National Drugs and Poisons Schedule Committee Record of Reasons 46th Meeting 21-23 February 2006 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 46 – February 2006 i TABLE OF CONTENTS GLOSSARY................................................................................................................................................ IV 1.7....................................................................................................................................................................1 1.8 NDPSC WORKING PARTIES ..........................................................................................................1 1.8.1 .......................................................................................................................................................1 1.8.1.2 Substances Identified in the OZNZ Scheduling Database as Unharmonised ............................... 1 1.8.1.2.1 Aconitum SPP.............................................................................................................................. 1 1.8.1.2.2 Acrivastine, Amidopyrine and Atosiban ..................................................................................... 4 1.8.1.2.3 Amorolfine................................................................................................................................... 5 1.8.1.2.4 Amphotericin .............................................................................................................................. 6 1.8.1.2.5 Antimony Organic Compounds .................................................................................................. 6 1.8.1.2.6 Aspirin ........................................................................................................................................ 8 1.8.1.2.7 Atropa Belladonna and Hyoscyamus Niger ................................................................................ 9 1.8.1.2.8 Beclomethasone and Budesonide.............................................................................................. 10 1.8.1.2.9 Boron/Boric Acid...................................................................................................................... 10 1.8.1.2.10 Camphorated Oil..................................................................................................................... 12 1.8.1.2.11 Cathine.................................................................................................................................... 14 1.8.1.2.12 Cephacetrile, Cephaloridine, Cephamandole and Cephapirin ................................................. 16 1.8.1.2.13 Cephazolin .............................................................................................................................. 16 1.8.1.2.14 Dibrompropamidine and Propamidine ................................................................................... 16 1.8.1.2.16 Mercury Organic Compounds................................................................................................. 18 1.8.1.2.17 Pirfenoxone Sodium (Catalin)................................................................................................. 19 1.8.1.2.18 Blood Products........................................................................................................................ 19 1.8.2.1 Outcomes of the TTHWP Meeting 15 (Cyclizine and Recombinant Medicines Nomenclature) 19 1.8.2.1.1 Cyclizine............................................................................................................................... 19 1.8.2.1.2 Recombinant Medicines........................................................................................................ 22 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1 TO 3 AND PART 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS.............................24 2.1 SUSDP, PART 1 ..........................................................................................................................24 2.2 SUSDP, PART 2 ..........................................................................................................................24 2.2.1 Approved Name for Amines Used as Curing Agents for Epoxy Resins .................................24 2.2.2 Storage Statements for Schedule 5 and 6 Products ...............................................................26 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS......................32 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ)....................................32 4. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS...................................32 4.1 PARAQUAT ..................................................................................................................................32 4.2 ALKALINE SALTS ........................................................................................................................37 4.2.1 LYE WATER ..................................................................................................................43 4.3 CHLORHEXIDINE .........................................................................................................................47 5. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................................................................................54 5.1 SUSDP, PART 4 ..........................................................................................................................54 5.1.1 Cysteamine Hydrochloride ....................................................................................................54 5.1.2 Sodium Polystyrene Sulphonate.............................................................................................59 National Drugs and Poisons Schedule Committee Record of Reasons of Meeting 46 – February 2006 ii 6. MATTERS REFERRED BY THE AUSTRALIAN PESTICIDES AND VETERINARY MEDICINES AUTHORITY. .....................................................................................................................63 6.1 PROHEXADIONE CALCIUM...........................................................................................................63 6.2 FLORASULAM..............................................................................................................................64 6.3 AMICARBAZONE..........................................................................................................................65 7. MATTERS REFERRED BY OFFICE OF CHEMICAL SAFETY (OCS) BRANCH................66 7.1 INDUSTRIAL BIOCIDES.................................................................................................................66 PHARMACEUTICALS..............................................................................................................................71 10. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ)....................................71 10.1 PHENYLEPHRINE .........................................................................................................................71 10.2 PARACETAMOL............................................................................................................................73 11. OTHER OUTSTANDING MATTERS FROM PREVIOUS MEETINGS ..............................75 11.1 PSEUDOEPHEDRINE .....................................................................................................................75 11.2 SEDATING ANTIHISTAMINES (BROMPHENIRAMINE, CHLORPHENIRAMINE, DEXCHLORPHENIRAMINE, DIPHENYLPYRALINE, DOXYLAMINE, PHENIRAMINE, THENYLDIAMINE, TRIMEPRAZINE, TRIPROLIDINE).................................................................................................................................77 11.2.1 SEDATING ANTIHISTAMINES IN TRAVEL SICKNESS PRODUCTS (CYCLIZINE, DIMENHYDRINATE, DIPHENHYDRAMINE, MECLOZINE AND PROMETHAZINE) ........................82 11.3 AMISULPRIDE..............................................................................................................................84 11.4 BLOOD PRODUCTS – APPENDIX A...............................................................................................86 11.4.1 Octocog Alfa .....................................................................................................................91 11.4.2 Human Plasma-Derived Protein C...................................................................................92 11.5 DEFINITION OF COMPOUNDED.....................................................................................................92 11.6 PANTOPRAZOLE ..........................................................................................................................95 12. PROPOSED CHANGES/ADDITIONS TO THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS...........................................................................................97 12.1 SUSDP, PART 4 ..........................................................................................................................97 12.1.1 Ketotifen............................................................................................................................97 12.1.2 Azelastine Hydrochloride................................................................................................101 12.1.3 Ibuprofen (400 mg Tablet) ..............................................................................................104