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Consultation: Proposed amendments to the Poisons Standard - ACMS meeting, July 2016

Scheduling medicines and poisons

7 April 2016

This consultation closed on 6 May 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).

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
2,4-DINITROPHENOL Proposal to create a new Schedule 10 entry for 2,4-dinitrophenol to prohibit human therapeutic use due to concerns for potential abuse.
PIPER METHYSTICUM (KAVA)

Proposal to amend part a) of the existing Schedule 4 entry to include the following:

  • iii) the amount of dried whole or peeled rhizome in the unit dose of powder does not exceed 3 g;

    and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

    and is packaged with a dose controlled measuring device (Scoop);

    and is limited to a maximum quantity of 200g of powder per package;

  • or
  • iv) the liquid form contains 125 mg or less of kavalactones per unit dose of liquid.

    and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

    and is packaged in a single serve packaging.

It is also proposed that there is the addition of the mandatory warning statement "Do not exceed recommended daily dose" to be added to all Kava packaging.

FEXOFENADINE Proposal to increase the pack size of unscheduled fexofenadine from not more than 5 days supply to not more than 10 days' supply in a primary pack containing 20 dosage units or less.
ULIPRISTAL To amend the existing Schedule 4 entry and create a new Schedule 3 entry to allow for emergency post-coital contraceptive use.
N,N-DIMETHYLTRYPTAMINE Proposal to amend the entry for N,N-dimethyltryptamine (DMT) in schedule 9 to allow exemptions for naturally occurring DMT in very low concentrations and liquid form for religious purposes. The quantity of DMT found per serving of the tea is approximately 0.25 mg/mL.

Timetable

Document released for consultation on Thursday 7 April 2016.

Interested parties should respond by close of business Friday 6 May 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 (Medicines) 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.

How to respond

All submissions should be accompanied by a TGA submission cover sheet. Submissions must include full personal or organisational contact details (including address, telephone number and email).

Electronic submissions are preferred and should be emailed to . Please include 'Proposed Amendments to the Poisons Standard (Medicines)' in the subject line of the email.

What will happen

All submissions will be placed on the TGA Internet site 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 Internet website: feedback on submissions will be provided through the TGA Internet site: Public submissions on scheduling matters.

Scheduling decisions made by the medicines delegate following consideration of submissions from interested parties, along with advice from 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 .