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NDPSC record of reasons, 39th meeting, 14-16 October 2003

National Drugs and Poisons Schedule Committee

The Record of the Reasons contains the basis of scheduling decisions and other outcomes arising from the meeting. Please note that the Record of the Reasons includes extracts from the NDPSC minutes which have been edited to remove confidential information.

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Contents

Glossary
  • 1.8.1.2.1 Unscheduled Injectables
  • 1.8.1.2.2 Fluorides
  • 1.8.1.2.3 Sedating/Hypnotic Antihistamines (promethazine, doxylamine and diphenhydramine)
    • 1.8.1.2.3.1 Promethazine
    • 1.8.1.2.3.2 Meclozine
    • 1.8.1.2.3.3 Dimenhydrinate
  • 1.8.1.2.4 Nitrofuran
Schedule 4 - Amendments
  • 1.8.1.2.5 Nifursol
  • 1.8.1.2.6 Nimorazole
  • 1.8.1.3 Matters arising from NDPSC Consideration of TTHWP Items
    • 1.8.1.3.1 Hydroquinone
    • 1.8.1.3.2 Paracetamol
    • 1.8.1.3.3 Aspirin
    • 1.8.1.3.4 Pyridoxine
    • 1.8.1.3.5 Amphotericin
    • 1.8.1.3.6 Part 2 labels and containers
    • 1.8.1.3.7 Nicotine in NRT

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2. Proposed changes/additions to Parts 1 to 3 and Part 5 of the Standard for the Uniform Scheduling of Drugs and Poisons
  • 2.3 SUSDP, Part 3
    • 2.3.1 Packaging of Schedule 8 Products
  • 2.4 SUSDP, Part 5
    • 2.4.1 Appendix D - Paragraphs 2 and 6
Agricultural/Veterinary, Industrial and Domestic Chemicals
  • 4.1 Labelling of Schedule 5 containers
  • 4.2 Carbon Tetrachloride
  • 4.3 Ivermectin
5. Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 5.1 SUSDP, Part 4
    • 5.1.1 Creosote and related compounds and fractions
    • 5.1.2 methylcyclopentadienyl manganese tricarbonyl
    • 5.1.3 Virginiamycin
6. Matters referred by the Australian Pesticides and Veterinary Medicines Authority
  • 6.1 1,2-Ethanediamine Polymer with (Chloromethyl) Oxirane and N-Methylmethanamine
  • 6.2 Etoxazole
  • 6.3 Endolsulfan
  • 6.4 Deltamethrin
  • 6.5 Ulocladium Oudemansii
  • 6.6 Naphthalene

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7. Matters referred by Office of Chemical Safety (OCS) Branch
  • 7.1 Home Garden Products - Pack sizes
8. Antibiotics for consideration following recommendations of the Joint Expert Technical Advisory Committee on Antibiotic Resistance (JETACAR)
  • 8.1 Avilamycin
  • 8.2 Bambermycin (Flavophospholipol)
  • 8.3 Olaquindox
  • 8.4 Cefadroxil
  • 8.5 Penethamate Hydriodide
  • 8.6 Phthalylsulfathiazole
  • 8.7 Tylosin
  • 8.8 Nalidixic Acid

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Pharmaceuticals
12. Matters arising from the minutes of the previous meeting (consideration of post-meeting submissions under 42ZCZ)
  • 12.1 Levonorgestrel
  • 12.2 Ibuprofen
  • 12.3 Teriparatide
  • 12.4 Fluconazole
13. Other outstanding matters from previous meetings
  • 13.1 Silicones
  • 13.2 Pseudoephedrine
  • 13.4 Mitragynine
  • 13.5 Trichloroacetic Acid
  • 13.6 Memantine
  • 13.7 Review of Non-Prescription Analgesics
    • 13.7.1 Paracetamol
    • 13.7.2 Aspirin
    • 13.7.3 Ibuprofen
    • 13.7.4 Naproxen
    • 13.7.5 Mefenamic acid
  • 13.8 Ibuprofen
  • 13.9 Hyoscyamus Niger

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14. Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 14.1 SUSDP, Part 4
    • 14.1.1 Orlistat
    • 14.1.2 Paracetamol / Caffeine
    • 14.1.3 Fluticasone
    • 14.1.4 Kava (Piper Methysticum)
  • 14.2 SUSDP, Part 5
    • 14.2.1 Appendix F - Consideration of Warning Statements for S2 Products
    • 14.2.2 Appendix G
      • 14.2.2.1 Mercury
15. Matters referred by the Australian Drug Evaluation Committee (ADEC)
  • 15.1 New Substances
    • 15.1.1 Pimecrolimus
    • 15.1.2 Aripiprazole
    • 15.1.3 Anakinra
    • 15.1.4 Ezetimibe
    • 15.1.5 Gefitinib
    • 15.1.6 Fenofibrate
  • 15.2 For Information (Substances Already Scheduled)
  • 15.3 Other ADEC Matters for Consideration
    • 15.3.1 Pancreatic Enzyme Extract

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16. Other matters for consideration
  • 16.1 Aminolevulinic Acid
  • 16.2 Ibuprofen and Codeine
  • 16.3 1,4-Butanediol, Gamma Aminobutyric Acid, Gamma Butyrolactone, Gamahydroxybutyraldehyde and Related Analogues
17. Matters referred by the Medicines Evaluation Committee (MEC)
  • 17.1 Drometrizole Trisiloxane
18. Matters referred by the Medicines Classification Committee (MCC) of New Zealand
  • 18.4 Sedating Antihistamines/Codeine
19. Initial review/formal opinions (pharmaceuticals)
  • 22.1.1 3,4-methylenedioxy-N,a-dimethylphenylethylamine (MDMA)
24. Attachments
  • Attachment 1 - Nicotine in NRT summary of post-meeting comments - Item 1.8.1.3.7
  • Attachment 2 - Levonorgestrel summary of post-meeting comments - Item 12.1
  • Attachment 3 - Ibuprofen summary of post-meeting comments - Item 12.2
  • Attachment 4 - Summary and TGA response on the public comments received by the NDPSC following the June 2003 meeting (provided by MEC) - Item 13.7
    • General comments
    • Paracetamol
    • NSAIDS
      • 1. Aspirin
      • 2. Ibuprofen
      • 3. Naproxen
      • 4. Mefenamic Acid
      • Comments
  • Attachment 5 - Summary of public submissions for Orlistat - Item 14.1.1

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