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NDPSC Record of Reasons February 2009

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NDPSC Record of Reasons February 2009 National Drugs and Poisons Schedule Committee Record of Reasons 55th Meeting 17-18 February 2009 CAUTION: THIS DOCUMENT MAY CONTAIN COMMERCIALLY CONFIDENTIAL INFORMATION SECTION 162(1) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE AG/VET CODE) CREATES AN OFFENCE FOR UNAUTHORISED DISCLOSURE OF COMMERCIALLY CONFIDENTIAL INFORMATION. SECTION 162(8) OF THE AG/VET CODE EXTENDS THIS PROVISION TO AUTHORITIES OR PERSONS TO WHOM SUCH INFORMATION IS DIVULGED FOR THE EXERCISE OF THEIR DUTIES. National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 55 – February 2009 i TABLE OF CONTENTS GLOSSARY................................................................................................................................................ IV 1. PRELIMINARY MATTERS..............................................................................................................1 1.5 ADMINISTRATION ...................................................................................................................1 1.5.1 Elimination of the 16 Week Submission Cut-Off......................................................................1 1.5.2 Electronic SUSDP ...................................................................................................................6 1.5.3 Scheduling/Rescheduling Template .........................................................................................7 1.7 PROCEDURAL MATTERS......................................................................................................11 1.7.1 Operations/Policies of the Committee ...................................................................................11 1.7.1.1 Endorsement of references in the new Poisons Standard (SUSDP No.24)................................. 11 1.7.1.2 Endorsement of the new Poisons Standard (SUSDP No.24)...................................................... 12 1.8 NDPSC WORKING PARTIES ..................................................................................................12 1.8.1 Codeine Working Party .........................................................................................................12 1.8.2 Globally Harmonised System (GHS) for Classification and Labelling of Chemicals (Standing Item).....................................................................................................................................32 1.9 PROPOSED ROUTINE CHANGES TO THE SUSDP..............................................................33 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1 TO 3 AND PART 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.............................33 2.1 SUSDP, PART 1.........................................................................................................................33 2.1.1 Part 1, Interpretation – “approved name”............................................................................33 2.1.2 Definition of Compounded.....................................................................................................33 2.2 SUSDP, PART 2.........................................................................................................................42 2.3 SUSDP, PART 3.........................................................................................................................42 2.3.1 Schedule 5 and Schedule 6 storage statements......................................................................42 2.4 SUSDP, PART 5.........................................................................................................................45 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS......................45 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY(1)(c)) ..........................45 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS...................................45 4.1 LIQUID HYDROCARBONS – FOOD & PHARMACEUTICAL GRADE WHITE MINERAL OIL ...................45 4.2 PROTHIOCONAZOLE-DESCHLORO & PROTHIOCONAZOLE-TRIAZOLIDINETHIONE.........................55 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................................................................................58 5.1 SUSDP, PART 4.........................................................................................................................58 5.1.1 Ethylene glycol and diethylene glycol....................................................................................58 5.1.2 Guanidine ..............................................................................................................................74 5.2 SUSDP, PART 5.........................................................................................................................83 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY (APVMA)....................................................................................................83 6.1 TRALOPYRIL................................................................................................................................83 6.2 DIQUAT .......................................................................................................................................83 6.3 EUBACTERIUM SPP. STRAIN DSM 11798....................................................................................83 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 55 – February 2009 ii 7. MATTERS REFERRED BY OFFICE OF CHEMICAL SAFETY (OCS) OR THE NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS)............89 8. OTHER MATTERS FOR CONSIDERATION ..............................................................................89 8.1 N-PHENETHYL-4-PIPERIDONE......................................................................................................89 8.2 4-FLUORO-N-METHYLAMPHETAMINE..........................................................................................92 8.3 1-(8-BROMOBENZO[1,2-B;4,5-B’]DIFURAN-4-YL)-2-AMINOPROPANE (BROMODRAGONFLY) ......93 9. INFORMATION ITEMS (AG/VET, INDUSTRIAL & DOMESTIC CHEMICALS)................96 PHARMACEUTICALS..............................................................................................................................96 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCY(1)(c)............................96 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ..............................96 11.1 PHOSPHODIESTERASE TYPE 5 INHIBITORS....................................................................................96 11.2 HYDROQUINONE .......................................................................................................................100 11.3 CODEINE IN COMBINATION WITH AMMONIUM CHLORIDE AND MENTHOL ..................................110 12. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.........................................................................................113 12.1 SUSDP, PART 4.......................................................................................................................113 12.1.1 Famciclovir for herpes labialis.......................................................................................113 12.1.2 XXXXX ............................................................................................................................120 12.1.3 Guaiphenesin ..................................................................................................................121 12.1.4 Diclofenac.......................................................................................................................126 12.1.5 Piper methysticum (kava)................................................................................................132 12.1.6 Tetrahydrocannabinol (THC) and cannabidiol (CBD)...................................................142 12.1.7 Magnesium sulfate ..........................................................................................................148 12.2 SUSDP, PART 5.......................................................................................................................152 12.2.1 Ibuprofen.........................................................................................................................152 12.2.2 Pantoprazole...................................................................................................................159 13. MATTERS REFERRED BY THE REGISTRATION PROCESS FOR PRESCRIPTION MEDICINES..............................................................................................................................................167 13.1 NEW SUBSTANCES (NOT SEEN BEFORE BY THE NDPSC) .....................................................167 13.1.1 Gemtuzumab ozogamicin................................................................................................167 13.1.2 Cilostazol ........................................................................................................................169 13.1.3 Bazedoxifene ...................................................................................................................170 13.1.4 Ambrisentan....................................................................................................................171 13.1.5 Methylnaltrexone ............................................................................................................172
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