and your personal information

  • The TGA collects your personal information in this submission in order to:
    • Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet, see How to respond above).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
  • Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).


Footnotes