National Drugs and Poisons Schedule Committee Record of the Reasons 37th Meeting 25-26 February 2003 The Record of the Reasons contains the basis of scheduling decisions and other outcomes arising from the meeting. Please note that the Record of the Reasons includes extracts from the NDPSC minutes which have been edited to remove confidential information. National Drugs and Poisons Schedule Committee Record of the Reasons Meeting 37 - February 2003 i TABLE OF CON TEN TS GLOSSARY.........................................................................................................................IV 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1 TO 3 AND PART 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS. ........................9 2.1 SUSDP, PART 1 ..........................................................................................................9 2.2 SUSDP, PART 2 ..........................................................................................................9 2.3 SUSDP, PART 3 ..........................................................................................................9 2.3.1 Organotin Compounds...........................................................................................9 2.4.1 BORON TRIFLUORIDE, BIFLUORIDES AND HYDROSILICOFLUORIC ACID – APPENDIX F PART 3 ...9 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS.................. 11 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ).............................. 11 3.1 FLUMIOXAZIN ............................................................................................................ 11 3.2 CHLORINATING COMPOUNDS......................................................................................... 12 3.3 EXTRACT OF LEMON EUCALYPTUS.................................................................................. 15 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ............................ 17 4.1 VARIATION OF REQUIREMENT FOR CLAUSE 7(1)(D)............................................................ 17 4.2 APPENDIX B............................................................................................................... 20 4.3 LITHIUM IN PIGMENTS .................................................................................................. 31 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS............................................................................ 32 5.2 SUSDP, PART 5 ........................................................................................................ 32 5.2.1 Sodium Hydroxide............................................................................................... 32 5.3 WARNING STATEMENTS AND GENERAL SAFETY DIRECTIONS ESTABLISHED BY CPAS FOR AGRICULTURAL AND VETERINARY CHEMICALS (STANDING AGENDA ITEM)....................................... 35 6. MATTERS REFERRED BY THE NATIONAL REGISTRATION AUTHORITY FOR AGRICULTURAL AND VETERINARY CHEMICALS ........................................................... 36 6.1 FENBUCONAZOLE........................................................................................................ 36 6.2 MORANTEL TARTRATE ................................................................................................. 37 6.3 BACILLUS SPHAERICUS STRAIN 2362 ............................................................................... 38 6.4 CADUSAFOS ............................................................................................................... 39 6.5 MARBOFLOXACIN........................................................................................................ 42 6.6 IVERMECTIN ............................................................................................................... 43 7. MATTERS REFERRED BY SCIENTIFIC DIRECTOR OF THE NON-PRESCRIPTION MEDICINES BRANCH ......................................................................................................... 44 8. ANTIBIOTICS FOR CONSIDERATION FOLLOWING RECOMMENDATIONS OF THE JOINT EXPERT TECHNICAL ADVISORY COMMITTEE ON ANTIBIOTIC RESISTANCE (JETACAR).......................................................................................................................... 44 8.1 VIRGINIAMYCIN.......................................................................................................... 45 8.2 BACITRACIN............................................................................................................... 47 8.3 CUPRIMYXIN.............................................................................................................. 49 National Drugs and Poisons Schedule Committee Record of the Reasons Meeting 37 - February 2003 ii 8.4 ERYTHROMYCIN.......................................................................................................... 50 8.5 HYGROMYCIN............................................................................................................. 51 8.6 NALIDIXIC ACID ......................................................................................................... 52 8.7 NISIN........................................................................................................................ 52 8.8 SPIRAMYCIN............................................................................................................... 53 8.9 AVOPARCIN ............................................................................................................... 54 9. OTHER MATTERS FOR CONSIDERATION................................................................. 55 10. INITIAL REVIEW AND/OR FORMAL OPINIONS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)......................................................................................................................55 11. INFORMATION ITEMS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)............. 56 PHARMACEUTICALS ......................................................................................................... 57 12. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ).............................. 57 12.1 AZADIRACHTA INDICA (NEEM)................................................................................... 57 12.2 POLYACRYLAMIDE................................................................................................... 65 13. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ............................ 68 13.1 CLOBETASONE, ALCLOMETASONE AND HYDROCORTISONE.............................................. 68 13.2 PSEUDOEPHEDRINE.................................................................................................. 70 13.3 COLLAGEN, HYALURONIC ACID, POLYLACTIC ACID ....................................................... 73 13.4 IRON COMPOUNDS................................................................................................... 75 13.5 (DELETED)............................................................................................................. 76 13.6 OXEDRINE ............................................................................................................. 76 14. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS............................................................................ 79 14.1 SUSDP, PART 4 .................................................................................................... 79 14.1.1 Lansoprazole..................................................................................................... 79 14.1.2 Ketoprofen......................................................................................................... 85 14.1.3 Dextromethorphan............................................................................................... 88 14.1.4 Orlistat............................................................................................................. 94 14.1.5 Nabilone..........................................................................................................102 14.1.6 beclomethasone..................................................................................................105 14.1.7 Mitragynine......................................................................................................108 14.2 SUSDP, PART 5 ...................................................................................................110 14.2.1 APPENDIX H....................................................................................................110 14.2.1.1 Sodium Phosphate........................................................................................110 15. MATTERS REFERRED BY THE AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC)...............................................................................................................................115 15.1 NEW SUBSTANCES.............................................................................................115 15.1.1 Tadalafil..........................................................................................................115 15.1.2 Etoricoxib.........................................................................................................116 15.1.3 Valdecoxib........................................................................................................116 15.1.4 Pegfilgrastim ....................................................................................................117