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Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, November 2014

25 September 2014

This consultation closed on 23 October 2014.

Notice inviting public submissions under subsection 42ZCZK of the Therapeutic Goods Regulations 1990 (the Regulations)

The delegate of the Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the following scheduling proposals are open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Persons wishing to make a submission for items referred to the Advisory Committee on Chemicals Scheduling are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided below by 23 October 2014.

Email: chemicals.scheduling@health.gov.au

The Secretary
Chemicals Scheduling Secretariat
Office of Chemical Safety (MDP 88)
GPO Box 9848
CANBERRA ACT 2601

Facsimile: 02 6289 2650

Persons wishing to make a submission for items referred to the Advisory Committee on Medicines Scheduling are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided below by 23 October 2014.

Email: medicines.scheduling@tga.gov.au

Medicines Scheduling Secretariat
Therapeutic Goods Administration
PO Box 100 (MDP122)
WODEN ACT 2606

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Poisons (SPF, 2010), issued by the National Coordinating Committee on Therapeutic Goods. The SPF is accessible at NCCTG scheduling policy framework.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 5 February 2015. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegate's interim decision.

The current Poisons Standard is available at The Poisons Standard (also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)). Queries regarding medicine scheduling can be directed to the Medicine Scheduling Secretariat at medicine.scheduling@tga.gov.au. Chemical scheduling related queries can be directed to the Chemical scheduling Secretariat at chemicals.scheduling@health.gov.au.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS).
Substance Proposal
1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) and 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP) In response to issues raised in a NICNAS PEC report for Di(methoxyethyl) phthalate (DMEP) and a NICNAS IMAP report for C4-6 side chain transitional phthalates, the scheduling proposal is to create new Schedule entries for 1,2-Benzenedicarboxylic acid, bis(2-methoxyethyl) ester (DMEP) and 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester (DiBP) in Appendix C.
1,4-Benzenediamine, 2-nitro- At the July 2014 meeting of the Advisory Committee on Chemicals Scheduling (ACCS), a review of the scheduling of a number of phenylenediamine dyes was undertaken. NICNAS has referred another dye in this class for review (NICNAS IMAP report for 1,4-Benzenediamine, 2-nitro-). The scheduling proposal is to create a new Schedule entry for 1,4-Benzenediamine, 2-nitro- in Schedule 6 and Appendix C of the SUSMP or to modify the existing Schedule 6 and Appendix C entries for PHENYLENEDIAMINES to ensure that it captures this 2-nitro derivative.
Alkoxyethanols and their acetates There is currently a generic entry in Schedule 6 for ETHYLENE GLYCOL MONOALKYL ETHERS and their ACETATES. The NICNAS IMAP programme has reviewed a number of chemicals in this class and recommended that separate entries be created for selected chemicals in this class. A separate entry for 2-hexyloxyethanol was actioned as an outcome of the July 2013 ACCS meeting. The current proposals relate to developing separate entries for 2-methoxyethanol (IMAP report for Alkoxyethanols (C1-C2) and their acetates), 2-ethoxyethanol (IMAP report for Alkoxyethanols (C1-C2) and their acetates), 2-(1-methylethoxy)ethanol (IMAP report for 2-(1-methylethoxy)ethanol and its acetate), 2-butoxyethanol (IMAP report for Ethanol, 2-butoxy-, acetate) and 2-propoxyethanol (IMAP report for Ethanol, 2-propoxy), along with their acetates. These proposals may consider changes to the exemption cut-offs for the Schedule 6 entries, and the need for separate entries in Appendices E, F and I.
Benzidine-Congener-Based Dyes In response to issues raised in a NICNAS IMAP report forSelected benzidine-congener-based dyes, the scheduling proposal is to insert a new entry for benzidine-congener-based dyes in the SUSMP, to prohibit their sale, supply and use in dyes for home use.
C. I. Acid Black 29 In response to issues raised in a NICNAS IMAP report for C.I. Acid Black 29, the scheduling proposal is to create a new entry for C. I. Acid Black 29 in Schedule 7.
Fenpyrazamine A Schedule 5 entry for fenpyrazamine.
Formaldehyde donors In response to issues raised in a NICNAS IMAP report for Formaldehyde donors, the scheduling proposal is to include the specified seven formaldehyde donor chemicals in the index of the SUSMP with a cross-reference to the formaldehyde schedule entries or to develop separate entries in Schedules 2 and 6, and Appendix C, that mirror the formaldehyde entries in those Schedules.
Fluopyram To create a new Schedule 5 entry for fluopyram with appropriate low concentration cut-off to exempt from scheduling.
Methyl ethyl ketone oxime Proposal to amend the current Schedule 6 methyl ethyl ketone oxime entry to exempt from scheduling for silicone adhesive and sealant preparations containing 2.5% or less of methyl ethyl ketone oxime.
Methylated spirits Based on advice received during consultation on the interim decision from the March 2014 ACCS meeting to develop suitable label statements to warn consumers of the fire risks associated with using methylated spirits to refill burners while alight or hot, the delegate determined that the interim decision be set aside. The delegate now proposes to seek further advice on the practicality of attaching the suggested warning statements to either/both the burners and/or the fuels. The delegate also notes that, under the current Schedule 5 entry for METHYLATED SPIRIT(S), some fuels would not be captured even if a warning statement were to be included in the schedule entry (e.g. those in containers containing 5 litres of more and those biofuels not meeting the current specification for methylated spirits). The delegate proposes to seek advice on the matter of which ingredients may be used to denature alcohol, in order to better align the SUSMP methylated spirits definition with current industry practice and to ensure that biofuels to which any warning statement would be applied are consistent with the wording of the Schedule 5 entry.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the joint committee of the ACCS and the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
1-Butanol Based on advice received during consultation on the interim decision from the March 2014 ACCS meeting to include 1-butanol in Schedules 5 and 6, the delegate determined that the interim decision be set aside, and that further advice be sought on the specific range of products containing 1-butanol that would warrant scheduling to protect against eye damage, and whether these should include such products as aerosol or spray products and/or arts & craft materials, where there may be a greater risk of being taken into the eye. This may include further consideration of ACCS advice that 1-butanol in cosmetics and therapeutic goods be exempted from any proposed schedule entry.
1-Propanol Based on advice received during consultation on the interim decision from the March 2014 ACCS meeting to include 1-propanol in Schedules 5 and 6, the delegate determined that the interim decision be set aside, and that further advice be sought on the specific range of products containing 1-propanol that would warrant scheduling to protect against eye damage, and whether these should include such products as alcohol-based handrubs, and/or arts & craft materials, where the 1-propanol concentrations are likely to be substantively higher than the proposed scheduling cut-offs or spray products where there may be a greater risk of being taken into the eye. This may include further consideration of ACCS advice that 1-propanol in cosmetics and therapeutic goods be exempted from any proposed schedule entry.
2-Cyclohexylphenol The scheduling proposal is create a new Schedule 6 entry for 2-cyclohexylphenol with appropriate exemption cut-offs for some specific uses, and to amend, as necessary, the current entry in Schedule 9 for CYCLOHEXYLPHENOLS.
Lemongrass oil Based on advice received from the November ACCS meeting and the July ACCS-ACMS meeting, the delegates have made an interim decision for a new listing in Schedule 5 for '3,7-DIMETHYL-2-6,-OCTADIENAL and its isomers, in cosmetic and household cleaning preparations except in preparations containing 5 per cent or less of 3,7-Dimethyl-2,6-octadienal isomers'. This entry is cross-referenced in the SUSMP index to the three isomers considered under this entry (citral, neral and geranial). Since lemongrass oil can contain up to 90% citral, there is a need to review the current Appendix B entry for lemongrass oil. Accordingly, the scheduling proposal is to delete the LEMONGRASS OIL entry from Appendix B and to develop a listing in Schedule 5 to complement the entry for 3,7-DIMETHYL-2-6,-OCTADIENAL and its isomers.
Polihexanide The scheduling proposal is to delete the current Schedule 5 polihexanide entry and create a new Schedule 6 entry. Consideration will also be given to whether the existing exemption for preparations containing 5% or less of polihexanide should be maintained, or transferred to a new listing in Schedule 5. Consideration will also be given to the need to amend the existing Appendix E safety directions for products not regulated by the APVMA.
Soluble oxalates At the March 2014 meeting of the ACCS, an issue was raised regarding whether soluble oxalate salts used in therapeutic goods such as mouthwashes would be captured by the current Schedule 6 entry OXALIC ACID except its derivatives and insoluble salts. This issue needs to be clarified along with the need for a specific clause exempting soluble oxalates in mouthwashes.
3. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
Cyclizine To amend Schedule 3 entry for cyclizine for oral use to include a pack size limit of 10 tablets
Enzalutamide Proposal to include enzalutamide in Appendix L and Appendix F, Part 3
Performance and Image Enhancing Drugs Proposal to include new entries for Growth Hormone Releasing Hormones and Analogues, Growth Hormone Secretagogues, Growth Hormone Releasing Peptides and Growth Hormone Variant, as well as new individual entries for CJC-1295, ipamorelin, GHRP-2, GHRP-6, hexarelin and AOD-9604 in Schedule 4 and Appendix D.
Pomalidomide Proposal to include pomalidomide in Appendix D Item 4, Appendix L Part 2 and Appendix Part 3.
Ponatinib Proposal to include ponatinib in Appendix D, Item 1.