Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS meeting, March 2016

Scheduling medicines and poisons

20 January 2016

This consultation closed on 18 February 2016

Invitation to comment

The TGA sought comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
Benzodiazepine derivatives To up-schedule the Schedule 4 entry of benzodiazepine, which reads BENZODIAZEPINE derivatives except when separately specified in these Schedules, to Schedule 9.
Cannabis and cannabinoids

Proposal to enable appropriate access to medicinal cannabis products by creating new Schedule 8 entries for the following substances for internal human therapeutic use:

  • Cannabis (plant and flowering tops),
  • Botanically derived extracts (or derivatives) of cannabis, and
  • Tetrahydrocannabinols (THC) where they are botanically derived from cannabis.

including when prepared or packed for therapeutic use, and where the substances:

  • have been produced or manufactured in accordance with the Narcotic Drugs Act 1967; or
  • have been imported in accordance with the Customs (Prohibited Imports) Regulations 1956.

except when included elsewhere in Schedule 8 or Schedule 4.

Cannabis and THC would remain Schedule 9 substances:

  • for human therapeutic use when it does not fit the above criteria, or
  • when not for human therapeutic use, or
  • does not fit any other current exceptions.

Options for additional controls on these substances through an entry in Appendix D of the SUSMP could include one of the following:

  • restriction of access to state/territory authorised medical practitioners (current Item 1 - Poisons available only from or on the prescription or order of an authorised medical practitioner); or
  • restricting access to:
    • clinical trials conducted under the TG Act when unapproved products including these substances are used i.e. Clinical trial Notification (CTN) or Clinical Trial Exemption (CTX); and
    • supply as an unapproved product through the TGA Special Access Scheme Category B or the Authorised Prescriber scheme similar to the current Item 3 ( Poisons available only from or on the prescription or order of a medical practitioner authorised or approved by the Secretary of the Commonwealth Department of Health under section 19 of the Therapeutic Goods Act 1989.); or
  • restricting access by creating an entry such as "Poisons available only from or on the order of a specialist physician"
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS).
Substance Proposal
2,4-Diamino-5-methylphenetole In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 2,4-diamino-5-methylphenetole, the scheduling proposal is to create a new Schedule 6 entry for 2,4-diamino-5-methylphenetole with an appropriate exemption and cut-off to regulate its use in hair dyes and eyelash colouring products.
2-Chloro-5-nitro-N-hydroxyethyl p-phenylenediamine In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 2-chloro-5-nitro-N-hydroxyethyl p-phenylenediamine, the scheduling proposal is to create a new Schedule 6 entry for 2-chloro-5-nitro-N-hydroxyethyl p-phenylenediamine with an appropriate exemption and cut-off to regulate its use in hair dye and eyelash colouring products.
2-Methylresorcinol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 2-methylresorcinol, the scheduling proposal is to create a new Schedule 6 entry for 2-methylresorcinol, with appropriate exemption and cut-off to regulate its use in hair dye and eyelash colouring products.
4,5-Dichloro-2-N-octyl-3(2H)-isothiazolone To amend the current 4,5-Dichloro-2-N-octyl-3(2H)-isothiazolone Schedule 6 entry to exclude water-based, acrylic or silicone paints, jointing compounds and sealants containing 0.1% or less of 4,5-Dichloro-2-N-octyl-3(2H)-isothiazolone. This is a matter that was first considered at the March 2015 ACCS meeting. It is being reconsidered after submission of additional data.
Bis-Isobutyl PEG/PPG-20/35/Amodimethicone Copolymer In response to issues raised in a NICNAS New Chemical Assessments public report, the scheduling proposal is to create a new Schedule 6 entry for Bis-Isobutyl PEG/PPG-20/35/Amodimethicone Copolymer with appropriate exemption and cut-off to regulate its use in rinse-off cosmetic products.
Chrysoidine base and its salts In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on chrysoidine base and its salts, the scheduling proposal is to create a new Schedule 6 entry for chrysoidine base to regulate its use in domestic and cosmetic products.
Crystal Violet and related dyes (Group) In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on crystal violet and related dyes, the scheduling proposal is to create a new group Schedule 6 entry for Crystal violet and related dyes to regulate their use in hair dye products and to provide appropriate exemptions.
DiBak parkinsonia bioherbicide To consider the need for scheduling a new biological pesticide containing three fungal strains, Lasiodiplodia pseudotheobromae (strain NT039), Neoscytalidium novaehollandiae (strain QLD003), and Macrophomina phaseolina (strain NT094).
Disperse Yellow 3 In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on Disperse Yellow 3, the scheduling proposal is to create a new Schedule 6, 7 or 10 entry for Disperse Yellow 3 to regulate its use in hair dyes and other products.
Fluopicolide To consider whether fluopicolide requires listing in the Schedules.
Isopyrazam The scheduling proposal is to create a new Schedule 6 entry for isopyrazam.
Methyldibromo glutaronitrile To resolve an apparent ambiguity between the Schedule 6 and Schedule 10 entries relating to duplication of the exception clause "except in preparations intended to be in contact with the skin, including cosmetic use".
Nonanoic acid To create a new Schedule 5 entry for the use of nonanoic acid in agricultural preparations with a proposed exemption concentration cut-off at 3%.
p-Aminophenol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report, the scheduling proposal is to create a new Schedule 6 entry for p-aminophenol with appropriate exemption and cut-off to regulate its use in hair dyes and eyelash colouring products.
Potassium hydroxide and sodium hydroxide To amend the existing Schedule 6 or 10 entries to address possible ambiguities in the duplication of the exception clause c) that relates to liquid or semi-solid food additive preparations, the pH of which is more than 11.5, for domestic use.
Propamocarb To delete the current Schedule 5 entry and create a new entry in Appendix B.
Streptomyces lydicus WYEC 108 To create a new Schedule 6 entry for Streptomyces lydicus WYEC 108 for agricultural use, with an exemption for preparations containing 0.037% or less.
3. Proposed amendments referred by the delegate for scheduling advice for consideration by the Joint ACCS-ACMS.
Substance Proposal
Symphytum spp. (Comfrey) To amend the existing Schedule 5 and 10 entries to address ambiguity between what constitutes dermal therapeutic and cosmetic use and which products applied dermally should be covered by the Schedule 5 entry.

Timetable

Document released for consultation on Thursday 21 January 2016.

Interested parties should respond by close of business Thursday 18 February 2016.

Feedback will be released following consideration of submissions (see 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK/42ZCZL 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 above 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.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All submissions will be placed on the TGA website unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the TGA website. Feedback on submissions will be provided through the TGA website at Public submissions on scheduling matters.

Scheduling decisions made by the medicines and chemicals delegates following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS) or the Advisory Committee on Medicines Scheduling (ACMS) will be published on the TGA website as interim decisions.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to: