National Drugs and Poisons Schedule Committee Record of Reasons 53rd Meeting 17-18 June 2008 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 53 – June 2008 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 Interpretation of aerosol concentration in the SUSDP............................................................1 2.2 SUSDP, PART 2...........................................................................................................................1 2.3 SUSDP, PART 3...........................................................................................................................1 2.4 SUSDP, PART 5...........................................................................................................................1 2.4.1 Appendix I (The Uniform Paint Standard - UPS) including lead in paints or tinters..............1 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS......................19 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ)....................................19 3.1 PYRITHIONE ZINC ........................................................................................................................19 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS...................................25 4.1 1,4-BUTANEDIOL.........................................................................................................................25 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................................................................................33 5.1 SUSDP, PART 4.........................................................................................................................33 5.1.1 Carbendazim..........................................................................................................................33 5.1.2 Octhilinone ............................................................................................................................35 5.1.3 Methylnorbornylpyridine (MNBP) ........................................................................................37 5.2 SUSDP, PART 5.........................................................................................................................42 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY (APVMA)....................................................................................................42 6.1 PROTHIOCONAZOLE ....................................................................................................................42 6.2 FLUOXETINE................................................................................................................................47 6.3 MAROPITANT ..............................................................................................................................50 6.4 SPIROTETRAMAT .........................................................................................................................52 6.5 DELTAMETHRIN ..........................................................................................................................61 6.6 ABAMECTIN ................................................................................................................................67 6.7 COUMAPHOS ...............................................................................................................................72 6.8 CYANOGEN (ETHANEDINITRILE) .................................................................................................79 7. MATTERS REFERRED BY OFFICE OF CHEMICAL SAFETY (OCS) OR THE NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)............86 7.1 ATROPINE....................................................................................................................................86 7.2 METHYLDIBROMO-GLUTARONITRILE (MDBGN)........................................................................90 7.3 DIETHYLENE GLYCOL (DEG) ......................................................................................................96 8. OTHER MATTERS FOR CONSIDERATION ............................................................................101 9. INFORMATION ITEMS (AG/VET, INDUSTRIAL AND DOMESTIC CHEMICALS).........101 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 53 – June 2008 ii PHARMACEUTICALS............................................................................................................................102 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY(1)(C)) .......................102 10.1 SEDATING ANTHIHISTAMINES....................................................................................................102 10.2 FLUORIDES ................................................................................................................................107 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETING ..............................118 11.1 CODEINE AND IBUPROFEN COMBINATIONS ................................................................................118 11.2 BORON ......................................................................................................................................145 12. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.........................................................................................155 12.1 SUSDP, PART 4.......................................................................................................................155 12.1.1 Oseltamivir......................................................................................................................155 13. MATTERS REFERRED BY THE REGISTRATION PROCESS FOR PRESCRIPTION MEDICINES..............................................................................................................................................176 13.1 NEW SUBSTANCES (NOT SEEN BEFORE BY THE NDPSC) .....................................................176 13.1.1 Raltegravir......................................................................................................................177 13.1.2 Maraviroc .......................................................................................................................178 13.1.3 Nitric Oxide.....................................................................................................................179 13.1.4 Rotigotine........................................................................................................................181 13.1.5 Lenalidomide ..................................................................................................................182 13.1.6 Alglucosidase alfa...........................................................................................................185 13.1.7 Temsirolimus...................................................................................................................186 13.1.8 Idursulfase ......................................................................................................................187 13.2 FOR INFORMATION (SUBSTANCES ALREADY SCHEDULED) ..................................................188 13.2.1 Vildagliptin .....................................................................................................................188 13.2.2 Nilotinib ..........................................................................................................................189 13.2.3 Sitagliptin........................................................................................................................190 13.2.4 Sertindole........................................................................................................................191 13.2.5 Levosimendan .................................................................................................................191 13.2.6 Insulin human (inhaled)..................................................................................................192 13.2.7 Fluticasone furoate .........................................................................................................193 13.2.8 Human normal immunoglobulin .....................................................................................194 14. OTHER MATTERS FOR CONSIDERATION .......................................................................196 14.1 HYDROQUINONE .......................................................................................................................196 15. MATTERS REFERRED BY THE MEDICINES EVALUATION COMMITTEE (MEC).198 15.1 ITEM DELETED...........................................................................................................................198 15.2 GLYCERYL TRINITRATE.............................................................................................................198