NDPSC May 1997 post-meeting gazette notice
National Drugs and Poisons Schedule Committee
Published in the Commonwealth of Australia Gazette, 9 July 1997
Australian Health Ministers' Advisory Council
OUTCOME OF CONSIDERATION BY THE NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE AT ITS MAY 1997 MEETING OF PROPOSALS FOR ALTERATIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS
Preamble
The information set forth in the Schedule below is the outcome of the consideration by the National Drugs and Poisons Schedule Committee at its meeting on 20-22 May 1997 of the scheduling proposals notified in the Commonwealth of Australia Gazette of 9 April 1997 (Part A) as well as other scheduling proposals (Part B and Part C).
Interested parties are invited to comment and any comment on these decisions should be forwarded by close of business on 24 July 1997 to:
The Secretary
National Drugs and Poisons Schedule Committee
PO Box 100
WODEN ACT 2606
SCHEDULE
PART A - PROPOSALS NOTIFIED IN THE COMMONWEALTH OF AUSTRALIA GAZETTE OF 9 APRIL 1997.
1. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.
(a) BIFONAZOLE - Schedule 4 to Schedule 2 in preparations for dermal use
Outcome
Schedule 2 - New entry
BIFONAZOLE for human use in dermal preparations.
Schedule 4 - Amendment
BIFONAZOLE except when included in Schedule 2.
(b) NICOTINE - Schedule 4 to Schedule 2 for transdermal patches.
Outcome
Schedule 3 - Amendment
NICOTINE - amend entry to read:
NICOTINE as an aid in withdrawal from tobacco smoking
(a) in chewing gum containing 4 mg or less of nicotine except when included in Schedule 2; or
(b) in patches for transdermal delivery.
APPENDIX F, Part 3 - Amendment
Nicotine - amend entry to read:
Nicotine except when in tobacco Safety directions 1,4
or Schedule 2 or Schedule 3
(c) CETIRIZINE - Schedule 4 to Schedule 3 for 10 mg tablets in packs of 10.
Outcome
Schedule 3 - New entry
CETIRIZINE as the only therapeutically active substance in divided preparations for
oral use containing 10 mg or less of cetirizine.
Schedule 4 - Amendment
CETIRIZINE - amend entry to read:
CETIRIZINE except when included in Schedule 3.
(d) LORATADINE - Schedule 3 to Schedule 2 for oral preparations where loratadine is the only therapeutically active ingredient.
Outcome
Deferred pending the receipt of further information.
(e) LORATADINE - Schedule 4 to Schedule 2 for a divided dose preparation containing loratadine and pseudoephedrine.
Outcome
The Committee did not support the proposal.
2. MATTERS REFERRED BY AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC)
(a) Nevirapine - New drug - Schedule required
Outcome
Schedule 4 - New entry
NEVIRAPINE.
3. OTHER MATTERS FOR CONSIDERATION
(a) FLUNITRAZEPAM - Schedule status to be reviewed in view of concerns raised over its abuse.
Outcome
The Committee foreshadowed the following decision:
Schedule 8 - New entry
FLUNITRAZEPAM.
Schedule 4 - Amendment
FLUNITRAZEPAM - delete entry.
(b) MELATONIN - Assessment of scheduling status (safety concerns)
Outcome
Schedule 4 - New entry
MELATONIN for human use.
(c) Schedule 8 review - Review of Schedule 8 drugs (and Schedule 4 counterparts) with no recognised medical use in Australia.
Outcome
Schedule 4 - Amendments
ACETYLDIHYDROCODEINE - Delete entry
NICOCODINE - Delete entry
NICODICODINE - Delete entry
NORCODEINE - Delete entry
Schedule 8 - Amendments
ACETYLDIHYDROCODEINE - Delete entry
ACETYLMORPHINES - Delete entry
ALLYLPRODINE - Delete entry
ALPHAMEPRODINE - Delete entry
ALPHAMETHADOL - Delete entry
BENZETHIDINE - Delete entry
BENZYLMORPHINE - Delete entry
BETACETYLMETHADOL - Delete entry
BETAMEPRODINE - Delete entry
BETAMETHADOL - Delete entry
BETAPRODINE - Delete entry
CLONITAZENE - Delete entry
COCA LEAF - Delete entry
CODEINE-N-OXIDE - Delete entry
CODOXIME - Delete entry
4-CYANO-2-DIMETHYLAMINO-4-DIPHENYLBUTANE - Delete entry
4-CYANO-1-METHYL-4-PHENYLPIPERIDINE - Delete entry
DIAMPROMIDE - Delete entry
DIETHYLTHIAMBUTENE - Delete entry
DIHYDROMORPHINE - Delete entry
DIMENOXADOL - Delete entry
DIMEPHEPTANOL - Delete entry
DIMETHYLTHIAMBUTENE - Delete entry
DIOXAPHETYL BUTYRATE - Delete entry
ECGONINE - Delete entry
ETHYLMETHYLTHIAMBUTENE - Delete entry
ETONITAZENE - Delete entry
ETOXERIDINE - Delete entry
FENETYLLINE - Delete entry
FURETHIDINE - Delete entry
HYDROMORPHINOL - Delete entry
HYDROXYPETHIDINE - Delete entry
ISOMETHADONE - Delete entry
LEVOMETHORPHAN - Delete entry
LEVOPHENACYLMORPHAN - Delete entry
MECLOQUALONE - Delete entry
METAZOCINE - Delete entry
METHYLDESORPHINE - Delete entry
METHYLDIHYDROMORPHINE - Delete entry
2-METHYL-3-MORPHOLINO-1,
1-DIPHENYLPROPANE CARBOXYLIC ACID - Delete entry
1-METHYL-4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID - Delete entry
METOPON - Delete entry
MORPHERIDINE - Delete entry
MORPHINE METHOBROMIDE - Delete entry
MORPHINE-N-OXIDE - Delete entry
MYROPHINE - Delete entry
NICOCODINE - Delete entry
NICODICODINE - Delete entry
NICOMORPHINE - Delete entry
NORACYMETHADOL - Delete entry
NORCODEINE - Delete entry
NORLEVORPHANOL - Delete entry
NORMORPHINE - Delete entry
NORPIPANONE - Delete entry
PHENADOXONE - Delete entry
PHENAMPROMIDE - Delete entry
PHENAZOCINE - Delete entry
PHENOMORPHAN - Delete entry
4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID ETHYL ESTER - Delete entry
PIMINODINE - Delete entry
PROHEPTAZINE - Delete entry
PROPERIDINE - Delete entry
RACEMETHORPHAN - Delete entry
RACEMORPHAN - Delete entry
TRIMEPERIDINE - Delete entry
Schedule 9 - New entries
ACETYLDIHYDROCODEINE.
ACETYLMORPHINES.
ALLYLPRODINE.
ALPHAMEPRODINE.
ALPHAMETHADOL.
BENZETHIDINE.
BENZYLMORPHINE.
BETACETYLMETHADOL.
BETAMEPRODINE.
BETAMETHADOL.
BETAPRODINE.
CLONITAZENE .
COCA LEAF.
CODEINE-N-OXIDE.
CODOXIME.
4-CYANO-2-DIMETHYLAMINO-4-DIPHENYLBUTANE (Methadone intermediate)
4-CYANO-1-METHYL-4-PHENYLPIPERIDINE (Pethidine intermediate A)
DIAMPROMIDE.
DIETHYLTHIAMBUTENE.
DIHYDROMORPHINE.
DIMENOXADOL.
DIMEPHEPTANOL.
DIMETHYLTHIAMBUTENE.
DIOXAPHETYL BUTYRATE.
ECGONINE.
ETHYLMETHYLTHIAMBUTENE.
ETONITAZENE.
ETOXERIDINE.
FENETYLLINE.
FURETHIDINE.
HYDROMORPHINOL.
HYDROXYPETHIDINE.
ISOMETHADONE.
LEVOMETHORPHAN.
LEVOPHENACYLMORPHAN.
MECLOQUALONE.
METAZOCINE.
METHYLDESORPHINE.
METHYLDIHYDROMORPHINE.
2-METHYL-3-MORPHOLINO-1, 1-DIPHENYLPROPANE CARBOXYLIC ACID (Moramide intermediate)
1-METHYL-4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID (Pethidine intermediate C)
METOPON.
MORPHERIDINE.
MORPHINE METHOBROMIDE.
MORPHINE-N-OXIDE.
MYROPHINE.
NICOCODINE.
NICODICODINE.
NICOMORPHINE.
NORACYMETHADOL.
NORCODEINE.
NORLEVORPHANOL.
NORMORPHINE.
NORPIPANONE.
PHENADOXONE.
PHENAMPROMIDE.
PHENAZOCINE.
PHENOMORPHAN.
4-PHENYLPIPERIDINE-4-CARBOXYLIC ACID ETHYL ESTER (Pethidine intermediate B)
PIMINODINE.
PROHEPTAZINE.
PROPERIDINE.
RACEMETHORPHAN.
RACEMORPHAN.
TRIMEPERIDINE.
(d) DICAMBA - The following change to the scheduling of dicamba and its salts and derivatives is proposed and data are sought on an appropriate cut-off to Schedule 5.
Schedule 6 - New entry
DICAMBA (including its salts and derivatives) except when included in Schedule 5.
Schedule 5 - Amendment
DICAMBA - amend entry to read:
DICAMBA (including its salts and derivatives) in preparations containing X per cent or less of dicamba.
Outcome
Deferred pending the receipt of further information.
(e) DIMETHYLACETAMIDE - NDPSC has foreshadowed the inclusion of dimethylacetamide in Schedule 6 and is seeking further toxicological information to allow classification of lower concentrations to less restrictive categories e.g. S5 and exempt.
Outcome
Schedule 6 - New entry
DIMETHYLACETAMIDE except when included in Schedule 5.
Schedule 5 - New entry
DIMETHYLACETAMIDE in preparations containing 20 per cent or less of dimethylacetamide.
PART B - PROPOSALS MADE IN GAZETTAL NOTICES RELATING TO EARLIER MEETINGS
(a) POLYCHLORINATED BIPHENYLS - Review of scheduling status of polybrominated biphenyls
Outcome
The Committee considered that adequate controls on polychlorinated biphenyls were provided by other regulatory bodies.
Schedule 7 - Amendment
POLYCHLORINATED BIPHENYLS - delete entry.
APPENDIX E, Part 2 - Amendment
Polychlorinated biphenyls - delete entry.
APPENDIX J , Part 2 - Amendment
Polychlorinated biphenyls - delete entry.
(b) TESTOSTERONE - Review of Schedule 6 status for implant formulations for animal use.
Outcome
The Committee considered the current scheduling for testosterone implant formulations remained appropriate.
(c) PHOSPHORIC ACID - Review of Appendix E First Aid Instructions.
Outcome
DECISION (FORESHADOWED)
Schedule 6 - New entry
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 and semi-solid preparations; or
(d) in professional dental kits.
Schedule 5 - Amendment
PHOSPHORIC ACID (excluding its salts and derivatives) in preparations containing 35 per cent or less of phosphoric acid except:
(a) in preparations containing 15 per cent or less of phosphoric acid (H3PO4);
(b) in solid and semi-solid preparations; or
(c) in professional dental kits.
(d) COPPER SULFATE - Review of scheduling status
Outcome
Schedule 6 - New entry
COPPER SULFATE except:
(a) when included in Schedule 5;
(b) in preparations for internal use; or
(c) in other preparations containing 5 per cent or less of copper sulfate.
Schedule 5 - Amendment
COPPER SULFATE - amend entry to read:
COPPER SULFATE in preparations containing 15 per cent or less of copper sulfate
except:
(a) in preparations for internal use; or
(b) in other preparations containing 5 per cent or less of copper sulfate.
Appendix E, Part 2 - Amendment
Copper sulfate - amend entry to read:
Copper sulfate.........................a,b,f,s
(e) HYDROCARBONS, LIQUID AROMATIC - Review wording of Schedule 7 entry
Outcome
APPENDIX J Part 2- Amendment
HYDROCARBONS, LIQUID AROMATIC - delete entry
APPENDIX A - Amendment
PRINTING INKS or INK ADDITIVES - amend entry to read:
PRINTING INKS or INK ADDITIVES except when containing a pesticide.
PART C - DECISIONS WITHOUT PRE-MEETING CONSULTATION, AND NOTICE OF REASONS.
(a) MATTERS REFERRED BY AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC)
New drugs - Schedule 4 classification
Desflurane
Tacrolimus
Latanoprost
Toremifene
Tiagabine
Reason
The above decisions were routine classifications of drugs recommended for registration by ADEC
Terfenadine
Following a request from ADEC, the Committee will consider the rescheduling of terfenadine to Schedule 4 at the August 1997 meeting. Interested parties are invited to comment. The Committee will also consider the scheduling of astemizole and loratadine.
(b) DIMETHYLFORMAMIDE
Schedule 6 - Amendment
DIMETHYLFORMAMIDE - amend entry to read:
DIMETHYLFORMAMIDE except:
(a) when included in Schedule 5; or
(b) in silicone rubber mastic containing 2 per cent or less of dimethylformamide.
Schedule 5 - Amendment
DIMETHYLFORMAMIDE - amend entry to read:
DIMETHYLFORMAMIDE in preparations containing 10 per cent or less of dimethylformamide except in silicone rubber mastic containing 2 per cent or less of dimethylformamide.
Reason
The Committee does not wish to schedule silicone rubber mastic containing 2% or less of dimethylformamide.
(c) SODIUM HYDROXIDE AND POTASSIUM HYDROXIDE
The Committee agreed there is a need to consider whether additional safety directions and warning statements are required on products containing sodium hydroxide and potassium hydroxide and that such statements may be use specific. Therefore, the Committee is seeking advice on the range of products and product types that may be affected by such a review.
(d) IRON COMPOUNDS
Schedule 2 - Amendment
IRON COMPOUNDS - amend entry to read:
IRON COMPOUNDS (excluding iron oxides when present as an excipient up to 1 per cent in undivided preparations or up to 10 mg per dosage unit in the casing or coating of divided preparations) for human internal use except:
(a) when included in Schedule 4;
(b) in divided preparations containing 5 mg or less of iron per dosage unit; or
(c) in oral undivided preparations containing 0.1 per cent or less of iron.
Schedule 5 - Amendment
IRON COMPOUNDS - amend entry to read:
IRON COMPOUNDS (excluding up to 1 per cent of iron oxides when present as an excipient) for the treatment of animals, in preparations containing 4 per cent or less of iron except:
(a) in liquid or gel preparations containing 0.1 per cent or less of iron; or
(b) in animal feeds or feed premixes.
Schedule 6 - Amendment
IRON COMPOUNDS - amend entry to read:
IRON COMPOUNDS (excluding up to 1 per cent of iron oxides when present as an excipient) for the treatment of animals except:
(a) when included in Schedule 5;
(b) in liquid or gel preparations containing 0.1 per cent or less of iron; or
(c) in animal feeds or feed premixes.
Reason
The above minor amendment was made to clarify that it was the intent of the Committee to exempt iron oxides from scheduling when used as an excipient in divided preparations containing 10 mg or less of iron oxides or in undivided preparations containing 1% or less of iron oxides.
(e) APPENDIX E AND APPENDIX F - "Changes to Introduction"
SUSDP, Part 2, Division 1 - Amendments
Sub-paragraph 11(1)(n) - amend to read:
(n) if use of the poison may be harmful to the user it should be labelled with safety directions, which must include any safety directions for the poison in Appendix F, grouped together as a distinct section of the label and prefaced by the words -
SAFETY DIRECTIONS
written in bold-face capital letters;
Sub-paragraph 11(1)(p) - amend to read:
(p) if the poison is not for human internal use and is not a Schedule 3,
Schedule 4 or Schedule 8 poison, with appropriate first aid instructions (see Appendix E):
(i) (to remain as is)
(ii) (to remain as is)
SUSDP, Part 2, Division 2 - Amendments
Sub-paragraph 29(5) - amend to read:
(5) safety directions, which must include any safety directions specified for the poison in Appendix F, grouped together as a distinct section of the label and prefaced by the words "SAFETY DIRECTIONS" written in bold-face capital letters;
Sub-paragraph 29(8) - amend to read:
(8) appropriate first aid instructions (see Appendix E), unless the poison is for human internal use or is included in Schedule 3, Schedule 4 or Schedule 8, prefaced by the words "FIRST AID" written in bold-face capital letters.
APPENDIX E, FIRST AID INSTRUCTIONS - Amendments
Amend heading "FIRST AID INSTRUCTIONS" to read:
FIRST AID INSTRUCTIONS FOR POISONS
[other than agricultural and veterinary chemicals (including pesticides) registered by the National Registration Authority for Agricultural and Veterinary Chemicals]
Amend first paragraph to read:
INTRODUCTION
Directions for First Aid Attention
Under poisons legislation, scheduled substances and their preparations are required to be labelled with directions for first aid attention in case of poisoning. The following code has been prepared as a guide for health authorities and manufacturers in drafting suitable first aid directions for this purpose.
APPENDIX E, Part 2 - Amendment
Amend heading 'FIRST AID INSTRUCTIONS' and following statement to read:
FIRST AID INSTRUCTIONS
Standard statements in this Appendix apply to poisons other than agricultural and veterinary chemicals (including pesticides) registered by the National Registration Authority for Agricultural and Veterinary Chemicals. First aid instructions are not required at concentrations below scheduled levels (see the INTRODUCTION to this Appendix).
APPENDIX F - Amendment
Amend heading 'WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS' to read:
WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS FOR POISONS
[other than agricultural and veterinary chemicals (including pesticides) registered by the National Registration Authority for Agricultural and Veterinary Chemicals]
APPENDIX F, Part 3 - Amendment
Amend heading 'POISONS TO BE LABELLED WITH WARNING STATEMENTS OR SAFETY DIRECTIONS' to read:
POISONS (other than agricultural and veterinary chemicals) TO BE LABELLED WITH WARNING STATEMENTS OR SAFETY DIRECTIONS
Reason
The above amendment is to clarify that it is the intent of the Committee that the requirements of the SUSDP do not preclude the addition of other statements that may be required, and to advise that first aid instructions and safety directions for agricultural and veterinary chemicals are found in the Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals.