Jump to top navigation | Jump to main navigation | Jump to content
Therapeutic Goods Administration logo

NDPSC record of reasons, 47th meeting, 20-22 June 2006

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.

How to access a pdf document

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

NDPSC Record of reasons, Meeting 47 Sections 1-9 (pdf,558kb)*

NDPSC Record of reasons, Meeting 47 Sections 10-21 (pdf,264kb)

Contents

Glossary
  • 1.7 Procedural matters
    • 1.7.1 Operations/policies of the committee
      • 1.7.1.1 Draft template for scheduling/rescheduling
      • 1.7.1.2 Procedural and governance issues
      • 1.7.1.3 Outcomes from the May 2006 NCCTG meeting
        • 1.7.1.3.1 Sponsor access to evaluation reports
        • 1.7.1.3.2 Release of information in the record of reasons
        • 1.7.1.3.3 A policy for the harmonisation of Schedule 4 Medicines
        • 1.7.1.3.4 Item deleted
  • 1.8 NDPSC working parties
    • 1.8.1 Minutes of the TTHWP February 2006 Meeting (Meeting 15)
      • 1.8.1.1 Nomenclature of Recombinant Medicines
      • 1.8.1.2 Unharmonised Medicines in the AusNZ Scheduling Database
        • TABLE 1 - Harmonisation Recommendations to NDPSC
          • Proposals based on least restrictive scheduling and nomenclature or wording issues
          • Other harmonisation proposals
          • Proposals based on the policy for OTC and Prescription medicines and policy for naming botanicals
        • TABLE 2 - Harmonisation Recommendations to MCC
          • Proposals based on the least restrictive scheduling and nomenclature or wording issues
          • Proposals based on the policy for OTC and Prescription medicines and policy for naming botanicals
        • TABLE 3 - Deferred Items
        • TABLE 4 - Substances Remaining Unharmonised At This Time
    • 1.8.2 Globally Harmonised System (GHS) for Classification and Labelling of Chemicals
  • 1.9 Proposed routine changes to the SUSDP

Top of page

2. Proposed changes/additions to Parts 1 to 3 and Part 5 of the Standard for the Uniform Scheduling of Drugs and Poisons
  • 2.1 SUSDP, Part 1
  • 2.2 SUSDP, Part 2
    • 2.2.1 Storage Statements for Schedule 5 and 6 products
  • 2.3 SUSDP, Part 3
Agricultural/Veterinary, Industrial and Domestic Chemicals
3. Matters arising from the minutes of the previous meeting
4. Other outstanding matters from previous meetings
  • 4.1 Lye water
  • 4.2 N-oleyl-1,3-diaminopropane
  • 4.3 Amines used as curing agents for epoxy resins
5. Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 5.1 SUSDP, Part 4
    • 5.1.1 Potassium azeloyl diglycinate, azelaic acid and the definition of derivative
    • 5.1.2 Eyelash and eyebrow tints
  • 5.2 SUSDP, Part 5
    • 5.2.1 Item deleted

Top of page

6. Matters referred by the Australian Pesticides and Veterinary Medicines Authority
  • 6.1 Cydia pomonella granulosis virus
  • 6.2 Sulfuryl fluoride
  • 6.3 Prosulfocarb
  • 6.4 Trenbolone acetate/oestradiol/tylosin tartrate
  • 6.5 Acetyl isovaleryltylosin tartrate
  • 6.6 Acetamiprid
  • 6.7 Metflumazone/amitraz
  • 6.8 Tulathromycin
  • 6.9 Indoxacarb
  • 6.10 Sulfentrazone
7. Matters referred by Office of Chemical Safety (OCS)
8. Other matters for consideration
  • 8.1 Paint for children's play equipment and the definition of toy
9. Information items
  • 9.1 Naphthalene

Top of page

Pharmaceuticals
10. Matters arising from the minutes of the previous meeting
  • 10.1 Potassium chloride
  • 10.2 Orlistat
  • 10.3 Ibuprofen
  • 10.4 Ketotifen
11. Other outstanding matters from previous meetings
  • 11.1 Fractionated plasma products
  • 11.2 Octocog alfa
  • 11.3 Human plasma-derived Protein C
  • 11.4 Cetirizine
  • 11.5 Aconitum SPP
  • 11.6 Schoenocaulon officinale (Sabadilla)
  • 11.7 Item deleted
  • 11.8 Ibuprofen
  • 11.9 Flupenthixol
  • 11.10 Clotrimazole, ciclopirox and Amorolfine - clarifying Schedule entries in relation to application to nails
    • 11.10.1 Clotrimazole
    • 11.10.2 Ciclopirox
    • 11.10.3 Amorolfine
  • 11.11 Codeine - further consideration of the Scheduling of liquid preparations containing codeine as a single active ingredient
  • 11.12 Azelastine hydrochloride

Top of page

12. Proposed changes/additions to the Standard for the Uniform Scheduling of Drugs and Poisons
  • 12.1 SUSDP, Part 4
    • 12.1.1 Mometasone furoate
    • 12.1.2 Hydrocortisone and hydrocortisone acetate
    • 12.1.3 Sumatriptan
  • 12.2 SUSDP, Part 5
13. Matters referred by the Australian Drug Evaluation Committee (ADEC)
  • 13.1 New substances (not seen before by the NDPSC)
    • 13.1.1 Plasma-derived Factor VIII
    • 13.1.2 Bortexomib
    • 13.1.3 Azacitidine
  • 13.2 For information (substances already Scheduled)
    • 13.2.1 Item deleted
    • 13.2.2 Fulvestrant
    • 13.2.3 Anecortave acetate
    • 13.2.4 Erlotinib
    • 13.2.5 Posaconazole
    • 13.2.6 Entecavir

Top of page

14. Other matters for consideration
  • 14.1 Caffeine
15. Matters referred by the Medicines Evaluation Committee (MEC)
16. Matters referred by the Medicines Classification Committee (MCC) of New Zealand
17. Item deleted
18. Minutes of the Medical Devices Evaluation Committee (MDEC)
19-20. Items deleted
21. Amendments to the SUSDP
  • 21.1 Editorial changes and errata
    • 21.1.1 Editorial changes and errata included in the SUSDP 21 consolidation - Aspirin, Bergamot Oil, Camphor, Clotrimazole, Dextromethorphan, Econazole, Emodepside, Fluorides, Ibuprofen, Lemon Oil, Lime Oil, Methylene Blue, Miconazole, Orange Oil (Bitter), Paracetamol, Pennyroyal Oil, "Pyridoxine, Pyridoxal or Pyridoxamine", Silver, Tioconazole, Toluenediamine, Vitamin A and Zinc compounds
    • 21.1.2 Editorial changes for SUSDP 21 amendment 1
      • 21.1.2.1 Sedating Antihistamines: Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Diphenylpyraline, Doxylamine, Pheniramine, Promethazine, Thenyldiamine, Trimeprazine, Triprolidine
      • 21.1.2.2 Post-meeting editorials - approved name of poisons and amorolfine
    • 21.1.3 Errata included in SUSDP 21 amendment1 - Cetirizine

Top of page