Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act also provides a framework for State and Territory governments to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of medicines and poisons in Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health and Aged Care.

Part 6-3 of the Act (sections 52AA to 52EC) provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.

Subsection 52D(2) of the Act empowers the Secretary to amend the current Poisons Standard or to prepare a document in substitution for the current Poisons Standard. The current Poisons Standard includes Schedules containing the names or descriptions of substances, with certain levels of control applying to each Schedule in accordance with the risk associated with the substances in a Schedule.

The Therapeutic Goods (Poisons Standard—February 2024) Instrument 2024 (“the Instrument”) repeals and replaces the Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023, which had been in effect since 1 October 2023.

The purpose of the Instrument is principally to incorporate a number of changes to existing Schedule entries, and to include a number of specified substances in the current Poisons Standard for the first time.

In relation to existing entries in the current Poisons Standard, the Instrument incorporates minor amendments to the entries for amidopropyl betaines, bismuth compounds, asparaginase, benzene, gliptins, immunoglobulins, psilocybine, somatropin, alprazolam, bromazepam, chlordiazepoxide, clonazepam, clorazepate, diazepam, nitrazepam, triazolam and flunitazene, principally to add clarity and correct typographical errors. For example, the Index entry for psilocybine has been amended to include a cross reference to psilocybin.

In relation to substances that have been introduced in the Poisons Standard for the first time, the Instrument introduces the following entries:

• in Schedule 9 — ibotenic acid;
• in Schedule 4 — palovarotene (which is also included in clause 4 of Appendix F, and clause 2 in Appendix L);
• in Schedule 4 — nirsevimab; and
• in Schedule 4 — tislelizumab.

The Instrument also includes several changes to the existing entries for lead and lead compounds, that were inadvertently omitted from the Therapeutic Goods (Poisons Standard—October 2023) Instrument 2023. These include:

• deletion of the Schedule 4 entry for lead;
• changes to the permissible limits in the Schedule 6 entry for lead compounds in preparations for cosmetic use and graphic materials;
• a change to the Schedule 10 entry to include therapeutic use of lead;
• update to Appendix A regarding lead in paint;
• update to Appendix F to reflect the changes to the Schedule 6 entry.

Background

The Poisons Standard reflects decisions of the Secretary or a delegate of the Secretary regarding the classification of medicines and poisons into the different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public. These decisions are published on the TGA website.

The Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (“the ACMS”) (section 52B of the Act refers) and the Advisory Committee on Chemicals Scheduling (“the ACCS”) (section 52C of the Act refers), which provide advice and make recommendations to the Secretary on matters relating to medicines and chemicals scheduling decisions.

The Scheduling Policy Framework (“the SPF”) provides guidance on whether a decision concerning the scheduling of substances would benefit from being referred to ACMS or ACCS for advice. A copy of the SPF can be found at: www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

The Schedules to the Poisons Standard are incorporated by reference in State and Territory legislation for regulatory purposes. This enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk associated with the substances and the level of control recommended over their availability, in the interest of public health and safety.

Similarly, the Commonwealth utilises the scheduling and classification of substances in the current Poisons Standard for some regulatory and enforcement purposes under the Act. For example, the Act prohibits the publication or broadcasting of advertisements to consumers about prescription medicines containing substances included in Schedule 4 or Schedule 8 to the current Poisons Standard, or over-the-counter medicines containing substances included in Schedule 3 and not included in Appendix H of the current Poisons Standard. The advertising of substances included in Schedule 9 or Schedule 10 to the current Poisons Standard is also prohibited.

Purpose

The Instrument incorporates changes to several existing entries in the current Poisons Standard and provides for the inclusion of a number of specified substances in the current Poisons Standard for the first time. Some of these changes are made following the provision of advice from the ACMS or the ACCS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 (“the Regulations”) for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee. Other changes are made following a delegate-only-decision.

New schedule entries

The Instrument incorporates entries in the current Poisons Standard for three new chemical entities in Schedule 4 (“prescription-only medicines”):

• nirsevimab;
• palovarotene (which is also included in clause 4 of Appendix F, and clause 2 in Appendix L); and
• tislelizumab.

In addition, the Instrument provides for the inclusion of entries in the current Poisons Standard for:

• in Schedule 9 — ibotenic acid, meaning that the manufacture, possession, supply or use of this substance is prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities;
• in Schedule 3 and Appendix H, clause 1 — celecoxib, and the consequential amendment to the Schedule 4 entry of celecoxib, meaning that Schedule 3 preparations of celecoxib are available from pharmacists without a prescription, and such preparations are permitted for advertising; and
• in Schedule 2 — olopatadine, and consequential amendment to the Schedule 4 entry for olopatadine and Appendix F, clause 1 for antihistamines. Schedule 2 preparations of olopatadine is available in pharmacies without a prescription.

Amendments to existing schedule entries

The Instrument incorporates minor editorial amendments to the existing entries for amidopropyl betaines (Schedule 6) and bismuth compounds (Schedule 4) to correct formatting and typographical errors. Several changes regarding the scheduling of lead (Schedule 4) and lead compounds (Schedules 6 and 10) that were intended to be included in the 1 October 2023 update to the Poisons Standard have also been incorporated into the Instrument.

The Instrument also incorporates editorial amendments to the Index in relation to a small number of substances with existing entries in the current Poisons Standard. The purpose of these amendments is to:

• in relation to asparaginase — to insert a cross reference to crisantaspase for clarity and to assist searchability;
• in relation to benzene — to insert a cross reference to liquid hydrocarbons to add clarity;
• in relation to gliptins — to insert a cross reference to dipeptidyl peptidase-4 (DDP-4) inhibitors for clarity and to assist searchability;
• in relation to immunoglobulins — to insert a cross reference to polyclonal antibodies for clarity and to assist searchability;
• in relation to psilocybine — to insert a cross reference to psilocybin for clarity and to assist searchability;
• in relation to somatropin — to remove an erroneous reference to Appendix G, clause 1;
• in relation to alprazolam, bromazepam, chlordiazepoxide, clonazepam, clorazepate, diazepam, nitrazepam and triazolam — to amend the reference to benzodiazepine derivatives in Appendix D, clause 5 for consistency; and
• in relation to flunitazene — to amend the CAS number of this entry for correction, and to insert a cross reference to flunitazene hydrochloride for clarity and to assist searchability.

Other amendments

Finally, the Instrument includes a minor amendment to replace references to the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 with the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021, to reflect recent amendments made to the name of that instrument.

Incorporation by reference

Subsection 52D(4B) of the Act relevantly provides that, despite subsection 14(2) of the Legislation Act 2003 (“the Legislation Act”), an instrument made under paragraph 52D(2)(a) or (b) may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.

The Instrument incorporates the following documents by reference, in the manner outlined:

• United States Code of Federal Regulations, Title 16, Section 1700.15, Poison prevention packaging standards and Section 1700.20, Testing procedure for special packaging. The intended manner of incorporation is as in force from time to time, as specifically provided for in paragraph (b)(iv) of the definition of child-resistant packaging in section 6 of the Instrument. This document is freely available from the Code of Federal Regulations website (www.ecfr.gov); and

• National Transport Commission, Australian Code for the Transport of Dangerous Goods by Road & Rail. The intended manner of incorporation is as it exists from time to time, as identified in section 10 of the Instrument. This document is freely available from the National Transport Commission website (www.ntc.gov.au).

The following documents are also incorporated by reference, with the intended manner of incorporation being as they exist from time to time, as provided in section 10 of the Instrument:

• Australian Standard AS 1928‑2007, Child‑resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD);

• International Organization for Standardization Standard ISO 8317:2015, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

• Australian Standard AS 2216‑1997, Packaging for poisonous substances;

• Australian Standard AS 4710-2001, Packages for chemicals not intended for access or contact with their contents by humans;

• Australian Standard AS 1580-301.1-2005, Paints and related materials – Methods of test – Non-volatile content by mass;

• Australian Standard AS 8124.4-2003, Safety of toys, Part 4: Experimental sets for chemistry and related activities;

• Australian/New Zealand Standard AS/NZS ISO 8124.3:2012, Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD);

• Australian Standard AS 1928‑2001, Child‑resistant packages;

• Australian Standard AS 4020:2018, Testing of products for use in contact with drinking water;

• British Standards Institution Standard BS EN ISO 8317:2004, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

• Canadian Standards Association Standard CSA Z76.1‑06, Reclosable Child‑Resistant Packages;

• Personal Care Products Council of America, International Cosmetic Ingredient Dictionary & Handbook; and

• Agricultural and Veterinary Chemicals Code (Agricultural Active Constituents) Standards 2022, published by the Australian Pesticides and Veterinary Medicines Authority.

However, these documents are not publicly available for free. Rather, they can, by prior written arrangement where possible and without charge, be viewed by members of the public at the TGA office in Fairbairn, ACT. While these documents are not available for free, it is anticipated that the persons most affected by their adoption in the current Poisons Standard would likely be in possession of these documents. As important benchmarks for the safety of therapeutic goods and other consumer goods, it would be infeasible from a regulatory perspective to not adopt such benchmarks on the basis that the publications are not available for free.

Consultation

Proposed amendments referred to an expert advisory committee

Public comment was invited in relation to the following proposed amendments that were referred to the March 2023 meeting of the ACMS:

• the proposal to create a new entry for celecoxib in Schedule 3 and Appendix H, clause 1 to the current Poisons Standard.

Invitation to comment on these proposed amendments was published on the TGA website on 5 January 2023, with a closing date of 3 February 2023. A further invitation to comment on the interim decisions in respect of these proposed amendments was published on the TGA website on 13 July 2023, with a closing date of 10 August 2023.

The scheduling delegate’s final decisions concerning these proposed amendments were published on the TGA website on 4 September 2023. The delegate decided to create a new Schedule 3 entry for celecoxib for oral use in capsules containing 200 mg or less per capsule when in packs containing not more than 10 dosage units for the short-term treatment of acute pain due to primary dysmenorrhea or musculoskeletal or soft tissue injuries in adults, and a new entry for celecoxib in Appendix H, clause 1 to permit advertising of Schedule 3 preparations.

Public comment was also invited in relation to the following proposed amendments that were referred to the June 2023 meeting of the ACMS and Joint ACMS-ACCS:

• the proposal to include olopatadine in Schedule 2 to the current Poisons Standard; and
• the proposal to create new entries for ibotenic acid in Schedule 4 and Schedule 7 to the current Poisons Standard.

Invitation to comment on these proposed amendments was published on the TGA website on 18 April 2023, with a closing date of 17 May 2023. A further invitation to comment on the interim decisions in respect of these proposed amendments was published on the TGA website on 5 October 2023, with a closing date of 2 November 2023.

The scheduling delegate’s final decisions concerning these proposed amendments were published on the TGA website on 15 December 2023. In relation to the olopatadine proposal, the delegate decided to create a new Schedule 2 entry for preparations for nasal use delivering 600 micrograms or less of olopatadine per dose when the maximum recommended daily dose is no greater than 4,800 micrograms for the treatment of allergic rhinitis or rhinoconjunctivitis for up to 6 months in adults and children 12 years of age and over. In relation to the ibotenic acid proposal, the delegate decided to create a new Schedule 9 entry for ibotenic acid, and insert a cross reference to muscimol in the Index.

Other details

The Instrument is a legislative instrument for the purposes of the Legislation Act. However, section 42 of the Legislation Act relating to disallowance does not apply (subsection 52D(4A) of the Act refers). As the Instrument is not disallowable, subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 does not require that the Instrument be accompanied by a statement of compatibility with the human rights recognised under that Act.

In providing that disallowance does not apply to an instrument made under paragraphs 52D(2)(a) or (b) of the Act, subsection 52D(4A) of the Act appropriately recognises that instruments made under these paragraphs form part of an intergovernmental scheme, which should not be subject to unilateral disallowance by the Commonwealth Parliament, consistent with section 44 of the Legislation Act. Under this scheme, the current Poisons Standard principally provides a set of recommendations to the States and Territories as to the appropriate level of controls that should apply to medicines and poisons.

The States and Territories regulate such substances by electing to apply the current Poisons Standard as a law within their own jurisdiction. In this way, the current Poisons Standard does not have direct application in its own right. If the current Poisons Standard was to be subject to disallowance, this would impact the current uniform system of restrictions in Australia relating to the supply of scheduled substances, and would lead to confusion and different approaches across different States and Territories with respect to their handling, storage, possession and supply of scheduled substances.

Further, as inclusion of new medicines in the current Poisons Standard is often a consequence of the granting of marketing approval of new medicines under the Act, it is likely that disallowance would also lead to delays for Australian patients in accessing new and effective treatments.

The Instrument commences on 1 February 2024.