Notice of final decisions to amend (or not amend)
the current Poisons Standard
Final decisions and reasons for New Chemical Entities and medicines and
chemicals referred to the November 2018 scheduling meetings
26 April 2019
Scheduling amendments referred to expert advisory committee
Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the
procedure to be fol owed where the Secretary receives an application under section 52EAA of
the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard 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 wil 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, al owing at least 20 business days after
publication of the notice. Such a notice relating to the final decisions herein was made available
on the TGA website at Scheduling advisory committees: invitations for public comment on 31
August 2018 and closed on 28 September 2018. Public submissions received on or before this
closing date were published on the TGA website at Public submissions on scheduling matters
referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November
2018, in accordance with regulation 42ZCZL.
Under regulation 42ZCZN of the Regulations, the Secretary, after considering the advice or
recommendation of the expert advisory committee, must (subject to regulation 42ZCZO) make
an interim decision in relation to the proposed amendment. If the interim decision is to amend
the current Poisons Standard, the Secretary must, in doing so, take into account the matters
mentioned in subsection 52E(1) of the Act (including, for example, the risks and benefits of the
use of a substance, and the potential for abuse of a substance) and the scheduling guidelines as
set out in the Scheduling Policy Framework for Medicines and Chemicals.
Under regulation 42ZCZP of the Regulations, the Secretary must, among other things, publish (in
a manner the Secretary considers appropriate) the scheduling interim decision, the reasons for
that decision and the proposed date of effect (for decisions to amend the current Poisons
Standard, this wil be the date when it is expected that the current Poisons Standard wil be
amended to give effect to the decision). Also in accordance with regulation 42ZCZP of the
Regulations, the Secretary must invite the applicants and persons who made a submission in
response to the original invitation under paragraph 42ZCZK(1)(d), to make further submissions
to the Secretary in relation to the interim decisions by a date mentioned in the notice as the
closing date, al owing at least 10 business days after publication of the notice. Such a notice
relating to the interim decisions of substances initial y referred to the November 2018 meetings
26 April 2019 Scheduling Final Decisions Public Notice for: (A) substances referred to the November
2018 meetings of the ACCS, ACMS & Joint ACCS-ACMS; and (B) matters not referred to an expert
Page 1 of 33
advisory committee

of the Advisory Committee on Medicines Scheduling (ACMS #25), the Advisory Committee on
Chemicals Scheduling (ACCS #23), and the Joint Advisory Committee on Medicines and
Chemicals Scheduling (Joint ACMS-ACCS #20) was made available on the TGA website at
Publication of interim decisions amending, or not amending, the current Poisons Standard,
February 2019 on 7 February 2019 and closed on 7 March 2019. Public submissions received on
or before this closing date wil  be published on the TGA website at Public submissions on
scheduling matters in accordance with regulation 42ZCZQ.
Under regulation 42ZCZR of the Regulations, the Secretary may make a final decision by
confirming, varying or setting aside the interim decision, but only after considering al  relevant
submissions and any advice received under request 42ZCZQ(2)(a). In accordance with 42ZCZS
the Secretary publishes here the scheduling final decision, the reasons for that decision and the
date of effect (for decisions to amend the current Poisons Standard, this wil  be the date when it
is expected that the current Poisons Standard wil  be amended to give effect to the decision).
These Secretary's final decisions and reasons related to:
•  scheduling proposals initial y referred to the November 2018 meeting of the Advisory
Committee on Medicines Scheduling (ACMS #25);
•  scheduling proposals initial y referred to the November 2018 meeting of the Joint meeting of
the Advisory Committees on Chemicals and Medicines Scheduling (ACCS-ACMS #20); and
•  scheduling proposals initial y referred to the November 2018 meeting of the Advisory
Committee on Chemicals Scheduling (ACCS #23).
Scheduling amendments not referred to expert advisory committee
Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the
procedure to be fol owed where the Secretary receives an application under section 52EAA of
the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides not
to refer the proposed amendment to an expert advisory committee. These include, under
regulation 42ZCZU, that the Secretary decides to make a final decision in relation to the
proposed amendment without an interim decision. If the final decision is to amend the current
Poisons Standard, the Secretary must, in doing so, take into account the matters mentioned in
subsection 52E(1) of the Act (including, for example, the risks and benefits of the use of a
substance, and the potential for abuse of a substance) and the scheduling guidelines as set out in
the Scheduling Policy Framework for Medicines and Chemicals.
In accordance with 42ZCZX of the Regulations, the Secretary publishes here the scheduling final
decision, the reasons for that decision and the date of effect (for decisions to amend the current
Poisons Standard, this wil  be the date when it is expected that the current Poisons Standard wil
be amended to give effect to the decision). These Secretary's final decisions and reasons related
to:
•  New therapeutic Prescription Only medicines known as New Chemical Entities (NCEs).
Privacy and your personal information
The Therapeutic Goods Administration (TGA) wil  not publish information it considers
confidential, including yours/other individuals' personal information (unless you/they have
consented to publication) or commercial y sensitive information. Also, the TGA wil  not publish
information that could be considered advertising or marketing (e.g. logos or slogans associated
with products), information about any al eged unlawful activity or that may be defamatory or
offensive.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

For general privacy information, go to Privacy. The TGA is part of the Department of Health and
the link includes a link to the Department's privacy policy and contact information if you have a
query or concerns about a privacy matter.
The TGA may receive submissions from the public on a proposed amendment to the Poisons
Standard where there has been an invitation to the public for submissions on the proposal in
accordance with the Therapeutic Goods Regulations 1990. These submissions may contain
personal information of the individual making the submissions and others.
The TGA col ects this information as part of its regulatory functions and may use the information
to contact the individual who made the submissions if the TGA has any queries.
As set out above, the TGA is required to publish these submissions unless they contain
confidential information.
If you request for your submission to be published in full, including your name and any other
information about you, then the TGA wil  publish your personal information on its website.
However, if at any point in time, you change your mind and wish for your personal information
to be redacted then please contact the Scheduling Secretariat at
[email address] so that the pubic submissions can be updated accordingly.
Please note that the TGA cannot guarantee that updating the submissions on the TGA website
wil  result in the removal of your personal information from the internet.
Please note that the TGA wil  not publish personal information about you/others without
your/their consent unless authorised or required by law.
Enquiries
Any questions relating to submissions should be directed by email to
[email address] (for substances referred to the ACMS or Joint ACCS-ACMS)
or [email address] (for substances referred to the ACCS).
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 3 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Part A - Final decisions on matters referred to an expert
advisory committee (November 2018)
1.  Advisory Committee on Medicines Scheduling (ACMS #25)
1.1.  Nabiximols
Delegate’s final decision
Final decision
The delegate’s final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990
(the Regulations) is not to amend the current Poisons Standard in relation to nabiximols.
Reasons
The delegate has confirmed that the reasons for the final decision align with those for the
interim decision.
Additional reasons, including consideration of the public submission on the interim decision:
The delegate acknowledges that the WHO Expert Committee on Drug Dependence has recently
made a recommendation to ease the international restrictions on preparations containing delta-
9-tetrahydrocannabinol (dronabinol) by down scheduling it to Schedule III in the United Nations
Single Convention on Narcotic Drugs of 1961. Should this occur it would mean that one of the
scheduling factors under the Scheduling Policy Framework for Schedule 8 would not be met.
However it would not automatical y mean that Schedule 4 is appropriate. However, the United
Nations Commission on Narcotic Drugs (CND) has postponed their vote on the WHO
recommendations to reschedule delta-9-tetrahydrocannabinol-containing preparations. This
means that, under the current Scheduling Policy Framework, XXXXXX is stil  required to be
classified as a Schedule 8 poison. Not only is the current scheduling of nabiximols consistent
with international restrictions on narcotics, but I believe that the current scheduling controls for
nabiximols in Australia are comparable to those overseas countries, as evidenced by the
information provided by the applicant.
Overall conclusions
On balance, the delegate considers that the risk of misuse and abuse of nabiximols cannot be
accurately quantified based of the current level of clinical evidence. In addition, amending the
scheduling of nabiximols as proposed would be inconsistent with current scheduling policy and
with the Schedule 8 status of other THC/CBD combinations for therapeutic use. As the United
Nations Commission on Narcotic Drugs (CND) has postponed their vote on the WHO’s
recommendation to reschedule delta-9-tetrahydrocannabinol-containing preparations, the
delegate considers that the loss of the current Schedule 8 regulatory controls over the
prescribing of nabiximols would be premature, and therefore has made the final decision not to
amend its current scheduling.
Public submissions on the interim decision
One (1) public submission was received before the second closing date in response to an
invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. The
submission opposed the interim decision.
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

The main points provided in opposition of the amendment were:
•  on the balance of risks, the benefit to those limited numbers of Australian patients in medical
need of a prescription medicine containing nabiximols such as XXXXXX is far outweighed by
the perceived risks intended to be controlled by retaining this specific pharmaceutical
product in S8 and Appendix D.
•  the proposed change is specifical y only applicable to nabiximols as contained in
prescription medicines on the ARTG. This means that the attendant regulatory controls of a
registered prescription medicine apply now, and would continue to apply regardless of
whether it is down scheduled to Schedule 4 or removed from Appendix D
•  post-marketing experience international y and within Australia demonstrate that XXXXXX as
a nabiximols registered medicine is not associated with problems of abuse, dependence or
diversion
•  XXXXXX is available as a prescription-only medicine in major European countries, with
scheduling similar to the proposed Australian Schedule 4
•  The World Health Organisation (WHO) Expert Committee on Drug Dependence made a
recommendation to ease the international restrictions on preparations containing delta-9-
tetrahydrocannabinol (dronabinol) by down scheduling it to Schedule III in the U.N. Single
Convention on Narcotic Drugs of 1961. This would potential y remove the requirement for
the inclusion of XXXXXX in the SUSMP Schedule 8 under the Scheduling Policy Framework.
Interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling
delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 –
1.1. Nabiximols.
Scheduling proposal
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at
Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-
ACMS meetings, November 2018.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

1.2. Racetams
Delegate’s final decision
Final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990
(the Regulations) is to amend the current Poisons Standard in relation to racetams as follows:
Schedule 4 – New Entries
RACETAMS except when separately specified in these Schedules.
ANIRACETAM.
COLURACETAM.
DIMIRACETAM.
FASORACETAM.
METHYLPHENYLPIRACETAM.
NEBRACETAM.
NEFIRACETAM.
OMBERACETAM.
OXIRACETAM.
PHENYLPIRACETAM.
PRAMIRACETAM.
ROLZIRACETAM.
SELETRACETAM.
SUNIFIRAM.
UNIFIRAM.
Appendix K – New entry
SELETRACETAM
Index – New Entries
RACETAMS
Schedule 4
ANIRACETAM
cross reference: RACETAMS
Schedule 4
COLURACETAM
cross reference: RACETAMs
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Schedule 4
DIMIRACETAM
cross reference: RACETAMS
Schedule 4
FASORACETAM
cross reference: RACETAMS
Schedule 4
METHYLPHENYLPIRACETAM
cross reference: RACETAMS
Schedule 4
NEBRACETAM
cross reference: RACETAMS
Schedule 4
NEFIRACETAM
cross reference: RACETAMS
Schedule 4
OMBERACETAM
cross reference: RACETAMS
Schedule 4
OXIRACETAM
cross reference: RACETAMS
Schedule 4
PHENYLPIRACETAM
cross reference: RACETAMS
Schedule 4
PRAMIRACETAM
cross reference: RACETAMS
Schedule 4
ROLZIRACETAM
cross reference: RACETAMS
Schedule 4
SELETRACETAM
Cross reference RACETAMS
Schedule 4
Appendix K
Schedule 4
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

SUNIFIRAM
cross reference: RACETAMS
Schedule 4
UNIFIRAM
cross reference: RACETAMS
Index – Amended Entries
BRIVARACETAM
cross reference: RACETAMS
Schedule 4
Appendix K
LEVETIRACETAM
cross reference: RACETAMS
Schedule 4
Appendix K
PIRACETAM
cross reference: RACETAMS
Schedule 4
Implementation date: 1 June 2019
Reasons
The reasons for the final decision remain the same as for the interim decision.
Public submissions on the interim decision
Nil received
Interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling
delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 –
1.2 Racetams.
Scheduling proposal
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at
Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-
ACMS meetings, November 2018.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

2.  Joint meeting of the Advisory Committee on Chemicals and
Medicines Scheduling (ACCS-ACMS #20)
2.1.  Salts of boric acid
Delegate’s final decision
Final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990
(the Regulations) is to amend the current Poisons Standard in relation to boric acid and its salts.
The amendments relate to the delegate’s final decision (published on 10 April 2018) to amend
the Schedule 5 entry for boric acid aligning it with the European Union cut-off concentrations for
cosmetics, to create new entries in Schedule 5 for the salts of boric acid (due to be implemented
on 1 June 2019) and to create new Appendix F, Part 3 entries, as follows:
Schedule 5
BORIC ACID except:
a)  when included in Schedule 4; or
b)  in preparations, other than insect baits, containing 1 per cent or less calculated as boron;
or; c) cosmetic hand cleaning preparations when label ed with a warning to the following
effect:
NOT TO BE USED FOR CHILDREN UNDER 3 YEARS OF AGE; and if the concentration
of free soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO
BE USED ON PEELING OR IRRITATED SKIN; or
c)  in cosmetic talc preparations containing 5 % per cent or less calculated as boron boric
acid when labelled with a warning to the following effect:
DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR
CHILDREN UNDER 3 YEARS OF AGE OR LESS; and if the concentration of free
soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE
USED ON PEELING OR IRRITATED SKIN; or
d)  in cosmetic oral hygiene preparations containing 0.1% per cent or less calculated as
boron boric acid when label ed with a warning to the following effect:
NOT TO BE SWALLOWED.  DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF
PRODUCT) IN FOR CHILDREN UNDER 3 YEARS OF AGE OR LESS; or
e)  in other cosmetic preparations containing 3% per cent or less calculated as boron  boric
acid when labelled with a warning to the following effect:
DO NOT TO BE USED (THIS PRODUCT/INSERT NAME OF PRODUCT) IN FOR
CHILDREN UNDER 3 YEARS OF AGE OR LESS; and if the concentration of free
soluble borates exceeds 1.5 per cent (as boric acid), with the words: NOT TO BE
USED ON PEELING OR IRRITATED SKIN; or
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

f)  in preparations, other than insect baits, containing 6 per cent or less calculated as boric
acid.
Schedule 5 – New Entries
SODIUM BORATE (CAS No. 1330-43-4) except:
a)  in talc preparations containing 5% or less of sodium borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS; or
b)  in oral preparations containing 0.1% or less of sodium borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3
YEARS OF AGE OR LESS; or
c)  in other preparations containing 3% or less of sodium borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS.
POTASSIUM BORATE (CAS No. 1332-77-0) except:
a)  in talc preparations containing 5% or less of potassium borate when label ed with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS; or
b)  in oral preparations containing 0.1% or less of potassium borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3
YEARS OF AGE OR LESS; or
c)  in other preparations containing 3% or less of potassium borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS.
MEA-borate (CAS No. 26038-87-9) except:
a)  in talc preparations containing 5% or less of MEA-borate when labelled with a warning
to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS; or
b)  in oral preparations containing 0.1% or less of MEA-borate when labelled with a warning
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3
YEARS OF AGE OR LESS; or
c)  in other preparations containing 3% or less of MEA-borate when labelled with a warning
to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS.
MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4) except:
a)  in talc preparations containing 5% or less of MIPA-borate when labelled with a warning
to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS; or
b)  in oral preparations containing 0.1% or less of MIPA-borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3
YEARS OF AGE OR LESS; or
c)  in other preparations containing 3% or less of MIPA-borate when labelled with a
warning to the following effect:
DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 3 YEARS
OF AGE OR LESS.
Index – New Entries
SODIUM BORATE (CAS No. 1330-43-4)
Schedule 5
POTASSIUM BORATE (CAS No. 1332-77-0)
Schedule 5
MEA-BORATE (CAS No. 26038-87-9)
Schedule 5
MIPA-BORATE (CAS No. 26038-90-4 and 68003-13-4)
Schedule 5
Appendix E, Part 2
BORIC ACID
First aid instructions: A.
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Appendix F, Part 3 – New Entry
BORIC ACID when included in Schedule 5
Warning statements: 25, 26.
Index – Amend Entry
BORIC ACID cross reference: BORAX, SODIUM BORATE, POTASSIUM BORATE, MEA-BORATE,
MIPA-BORATE
Schedule 5
Schedule 4
Appendix E, Part 2
Appendix F, Part 3
Implementation date: 1 February 2021
Reasons
The delegate has confirmed that the reasons for the final decision align with those for the
interim decision.
Additional reasons, including consideration of the public submission on the interim decision:
Having considered the public submission on the interim decision, to further clarify which
substances are captured by the boric acid entry and to facilitate compliance, the index entry wil
be further amended to include cross references to the additional compounds, sodium borate,
potassium borate, meta-borate and mipa-borate.
Public submissions on the interim decision
One (1) public submission was received before the second closing date in response to an
invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. While the
submission was general y supportive, it did request minor changes to the interim decision to
provide clarity and reduce the regulatory burden on industry.
The main points raised in the submission were:
•  It was previously indicated that there was a preference for the scheduling of the four salts
specifical y (i.e. by CAS number). If separate entries by CAS number are not supported in this
case, other ways of easily identifying the substances intended to be captured by the Schedule
entry should be considered i.e. by adding the four borate salts (sodium borate, potassium
borate, MEA-borate, MIPA-borate) to the index with cross-references to the boric acid entry.
•  The concentration cut-off for the exemption for non-cosmetic preparations (other than
insect baits) is now expressed as a percentage of boric acid instead of boron, though the
effective concentration remains the same. This change provides consistency with the
exemptions for cosmetic products, based on the European Union Cosmetics Regulation.
•  An adequate transition period of at least 12 months, preferably 24 months, is necessary to
accommodate these changes as there is no evidence that would suggest immediate action is
required for the risk management of these substances.
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling
delegates' interim decisions and invitation for further comment: ACCS/ACMS #20, November
2018 – 2.1 Salts of boric acid.
Scheduling proposal
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at
Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-
ACMS meetings, November 2018.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

2.2.
Naphthalene
Delegate’s final decision
Final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990
(the Regulations) is to amend the current Poisons Standard in relation to naphthalene as
fol ows:
Schedule 10 – New Entry
NAPHTHALENE (excluding derivatives) in preparations in block, bal , disc, pellet or flake
form for domestic use except when enclosed in a device which, in normal use, prevents
removal or ingestion of its contents.
Schedule 6 – Amend Entry
NAPHTHALENE (excluding its derivatives) except in liquid hydrocarbons as an impurity.
Index – Amend Entry
NAPHTHALENE
Schedule 10
Schedule 6
Appendix E, Part 2
Appendix F, Part 3
Appendix G
Implementation date: 1 June 2019
Reasons
The delegate has confirmed that the reasons for the final decision align with those for the
interim decision.
Additional reasons, including consideration of the public submissions on the interim decision:
The purpose of the Schedule 10 entry is to address public health risks associated with the
importation, retail and use of non-compliant naphthalene in domestic situations for the control
of moths and larvae which are destructive to natural-fibre textiles. However, having considered
the public submissions on the interim decision, the interim decision has been qualified to ensure
that legitimate domestic uses of naphthalene are not inadvertently captured.
Public submissions on the interim decision
Four (4) public submissions were received before the second closing date in response to an
invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. Al four
submissions were not supportive of the proposed amendments.
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

The main points provided in opposition of the amendment were:
•  The proposed Schedule 10 entry should be qualified as it is not currently clear as to what
products would potential y be incorporated under the proposed entry.
•  By extension, clarification is required as to what is meant by the Schedule 6 statement
‘except in liquid hydrocarbons as an impurity’. Industry have been able to quantify the
benzene content in fuels and solvents and schedule high boiling aromatic hydrocarbon
solvents with particular exclusions, yet industry has been left in a state of unknown
compliance in respect to when naphthalene should be considered to be an impurity. It would
be useful to resolve the issue of what is a naphthalene solvent impurity at this stage to
minimise the uncertainty to the manufacturing industry.
•  Naphthalene in each Schedule needs to be considered on its own individual merit as
presented, as there is no link or reference between the schedules. Consequently, anything
that meets the Schedule 10 definition of naphthalene wil  be prohibited from sale and supply
for domestic use and this wil  lead to prohibition of critical products from the market place,
beyond the intention of the review.
•  The proposal would have substantial and widespread impacts on the economy. If the
decision is to maintain the current interim decision, the proposal is likely to have a
measurable impact on business, community or individuals. Under such circumstances it is
considered that a RIS (Regulatory Impact Statement) would be required to ensure the net
impact is fully evaluated as recommended.
Interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling
delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2018 –
2.2 Naphthalene.
Scheduling proposal
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at
Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-
ACMS meetings, November 2018.
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the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

3.  Advisory Committee on Chemicals Scheduling (ACCS #23)
3.1.  2-chloro-p-phenylenediamine/2-chloro-p-phenylenediamine sulfate
Delegate’s final decision
Final decision
The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990
(the Regulations) is to amend the current Poisons Standard in relation to 2-chloro-p-
phenylenediamine/2-chloro-p-phenylenediamine sulfate as fol ows:
Schedule 6 – Amend Entry
PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives not
elsewhere specified in these Schedules:
a)  in preparations packed and label ed for photographic purposes;
b)  in preparations packed and label ed for testing water except tablets containing 10 mg or
less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque
strip packaging provided the directions for use include the statement, “Do not discard
testing solutions into the pool”;
c)  in hair dye preparations except when the immediate container and primary pack are
label ed with the following statements:
KEEP OUT OF REACH OF CHILDREN, and
WARNING ‒ This product contains ingredients which may cause skin irritation to
certain individuals. A preliminary test according to the accompanying directions
should be made before use. This product must not be used for dyeing eyelashes or
eyebrows; to do so may be injurious to the eye.
written in letters not less than 1.5 mm in height; or
d)  in eyelash and eyebrow tinting products when the immediate container and primary
pack are label ed with the following statement:
WARNING ‒ This product contains ingredients which may cause skin irritation to
certain individuals, and when used for eyelash and eyebrow tinting may cause injury
to the eye. A preliminary test according to the accompanying directions should be
made before use.
written in letters not less than 1.5 mm in height.
Schedule 10 – Amend Entry
PHENYLENEDIAMINES, including alkylated, arylated, halogenated and nitro derivatives, in
preparations for skin colouration, tattooing and dyeing of eyelashes or eyebrows except
when included in Schedule 6.
Appendix E Part 2 – Amend Entry
PHENYLENEDIAMINES, including alkylated, arylated, halogenated and nitro derivatives
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 17 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

•  Standard statements when used in hair dyes: A, E1.
•  Standard statements when used in preparations other than hair dyes: A, G1, G3, E1, S1.
Appendix F Part 3 – Amend Entry
PHENYLENEDIAMINES including alkylated, arylated, halogenated and nitro derivatives
•  Warning statements when used in hair dyes: 21.
•  Warning statements when used in in preparations other than hair dyes: 28.
•  Safety directions when used in preparations other than hair dyes: 1, 4, 8.
Index – Amend entry
PHENYLENEDIAMINES cross reference: ALKYLATED PHENYLENEDIAMINES, ALKYLATED,
ARYLATED, HALOGENATED and NITRO- PHENYLENEDIAMINES, DIETHYL-PARA-
PHENYLENEDIAMINE, DIMETHYL-PARA-PHENYLENEDIAMINE
INDEX
Schedule 10
Schedule 6
Appendix E, Part 2
Appendix F, Part 3
Implementation date: 1 June 2019
Reasons
The reasons for the final decision remain the same as for the interim decision. It is noted that the
public submission received in response to the interim decision, did not present any new
evidence.
Public submissions on the interim decision
One public submission was received before the second closing date in response to an invitation
published on 7 February 2019 under regulation 42ZCZP of the Regulations. The submission
supported the interim decision.
The main points provided in support of the amendment were:
•  The proposed amendment wil  clarify that halogenated derivatives are captured by the
existing scheduling entries for phenylenediamines; and
•  The clarification is not expected to result in any regulatory impact.
Interim decision
The interim decision was published on the TGA website on 7 February 2019 at Scheduling
delegates' interim decisions and invitation for further comment: ACCS #23, November 2018 –
3.1 2-chloro-p-phenylenediamine.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 18 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Scheduling proposal
The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at
Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-
ACMS meetings, November 2018.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 19 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Part B - Final decisions on matters not referred to an expert
advisory committee
4. New Chemical Entities – medicines for human therapeutic use
4.1. Galcanezumab
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include galcanezumab in
Schedule 4 as follows:
Schedule 4 – New Entry
GALCANEZUMAB
Index – New Entry
GALCANEZUMAB
Schedule 4
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
It is a new chemical entity with no clinical or marketing experience in Australia.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Migraine prophylaxis requires medical assessment and monitoring.
c.  the toxicity of a substance:
Potential toxicity is not known.
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Substance requires subcutaneous injection
e.  the potential for abuse of a substance:
Nil
f.  any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 20 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
galcanezumab, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Galcanezumab is not specifical y scheduled in the Poisons Standard but as it is a monoclonal
antibody, galcanezumab is captured by the Schedule 4 entry for monoclonal antibodies as
fol ows:
Schedule 4
MONOCLONAL ANTIBODIES for therapeutic use except:
a)  in diagnostic test kits; or
b)  when separately specified in these Schedules.
Delegate’s considerations
•  Section 52E(1) of the Therapeutic Goods Act 1989;
•  Scheduling Policy Framework (SPF 2018); and
•  Advice on the place in therapy of this NCE.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 21 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.2.  Doravirine
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include doravirine in
Schedule 4 as follows:
Schedule 4 – New Entry
DORAVIRINE
Index – New Entry
DORAVIRINE
Schedule 4
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
It is a New Chemical Entity with no clinical or marketing experience in Australia. The
risk-benefit requires appropriate selection of patients by the treating physician.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Used in the treatment of a serious infection (HIV) requiring specialised medical
oversight and monitoring.
c.  the toxicity of a substance:
Doravirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Toxicity
typical of NNRTI agents is expected. Drug interactions are also a safety concern.
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Presentation and packaging consistent with the label ing requirements for prescription
medicine.
e.  the potential for abuse of a substance:
Nil
f.  any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
doravirine, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 22 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Scheduling status
Doravirine is not specifical y scheduled and is not captured by any entry in the Poisons
Standard.
Delegate’s considerations
•  Section 52E(1) of the Therapeutic Goods Act 1989;
•  Scheduling Policy Framework (SPF 2018); and
•  Advice on the place in therapy of this NCE.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 23 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.3.  Abemaciclib
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include abemaciclib in
Schedule 4 as follows:
Schedule 4 – New Entry
ABEMACICLIB
Index – New Entry
ABEMACICLIB
Schedule 4
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
As per palbociclib which is Schedule 4.
Benefit: Improvement in PFS (Progression Free Survival- length of time during and after
the treatment of a disease, such as cancer, that a patient lives with the disease without it
getting worse).
Risks: VTE (Venous thromboembolism), diarrhoea, neutropenia.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Abemaciclib is indicated for the treatment of women with hormone receptor (HR)
positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or
metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as
initial endocrine-based therapy, or in women who have received prior endocrine therapy
(MONARCH-2,3).
In pre- or perimenopausal women, the endocrine therapy should be combined with a
luteinising hormone-releasing hormone (LHRH) agonist.
c.  the toxicity of a substance:
Nil
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Nil
e.  the potential for abuse of a substance:
Nil
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 24 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

f.  any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
abemaciclib, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Abemaciclib is not specifical y scheduled and is not captured by any entry in the Poisons
Standard.
Delegate’s considerations
•  Section 52E(1) of the Therapeutic Goods Act 1989;
•  Scheduling Policy Framework (SPF 2018); and
•  Advice on the place in therapy of this NCE.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 25 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.4.  Plitidepsin
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include plitidepsin in Schedule
4 as follows:
Schedule 4 – New Entry
PLITIDEPSIN
Appendix L –New Entry
PLITIDEPSIN
Warning statements: 7 (WARNING – Causes birth defects), 62 (Do not use if pregnant), 63
(See a doctor if you are pregnant or diabetic), 76 (Do not become pregnant during use or
within 6 months of stopping treatment), 87 (Plitidepsin remains in the body for many months
after treatment has stopped. Do not become pregnant or father a child before consulting your
doctor)
Index - New Entry
PLITIDEPSIN
Schedule 4
Appendix L
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
It is a new cytotoxic chemical entity with no marketing experience in Australia.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Plitidepsin is used for the treatment of patients with relapsed or refractory multiple
myeloma who have received at least three prior treatment regimens, including both a
proteasome inhibitor and an immunomodulator. Aplidin may be used after two prior
lines of therapy if refractory and/or intolerant to both a proteasome inhibitor and an
immunomodulator.
c.  the toxicity of a substance:
Reported adverse effects from plitidepsin exposure include cytopaenias, elevation of
creatine phosphokinase, liver enzyme derangement, cardiac rhythm disturbance and
fatigue.
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Plitidepsin is presented as a powder for reconstitution and administered by intravenous
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 26 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

injection.
e.  the potential for abuse of a substance:
There is no identified risk of abuse of plitidepsin outside the registered indication.
f.  any other matters that the Secretary considers necessary to protect public health:
Nil.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
plitidepsin, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Plitidepsin is not specifical y scheduled and is not captured by any entry in the Poisons Standard.
Delegate’s considerations
•  Subsection 52E(1) of the Therapeutic Goods Act 1989;
•  The Scheduling Policy Framework (2018) scheduling factors;
•  The TGA evaluation report;
•  The advice of the Advisory Committee Medicines; and
•  The new drug application.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 27 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.5.  Isavuconazole
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include isavuconazole in
Schedule 4 as follows:
Schedule 4 – New Entry
ISAVUCONAZOLE
Appendix L – New Entry
ISAVUCONAZOLE
Warning statement: 53 (CAUTION – Isavuconazole should not be used by pregnant
women)
Index – New Entries
ISAVUCONAZOLE
Schedule 4
Appendix L
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
Isavuconazole is a new chemical entity with no clinical or marketing experience in
Australia.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Isavuconazole is used for the treatment of invasive aspergil osis and mucormycosis in
patients for whom amphotericin B is inappropriate.
c.  the toxicity of a substance:
Safety issues include hepatotoxicity and the potential for drug-drug interactions.
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Isavuconazole should be prescribed by medical professionals who are familiar with the
management of invasive fungal infections. Patients need to be instructed to follow the
dosing regimens.
e.  the potential for abuse of a substance:
Nil
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 28 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

f.  any other matters that the Secretary considers necessary to protect public health:
The Australian Pregnancy Categorisation for isavuconazonium is D, as reproductive
toxicity studies showed an increased incidence of bone abnormalities in rats and rabbits.
Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
isavuconazole, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Isavuconazole is not specifical y scheduled and is not captured by any entry in the Poisons
Standard.
Delegate’s considerations
•  Section 52E(1) of the Therapeutic Goods Act 1989;
•  Scheduling Policy Framework (SPF 2018); and
•  Advice on the place in therapy of this NCE.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 29 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.6.  Semaglutide
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include semaglutide in
Schedule 4 as follows:
Schedule 4 – New Entry
SEMAGLUTIDE
Index - New Entry
SEMAGLUTIDE
Schedule 4
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
It is a new biological entity with no clinical or marketing experience in Australia.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist
(GLP=1RA), with suggested indication for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
−  as monotherapy when metformin is considered inappropriate due to intolerance or
contraindications
−  in addition to other medicinal products for the treatment of type 2 diabetes
c.  the toxicity of a substance:
No known major/serious toxicities
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
No specific requirements over existing regulations and guidelines
e.  the potential for abuse of a substance:
Unlikely
f.  any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 30 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
semaglutide, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Semaglutide is not specifical y scheduled and is not captured by any entry in the Poisons
Standard.
Delegate’s considerations
•  Advice on the place in therapy of this NCE;
•  Scheduling Policy Framework (SPF 2018); and
•  Section 52E(1) of the Therapeutic Goods Act 1989.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 31 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

4.7.  Cenegermin
Delegate’s final decision
Final decision
The delegate’s final decision is to amend the Poisons Standard to include cenegermin in
Schedule 4 as follows:
Schedule 4– New Entry
CENEGERMIN
Index- New Entry
CENEGERMIN
Schedule 4
Implementation date: 1 June 2019
Reasons
The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by
the delegate for the decision include:
a.  the risks and benefits of the use of a substance:
Cenegermin is a new biological medicine not currently captured under an existing
schedule.
In clinical trials, treatment with cenegermin resulted in healing of corneal epithelial
defects, improvement of corneal sensation, and improvement in vision. There were no
major adverse effects.
b.  the purposes for which a substance is to be used and the extent of use of a substance:
Cenegermin is indicated for the treatment of neurotrophic keratitis.
The diagnosis of neurotrophic keratitis requires a detailed clinical assessment and
ongoing assessment by an ophthalmologist. This is a prescription medicine.
c.  the toxicity of a substance:
Clinical trials did not show any evidence of toxicity when used as directed in the clinical
trial protocol.
d.  the dosage, formulation, label ing, packaging and presentation of a substance:
Eye drop. given as 1 drop 6 times a day
e.  the potential for abuse of a substance:
Low
f.  any other matters that the Secretary considers necessary to protect public health:
Nil
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 32 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Scheduling proposal
The delegate of the Secretary proposed to amend the Poisons Standard with respect to
cenegermin, a new chemical entity (NCE) for a human therapeutic medicine.
Scheduling status
Cenegermin is not specifical y scheduled and is not captured by any entry in the Poisons
Standard.
Delegate’s considerations
•  Advice on the place in therapy of this NCE;
•  Scheduling Policy Framework (SPF 2018); and
•  Section 52E(1) of the Therapeutic Goods Act 1989.
Scheduling Final Decisions Public Notice for: (A) substances referred to the November 2018 meetings of
Page 33 of 33
the ACCS, ACMS & Joint ACCS-ACMS; and (B) New Chemical Entities

Document Outline

Notice of final decisions to amend (or not amend) the current Poisons Standard
- Part A - Final decisions on matters referred to an expert advisory committee (November 2018)
- Part B - Final decisions on matters not referred to an expert advisory committee
  - 4. New Chemical Entities – medicines for human therapeutic use