Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018

Scheduling medicines and poisons

21 December 2017

This consultation closes on 2 February 2018.

Invitation to comment

The TGA is seeking 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 Chemicals Scheduling (ACCS), the Advisory Committee on Medicines Scheduling (ACMS) and the Joint ACCS-ACMS.

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)
Substance Proposal
Eprinomectin CAS Number 123997-26-2
Alternative names

Mixture of eprinomectins B1a and B1b;

(2aE,4E,8E)-(5'S,6S,6′R,7S,11R,13S,15S,17aR,20R,20aR,20bS)-6′-[(S)-sec-butyl]-5′,6,6′,7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-5′,6,8,19-tetramethyl-17-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 4-O-(4-acetamido-2,4,6-trideoxy-3-O-methyl-α-L-lyxo-hexopyranosyl)-2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranoside (major component);

(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13S,15S,17aR,20R,20aR,20bS)- 5′,6,6′,7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-6′-isopropyl-5′,6,8,19-tetramethyl-17-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 4-O-(4-acetamido-2,4,6-trideoxy-3-O-methyl-α-L-lyxo-hexopyranosyl)-2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranoside (minor component).

Current scheduling Schedule 7 and Schedule 5.
Proposed scheduling

Schedule 5 - Amend Entry

EPRINOMECTIN in preparations for internal use containing 0.5 per cent or less of eprinomectin.

Key uses / expected use Veterinary endectocide (effective against endoparasites and ectoparasites).
Reasons for proposal
  • Eprinomectin preparations are currently registered for use in Australia as a pour-on formulation for beef and dairy cattle.
  • This application is for a long-acting injectable product for use in cattle.
  • Advice from the APVMA is that there are no objections on human health grounds for the registration of an injectable product containing eprinomectin.
Moxidectin CAS Number 113507-06-5
Alternative names

(6R,25S)-5-O-Demetyl-28-deoxy-25-[(E)-1,3-dimetyl-1-butenyl]-6,28-epoxy-23-oxomilbemycin B 23-(E)-(O-metyloxime) (WHO);

Milbemycin B, 5-O-demetyl-28-deoxy-25-(1,3-dimetyl-1-butenyl)-6,28-epoxy-23-(metoxyimino)-, [6R,23E,25S(E)]- (USAN)

Applicant APVMA
Current scheduling Schedules 4, 7, 6 and 5.
Proposed scheduling

Schedule 5 - Amend Entry

MOXIDECTIN:

  1. in preparations for external use for the treatment of animals other than cats and dogs, containing 0.5 per cent or less of moxidectin;
  2. in preparations for external use for the treatment of cats and dogs, containing 2.5 per cent or less of moxidectin packed in single dose tubes with a volume of 1 mL or less; or
  3. for internal use for the treatment of animals:
    1. in divided preparations for dogs, containing 250 micrograms or less of moxidectin per dosage unit in a pack containing six or less dosage units; or
    2. in other preparations containing 2 per cent or less of moxidectin. or
  4. in preparations for injection for the treatment of sheep and cattle, containing 10 per cent or less of moxidectin.

Schedule 4 - Amend Entry

MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin except when included in Schedule 5 for the treatment of dogs containing 10 per cent or less of moxidectin.

Key uses / expected use Veterinary
Reasons for proposal Due to amendments to the scheduling entries over the years, the wording of entry relating to injections for food-producing animals is now ambiguous.
Mefentrifluconazole CAS Number 1417782-03-6
Alternative names

(2RS)-2-[4-(4-chlorophenoxy)-2- (trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl) propan-2-ol (IUPAC);

alpha-[4-(4-chlorophenoxy)-2-(trifluoromethyl) phenyl]- alpha-methyl-1H-1,2,4-triazole-1-ethanol (CAS).

Applicant APVMA
Current scheduling Not currently scheduled.
Proposed scheduling To exempt mefentrifluconazole from scheduling.
Key uses / expected use Agricultural fungicide
Reasons for proposal
  • The available toxicological data for mefentrifluconazole is considered to be sufficient for the purposes of recommending a scheduling decision.
  • Advice from the APVMA is that there are no objections on human health grounds for the approval of the active constituent.
2. Proposed amendments referred by the delegates to the Joint Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS) for scheduling advice
Substance Proposal
Vinyl acetate CAS Number 108-05-4
Alternative names

Ethenyl acetate (IUPAC);

Vinyl acetate (INCI);

Acetic acid ethenyl ester (CAS);

Vinyl acetate monomer (VAM).

Current scheduling

Not currently scheduled.

To be included in the Poisons Standard from 1 October 2018, as follows:

Schedule 6

VINYL ACETATE MONOMER (excluding its derivatives) except:

  1. in preparations for therapeutic use; or
  2. in preparations for domestic use containing 1 per cent or less of vinyl acetate; or
  3. in preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer.

Appendix E, Part 2

VINYL ACETATE

Standard Statements: A (For advice, contact a Poisons Information Centre or a doctor); R1 (If inhaled, removed from contaminated area. Apply artificial respiration if not breathing).

Appendix F, Part 3

VINYL ACETATE

Warning Statement: 11 (Vapour may be harmful).

Safety Directions: 8 (Avoid breathing vapour); 9 (Use only in well ventilated area).

Proposed scheduling

Schedule 6 - Amend Entry

VINYL ACETATE MONOMER (excluding its derivatives) except:

  1. in preparations for therapeutic use; or
  2. in preparations for domestic use containing 1 per cent or less of vinyl acetate; or
  3. in preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer used in direct contact with the body, such as cosmetic preparations.
Key uses / expected use Domestic, cosmetic.
Reasons for proposal
  • To ensure that the scheduling of preparations not intended for skin contact that contain residual monomer vinyl acetate in a polymer are exempt from scheduling.
  • Preparations containing over the cut-off level of point (b) of more than 1 per cent would still be captured by the Schedule 6 listing.

PROSTAGLANDINS:

  • Carboprost
  • Cloprostenol
  • # Dinoprost
  • # Dinoprostone
  • Etiproston
  • Fenprostalene
  • Fluprostenol
  • Gemeprost
  • Misoprostol
  • Prostianol

Due to inconsistencies with the inclusion of prostaglandins that have obstetric/gynaecological indications in Appendix D Item 1, it is proposed to standardise the scheduling of all applicable prostaglandins with obstetric/gynaecological indications with one of the following options:

  • place all applicable prostaglandins in Appendix D Item 1 and include a general entry in Appendix D Item 1 for PROSTAGLANDINS "when used in obstetrics/gynaecology".
  • OR
  • remove those prostaglandins currently listed in Appendix D Item 1;
3. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance Proposal
Diclofenac A request has been made to amend the Schedule 2 entry for diclofenac to increase the amount for exempt preparations for dermal use except when labelled for the treatment of solar keratosis from 1% to 2% or less of diclofenac.
Fluticasone A request has been made to amend the Schedule 2 entry for fluticasone to remove the limit of 200 actuations.
Cannabidiol

Due to queries at both Commonwealth and state/territory level on the meaning of the cannabidiol entry and how it affects products it is proposed to amend the following entries for cannabidiol, cannabis and tetrahydrocannabinols to ensure that the cannabidiol entry is clearly understood:

Schedule 4

CANNABIDIOL in preparations for therapeutic use in which:

  1. cannabidiol comprises at least 98 per cent of the total cannabinoid content of the preparation; and
  2. any other cannabinoids present are only those naturally found in cannabis, and are present only as unavoidable impurities in the cannabidiol component of the preparation.

Appendix K

CANNABIS except when included in Schedule 4.

TETRAHYDROCANNABINOLS except when included in Schedule 4.

Schedule 8

# TETRAHYDROCANNABINOLS when extracted from cannabis for human therapeutic use, when:

  1. included in products manufactured in accordance with the Narcotic Drugs Act 1967; and/or
  2. imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989; and/or
  3. in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989, except when:
    1. it is a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; or
    2. ii) in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols when labelled with either of the following warning statements:
      1. Not for internal use; or
      2. Not to be taken; or
    3. separately specified in the NABIXIMOLS entry in this Schedule; or
    4. separately specified in Schedule 4.

Timetable

Document released for consultation on 21 December 2017.

Interested parties should respond by close of business 2 February 2018.

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 to 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 the relevant expert advisory committees as advised in the above tables, for consideration in March 2018.

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.

How to respond

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

How to access a Word document

Electronic submissions are preferred:

  • Submissions regarding substances referred to the ACMS or Joint ACCS-ACMS should be emailed to . Please include 'Proposed Amendments to the Poisons Standard (Medicines)' in the subject line of the email.
  • Submissions regarding substances referred to the ACCS should be emailed to . Please include 'Proposed Amendments to the Poisons Standard (Chemicals)' 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 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 (for substances referred to the ACMS or Joint ACCS-ACMS) or (for substances referred to the ACCS).