Outcome

The Committee did not support this proposal.

Outcome

Schedule 2 - New entry

PENCICLOVIR in preparations for dermal use containing 1 per cent or less of penciclovir.

Schedule 4 - Amendment

PENCICLOVIR - amend entry to read:

PENCICLOVIR except when included in Schedule 2.

Outcome

The Committee did not support this proposal.

Outcome

Schedule 3 - New entry

MINOXIDIL in preparations for dermal use containing 2 per cent or less of minoxidil.

Schedule 4 - Amendment

MINOXIDIL - amend entry to read:

MINOXIDIL except when included in Schedule 3.

Outcome

The Committee did not support this proposal.

Outcome

Schedule 4 - New entry

MONTELUKAST.

Outcome

The Committee agreed that finasteride had been gazetted in error as a new drug. It was agreed the current Schedule 4 classification remained appropriate.

Outcome

Schedule 4 - New entry

CIDOFOVIR.

Outcome

Schedule 4 - New entry

NARATRIPTAN.

Outcome

Schedule 4 - New entry

EPROSARTEN MESYLATE.

Outcome

Schedule 5 - New entry

BENZOFENAP

Outcome

The Committee agreed that the consolidated toxicological data on ethephon indicated a Schedule 6 classification was appropriate.

Schedule 5 - Amendment (foreshadowed)

ETHEPHON - delete entry

Schedule 6 - New entry (foreshadowed)

ETHEPHON (excluding its salts and derivatives)

Outcome

Schedule 6 - New entry

1-AMINOMETHANAMIDE DIHYDROGEN TETRAOXOSULFATE

Outcome

APPENDIX E, Part 1 - Amendment

Standard statement (t) - amend entry to read:

t. If available, apply calcium gluconate gel to affected skin

APPENDIX E, Part 2 - Amendment

Hydrofluoric acid and/or Hydrosilicofluoric acid - amend entry to read:

Hydrofluoric acid and/or
  Hydrosilicofluoric acid

APPENDIX F, Part 2 - New entry

29. If used frequently, obtain a supply of calcium gluconate gel

APPENDIX F, Part 3 - Amendment

Hydrofluoric acid - amend entry to read:

(a) when included in Schedule 5

(b) when in Schedule 6 or 7

Outcome

Schedule 5 - Amendment

ALKALINE SALTS - amend entry to read:
ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination:
(a) in solid orthodontic device cleaning preparations, the pH of which as an "in-use" aqueous solution is more than 11.5;
(b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 11.5;
(c) in other solid preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5; or
(d) in liquid or semi-solid preparations the pH of which is more than 11.5.

Outcome

Schedule 6 - Amendment

SODIUM PERCARBONATE - amend entry to read:

SODIUM PERCARBONATE (CAS No. 15630-89-4) except:
(a) when included in Schedule 5; or
(b) in preparations containing 15 per cent or less of sodium percarbonate.

Schedule 5 - New entry

SODIUM PERCARBONATE (CAS No. 15630-89-4) in preparations containing 35 per cent or less of sodium percarbonate except in preparations containing 15 per cent or less of sodium percarbonate.

APPENDIX E, Part 2 - New entry

Sodium percarbonate

* when included in Schedule 5

* when included in Schedule 6

Outcome

Deferred pending the receipt of further information.

Outcome

Schedule 3 - New entry

DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate.

Schedule 4 - Amendment

DIPHENOXYLATE- amend entry to read:

DIPHENOXYLATE in preparations containing per dosage unit 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate except when included in Schedule 3.

Schedule 8 - Amendment

DIPHENOXYLATE - amend entry to read:

DIPHENOXYLATE except when included in Schedule 3 or 4.

APPENDIX F, Part 3 - New entry

Diphenoxylate when included in Schedule 3
Warning statements    39 or 40, 41

Outcome

Schedule 6 - New entry

NONOXINOL 9 except:

(a) when included in Schedule 5;

(b) in preparations containing 25 per cent or less of nonoxinol 9 when labelled with the statements:

(c) in preparations containing 12.5 per cent or less of nonoxinol 9; or

(d) in preparations for human use.

Schedule 5 - New entry

NONOXINOL 9 in preparations containing 25 per cent of nonoxinol 9 except:

(a) when labelled with the statements:

(b) in preparations containing 12.5 per cent or less of nonoxinol 9; or

(c) in preparations for human use.

APPENDIX E, Part 2 - New entry

Nonoxinol 9

Standard statements   a,s

T-Value   180

Outcome

Schedule 5 - New entry

SODIUM DODECYLBENZENE SULFONATE except in preparations containing 20 per cent or less of sodium dodecylbenzene sulfonate labelled with an appropriate warning statement in relation to eye irritancy.

APPENDIX E, Part 2 - New entry

Sodium dodecylbenzene sulfonate

APPENDIX F, Part 1 - New entry

78. Will irritate eyes.

Appendix F, Part 3 - New entry

Sodium dodecylbenzene sulfonate

The Committee is seeking comment from industry on necessary time frames to implement label warning statements.

Deferred pending an omnibus review of the scheduling of all chlorinating compounds.

Outcome

Deletion of Schedule 3 entry at the request of the sponsor.

Schedule 3 - Amendment

ASTEMIZOLE - delete entry

Schedule 4 - Amendment

ASTEMIZOLE - amend entry to read:

ASTEMIZOLE.

Outcome

SUSDP, PART 1, INTERPRETATION - AMENDMENT

Amend by adding:

"Hemp seed oil" means the oil obtained by cold expression from the ripened fruits(seeds) of Cannabis sativa.

Schedule 9 - Amendment

TETRAHYDROCANNABINOLS - amend entry to read:

TETRAHYDROCANNABINOLS and their alkyl homologues except:

(a) when separately specified in this Schedule;
(b) when included in Schedule 8;
(c) in hemp seed oil, containing 50 mg/kg or less of tetrahydrocannabinols, when labelled "Not for internal use" or "Not to be taken"; or
(d) in products for purposes other than internal human use containing 50 mg/kg or less of tetrahydrocannabinols.

Outcome

The Committee agreed that warning statements on toothpastes mandated through the Scheduling process are not warranted at this time. The Committee strongly supports the voluntary labeling of toothpastes.

Outcome

The Committee agreed that scheduling need not be progressed at this time.

New Drugs - Schedule 4 classification

TRAMADOL.

CANDESARTEN CILEXETIL.

APPENDIX K - New entry

Tramadol

Reason

The above decisions were routine classifications of drugs recommended for registration by ADEC

Schedule 5 - Amendment

SYMPHYTUM - amend entry to read:

SYMPHYTUM spp (Comfrey) for dermal use.

APPENDIX C - Amendment

SYMPHYTUM - amend entry to read:

SYMPHYTUM spp (Comfrey) for therapeutic or cosmetic use except when included in Schedule 5.

Reason

The Committee agreed that there was no requirement to distinguish between creams or ointments and other preparations of comfrey for dermal use, and that comfrey for cosmetic use should be controlled in the same way as therapeutic preparations.

Schedule 4 - Amendment

CODEINE - amend entry to read:

CODEINE when compounded with one or more other therapeutically active substances:
(a) in divided preparations containing 30 mg or less of codeine per dosage unit; or
(b) in undivided preparations containing 1 per cent or less of codeine;
except when included in Schedule 2 or 3.

Reason

Minor amendment for clarity and consistency.

SUSDP PART 3, RECOMMENDED STANDARD - MISCELLANEOUS - Amendment

Paragraph 62 - amend to read:

62. A person must not include any reference to a poison included in:

(a) Schedule 3 unless included in Appendix H; or

(b) Schedule 4 or Schedule 8,

of this Standard in any advertisement except in genuine professional or trade journals or other publications intended for circulation only within the medical, nursing, veterinary, dental or pharmaceutical professions or the wholesale drug industry.

PART 5 - APPENDIX H - Amendment

Amend to read:

Schedule 3 POISONS PERMITTED TO BE ADVERTISED

Reason

Amendment to facilitate Schedule 3 brand advertising, as agreed by Australian Health Ministers.

Schedule 5 - Amendment

PHOSPHORIC ACID - amend entry to read:

PHOSPHORIC ACID (excluding its salts and derivatives) in preparations containing 35 per cent or less of phosphoric acid (H3PO4) except:

(a) in preparations containing 15 per cent or less of phosphoric acid (H3PO4);
(b) in solid or semi-solid preparations; or
(c) in professional dental kits.

Schedule 6 - Amendment

PHOSPHORIC ACID - amend entry to read:

PHOSPHORIC ACID (excluding its salts and derivatives) except:

(a) when included in Schedule 5;
(b) in preparations containing 15 per cent or less of phosphoric acid (H3PO4);
(c) in solid or semi-solid preparations; or
(d) in professional dental kits.

Reason

Minor amendment to clarify the intent of the Committee that exemption from scheduling applies to both solid preparations and semi-solid preparations.

Schedule 5 - Amendment

IMAZAMETH - amend entry to read:

IMAZAPIC except in preparations containing 25 per cent or less of imazapic.

Reason

The Committee agreed that the SUSDP should be amended to reflect the approved name of the chemical.

APPENDIX F, Part 3 - Amendment

Camphor - amend entry to read:

Camphor

1. in block, ball, disc or pellet form, 
   Warning Statement 9
           enclosed in a device which, in
           normal use, prevents removal or
           ingestion of its contents:
2. in other forms.                
   Warning Statement 9
   Safety Direction 1

Reason

Amendment to correct an error detected in SUSDP 12. This amendment will be incorporated in Amendment 4 to SUSDP 12 (effective date 21 September 1998). Affected companies unable to rectify labels within this time frame should contact an appropriate authority.

PART 1 - INTERPRETATION - Amendment (foreshadowed)

Amend by adding to the list of substances under "Designated solvent":

    N-(N-octyl)-2-pyrrolidone; and

    N-(N-dodecyl)-2-pyrrolidone

Schedule 6 - New entries (foreshadowed)

N-(N-DODECYL)-2-PYRROLIDONE except:

(a) when included in Schedule 5; or
(b) in preparations containing 25 per cent or less of designated solvents.

N-(N-OCTYL)-2-PYRROLIDONE except:
(a) when included in Schedule 5; or
(b) in preparations containing 25 per cent or less of designated solvents.

Schedule 5 - New entries (foreshadowed)

N-(N-DODECYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-dodecyl)-2- pyrrolidone except in preparations containing 25 per cent or less of designated solvents.
N-(N-OCTYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-octyl)-2- pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

Reason:

The Committee agreed that these solvents exhibited toxicity profiles consistent with a Schedule 6 classification. Further information is sought on appropriate cut-offs from Schedule 6 to Schedule 5 and exempt.

Schedule 4 - Amendments

CHLORTETRACYCLINE - amend entry to read:

CHLORTETRACYCLINE except when included in Schedule 5.

OXYTETRACYCLINE - amend entry to read:

OXYTETRACYCLINE except when included in Schedule 5.

TETRACYCLINE - amend entry to read:

TETRACYCLINEexcept when included in Schedule 5.

Schedule 5 - Amendments

CHLORTETRACYCLINE - amend entry to read:

CHLORTETRACYCLINE in preparations:
(a) for topical application to animals for ocular use only;
(b) containing not more than 100 000 international units of chlortetracycline per dose, for intramammary infusion in animals; or
(c) containing 40 per cent or less of chlortetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

OXYTETRACYCLINE - amend entry to read:

OXYTETRACYCLINE in preparations:
(a) for topical application to animals for ocular use only;
(b) containing not more than 100 000 international units of oxytetracycline per dose, for intra-mammary infusion in animals; or
(c) containing 40 per cent or less of oxytetracycline per dose, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

TETRACYCLINE - amend entry to read:

TETRACYCLINE in preparations:
(a) for topical application to animals for ocular use only;
(b) containing not more than 100 000 international units of tetracycline per dose, for intramammary infusion in animals; or
(c) containing 40 per cent or less of tetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

Schedule 6 - Amendments

CHLORTETRACYCLINE - delete entry

OXYTETRACYCLINE - delete entry

TETRACYCLINE - delete entry

Reason

The Committee agreed that it was appropriate that chlortetracycline, oxytetracycline and tetracycline preparations for topical, ocular application to animals or intra-mammary infusion in animals be scheduled in the same way as preparations for the treatment of ornamental caged birds or ornamental fish.

Schedule 6 - Amendment

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT - amend entry to read:

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT except:

1. when included in Schedule 5;
2. when in solid orthodontic device cleaning preparations, the pH of which as an "in-use" aqueous solution is neutral; or
3. in preparations containing 5 per cent or less of potassium peroxomonosulfate triple salt being:
   1. solid preparations the pH of which in a 10 g/L aqueous solution is 2.5 or more; or
   2. liquid or semi-solid preparations the pH of which is 2.5 or more.
      
      

Schedule 5 - New entry

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT in preparations containing 5 per cent or less of potassium peroxomonosulfate triple salt being:
(a) solid preparations the pH of which in a 10 g/L aqueous solution is less than 2.5; or
(b) liquid or semi-solid preparations the pH of which is less than 2.5.

APPENDIX E, Part 2 - New entry

Potassium peroxomonosulfate triple salt when included in Schedule 6

Reason

The Committee agreed that the toxicological data supported an amendment to the Schedule 6 classification for potassium peroxomonosulfate to include cut-offs to Schedule 5 and exempt.

Schedule 4 - Amendment

VITAMIN A - amend entry to read:

VITAMIN A for human therapeutic or cosmetic use, except:

1. in preparations for topical use containing 1 per cent or less of vitamin A;
2. in preparations for internal use, containing 100 IU or less of vitamin A per dosage unit of a divided preparation, or 100 IU or less of vitamin A per gram of an undivided preparation; or
3. in other preparations for internal use labelled:
   1. with a recommended daily amount of 5 000 IU or less of vitamin A; and
   2. where the preparation is labelled for adult use, in bold face letters not less than 1.5 mm high:
      1. with a statement to the following effect:
         The recommended adult daily amount of vitamin A from all sources is 2 500 IU.
      2. and, at the beginning of the directions for use, with a warning statement to the following effect:
         WARNING - Taking more than 2 500 IU a day during pregnancy may cause birth defects.

Reason

The Committee agreed that the requirement to label preparations for internal use with a recommended daily amount of Vitamin A and a warning relating to doses in pregnancy applies only to preparations for adult use.

These Guidelines have been developed by the National Co-ordinating Committee on Therapeutic Goods for use by the NDPSC in considering submissions relating to brand advertising of substances included in Schedule 3 of the SUSDP. Copies of the Guidelines are available from the Secretary.

The Committee is seeking information which will assist in the re-assessment of the toxicity of chlorinating compounds.