National Drugs and Poisons Schedule Committee Record of the Reasons 36th Meeting 15-17 October 2002 The Record of the Reasons contains the basis of scheduling decisions and other outcomes arising from the meeting. Please note that the Secretariat is moving towards including the edited minutes as the Record of the Reasons. With this document, we have included edited extracts relating to scheduling considerations for OTC medicines, domestic poisons and certain matters related to pesticides. The Secretariat is hopeful of including the edited minutes for all sectors following consultation with the respective industry bodies. National Drugs and Poisons Schedule Committee Record of the Reasons for Meeting 36 - October 2002 i TABLE OF CONTENTS 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............................. 1 2.1 SUSDP, PART 1......................................................................................................................... 1 2.1.1 Definition in Part 1 of the SUSDP for “aqueous preparations” .......................................... 1 2.2 SUSDP, PART 2......................................................................................................................... 1 2.2.1 Variation of Requirement for Clause 7(1)(d)....................................................................... 1 2.4 SUSDP, PART 5 .......................................................................................................................... 2 2.4.1 Pesticides Listed in Appendix J .......................................................................................... 2 2.4.2 Appendix B ........................................................................................................................ 4 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS........................... 14 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ................................ 14 4.1 PESTICIDES IN PAINT.................................................................................................................. 14 4.2 APPENDIX E, PART 1, STATEMENT A – NZ PIC NO. ................................................................... 15 4.3 APPENDIX E, PART 2 - PHENOLS ................................................................................................ 16 4.4 CHLORINATING COMPOUNDS ..................................................................................................... 18 4.5 LITHIUM IN PIGMENTS ............................................................................................................... 23 4.6 INSULIN-LIKE GROWTH FACTORS............................................................................................... 24 6. MATTERS REFERRED BY THE NATIONAL REGISTRATION AUTHORITY FOR AGRICULTURAL AND VETERINARY CHEMICALS ................................................................... 25 6.1 DIRECT-FED MICROBIALS .......................................................................................................... 25 6.2 FLUMIOXAZIN............................................................................................................................ 27 6.3 BIFENAZATE.............................................................................................................................. 27 6.4 TETRACONAZOLE ...................................................................................................................... 27 6.5 CLOTHIANIDIN........................................................................................................................... 28 6.6 MOXIDECTIN ............................................................................................................................. 28 6.7 MAGNESIUM FLUOROSILICATE/SULFUR/ROTENONE.................................................................... 28 6.8 EXTRACT OF LEMON EUCALYPTUS ............................................................................................. 29 6.9 CARBARYL ................................................................................................................................30 6.10 DIQUAT ................................................................................................................................30 6.11 CODLING MOTH GRANULOSIS VIRUS ..................................................................................... 31 8. ANTIBIOTICS FOR CONSIDERATION FOLLOWING RECOMMENDATIONS OF THE JOINT EXPERT TECHNICAL ADVISORY COMMITTEE ON ANTIBIOTIC RESISTANCE (JETACAR) .......................................................................................................................................... 31 8.1 VIRGINIAMYCIN......................................................................................................................... 31 8.2 ANTIBIOTICS IN PREPARATIONS FOR INTRA-MAMMARY INFUSION IN ANIMALS ............................ 31 8.3 FUTURE REVIEWS/TIMETABLE ................................................................................................... 33 8.3.1 Antibiotic Substances Already Gazetted For Review ......................................................... 35 8.3.2 Substances To Be Included In The Post-NDPSC 36 Meeting Gazette Notice...................... 36 PHARMACEUTICALS ....................................................................................................................... 38 13. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ................................ 38 13.1 MELIA AZEDARACH .............................................................................................................. 38 National Drugs and Poisons Schedule Committee Record of the Reasons for Meeting 36 - October 2002 ii 13.2 AZADIRACHTA INDICA (NEEM).............................................................................................. 41 13.3 FLUVOXAMINE AND VENLAFAXINE........................................................................................ 49 13.5 PSEUDOEPHEDRINE ............................................................................................................... 51 13.6 SODIUM PICOSULFATE AND MACROGOL 3350 ........................................................................ 56 13.7 POLYACRYLAMIDE................................................................................................................ 58 13.8 RANITIDINE, CIMETIDINE, FAMOTIDINE AND NIZATIDINE ....................................................... 59 13.9 HYDROCORTISONE/CLOTRIMAZOLE ....................................................................................... 62 14. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...................................................................................... 64 14.1 SUSDP, PART 4.................................................................................................................... 64 14.1.1 Flurbiprofen .................................................................................................................... 64 14.1.2 Acetylcysteine .................................................................................................................. 66 14.1.3 Macrogol 3350, Sodium Phosphate and Sodium Picosulfate ............................................. 69 14.1.4 Budesonide ...................................................................................................................... 70 14.1.5 Mometasone .................................................................................................................... 73 14.1.6 Ibuprofen......................................................................................................................... 77 14.1.7 Oxedrine.......................................................................................................................... 79 14.1.8 Hyoscine Butylbromide .................................................................................................... 82 14.1.9 Iodine .............................................................................................................................. 82 14.2 SUSDP, PART 5.................................................................................................................... 84 14.2.1 Appendix H...................................................................................................................... 84 15. MATTERS REFERRED BY THE AUSTRALIAN DRUG EVALUATION COMMITTEE (ADEC) ................................................................................................................................................. 84 15.1 NEW SUBSTANCES........................................................................................................... 84 15.1.1 Riluzole ........................................................................................................................... 84 15.1.2 Ertapenem....................................................................................................................... 84 15.1.3 Valganciclovir ................................................................................................................. 84 15.1.4 Tenofovir......................................................................................................................... 85 15.1.5 Parecoxib