Scheduling medicines and poisons
This web publication constitutes a notice for the purposes of regulation 42ZCZS and regulation 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulations 42ZCZS and 42ZCZX, this notice publishes:
Note that the final decisions on nicotine and cannabidiol (private application and delegate initiated) are not published in this notice. Publication is expected in mid December and late December 2020, respectively.
In my capacity as a delegate of the Secretary for the purpose of regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (Regulations), I have made final decisions under regulation 42ZCZU with respect to the following substances:
Scheduling medicines and poisons
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and not amend the current Poisons Standard in relation to oxymetazoline.
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to not amend the current Poisons Standard with respect to oxymetazoline. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations. I note that nine public submissions were in support of the interim decision. I acknowledge the one opposing submission, which makes reference to the global Adverse Event data provided in the application, however as stated in the interim decision, I consider that the risks associated with prolonged use and self-diagnosis indicate the requirement for pharmacist input.
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to eletriptan as follows:
Schedule 4 - Amend Entry
ELETRIPTAN except when included in Schedule 3.
Schedule 3 - New Entry
ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.
Appendix H - New Entry
ELETRIPTAN
Index - Amend Entry
ELETRIPTAN
Schedule 4
Schedule 3
Appendix H
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to eletriptan. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submission received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations. I note that seven of the eight public submissions were in support of my interim decision.
1 February 2021
Scheduling medicines and poisons
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and not amend the current Poisons Standard in relation to clotrimazole:
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to not amend the current Poisons Standard with respect to clotrimazole. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations. I note the public submissions were in support of my interim decision.
Scheduling medicines and poisons
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and not amend the current Poisons Standard in relation to sildenafil:
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to not amend the current Poisons Standard with respect to sildenafil. My reasons for making the final decision are those set out in the interim decision.
In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations.
I note the public submission on the interim decision from the Pharmaceutical Society of Australia, which reiterates their earlier submission, supporting the applicant's down-scheduling proposal. However, no new information has been provided to mitigate my concern that the down-scheduling of sildenafil may lead to risk for consumers accessing sildenafil without medical intervention and lack of follow up. I remain of the firm view that the medical practitioner oversight is required and the current scheduling of sildenafil under Schedule 4 is appropriate.
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to Ibuprofen as follows:
Schedule 2 - Amend Entry
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to ibuprofen. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations.
I have considered the public submission that opposes the amendment due to the risks of NSAIDs. I remain of the view that the net benefits of broadening the availability of immediate release ibuprofen with restrictions placed on age, dosage form and pack size, combined with warning labels, outweighs the potential risks associated with improper use.
I have considered the public submissions that oppose the confinement to immediate release ibuprofen, stating that modified release ibuprofen has an equivalent safety profile. Ibuprofen modified release was launched as Schedule 3 in November 2019 and as noted in my interim decision, has limited clinical experience in Australia. It is my view that this is a matter for a separate scheduling application. Therefore, I have not relied on the material in the public submissions in making my final decision.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to cumyl-pegaclone as follows:
Schedule 9 - New Entry
2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (SGT-151)
Index - New Entry
2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (SGT-151)
cross reference: SGT-151, CUMYL-PEGACLONE.
Schedule 9
In making this final decision, the Delegate considered the following material:
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to cumyl-pegaclone. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to bupivacaine as follows:
Schedule 5 - Amend Entry
BUPIVACAINE in aqueous gel preparations containing 0.5 per cent or less of bupivacaine, for the dermal spray-on administration to the wounds of animals post-surgical wounds associated with 'mulesing' of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves.
In making this final decision, the Delegate considered the following material:
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:
The purpose and extent for which the substance is to be used has been adequately outlined by the Applicant. I have taken into account that surgical procedures and treatment of significant injuries are adequately covered in the Australian Animal Welfare Standards and Guidelines. These standards provide animal age-related and developmental stage-related standards and guidance on when a non-veterinarian can and cannot perform such procedures (52E(1)(b)).
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to lidocaine as follows:
Schedule 5 - Amend Entry
LIDOCAINE in aqueous gel preparations containing 4.5 per cent or less of lidocaine, for the dermal spray-on administration to the wounds of animals post-surgical wounds associated with 'mulesing' of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves.
In making this final decision, the Delegate considered the following material:
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to bovine ephemeral fever vaccine as follows:
Schedule 4 - Amend Entry
VACCINES, veterinary live virus except:
In making this final decision, the Delegate considered the following material:
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to Fluazaindolizine as follows:
Schedule 5 - New entry
FLUAZAINDOLIZINE in preparations containing 50 per cent or less fluazaindolizine
Schedule 6 - New entry
FLUAZAINDOLIZINE except when included in Schedule 5.
Index - New entry
FLUAZAINDOLIZINE.
Schedule 6
Schedule 5
In making this final decision, the Delegate considered the following material:
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
1 February 2021
Scheduling medicines and poisons
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Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to florylpicoxamid as follows:
Substance | Date of entry | Reasons for listing | Area of use |
---|---|---|---|
FLORYLPICOXAMID |
1 February 2021 |
a |
1.3 |
Index - New entry
FLORYLPICOXAMID.
Appendix B, Part 3
In making this final decision, the Delegate considered the following material:
The proposed amendment was not referred to an expert advisory committee. In not referring this matter to either the ACCS or the Joint ACCS-ACMS, I am satisfied that sufficient information has been provided by the Applicant for me to exercise my delegation.
In determining that this matter will be a delegate-only decision, I note that:
Therefore, based on the information provided in the application, it is considered that florylpicoxamid does not meet the factors for inclusion in the Schedules of the Poisons Standard. Florylpicoxamid should be listed in Appendix B due to its low toxicity (Part 1, a; Part 2, 1.1).
1 February 2021