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This consultation closed on 7 July 2017.
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 Joint Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS).
| Substance | Proposal | |
|---|---|---|
| Phenibut | CAS Number | 1078-21-3 |
| Alternative names | 4-amino-3-phenylbutanoic acid (IUPAC), also commonly known as beta-phenyl-gamma-aminobutyric acid. | |
| Applicant | Delegate-initiated | |
| Current scheduling | Unscheduled | |
| Proposed scheduling | Due to serious public health concerns, the delegate is considering scheduling phenibut in Schedule 9 or Schedule 4 with an Appendix D, Part 5 entry. Consideration will also be given to whether a group entry is appropriate. | |
| Substance summary | Phenibut is a neuropsychotropic drug with anxiolytic and nootropic (cognition enhancing) effects. It acts as a GABA mimetic, primarily at GABAB and to some extent at GABAA receptors. Pharmacologically similar to Baclofen, which is in Schedule 4 of the Poisons Standard. | |
| International regulations | No evidence of scheduling in New Zealand, EMA, US FDA or Canada. | |
| Key uses / expected use | Marketed to relieve anxiety and depression, improve sleep and enhance cognition. | |
| Reasons for proposal | Case reports of significant toxicity have emerged, as well as evidence of dependence. | |
Timetable
Document released for consultation on Wednesday 7 June 2017.
Interested parties responded by close of business 7 July 2017.
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 Internet site unless marked confidential or indicated otherwise in the submission coversheet (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 and/or chemicals delegates following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-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 coversheet).
- 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 medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS).