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Invitation for public comment - ACMS and joint ACMS/ACCS meetings

Regulation 42ZCZK, Therapeutic Goods Regulations 1990

29 September 2010

This consultation closed on 29 October 2010.

Meeting of the Advisory Committee on Medicines Scheduling (date to be advised) and Joint Meeting of the Advisory Committees on Medicines & Chemicals Scheduling (date to be advised)

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 Poisons Standard contained in this notice will be referred for scheduling advice to an expert advisory committee.

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 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.

The closing date for submissions was Friday 29 October 2010.

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 will be made public as soon as practicable and will be open for further public comment from persons who made a submission in response to the original invitation and received on or before the closing date for public submission. If no submissions are received to the original invitation, then the interim decision may be considered final.

For more information on the scheduling processes please see the Scheduling Policy Framework. The Poisons Standard comprises the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) and can be accessed at www.comlaw.gov.au.

Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au or phone 02 6289 2584 during business hours.

Proposed amendments referred by the delegate for scheduling advice

Note: Details of recommendations from the last meeting of the National Drugs and Poisons Schedule Committee (NDPSC) are available publicly in the June 2010 Record of Reasons.

1. Advisory Committee on Medicines Scheduling (ACMS)

1.1 Cough and cold medicines - proposal to reschedule 19 substances used in over-the-counter cough and cold medicines to:

  • Schedule 4 for use in children less than 2 years of age.
  • Schedule 3 for use in children aged from 2 to 6 years of age.
  • Schedule 2 for use in children and adults above 6 years of age.

The Delegate proposes that this rescheduling apply to the following substances for use in cough and cold products (only where it will not result in less restrictive scheduling):

  • Brompheniramine
  • Carbetapentane
  • Chlorpheniramine
  • Codeine
  • Dexchlorpheniramine
  • Dextromethorphan
  • Dihydrocodeine
  • Diphenhydramine
  • Doxylamine
  • Ipecacuanha
  • Oxymetazoline (excluding for nasal spray use)
  • Pheniramine
  • Phenylephrine
  • Pholcodine
  • Promethazine
  • Pseudoephedrine
  • Senega
  • Triprolidine
  • Xylometazoline (excluding for nasal spray use)

This proposal is a result of recommendations from the June 2010 meeting of the NDPSC, following consideration of a review of cough and cold medicines by the TGA.

1.2 Diclofenac - proposal to include preparations containing 3 per cent or more of diclofenac for the treatment of solar keratoses in Schedule 4.

1.3 Mercury - proposal to clarify the Schedule 2 mercury entry by extending the current exemption for preparations containing 0.5 per cent or less of mercury to 0.50 per cent or less. This proposal may be applicable to mercurochrome (merbromin) products for external use.

1.4 Pseudoephedrine - proposal to delete the existing Appendix H entry. This proposal is a result of a recommendation from the June 2010 meeting of the NDPSC.

2. Joint meeting of the Advisory Committees on Medicines and Chemicals Scheduling (ACMS and ACCS)

2.1 5-aminolevulinic acid (5-ALA) - proposal to include in Schedule 4. This proposal is a result of a recommendation from the June 2010 meeting of the NDPSC.

2.2 Laureth carboxylic acids (LCA) - proposal to include LCA in Appendix E with appropriate labelling statements. Specifically, it is proposed that for preparations containing more than 5 per cent LCA:

  • standard statement E1 "if in eyes wash out immediately with water" apply; and
  • standard statement S1 "if skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water" apply to preparations which are not leave-on or wash-off.

The Delegate additionally proposes labelling requirements for products to qualify for the current exemptions from the Schedule 6 LCA entry. Specifically, it is proposed:

  • wash-off preparations, greater than 5 per cent up to 30 per cent or less are to be exempt only when labelled with "if in eyes wash out immediately with water";
  • leave-on (1.5 per cent or less), no additional labelling required; and
  • all other preparations, greater than 5 per cent up to 30 per cent or less are to be exempt only when labelled with "if in eyes wash out immediately with water" and "if skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water".

This proposal is a result of deliberations at the June 2010 meeting of the NDPSC.

2.3 Sodium lauryl sulfate (SLS) - proposal to include SLS in Appendix E with appropriate labelling statements. Specifically, it is proposed that for preparations containing more than 5 per cent SLS:

  • standard statement E1 "if in eyes wash out immediately with water" apply; and
  • standard statement S1 "if skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water" apply to preparations which are not leave-on or wash-off.

The delegate additionally proposes labelling requirements for products to qualify for the current exemptions from the Schedule 6 SLS entry. Specifically, it is proposed:

  • wash-off preparations, greater than 5 per cent up to 30 per cent or less are to be exempt only when labelled with "if in eyes wash out immediately with water";
  • leave-on (1.5 per cent or less), toothpaste and oral hygiene preparations (5 per cent or less) and other animal use (2 per cent or less) - no additional labelling required; and
  • all other preparations, greater than 5 per cent up to 30 per cent or less are to be exempt only when labelled with "if in eyes wash out immediately with water" and "if skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water".

This proposal is a result of deliberations at the June 2010 meeting of the NDPSC.

2.4 Triclosan - proposal to include in Schedule 6 with an exemption for:

  • non-therapeutic human use (e.g. cosmetic use) containing 0.2 per cent or less; and
  • all other preparations (e.g. therapeutic use and non-human use) containing 1 per cent or less of triclosan.

This proposal is a result of deliberations from the June 2010 meeting of the NDPSC, following consideration of recommendations from a NICNAS public report.

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