National Drugs and Poisons Schedule Committee Record of Reasons 49th Meeting 20-22 February 2007 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 49 – 20-22 February 2007 i TABLE OF CONTENTS GLOSSARY................................................................................................................................................ IV 1. PRELIMINARY MATTERS..............................................................................................................8 1.7 PROCEDURAL MATTERS........................................................................................................8 1.7.1 Operations/Policies of the Committee .....................................................................................8 1.7.1.1 [Item Deleted] .............................................................................................................................. 8 1.7.1.2 Guidelines for confidential information - Medicines ................................................................... 8 1.7.1.3 Derivative Usage in the SUSDP................................................................................................. 13 1.8 NDPSC WORKING PARTIES ..................................................................................................17 1.8.1 Trans-Tasman Harmonisation Working Party ......................................................................17 1.8.1.1 Foreshadowed harmonisation proposals – hyaluronidase and methyl salicylate........................ 17 1.8.1.2 Deferred harmonisation proposals from the June 2006 NDPSC Meeting .................................. 24 1.8.1.2.1 Aspirin combined with caffiene, paracetamol or salicylamide ............................................. 24 1.8.1.2.2 Iron compounds, selenium, vitamin A .................................................................................. 39 1.8.1.2.3 Laxatives (aloes for internal use, aloin, bisacodyl, colocynth, ipomoea, jalap resin, sennosides, sodium picosulphate) .............................................................................................................. 48 1.8.1.2.4 Medicines in Schedules 5, 6 or 7 which are in a New Zealand medicines classification – nicotine, picric acid, pyrethrins, sodium hydroxide, tar and xylenols........................................................ 55 1.8.1.2.5 Other deferred harmonisation proposals -ketoprofen, meptazinol, pyrithione zinc .............. 62 1.8.1.3.2 Cadmium Compounds Including Cadmium Sulphide........................................................... 68 1.8.1.4 Post-meeting comment on the October 2006 harmonisation decision – quaternary ammonium compounds, alendronic acid, cobalt, ethylhexanediol, hexoprenaline, nicotinic acid, potassium chloride, rifamycin, thyrotropin-releasing factor, vecuronium, viprynium (pyrvinium), vitamin D .............................. 71 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1, 2, 3 AND 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.............................................................80 2.1 SUSDP, PART 1.........................................................................................................................80 2.1.1 Interpretation of aerosol concentration in the SUSDP..........................................................80 2.2 SUSDP, PART 2.........................................................................................................................84 2.3 SUSDP, PART 3.........................................................................................................................84 2.3.1 [Item Deleted]........................................................................................................................84 2.3.2 Storage statements for Schedule 2.........................................................................................84 2.4 SUSDP, PART 5.........................................................................................................................90 2.4.1 Appendix A exemption for medical devices............................................................................90 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS......................94 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY) ...................................94 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS...................................94 4.1 METHYL METHACRYLATE AND ETHYL METHACRYLATE............................................................94 4.2 BASIC ORANGE 31.....................................................................................................................100 4.3 SULFENTRAZONE.......................................................................................................................105 4.4 CLOTHIANIDIN ..........................................................................................................................107 4.5 GHRH INJECTABLE PLASMID ...................................................................................................108 4.6 2,4-DICHLOROPHENOXYACETIC ACID.......................................................................................109 4.7 DICHLORPROP-P........................................................................................................................111 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 49 – 20-22 February 2007 ii 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.........................................................................................112 5.1 SUSDP, PART 4.......................................................................................................................112 5.1.1 Hydrocarbons, Liquid..........................................................................................................112 5.2 SUSDP, PART 5.......................................................................................................................114 5.2.1 Appendix J ...........................................................................................................................114 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY. ...................................................................................................................118 6.1 BIFENTHRIN ..............................................................................................................................118 6.2 BETACYFLUTHRIN.....................................................................................................................119 6.3 HYDROCORTISONE ACEPONATE................................................................................................120 6.4 PYRASULFATOLE.......................................................................................................................121 6.5 PROCYMIDONE ..........................................................................................................................121 7. MATTERS REFERRED BY THE OFFICE OF CHEMICAL SAFETY (OCS) OR THE NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)...................................................................................................................................................122 7.1 5,6-DIHYDROXYINDOLINE .........................................................................................................122 8. OTHER MATTERS FOR CONSIDERATION ............................................................................128 8.1 DIMETHICODIETHYLBENZALMALONATE (POLYSILICONE-15) ...................................................128 8.2 LABELLING FOR COMPOSITE PACK HAIR PREPARATIONS INCLUDING THOSE CONTAINING PHENYLENEDIAMINES AND TOLUENEDIAMINE .........................................................................................130 PHARMACEUTICALS............................................................................................................................135 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (POST- MEETING SUBMISSIONS UNDER 42ZCY)........................................................................................135 10.1 FLUORIDE..................................................................................................................................135 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ............................141 11.1 SEDATING ANTIHISTAMINES - BROMPHENIRAMINE, CHLORPHENIRAMINE, DEXCHLORPHENIRAMINE, DIPHENHYDRAMINE, DIPHENYLPYRALINE, DOXYLAMINE, PHENIRAMINE, PROMETHAZINE, TRIMEPRAZINE, TRIPROLIDINE .....................................................................................141 11.2 PANTOPRAZOLE ........................................................................................................................156 11.3 ORLISTAT..................................................................................................................................157 11.4 TOPICAL CORTICOSTEROIDS –ALCLOMETASONE, CLOBETASONE, MOMETASONE.....................177 11.5 PARACETAMOL 665 MG TABLETS ..............................................................................................193 11.6 TRANEXAMIC ACID....................................................................................................................196 11.7 SUMATRIPTAN...........................................................................................................................198