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This consultation closed on 19 January 2012.
Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990
The delegate of the Secretary of the Department of Health and Ageing 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 comment. Public 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.
Public submissions that simply reserve the right to comment on a scheduling proposal or are made after the closing date need not be considered by the advisory committee.
Public submissions must also include the name of the person making the submission and a postal or email (preferred) contact address.
Please note that all public 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 (SPF), issued by the National Coordinating Committee on Therapeutic Goods.
Persons making public submissions are strongly encouraged to lodge submissions in electronic format (word or unsecured PDF) via the email address provided below. Accordingly, public submissions, preferably in electronic format, should be made to:
The Secretary
Scheduling Secretariat
GPO Box 9848
CANBERRA ACT 2601
Email: SMP@health.gov.au
Facsimile: 02 6289 2650
The closing date for submissions is 19 January 2012.
The relevant expert advisory committee(s) will consider all valid public submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will then make an interim decision. This interim decision is expected to be published at Reasons for scheduling delegate's interim decisions and invitations for further comment on 26 April 2012 and will be open for further submissions from the applicant and persons who made a submission in response to the original invitation received on or before the closing date for public submissions. For more information on the scheduling processes please see the SPF.
The current Poisons Standard comprises the Standard for the Uniform Scheduling of Medicines and Poisons No. 2 (SUSMP 2) and SUSMP 1 Amendment 1 and 2. These can be accessed at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au or on 02 6289 2659 during business hours.
Proposed amendments referred by the delegate for scheduling advice
1. Advisory Committee on Chemicals Scheduling (ACCS)
1.1 Cyflufenamid - seeking advice on a proposal to capture in Schedule 6.
1.2 Diethylphthalate (DEP) and dimethylphthalate (DMP) - seeking advice on a proposal to consider scheduling when used in leave-on cosmetics. Particular consideration will be given to the recommendation from the National Industrial Chemicals Notification and Assessment Scheme's (NICNAS) DEP priority existing chemical assessment report to prohibit more than 0.5 per cent of DEP in body lotion type use patterns, i.e. longer duration leave-on preparations that might be applied to large areas of skin, through inclusion in Appendix C. A copy of the NICNAS DEP report is accessible at http://www.nicnas.gov.au/chemical-information/pec-assessments. In addition to the NICNAS recommendations, consideration might also extend to introducing a parent entry for DEP (such as in Schedule 6 or Schedule 7) and whether the current parallel scheduling of DEP and DMP (in Appendix C) should be maintained. As DMP was not addressed in the NICNAS DEP report, comment is particularly sought from industry on existing DMP usage in leave-on cosmetics.
1.3 Flonicamid - seeking advice on a proposal to capture in Schedule 6 or Schedule 7.
1.4 Formaldehyde and paraformaldehyde - seeking advice on a proposal to include a definition for 'free formaldehyde' to clearly encompass 'methylene glycol' (the bound hydrated form of formaldehyde created reversibly when formaldehyde is in an aqueous solution). It is proposed that 'free formaldehyde' could be defined as 'all hydrated or non-hydrated formaldehyde present in aqueous solution, including methylene glycol'. Alternatives will also be considered including, but not necessarily limited to, the scheduling of methylene glycol under the same terms as formaldehyde; or substituting 'methylene glycol (determined as formaldehyde)' for 'free formaldehyde'; or defining 'free formaldehyde' in terms of formaldehyde measured by a specific test.
1.5 Tranexamic acid and its salts and derivatives, including cetyl tranexamic hydrochloride - seeking advice on a proposal to exclude non-therapeutic use from the current Schedule 4 entry for tranexamic acid. Consideration will particularly be given to potentially exempting, or including in Schedule 5, cosmetic preparations for topical use containing 3 per cent or less of these substances.
Consideration may also be given to creating a different parent entry for these substances, such as Schedule 6, when for non-therapeutic use (all uses are currently captured by the Schedule 4 entry for tranexamic acid). Public comment is particularly invited to identify any non-therapeutic use pattern, including non-cosmetic uses, which might be affected by this consideration.
1.6 Zinc borate, boric acid and borax - proposal to consider scheduling zinc borate in Schedule 6. Consideration will be given to restricting the scheduling of zinc borate to exclude salts and derivatives. Advice will also be sought on the need to re-assess the current scheduling status of boric acid and borax (in Schedule 5), including a potential increase in scheduling to Schedule 6. There are no proposals to amend the exemptions in the current Schedule 5 entry, nor are there any proposals to reconsider the scheduling of boron compounds for human therapeutic use.
2. Advisory Committee on Medicines Scheduling (ACMS)
2.1 Adrenaline - consideration of a proposal to capture all preparations for injection containing adrenaline at concentrations of 1 per cent or less in Schedule 3 i.e. that the current exemption from scheduling for preparations containing 0.02 per cent or less of adrenaline not apply to preparations for injection. Consideration will also be given to possibly retaining a lower concentration cut-off for such preparations, including a proposal that this cut-off be set at 0.01 per cent or less of adrenaline. Non-injectable preparations containing adrenaline are not being considered.
2.2 Boceprevir - consideration of inclusion of boceprevir in Appendix L, including a proposal for a requirement for labelling with warning statement 77 "WARNING - May cause birth defects" and/or warning statement 67 "Do not use if pregnant or likely to become pregnant".
2.3 Ciclopirox - seeking advice on a proposal to reschedule ciclopirox from Schedule 3 to Schedule 2 when in preparations containing 8 per cent of less of ciclopirox. Advice is also sought on whether to maintain the Schedule 2 restriction of preparations for dermal use and for application to the nails, or whether this possible broadening of the Schedule 2 entry should be specifically restricted to use in fungal nail infections. Consideration will also be given to amending the Schedule 4 ciclopirox entry to clarify the intent of the June 2006 NDPSC decision to exempt ciclopirox for the treatment of tinea pedis from scheduling.
2.4 Ibuprofen - seeking advice on a proposal to reschedule from Schedule 3 to Schedule 2 ibuprofen divided preparations containing 400 mg or less of ibuprofen per dosage unit. This consideration may include, but is not limited to, restricting the entry to:
- small pack sizes (not more than 25 dosage units);
- a maximum daily dose of 1200 mg or less; and
- for the treatment of adults and children aged 12 years of age and over.
2.5 Loperamide - seeking advice on a proposal to amend the Schedule 2 entry for loperamide to include undivided preparations. Advice is also sought on potential restrictions on this rescheduling including, but not limited to, preparations containing 0.02 per cent loperamide and also possibly limiting to use in adults and children over 12 years of age.
2.6 Loratadine - seeking advice on a proposal to exempt from scheduling solid dose oral preparations containing loratadine. Advice is specifically sought, but is not limited to, restricting this possible exemption to preparations labelled with a recommended daily dose not exceeding 10 mg of loratadine, in packs containing 5 dosage units or less. Also for consideration is whether to specifically add a maximum length of treatment, i.e. maximum 5 days' treatment.
2.7 Pantoprazole - seeking advice on a proposal to reschedule from Schedule 3 to Schedule 2 oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-osesophageal reflux disease, in packs containing not more than 14 days of supply.
2.8 Paracetamol - seeking advice on a proposal to further restrict the pack size requirements for paracetamol to be exempt from scheduling (currently no more than 25 tablets at no more than 500 mg per tablet). This proposal arises from the minutes of the 45th meeting of New Zealand's Medicines Classification Committee (MCC), accessible at http://www.medsafe.govt.nz/profs/class/Minutes/2011-2015/mccMin12April2011.htm. The MCC have specifically proposed that unscheduled paracetamol packs be restricted to no more than 10 g of total paracetamol (e.g. 20 x 500 mg tablets).
2.9 Telaprevir - consideration of inclusion of telaprevir in Appendix L, including a proposal for a requirement for labelling with warning statement 77 "WARNING - May cause birth defects" and/or warning statement 67 "Do not use if pregnant or likely to become pregnant".