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Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, June 2019

Invitation to comment

11 April 2019

This consultation closed on 13 May 2019.

Scheduling amendments referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the June 2019 meetings of the Advisory Committee on Medicines Scheduling (ACMS #27) and the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #22).

Submissions must be received by close of business 13 May 2019. See How to respond.

1. Proposed amendments referred for scheduling advice to ACMS #27

1.1 Finasteride

1.1 Finasteride

CAS Number

98319-26-7

Applicant

Private applicant

Proposed scheduling

To amend the finasteride entry in the Poisons Standard as follows:

Schedule 4 - Amend Entry

FINASTERIDE for human therapeutic use except when included in Schedule 3.

Schedule 3 - New Entry

FINASTERIDE for use in males with androgenetic alopecia (male pattern hair loss) in preparations containing not more than 1 mg per dose unit in packs not greater than 30 dosage units.

Appendix H - New Entry

FINASTERIDE

Index - Amend Entry

FINASTERIDE

Schedule 4

Schedule 3

Appendix H

Key uses / expected use

For the treatment of androgenetic alopecia (male patterned hair loss) in men over 18.

Reasons for proposal
  • Finasteride fulfils the criteria for a Schedule 3 substance and will provide an alternative to topical minoxidil for consumers.
  • Consumers can easily identify the symptoms of male pattern hair loss and it can quite easily be verified by the pharmacist to ensure that there is no other reason for the hair loss.
  • The product has been on the market for a number of years and pharmacists are well equipped to provide advice to consumers on the adverse effects, interactions and contraindications (in particular, the potential risk to the male fetus if finasteride is handled by pregnant women).
  • The risk profile of the medicine is well defined and there are no identified drug interactions of clinical significance.
  • There is little risk of misuse, abuse or illicit use as it does not have any effect outside of its use in hair loss or in larger doses for benign prostatic hyperplasia (BPH).

1.2 1,4-dimethylpentylamine (DMPA)

1.2 1,4-dimethylpentylamine (DMPA)

CAS Number

28292-43-5

Alternative names:

2-hexanamine, 5-methyl-pentylamine, 1,4-dimethyl-; 1,4-dimethylamylamine; 2-amino-5-methylhexane; 5-methyl-2-hexylamine.

Applicant

Private Applicant

Proposed scheduling

To include DMPA as a specific entry in the Poisons Standard as follows:

Schedule 10 - New Entry

1,4-DIMETHYLPENTYLAMINE (DMPA)

Index - New Entry

1,4-DIMETHYLPENTYLAMINE (DMPA)

Schedule 10

Index - Add cross reference

ALKYLAMINES WITH STIMULANT PROPERTIES - Amend Entry
cross reference: 1,3-dimethylbutylamine, DMBA, octodrine, 1-aminoisoheptane, DMHA, 1,5-dimethylhexylamine, 4‑methylhexane-2-amine, 1,3-dimethylamylamine, DMAA, 4-amino-2-methylpentane citrate (AMP citrate), 1,4-dimethylpentylamine, DMPA.

Schedule 10

Key uses / expected use

An ingredient in sports supplements being used by athletes and members of the broader community as a stimulant before physical activity.

Reasons for proposal
  • This substance is currently captured under the Schedule 10 entry for alkylamines with stimulant properties due to its similarities to 1,3-dimethylamylamine (DMAA) and 1,3-dimethylbutylamine (DMBA).
  • The new entry for DMPA is proposed in order to remove any potential ambiguity about the scheduling status of this substance. This would characterise DMPA as a substance of such danger to health as to warrant prohibition of sale, supply and use.

1.3 Phenpromethamine

1.3 Phenpromethamine

CAS Number

93-88-9

Alternative names

benzeneethanamine, N,beta-dimethyl-; N,beta-dimethylphenethylamine; N,beta-dimethyl, 1-methylamino-2-methyl-2-phenylethane; 1-methylamino-2-phenylpropane; 1-phenyl-1-methyl-2-methylamino-ethan; 1-phenyl-1-methyl-2-ethylaminoethane; fenprometamina; phenpromethaminum; phenylpropylmethylamine; vonedrine; N-methyl-2-phenylpropylamine; N,beta-dimethylphenethylamine; phenpromethadrinum.

Applicant

Private applicant

Proposed scheduling

To create a new entry for phenpromethamine in the Poisons Standard as follows:

Schedule 10 - New Entry

PHENPROMETHAMINE

Index - New Entry

PHENPROMETHAMINE

Schedule 10

Key uses / expected use

The substance is being used by athletes and members of the broader sporting community as a stimulant in so called 'pre-workout' sports supplements typically ingested before physical activity. Sports supplements found to contain phenpromethamine were marketed as providing a stimulant effect, to improve athletic performance, and to increase weight loss.

Reasons for proposal
  • Phenpromethamine is considered a primary analogue of methamphetamine (structural isomers) as per section 301.9 of the Criminal Code Act 1995. Phenpromethamine is a stimulant; it is chemically and structurally related to amphetamine, its derivatives (e.g. methamphetamine) and analogues.
  • Phenpromethamine is a substance prohibited from sport by the World Anti-Doping Agency (WADA).
  • Phenpromethamine is currently controlled by the German regulator Betäubungsmittelgesetz (BtMG) and is classified as Anlage I, non-tradeable substances available only by special permission of the authorities, which is granted for scientific or other public interest purposes.
  • Phenpromethamine has been reported to the Early Warning Advisory on New Psychoactive Substances of the United Nations Office on Drugs and Crime (UNODC).

1.4 Sanguinarine

1.4 Sanguinarine

CAS Number

2447-54-3

Alternative names

13-Methyl[1,3]benzodioxolo[5,6-c][1,3]dioxolo[4,5-i]phenanthridin-13-ium; [1,3]Benzodioxolo[5,6-c]-1,3-dioxolo[4,5-i]phenanthridinium 13-methyl-; pseudochelerythrine; sanguinarin; sangvinarin.

Applicant

This proposed amendment has been initiated by a delegate of the Secretary of the Department of Health.

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 10 - New Entry

SANGUINARINE for therapeutic use except in preparations containing 0.1 per cent or less.

Index - New Entry

SANGUINARINE

Schedule 10

Key uses / expected use

Alternative medicines

Reasons for proposal
  • Sanguinaria Canadensis (also known as 'bloodroot') is a key ingredient of black salve. Sanguinarine derived from the root of Sanguinaria Canadensis is used as an alternative treatment for cancer, including skin cancer
  • Sanguinarine leads to the indiscriminate death of normal and cancerous cells and results in extensive tissue necrosis and the formation of a thick black scab (eschar) which eventually sloughs off, leaving an open wound[1],[2]
  • Multiple case studies have shown that sanguinarine is not selective for tumour cells and that extensive tissue damage can result as well as a recurrence or metastasis of skin cancer[3],[4],[5],[6]
  • Sanguinarine has the potential to cause epidemic dropsy, a severe form of oedema that results from ingesting sanguinarine[7]
  • Sanguinarine is in two listed medicines on the ARTG
  • There has never been a published controlled clinical trial conducted in black salve's 160-year history of clinical use.[1]

2. Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #22

2.1 Arbutin

2.1 Arbutin

CAS Number

497-76-7

Alternative names

Arbutoside; (2R,3S,4S,5R,6S)-2-Hydroxymethyl-6- (4-hydroxyphenoxy)oxane-3,4,5-triol; Hydroquinone 1-O-beta-D-glucopyranoside; Hydroquinone β-D-glucopyranoside; 4-hydroxyphenyl-beta-D-glucopyranoside.

Applicant

Private applicant

Proposed scheduling

To include arbutin as a specific entry in the Poisons Standard as follows:

Schedule 4 - New Entry

ARBUTIN in preparations for human therapeutic or cosmetic use except:

  1. when included in Schedule 2; or
  2. in hair preparations containing 0.75 per cent; or
  3. in cosmetic nail preparations containing 0.05 per cent; or
  4. in oral herbal preparations containing 500mg or less of arbutin per recommended daily dose.

Schedule 2 - New Entry

ARBUTIN in preparations for human external therapeutic or cosmetic use containing 5% or less of arbutin except:

  1. in hair preparations containing 0.75 per cent; or
  2. in cosmetic nail preparations containing 0.05 per cent

Index - New Entry/Amended entry

ARBUTIN

cross reference: HYDROQUINONE

Schedule 4

Schedule 2

Key uses / expected use

Medicines and cosmetics

Reasons for proposal
  • Commonplace and frequent population exposure to arbutin and hydroquinone via common dietary components at levels equal to likely levels arising from herbal exposure, combined with a lack of reports of adverse or toxic effects linked to naturally occurring arbutin, provides an established history of safety;
  • available evidence shows that almost all hydroquinone released upon ingestion of arbutin is rapidly conjugated and eliminated with the urine;
  • available evidence shows that the quantity of free, unconjugated hydroquinone released from arbutin in vivo is two orders of magnitude lower than the EMA permitted daily exposure (PDE) level for hydroquinone;
  • naturally occurring arbutin in herbal medicines therefore does not present an unacceptable risk to human health.

How to respond

Submissions must:

Submissions might also include:

  • Suggested improvements; and/or
  • 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 public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 12 September 2019.

Privacy and your personal 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, see How to respond above).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
  • Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
  • 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) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).


Footnotes