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National Drugs and Poisons Schedule Committee National Drugs and Poisons Schedule Committee Record of Reasons 56th Meeting 16-17 June 2009 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 56 – June 2009 i TABLE OF CONTENTS GLOSSARY................................................................................................................................................ IV 1. PRELIMINARY MATTERS..............................................................................................................1 1.5 ADMINISTRATION..........................................................................................................................1 1.5.1 Schedule for Future NDPSC Meetings ....................................................................................1 1.5.2 Meeting Date for the October 2009 Meeting...........................................................................1 1.6 XXXXX .......................................................................................................................................1 1.7 PROCEDURAL MATTERS................................................................................................................1 1.8 NDPSC WORKING PARTIES ..........................................................................................................1 1.9 PROPOSED ROUTINE CHANGES TO THE SUSDP ............................................................................1 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 2.2 SUSDP, PART 2...........................................................................................................................1 2.3 SUSDP, PART 3...........................................................................................................................1 2.4 SUSDP, PART 5...........................................................................................................................2 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS........................3 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY(1)(c)) ............................3 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS.....................................3 4.1 GUANIDINE ...................................................................................................................................3 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.............................................................................................9 5.2 SUSDP, PART 5.........................................................................................................................10 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY (APVMA)....................................................................................................10 6.1 MONEPANTEL..............................................................................................................................10 6.2 SAFLUFENACIL............................................................................................................................15 7. MATTERS REFERRED BY OFFICE OF CHEMICAL SAFETY AND ENVIRONMENTAL HEALTH (OCS&EH) OR THE NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)........................................................................................................20 8. OTHER MATTERS FOR CONSIDERATION ..............................................................................20 9. INFORMATION ITEMS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)................20 PHARMACEUTICALS..............................................................................................................................21 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY(1)(c)............................21 10.1 GUAIPHENESIN ............................................................................................................................21 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 56 – June 2009 ii 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ..............................23 11.1 ARBUTIN .....................................................................................................................................23 11.2 XXXXX .....................................................................................................................................31 11.3 SCHEDULING OF OTC PRODUCTS CONTAINING CODEINE ...........................................................32 11.4 MAGNESIUM SULFATE ................................................................................................................63 11.5 PIPER METHYSTICUM (KAVA).....................................................................................................67 11.6 SOMATROPIN...............................................................................................................................75 11.7 HYDROQUINONE .........................................................................................................................75 11.8 CLARIFICATION OF THE SCHEDULING OF CODEINE IN COMBINATION WITH MENTHOL & AMMONIUM CHLORIDE ...............................................................................................................81 12. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................................................................................84 12.1 SUSDP, PART 4.........................................................................................................................84 12.1.1 Fexofenadine.....................................................................................................................84 12.1.2 HMG-CoA Reductase Inhibitors (Statins) ........................................................................87 12.1.3 Loperamide .......................................................................................................................93 12.1.4 Rabeprazole ....................................................................................................................101 12.1.5 Succimer (DMSA) ...........................................................................................................119 12.2 SUSDP, PART 5.......................................................................................................................125 12.2.1 Di-Iodohydroxyquinoline (Iodoquinol)...........................................................................125 13. MATTHERS REFERRED BY THE REGISTRATION PROCESS FOR PRESCRIPTION MEDICINES..............................................................................................................................................128 13.1 NEW SUBSTANCES (NOT SEEN BEFORE BY NDPSC).....................................................................128 13.1.1 Doripenem ......................................................................................................................128 13.1.2 Japanese Encephalitis Vaccine.......................................................................................130 13.1.3 Human Papillomavirus Vaccine .....................................................................................132 13.2 FOR INFORMATION (SUBSTANCES ALREADY SCHEDULED).........................................................135 14. OTHER MATTERS FOR CONSIDERATION .......................................................................135 15. MATTERS REFERRED BY THE MEDICINES EVALUATION COMMITTEE (MEC).135 16. MATTERS REFERRED BY THE MEDICINES CLASSIFICATION COMMITTEE (MCC) OF NEW ZEALAND ................................................................................................................................135 16.1.1 Golimumab......................................................................................................................135 16.1.2 Lacosamide .....................................................................................................................136 16.1.3 Liraglutide ......................................................................................................................138 16.1.4 Prasugrel ........................................................................................................................139 16.2 MEDICINES HARMONISED – FOR INFORMATION........................................................................140 16.2.1 Anidulafungin..................................................................................................................140 16.2.2 Blood and Blood Products ..............................................................................................140 16.2.3 Desvenlafaxine................................................................................................................141 16.2.4 Fluorides.........................................................................................................................141 16.2.5 Glyceryl Trinitrate for Rectal Use ..................................................................................141 16.2.6 Ketotifen Fumarate 0.025 Per Cent for Ophthalmic
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