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

This consultation closed on 22 May 2020.

On this page: Scheduling amendments referred to expert advisory committee | Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #25 | How to respond | What will happen | Privacy and your personal information | Enquiries

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

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

Cannabidiol

Proposed scheduling

Cannabis

Cannabidiol

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

• According to the TGA Ingredient Database,^[3] cannabidiol is:
  • Available for use as an active ingredient in export only and prescription medicines
  • Not available as an excipient ingredient in any application
  • Not available as an equivalent ingredient in any application
• As of 1 April 2020, there are 6 medicines currently active on the Australian Register of Therapeutic Goods (ARTG)^[4] that contain cannbidiol as an active ingredient. Theseare all export only medicines.
• Cannabidiol is not permitted to be included in listed medicines as it is not included in the Therapeutic Goods (Permissible Ingredients) Determination^[5] No.1 of 2020.
• Cannabidiol is not included on the TGA prescribing medicines in pregnancy database.^[6]
• There are no warning statements pertaining to cannabidiol in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019.^[7]
• As of 1 April 2020, there were no reports of adverse events for products containing cannabidiol as an active ingredient on the Database of Adverse Event Notifications (DAEN).^[8]
• As of 1 April 2020, there were no products containing cannabdiol listed on the Public Chemical Registration Information System Search (PubCRIS).^[9]

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).