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National Drugs and Poisons Schedule Committee National Drugs and Poisons Schedule Committee Record of Reasons 41st Meeting 22-23 June 2004 Section 52D(2) of the Therapeutic Goods Act 1989 (the Act) provides the power for the NDPSC to amend the Poisons Standard or prepare a new Standard. The NDPSC takes into account relevant matters mentioned in Section 52E of the Act when making a scheduling decision. 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 Reasons 41 – June 2004 i TABLE OF CONTENTS GLOSSARY.................................................................................................................................................. IV 1.5 ADMINISTRATION ............................................................................................................................... 9 1.5.1 Correction to the Minutes of the NDPSC 38th Meeting – Melaleuca Oil ................................ 9 1.5.2 Correction to the Minutes of the NDPSC 39th (October 2003) & 40th (February 2004) Meetings – Hyoscyamus niger ............................................................................................................. 10 1.8 TRANS-TASMAN HARMONISATION WORKING PARTY...................................................................... 11 1.8.1 Minutes from the 10th (October 2003) TTHWP Meeting....................................................... 11 1.8.1.1 Phenylephrine .......................................................................................................................11 1.8.1.4 Propantheline........................................................................................................................12 1.8.2 Matters arising from previous consideration of TTHWP items............................................. 13 1.8.2.1 Meclozine.............................................................................................................................13 1.8.2.2 Amphotericin........................................................................................................................15 1.8.2.3 Definition for “Day-Night” Preparations..................................................................................17 1.8.2.4 Injectable Preparations...........................................................................................................17 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS...................... 18 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ) ................................... 18 3.1 10,10’-OXYDIPHENOXARSINE (OBPA) .............................................................................................. 18 3.2 CHILD-RESISTANT PACKAGING DEFINITION...................................................................................... 22 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS................................... 26 4.1 EYELASH AND EYEBROWN TINTING PRODUCTS ............................................................................... 26 4.2 METHYLCYCLOPENTADIENYL MANGANESE TRICARBONYL............................................................. 28 4.3 CREOSOTE......................................................................................................................................... 30 4.4 ALKALINE SALTS.............................................................................................................................. 34 4.5 VINCLOZO LIN.................................................................................................................................... 37 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS. .......................................................................................... 39 5.1 SUSDP, PART 4.............................................................................................................................. 39 5.2 SUSDP, PART 5................................................................................................................................ 40 5.2.1 Bifluorides.............................................................................................................................. 40 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY....................................................................................................................... 41 6.1 MOLINATE........................................................................................................................................ 41 6.2 GONADOTROPHIN RELEASING HORMONE ........................................................................................ 44 6.3 POTASSIUM BICARBONATE............................................................................................................... 44 6.4 OCTENOL .......................................................................................................................................... 46 6.5 FIROCOXIB........................................................................................................................................ 48 6.6 QUINCLORAC.................................................................................................................................... 50 6.7 FLUMICLO RAC PENTYL ESTER .......................................................................................................... 51 6.8 PERMETHRIN .................................................................................................................................... 52 7. MATTERS REFERRED BY THE OFFICE OF CHEMICAL SAFETY (OCS)......................... 55 7.1 ANDROSTENEDIONE ALBUMEN CONJUGATE WITH DEA DEXTRAN ADJUVANT.................................. 55 National Drugs and Poisons Schedule Committee Record of Reasons 41 – June 2004 ii 8. ANTIBIOTICS FOR CONSIDERATION FOLLOWING RECOMMENDATIONS OF THE JOINT EXPERT TECHNICAL ADVISORY COMMITTEE ON ANTIBIOTIC RESISTANCE (JETACAR) .................................................................................................................................................. 57 8.1-8.7 SULFONAMIDES....................................................................................................................... 58 8.8 TIAMULIN ......................................................................................................................................... 61 9. OTHER MATTERS FOR CONSIDERATION.............................................................................. 61 9.1 SODIUM HYPOCHLORITE .................................................................................................................. 61 9.2 SODIUM FLUOROACETATE................................................................................................................ 64 10. INITIAL REVIEW AND/OR FORMAL OPINIONS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS).............................................................................................................................................. 65 11. INFORMATION ITEMS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)................ 66 PHARMACEUTICALS .............................................................................................................................. 67 12. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ) ................................... 67 12.1 TRIAMCINOLONE ......................................................................................................................... 67 12.2 SODIUM FLUORIDE ...................................................................................................................... 68 12.3 MITRAGYNA SPECIOSA................................................................................................................ 72 13. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS................................... 76 13.1 MELIA AZEDARACH..................................................................................................................... 76 13.2 PANCREATIC ENZYMES................................................................................................................ 79 13.3 PSEUDOEPHEDRINE...................................................................................................................... 81 13.4 MEDIC AL DEVICES ...................................................................................................................... 86 13.5 KAVA AND KAVALACTONES........................................................................................................ 88 13.6 ARIPIPRAZOLE............................................................................................................................. 90 13. 7-13.9 [ITEMS DELETED ]..................................................................................................................... 91 13.10 IBUPROFEN .................................................................................................................................. 91 14. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS. ........................................................................................ 100 14.1 SUSDP, PART 4........................................................................................................................
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