NDPSC November 1997 post-meeting gazette notice
National Drugs and Poisons Schedule Committee
Published in the Commonwealth of Australia Gazette, 7 January 1998
Australian Health Ministers' Advisory Council
OUTCOME OF CONSIDERATION BY THE NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE AT ITS NOVEMBER 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 18-20 November 1997 of the scheduling proposals notified in the Commonwealth of Australia Gazette of 8 October 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 5 February 1998 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 8 OCTOBER 1997.
1. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.
(a) DEXTROMETHORPHAN - Schedule 4 to Schedule 3 for uncompounded liquid formulations containing 0.3 per cent or less of dextromethorphan. The Committee will also review the scheduling of compounded liquid formulations.
Outcome
Schedule 3 - New entry
DEXTROMETHORPHAN as the only therapeutically active substance in undivided preparations containing 0.3 per cent or less of dextromethorphan with a recommended dose of not more than 30 mg of dextromethorphan and in packs containing not more than 600 mg of dextromethorphan.
Schedule 4 - Amendment
DEXTROMETHORPHAN - amend entry to read:
DEXTROMETHORPHAN except when included in Schedule 2 or 3.
(b) GUAIPHENESIN - Exemption from scheduling for guaiphenesin in oral preparations for therapeutic use.
Outcome
Deferred pending receipt of further information.
(c) COPPER OXYCHLORIDE - Schedule 6.
Outcome
Schedule 6 - New entry
COPPER OXYCHLORIDE except:
(a) when included in Schedule 5; or
(b) in preparations containing 12.5 per cent of less of copper oxychloride.
Schedule 5 - New entry
COPPER OXYCHLORIDE in preparations containing 50 per cent or less of copper oxychloride except in preparations containing 12.5 per cent or less of copper oxychloride.
2. MATTERS REFERRED BY AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC)
(a)NISOLDIPINE - New drug - Schedule required
Outcome
Schedule 4 - New entry
NISOLDIPINE.
(b) IRINOTECAN - New drug - Schedule required
Outcome
Schedule 4 - New entry
IRINOTECAN.
(c) LETROZOLE - New drug - Schedule required
Outcome
Schedule 4 - New entry
LETROZOLE.
(d) ATORVASTATIN - New drug - Schedule required
Outcome
Schedule 4 - New entry
ATORVASTATIN.
(e) REMIFENTANIL - New drug - Schedule required
Outcome
Schedule 8 - New entry
REMIFENTANIL.
(f) MIBEFRADIL - New drug - Schedule required
Outcome
Schedule 4 - New entry
MIBEFRADIL.
(g) BRIMONIDINE - New drug - Schedule required
Outcome
Schedule 4 - New entry
BRIMONIDINE.
3. MATTERS REFERRED BY THE NATIONAL REGISTRATION AUTHORITY FOR AGRICULTURAL AND VETERINARY CHEMICALS
(a) METHYL NEODECANAMIDE - New chemical entity - Schedule required
Outcome
Schedule 6 - New entry
METHYL NEODECANAMIDE except in liquid preparations containing 2 per cent or less of methyl neodecanamide.
(b) XL HIGH BOILING POINT TAR ACIDS - Schedule required
Outcome
Schedule 6 - New entry
TAR ACIDS distilling within the range 230 - 290°C inclusive.
(c) DICYCLANIL - New chemical entity - Schedule required
Outcome
Schedule 6 - New entry
DICYCLANIL except in preparations containing 5 per cent or less of dicyclanil.
(d) MELOXICAM - New chemical entity - Schedule required
Outcome
Schedule 4 - New entry
MELOXICAM.
(e) BEAUVERIA BASSIANA - Schedule required
Outcome
Schedule 6 - New entry
BEAUVERIA BASSIANA except when included in Schedule 5.
Schedule 5 - New entry
BEAUVERIA BASSIANA in preparations containing 1 x 108 Colony Forming Units (CFU)/mL or less of Beauveria bassiana.
(f) METALAXYL M - Schedule required
Outcome
Schedule 6 - New entry
METALAXYL except when included in Schedule 5.
Schedule 5 - Amendment
METALAXYL - amend entry to read:
METALAXYL when included in preparations containing 35 per cent or less of metalaxyl.
4. OTHER MATTERS FOR CONSIDERATION
(a) KAVA (Piper methysticum) - Assessment of scheduling status of preparations for therapeutic use containing kava.
Outcome
The Committee foreshadowed a Schedule 4 entry for kava and its major active components, with exemption from scheduling for therapeutic products containing the equivalent of 100 mg of kava resin per recommended dose. Comment is sought by the Committee on the need for current products to carry a drowsiness warning statement.
(b) DINOPROST, DINOPROSTONE AND GEMEPROST - Need for an Appendix D rider to restrict availability to supply from or on the prescription or order of an authorised medical practitioner.
Outcome
Deferred pending receipt of further information.
(c) NALTREXONE - Consideration for scheduling
Outcome
Schedule 4 - New entry
NALTREXONE.
PART B - PROPOSALS MADE IN GAZETTAL NOTICES RELATING TO EARLIER MEETINGS
(a) QUATERNARY AMMONIUM COMPOUNDS - Review of Scheduling
Outcome
The Committee foreshadowed the following decision:
Schedule 6 - New entry
QUATERNARY AMMONIUM COMPOUNDS except:
(a) when separately specified in these schedules;
(b) when included in Schedule 5;
(c) di-tallow dimethyl ammonium chloride; or
(d) in preparations containing 5 per cent or less of such quaternary ammonium compounds.
Schedule 5 - Amendment
QUATERNARY AMMONIUM COMPOUNDS - amend entry to read:
QUATERNARY AMMONIUM COMPOUNDS in preparations containing 20 per cent or less of quaternary ammonium compounds except:
(a) when separately specified in these schedules;
(b) di-tallow dimethyl ammonium chloride; or
(c) in preparations containing 5 per cent or less of such quaternary ammonium compounds.
(b) N-METHYL-2-PYRROLIDONE - Scheduling
Outcome
Schedule 6 - New entry
N-METHYL-2-PYRROLIDONE except when included in Schedule 5.
Schedule 5 - New entry
N-METHYL-2-PYRROLIDONE
(a) in preparations containing 50 per cent or less of N-methyl-2-pyrrolidone; or
(b) when packed in single-use containers with a volume of 2 mL or less.
(c) FLUNITRAZEPAM - Schedule review
Outcome
Schedule 8 - New entry
FLUNITRAZEPAM.
Schedule 4 - Amendment
FLUNITRAZEPAM - delete entry
The Committee will be reviewing the scheduling of the benzodiazepine class at a future meeting.
PART C - DECISIONS WITHOUT PRE-MEETING CONSULTATION, AND NOTICE OF REASONS.
(a) MATTERS REFERRED BY THE AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC)
New Drugs - Schedule 4 classification
#FOLLITROPIN ALPHA.
NELFINAVIR MESYLATE.
RETEPLASE.
TOLCAPONE.
VINORELBINE.
ZOLMITRIPTAN.
Follitropin alpha was included in the list of substances at Appendix D, paragraph 1.
The Committee also foreshadowed Schedule 4 entries for:
ALTEPLASE
STEPTOKINASE
UROKINASE
Reason
The above decisions were routine classifications of drugs recommended for registration by ADEC. In consideration of reteplase the Committee noted that alteplase, streptokinase and urokinase were not currently scheduled and agreed to foreshadow Schedule 4 entries for these substances.
APPENDIX E, Part 2 - Amendment
Calcium hypochlorite - amend entry to read:
Calcium hypochlorite in preparations containing:
* above 4 per cent and below 10 per
cent of available chlorine ................................a,c,f
* 10 per cent or more of available
chlorine ........................................................a,c,f,s
Reason
It is the intention of the Committee that the first aid instructions for calcium hypochlorite should be consistent with those for chlorinating compounds.
(c) HYDROFLUORIC ACID AND HYDROSILICOFLUORIC ACID
Schedule 7 - Amendment
HYDROFLUORIC ACID - amend entry to read:
HYDROFLUORIC ACID (excluding its salts and derivatives) except when included in Schedule 5 or 6.
Schedule 7 - New entry
HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) except when included in Schedule 5 or 6.
Schedule 6 - Amendment
HYDROFLUORIC ACID - amend entry to read:
HYDROFLUORIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of hydrogen fluoride except when included in Schedule 5.
Schedule 6 - New entry
HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) in preparations containing 12 per cent or less of hydrosilicofluoric acid (H2SiF6) except when included in Schedule 5.
Schedule 5 - Amendment
HYDROFLUORIC ACID - amend entry to read:
HYDROFLUORIC ACID (excluding its salts and derivatives) in preparations containing 0.5 per cent or less of hydrogen fluoride.
Schedule 5 - New entry
HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) in preparations containing 0.5 per cent or less of hydrosilicofluoric acid (H2SiF6).
Reason
The Committee agreed that separate entries for hydrofluoric acid and hydrosilicofluoric acid would clarify the cut-off levels to Schedule 5 and 6 for these acids.
(d) FLUORIDES AND SILICOFLUORIDES
Schedule 6 - Amendment
FLUORIDES - amend entry to read:
FLUORIDES except:
(a) when included in Schedule 2, 3, 4 or 5; or
(b) when separately specified in this schedule; or
(c) in dentifrices containing 1000 mg/kg or less of fluoride ion; or
(d) in preparations containing 15 mg/kg or less of fluoride ion.
Schedule 6 - New entry
SILICOFLUORIDES except:
(a) when included in Schedule 5; or
(b) in preparations containing 15 mg/kg or less of fluoride ion.
Schedule 5 - Amendment
FLUORIDES - amend entry to read:
FLUORIDES in preparations containing 3 per cent or less of fluoride ion except:
(a) when included in Schedule 2, 3, or 4; or
(b) in dentifrices containing 1000 mg/kg or less of fluoride ion; or
(d) in preparations containing 15 mg/kg or less of fluoride ion.
Schedule 5 - New entry
SILICOFLUORIDES in preparations containing 3 per cent or less of fluoride ion
except:
(a) barium silicofluoride when separately specified in this schedule; or
(b) in preparations containing 15 mg/kg or less of fluoride ion.
Reason
Minor amendment for clarity and consistency.
(e) 4-CYANO-2-DIMETHYLAMINO-4,4-DIPHENYLBUTANE
Schedule 8 - Amendment
4-CYANO-2-DIMETHYLAMINO-4,4-DIPHENYLBUTANE - Delete entry
Schedule 9 - Amendment
4-CYANO-2-DIMETHYLAMINO-4-DIPHENYLBUTANE - amend entry to read:
4-CYANO-2-DIMETHYLAMINO-4,4-DIPHENYLBUTANE (Methadone intermediate)
Reason
Minor amendment to correct typographical error.
Schedule 6 - New entry (foreshadowed)
DICHLOROISOCYANURATES.
Schedule 5 - Amendment (foreshadowed)
DICHLOROISOCYANURATES - Delete entry
Reason
The Committee considered toxicological data indicating that a Schedule 6 classification was appropriate for dichloroisocyanurates. Further information is sought on appropriate cut-offs to Schedule 5 and exempt, and also on requirements for the packaging for toilet rim products containing dichloroisocyanurates and trichloroisocyanurates to prevent removal or ingestion of contents when in use.
Schedule 5 - Amendment
VIRGINIAMYCIN - amend entry to read:
VIRGINIAMYCIN
(a) in animal feed premixes or animal feed additives containing 2 per cent or less of virginiamycin activity; or
(b) in animal feed additives for the treatment of acidosis when packed in individual sachets each containing 20 g or less of virginiamycin activity.
Reason
Minor amendment recognising that the Committee considered feed additives and feed premixes should be scheduled in the same way.
APPENDIX D, Paragraph 5 - New entry
PRASTERONE.
Reason
Minor amendment for consistency with the Schedule 4 entry.
(i) ORAL PHOSPHATE LAXATIVE SOLUTIONS
Schedule 4 - New entry
SODIUM PHOSPHATE in preparations for oral use for laxative or bowel cleansing purposes.
Reason
The Committee considered reports of severe adverse reactions in use, including several deaths, justified a Schedule 4 classification for these preparations.