31st meeting – may 2001 national drugs …...record of reasons 31st meeting – may 2001 national...

RECORD OF REASONS31ST MEETING – MAY 2001

NATIONAL DRUGS AND POISONS SCHEDULE COMMITTEE

OUTCOME OF CONSIDERATION BY THE NATIONAL DRUGS AND POISONSSCHEDULE COMMITTEE AT ITS MAY 2001 MEETING OF PROPOSALS FORAMENDMENT TO THE STANDARD FOR THE UNIFORM SCHEDULING OFDRUGS AND POISONS

Notice under subsection 52D(4) Therapeutic Goods Act 1989 (the Act)

The NDPSC hereby gives notice, pursuant to subsection 52D(4) of the Act, that anamendment has been made to the Standard for the Uniform Scheduling of Drugs andPoisons (SUSDP).

The notice is divided into four parts:

Part A – DECISIONS. Amendments to the SUSDP in respect of substances mentioned inthe pre-meeting Gazette Notice;

Part B – OUTCOMES. Outcomes in respect of substances mentioned in the pre-meetingGazette Notice, where no amendment was made to the SUSDP;

Part C – RATIFIED DECISIONS. List of substances for which amendments will beincluded in Amendment 1 to SUSDP 16 (decisions of the February 2001meeting) and related matters; and

Part D - OTHER OUTCOMES. Other outcomes from the meeting includingforeshadowed scheduling recommendations.

PART A - DECISIONS

The amendments set out in this Part A were made in respect of substances mentioned inthe Gazette of 11 April 2001 as substances to be considered for scheduling at the May2001 meeting. These amendments are subject to the receipt of further publicsubmissions.

Persons who made a public submission in relation to the substances listed in this Part Aare invited to make a further submission to:

The Secretary,National Drugs and Poisons Schedule Committee (NDPSC),PO Box 100,Woden ACT 2606or Facsimile 02 6270 4353

Submissions must be made by 1 August 2001 and address a matter mentioned in section52E of the Act and be relevant to the reasons for the making of the decision.

If a submission is made to the Committee in respect of a substance set out below, theCommittee must consider the submission and then: confirm the amendment; vary theamendment; or set aside the amendment, replace it with a new scheduling decision andpublish notice of the decisions under section 52D of the Act. (If a new schedulingdecision is made and notice of it published under section 52D, the public consultationprocess commences again). Subject to the matters set out above, the amendments in PartA come into effect on 1 December 2001, unless otherwise indicated.

Copies of the amendments arising from Part A will be available for purchase fromAusInfo Government Information Shops in November 2001.

1. PROPOSALS FOR AMENDMENT TO THE STANDARD FOR THEUNIFORM SCHEDULING OF DRUGS AND POISONS

(b) Bergamot oil, lemon oil, lime oil Orange oil (bitter) – Consideration of additionalexemption from scheduling, for products that are washed off the skin.

DECISION 2001/31 – 21.

The Committee agreed to revise the Schedule 5 entries for the citrus oils to includeexemptions for the rectification process and preparations for internal use.

This decision below was based on:

• Recognition that processes other than steam distillation may be used to produce FCFcitrus oils.

• Oral toxicity consistent with exemption

Schedule 5 - Amendment

BERGAMOT OIL - amend entry to read:

BERGAMOT OIL except:

(a) when steam distilled or rectified;

(b) in preparations for internal use;

(c) in preparations containing 0.4 per cent or less of bergamotoil;

(d) in soaps or bath and shower gels that are washed off theskin; or

(e) when packed in containers labelled with the statement:

Application to skin may increase sensitivity to sunlight.

LEMON OIL - amend entry to read:

LEMON OIL except:



(c) in preparations containing 0.05 per cent or less of lemon oil;




LIME OIL - amend entry to read:

LIME OIL except:



(c) in preparations containing 0.5 per cent or less of lime oil;




ORANGE OIL (BITTER) - amend entry to read:

ORANGE OIL (BITTER) except:



(c) in preparations containing 1.4 per cent or less of orange oil(bitter);




(c) Ivermectin, milbemycin oxime, moxidectin, diethylcarbamazine (DEC) –further consideration of scheduling and the need for veterinary management andmonitoring when used for the prophylaxis of heartworm in companion animals.

DECISION 2001/31 – 18.

The decision to include ivermectin and milbemycin oxime in Schedule 5 for theprophylaxis of heartworm in companion animals was based on:

• Toxicity profile consistent with Schedule 5 for this use.

• Evidence of safety in use.

• Sufficient similarity of toxicity profiles in use to support the same scheduling forivermectin and milbemycin oxime as for moxidectin and abamectin (Schedule 5).

• Consistency with the decision not to schedule DEC.

Schedule 4 - Amendments

IVERMECTIN - amend entry to read:

IVERMECTIN for human use.

MILBEMYCIN OXIME - amend entry to read:

MILBEMYCIN OXIME except when included in Schedule 5.

Schedule 5 - New Entry

MILBEMYCIN OXIME for the prophylaxis of heartworm in dogs and cats.


IVERMECTIN - amend entry to read:

IVERMECTIN for use in animals:

(a) in preparations for the prophylaxis of heartworm in cats anddogs;

(b) in intraruminal implants containing 160mg or less ofivermectin; or

(c) in other preparations containing 2 per cent or less ofivermectin.

(d) Hydrofluoric acid consideration of scheduling and cut-offs for domestic use, firstaid instructions, warning statements .

DECISION 2001/31 – 19.

The decision below was based on:

• Sufficient evidence of delayed burns to humans on exposure to concentrations in therange 1-10% HF. Additional animal evidence of dermal injury down to 0.01%.

• Addition of a warning statement that conveys the hazard of delayed injury.

• The need for an explicit statement regarding eye protection.

• The consensus that calcium gluconate gel was essential as a first aid measure.

• The need to wash gloves to ensure that there was no subsequent exposure to HF fromthe gloves.


HYDROFLUORIC ACID - amend entry to read:

HYDROFLUORIC ACID (excluding its salts and derivatives) and admixtures thatgenerate hydrofluoric acid, in preparations containing 0.1 per cent or less ofhydrogen fluoride.



HYDROFLUORIC ACID (excluding its salts and derivatives) and admixtures thatgenerate hydrofluoric acid, in preparations containing 1 per cent or less ofhydrogen fluoride except when included in Schedule 5.

Appendix E Part 2 - Amendment


HYDROFLUORIC ACID and admixtures that generate hydrofluoric acid

(Note: The dot points and statements remain unchanged)

Appendix F Part 1 - New Entry

91. Causes severe burns, which are not likely to be immediately painful or visible.

Appendix F Part 2 - New Entry

35. Wash gloves thoroughly, immediately after use.

Appendix F Part 2 - Amendment

Statement 29 - amend statement to read:

29 Obtain a supply of calcium gluconate gel.

Appendix F Part 3 - Amendments


HYDROFLUORIC ACID (including mixtures that generate hydrofluoric acid)

(a) when included in Schedule 5.

WARNING STATEMENT

2

SAFETY DIRECTIONS

1,4

(b) When included in Schedule 6 or 7.

WARNING STATEMENTS

1,17,91

SAFETY DIRECTIONS

1,3,4,5,8,29,35

(e) Copper – consideration of the following entries for copper compounds includingan exemption for copper compounds in antifouling paints:

Schedule 6 – New entry

COPPER COMPOUNDS except:

(a) when separately specified in these Schedules;

(b) in preparations for human internal use containing 5mg orless of copper per recommended daily dose; or

(c) in other preparations containing 5 per cent or less of coppercompound.


COPPER COMPOUNDS for human use except:




Appendix A – New entry

COPPER COMPOUNDS in marine antifouling paints

DECISION 2001/31 – 20.


• The toxicity profile of most copper salts is consistent with a generic schedule 6 entry.

• Provision of appropriate exemptions particularly paints.

• Harmonisation with the New Zealand General Sales entry for copper.


COPPER COMPOUNDS for human use except:





COPPER COMPOUNDS except:





COPPER COMPOUNDS in paints.

Supplementary Gazette

(k) Desloratidine consideration of scheduling

DECISION 2001/31 – 28.

The Committee considered that the similarities between loratadine and desloratadineallowed for these substances to be scheduled identically. Accordingly, the Committeeagreed to include desloratadine in Schedule 4 of the SUSDP, with a cut-off to Schedule 2,for preparations for oral use.


• Safety profile appropriate for inclusion in Schedule 2.

• Consistent with scheduling of loratadine.


DESLORATADINE in preparations for oral use.


DESLORATADINE except when included in Schedule 2.

Appendix F, Part 3 – Amendment

Antihistamines not separately specified .................... 39 or 40in this Appendix except:

(a) dermal, ocular, parenteral and paediatric preparations;

(b) oral preparations of astemizole, fexofenadine, loratadine,desloratadine or terfenadine ; or

(c) preparations for the treatment of animals.

2. MATTERS REFERRED BY THE AUSTRALIAN DRUGEVALUATION COMMITTEE

(a) New Drugs – consideration of poisons schedule.

LevetiracetamZoledronic acid

DECISION 2001/31 – 30.


• The condition requires medical supervision and management required.

• There is a need for a sedation warning.

Schedule 4 - New entry

LEVETIRACETAM.

Appendix K – New Entry

LEVETIRACETAM

DECISION 2001/31 – 31.


• The condition requires medical management.


ZOLEDRONIC ACID.

(b) Other matters

Galactose/Palmitic Acid – consideration of scheduling and/or additions toAppendix A to cover proposed use (imaging agent/sonography agent).

DECISION 2001/31 – 32.


• No new safety issues were identified.

• Consistent with the exempt status of other diagnostic media in Appendix A.

Appendix A – Amendment

ENHANCING AGENTS – Amend entry to read:

ENHANCING AGENTS for use in ultrasonic and magnetic resonance imaging.

3. MATTERS REFERRED BY THE NATIONAL REGISTRATIONAUTHORITY FOR AGRICULTURAL AND VETERINARYCHEMICALS

(a) Spiroxamine – new chemical – consideration of poisons scheduling;

DECISION 2001/31 – 23.

The Committee agreed to include spiroxamine in Schedule 6 of the SUSDP, with no cut-off to a lower schedule to accommodate the product. The decision was based on thefollowing:

• acute toxicities of spiroxamine and Prosper 500 EC Fungicide are consistent withSchedule 6; and

• irritation and sensitisation potential of spiroxamine were consistent with Schedule 6.


SPIROXAMINE.

(b) Oxyfluorfen – consideration of amendment to poisons scheduling;

DECISION 2001/31 – 25.

The Committee agreed to exempt oxyfluorfen technical of greater than 96% purity and todelete the existing Schedule 7 entry on the basis that the NRA would be cancellingexisting TGAC approvals for oxyfluorfen which did not comply with the new TGACspecifications. This decision was based on the following:

• The acute toxicity profile and irritancy potential of the high purity TGAC wereappropriate for exempt status.

• Previous concerns on genotoxicity were not applicable to the new high purityspecifications.

• On the understanding that the NRA would remove existing TGAC approvals foroxyfluorfen technical not complying with the new high purity TGAC specificationsand that the existing NRA MCS for oxyfluorfen technical would be revised to >96%.

Schedule 7 – Amendment

OXYFLUORFEN – delete entry.

(c) Azafenidin – new chemical – consideration of poisons scheduling;

DECISION 2001/31 – 26.

The Committee agreed to include azafenidin in Schedule 7 of the SUSDP with nocut-off to accommodate the product in a lower Schedule. Additionally, the Committeesupported the inclusion of the following warning statement on labels for productscontaining azafenidin: “This product contains azafenidin which causes birth defects incertain laboratory animals. Women of child-bearing age are advised not to mix, load orspray this product. They should keep out of crops being sprayed.”

The decision was based on the following grounds:

• that although the acute toxicity was low, the irreversible developmental effects in ratsjustified inclusion in Schedule 7;

• developmental effects could be mediated by a single dermal or oral exposure;

• unknown mode of action for the observed developmental effects;

• absence of data on which to base appropriate cut-offs to lower Schedules; and

• Schedule 7 signal heading was consistent with the recommendation to require such awarning statement on products containing azafenidin.


AZAFENIDIN.

(d) Deltamethrin – consideration of amendment to poisons scheduling;

DECISION 2001/31 – 27.

The Committee agreed to a Schedule 6 entry for the 25% deltamethrin water-dispersibletablet with a Schedule 5 entry for the smaller packsize. The Schedule 5 entry was madeon the basis that:

• limiting the total dose per pack size to 2 grams or less deltamethrin would reduce therisk of poisoning, particularly in children, and is an appropriate cut-off to a Schedule5 entry;

• requirement of a child-resistant closure on products would provide a safeguardagainst access by children; and

• there was a low risk of exposure, consistent with a Schedule 5 entry, from theproposed manner of use of the product when packaged as specified.


DELTAMETHRIN – amend entry to read:

DELTAMETHRIN:

(a) in aqueous preparations containing 1 per cent or less ofdeltamethrin, when no organic solvent, other than a glycol,is present;

(b) in water-dispersible tablets containing 25 per cent or less ofdeltamethrin, in packs containing 2 grams or less ofdeltamethrin, with a child-resistant closure; or

(c) in other preparations containing 0.5 per cent or less ofdeltamethrin.


DELTAMETHRIN – amend entry to read:

DELTAMETHRIN:

(a) in aqueous preparations containing 25 per cent or less ofdeltamethrin, when no organic solvent, other than 10 percent or less of a glycol, is present;

(b) in water-dispersible tablets containing 25 per cent or less ofdeltamethrin; or

(c) in other preparations containing 3 per cent or less ofdeltamethrin

except when included in Schedule 5.

(g) Thiacloprid – new chemical – consideration of poisons scheduling;

DECISION 2001/31 – 24.

The Committee agreed to include thiacloprid in Schedule 6 of the SUSDP, with no cut-off to a lower Schedule to accommodate the product. The decision was based on:

• toxicity profile of thiacloprid consistent with Schedule 6;

• expected toxicity profile of product consistent with Schedule 6; and

• product unsuitable for use in home gardens based on the acute toxicity profile andpotential for poisoning particularly in young children.


THIACLOPRID.

(h) Tylosin – consideration of scheduling when used as a pre-mix for addition toanimal feed.

DECISION 2001/31 – 22.

The Committee agreed to amend the Schedule 4 and 5 entries in the SUSDP for tylosin,to include its use in the prevention of ileitis in pigs, on the basis of the NRA’srecommendation.


TYLOSIN – amend entry to read:

TYLOSIN except:

(a) when included in Schedule 5;

(b) in animal feeds containing 50 mg/kg or less of antibioticsubstances:

(i) for growth promotion;

(ii) for the prevention of liver abscesses in cattle; or

(iii) for the prevention of ileitis in pigs; or

(c) in milk replacers for calves, or starter rations for pigs,containing 100 mg/kg or less of antibiotic substances.


TYLOSIN – amend entry to read:

TYLOSIN in animal feed premixes containing 5 per cent or less of antibiotic substances:

(a) for growth promotion;

(b) for the prevention of liver abscesses in cattle; or

(c) for the prevention of ileitis in pigs.

4. OTHER MATTERS FOR CONSIDERATION

(a) Appendix F

Antihistamines – consideration of exemption for eye drops

DECISION 2001/31 – 29.

The Committee agreed to exempt eye drops containing antihistamines from the AppendixF, Part 3 requirement to label products with a drowsiness warning statement.


• Recommended dose is unlikely to cause drowsiness.

Appendix F, Part 3 - Amendment

Antihistamines not separately specified .................... 39 or 40in this Appendix except:

(a) dermal, ocular, parenteral and paediatric preparations;

(b) oral preparations of astemizole, fexofenadine, loratadine,desloratidine or terfenadine; or

(c) preparations for the treatment of animals.

5. MATTERS REFERRED BY THE NEW ZEALAND MEDICINESCLASSIFICATION COMMITTEE

(a) Iron Compounds – Consideration of a proposal to harmonise with New Zealand inregard to the scheduling of iron containing medicines. (from NDPSC 26)

DECISION 2001/31 – 33.

The decision to adopt a 24 mg of iron per recommended daily dose cut-off for Schedule 2was based on:

• The NDPSC consider that childhood poisoning due to ingestion of iron preparationscontaining up to 24 mg of elemental iron per recommended daily dose may becontrolled by limiting the overall amount of elemental iron in a pack.


IRON COMPOUNDS (excluding iron oxides when present as an excipient, up to 1 percent in undivided preparations or up to 10 mg per dosage unit in divided preparations) forhuman internal use except:

(a) when included in Schedule 4; or

(b) in preparations when labelled with a recommended dailydose of 24 mg or less of iron when supplied in themanufacturer’s original pack each containing 600 mg orless of iron.

(b) Boron, Boric acid and Sodium perborate – Consideration of a proposal toharmonise with New Zealand in regard to the scheduling of boron (to exempt fromscheduling), boric acid and sodium perborate. (from NDPSC 26)

DECISION 2001/31 – 34.

The Committee agreed to revise the boron Schedule 4 entry to exempt a daily oral dose of3 mg, and to exempt dermal preparations containing 0.34 per cent or less of boron.


• The recommended daily dose of 3 mg was well within acceptable limits.

Schedule 4 -Amendment

BORON – amend entry to read:

BORON for human therapeutic use (excluding when present as an excipient):

(a) in preparations for internal use containing more than 3milligrams per recommended daily dose;

(b) in glycerines and honeys of borax or boric acid;

(c) in preparations for vaginal use;

(d) in preparations for paediatric dermal use, being

(i) dusting powders; or

(ii) other preparations containing more than 0.34 percent of boron; or

(e) in other preparations for dermal use containing more than0.34 per cent of boron except antifungal preparations.

6. PROPOSALS ARISING FROM TRANS-TASMAN WORKINGPARTY ON THE HARMONISATION OF THE SCHEDULING OFDRUGS AND POISONS.

(a) Harmonisation of Nomenclature – Herbals

Juniperus sabine [savin(e)]

DECISION 2001/31 - 4.

The decision below to amend the Appendix C entry for Juniperus Sabina was based on:

• Harmonisation of herbal nomenclature with New Zealand.

Appendix C - Amendment

JUNIPERUS SABINA - amend entry to read:

JUNIPERUS SABINE [savin(e)] for therapeutic use.

(b) Other substances – scheduling recommendations on the grounds of harmonisation.

Folic acid Folinic acidSilver Silver sulfadiazineAntigens GuaiphenisinIodine TryptophanIpecacuanha Cephaelis ipecacuanhaPolymethylene bistrimethylammonium compounds

Hyaluronic AcidHypromellose Phthalate

DECISION 2001/31 – 1.

The Committee did not agree with the proposal to exempt Restylane®, and resolved toamend the Schedule entry for hyaluronic acid in Schedule 4 of the SUSDP, to include itspolymers.

The Committee’s decision was based on the following:

• Restylane® is an injectable product and contains hyaluronic acid, therefore subject tothe requirements of Schedule 4 of the SUSDP.

• The supply and use of Restylane® require the product to be administered byappropriately qualified health professionals.

• Amending the entry for hyaluronic acid to include its polymers would provide clarityas to the intent of the entry.


HYALURONIC ACID – Amend entry to read:

HYALURONIC ACID and its polymers, in preparations for injection.

DECISION 2001/31 – 2.

The Committee agreed to include an Appendix A entry for intraocular viscoelasticproducts.

The Committee’s decision was based on:

• The supply and use of intraocular viscoelastic products were appropriate for generalinclusion of these products in Appendix A.


INTRAOCULAR VISCOELASTIC PRODUCTS.


Podophyllotoxin - consideration of Scheduling.

DECISION 2001/31 – 3.

The decision below to amend the entries for podophyllotoxin was based on:

• The need for medical assessment of, and medical management during the treatment ofanogenital warts.

• To retain internal uses of podophyllotoxin in Schedule 4

• To maintain consistency of Scheduling for podophyllotoxin and podophyllum.


PODOPHYLLOTOXIN - amend entry to read:

PODOPHYLLOTOXIN for human use:

(a) for the treatment of anogenital warts; or

(b) for internal use.



PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllotoxinfor human use for the treatment of warts except when in Schedules 2 or 4.



PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllotoxinfor human use for the treatment of warts except when in Schedules 3 or 4.

DECISION 2001/31 – 5.

The decision below to amend the Schedule 3 entries for folic and folinic acids was basedon:

• Harmonisation of Scheduling with New Zealand.

• The intent that these changes apply only to human therapeutic uses.

Schedule 2 - New entries

FOLIC ACID for human therapeutic use except in preparations containing 500micrograms or less of folic acid per recommended daily dose.

FOLINIC ACID for human therapeutic use except in preparations containing 500micrograms or less of folinic acid per recommended daily dose.


FOLIC ACID - delete entry.

FOLINIC ACID - delete entry.

Schedule 4 - New entries

FOLIC ACID in preparations for human use for injection.

FOLINIC ACID in preparations for human use for injection.

Appendix H - Amendment

FOLIC ACID - delete entry.

DECISION 2001/31 – 6.

The decision below to amend the Schedule 2 entry for silver salts was based on:



SILVER SALTS - amend entry to read:

SILVER for therapeutic use except:

(a) in chewing gum each containing 5 mg or less of silver perdosage unit when labelled with the statement “Overusemay stain skin or mouth”;

(b) in solutions for human oral use containing 0.3 per cent orless of silver when labelled with the statement “Overusemay stain skin or mouth”; or

(c) in other preparations containing 1 per cent or less of silver.

DECISION 2001/31 – 7.

The decision below to amend the Schedule 4 entry for antigens was based on:



ANTIGENS - amend entry to read:

ANTIGENS for human therapeutic use except when separately specified in thisSchedule.

DECISION 2001/31 – 8.

The decision below to amend the Schedule 2 entry for iodine was based on:



IODINE - amend entry to read:

IODINE

(a) in preparations for human internal therapeutic usecontaining 300 micrograms or more of iodine perrecommended daily dose; or

(b) in preparations for human external therapeutic usecontaining more than 2.5 per cent of available iodine(excluding salts, derivatives or iodophors).

Appendix F Part 1 - New entries

91. CAUTION – Total iodine intake may exceed recommended level when takingthis preparation.

92. WARNING – Contains iodine - do not take when pregnant except onphysician’s advice.

Appendix F Part 3 - Amendment

IODINE - amend entry to read:

IODINE

(a) more than 20 per cent

WARNING STATEMENTS

Nil

SAFETY DIRECTIONS

1,4,8

(b) in preparations for human internal therapeutic usecontaining 300 micrograms or more of iodine perrecommended daily dose.

WARNING STATEMENTS

91,92

SAFETY DIRECTIONS

Nil

DECISION 2001/31 – 9.

The decision below to include a new entry in Schedule 4 entry for ipecacuanha was basedon:


• Clarification of the scheduling by including a complementary entry to emetine.


CEPHAELIS ACUMINATA (ipecacuanha) except in preparations containing 0.2 percent or less of emetine.

DECISION 2001/31 – 10.

The decision below to delete the existing Schedule 4 entry for polymethylenebistrimethyl ammonium compounds was based on:



POLYMETHYLENE BISTRIMETHYL AMMONIUM COMPOUNDS - delete entry.

DECISION 2001/31 - 11.

The decision below to amend the Schedules 2 and 4 entries for guaiphenesin was basedon:



GUAIPHENESIN - delete entry.

Schedule 4 - Amend ment

GUAIPHENESIN - amend entry to read:

GUAIPHENESIN for human therapeutic use except:

(a) in oral liquid preparations containing 2 per cent or less ofguaiphenesin; or

(b) in divided preparations containing 200mg or less ofguaiphenesin per dosage unit.

DECISION 2001/31 - 12.

The decision below to amend the Schedule 4 entry for tryptophan was based on:



TRYPTOPHAN - amend entry to read:

TRYPTOPHAN for human therapeutic use except in preparations labelled with arecommended daily dose of 100 mg or less of tryptophan.

DECISION 2001/31 – 13.

The Committee agreed to include hypromellose in preparations for injection, in Schedule4 of the SUSDP.

The decision was based on the following:

• Preparations for injection are appropriate for inclusion in Schedule 4 of the SUSDP.

• Such products require administration by appropriately qualified health professionals.

• The need to regulate the supply and use of such product to prevent diversion for usein inappropriate circumstances.


HYPROMELLOSE in preparations for injection.

(c) Recommendations to amend Part 1 to Part 3 of the SUSDP

No items

(d) Recommendations to amend Part 5 of the SUSDP

1. Appendix G – Consideration of entries for:Nux vomicaIgnatia amaraTansy OilCroton tiglium (croton oil)

DECISION 2001/31 – 14.

The decision below to delete the Appendix G entry for Nux vomica was based on:


Appendix G - Amendments

NUX VOMICA - delete entry:

DECISION 2001/31 – 15.

The decision below to delete the Appendix G entry for Ignatia amara was based on:



IGNATIA AMARA - amend entry to read:

STRYCHNOS SPP. 10mg

DECISION 2001/31 – 16.

The decision below to delete the Appendix G entry for Tansy oil was based on:

• Removal of a redundant entry from Appendix G.


TANSY OIL - delete entry.

DECISION 2001/31 – 17.

The decision below to amend the Appendix G entry for croton oil was based on:



CROTON OIL - amend entry to read:

CROTON TIGLIUM (croton oil) 1mg

PART B – OUTCOMES

Proposals in relation to other substances mentioned in the Gazette of 11 April 2001as being considered for scheduling at the May 2001 meeting and not resulting in anamendment to the Standard. These proposals have been finalised.

1. PROPOSALS FOR AMENDMENT TO THE STANDARD FOR THEUNIFORM SCHEDULING OF DRUGS AND POISONS

(a) Paracetamol – Consideration of variation to the dose limit for exempt status inrelation to sustained release preparations;

OUTCOME

The Committee did not agree to vary the exemption in Schedule 2 of the SUSDP for the500mg limit of paracetamol to include Panadol Extend®.

Record of Reasons:• Including the product in Schedule 2 would provide access to counselling for

consumers, particularly in relation to the modified dosing regimen of the sustained therelease preparation; and

• The need to accumulate safety-in-use experience under existing controls, relating tochange in marketing emphasis from the treatment of acute pain for standardparacetamol to what is seen as a greater emphasis on the treatment of persistent painassociated with chronic conditions.

(b) Bergamot oil, lemon oil, lime oil Orange oil (bitter) – Consideration of additionalexemption from scheduling, for products that are washed off the skin.

OUTCOME

The Committee confirmed the inclusion of paragraph:-

(c) in soaps or bath and shower gels that are washed off theskin; or

in the Schedule 5 entries for bergamot, lemon, lime and bitter orange oils.

(c) Ivermectin, milbemycin oxime, moxidectin, diethylcarbamazine (DEC) –further consideration of scheduling and the need for veterinary management andmonitoring when used for the prophylaxis of heartworm in companion animals.

OUTCOME

The Committee did not support the scheduling of DEC. This was based on:

• The toxicity profile in humans was consistent with being exempt from scheduling.

• Extensive experience with open sale of DEC had failed to produce any significantevidence of harm.

The Committee confirmed that moxidectin and abamectin were appropriately scheduledin Schedule 5 for the prophylaxis of heartworm in companion animals. This was basedon:

• The toxicity profile was consistent with Schedule 5.

• Evidence of safety in use for moxidectin.

• No harm has been demonstrated with the existing supply under Schedule 5.The Committee confirmed that selamectin was appropriately scheduled for theprophylaxis of heartworm in companion animals. This was based on:

• The toxicity profile was consistent with being exempt.

• Evidence of safety in use.

• No harm has been demonstrated with the existing unscheduled supply.

(d) Hydrofluoric acid consideration of scheduling and cut-offs for domestic use, firstaid instructions, warning statements .

OUTCOME

The Committee confirmed the existing Appendix J entry for hydrofluoric acid.

The Committee confirmed the existing first aid instructions as listed in Amendment 1 toSUSDP 16 for hydrofluoric acid in Schedules 7 or 6, and when in Schedule 5.

(f) Sodium nitrite – consideration of scheduling, first aid instructions and warningstatements.

Item withdrawn for consideration at a future meeting

(g) Methoxyflurane - consideration of scheduling.

OUTCOME

The Committee confirmed that the inclusion of methoxyflurane in Schedule 4 remainedappropriate. This was based on:

• Medical oversight was warranted for a product used for inhalational analgesia.

• Insufficient grounds to warrant restriction of use to a subset of the medical professioneg anaesthesiologists.

• It was inappropriate to include a product with an approved therapeutic use, inAppendix C, as this would have the effect of making the product unavailable to allusers.


(h) Fluorides including ammonium and sodium bifluoride, consideration of schedulingand cut-offs for domestic use, first aid instructions, warning statements.

(i) Silicofluorides including hexafluorosilicates and magnesium fluorosilicate,consideration of scheduling and cut-offs for domestic use, first aid instructions,warning statements.

(j) Boron trifluoride consideration of scheduling and cut-offs for domestic use, firstaid instructions, warning statements

OUTCOME

The Committee agreed to defer further discussion of other corrosive fluorides,hydrosilicofluorides and boron trifluoride to a future meeting.

2. MATTERS REFERRED BY THE AUSTRALIAN DRUGEVALUATION COMMITTEE

(a) New Drugs – consideration of poisons schedule.13C-UreaOctocog alfa

OUTCOME

The Committee agreed to exempt 13C-urea from scheduling.

OUTCOME

The Committee agreed that, at this stage, its policy of leaving blood products fortherapeutic use unscheduled remained appropriate.

3. MATTERS REFERRED BY THE NATIONAL REGISTRATIONAUTHORITY FOR AGRICULTURAL AND VETERINARYCHEMICALS

(e) Polysorbate 20 – consideration of poisons scheduling;

OUTCOME

The Committee agreed to exempt polysorbate 20 from the requirements of scheduling,based on the following:

• The toxicological profile was consistent with exempt status.

• Long history of safe use.

(f) Butyl, Isoamyl and Crotyl mercaptans – new chemicals - consideration ofpoisons scheduling;

OUTCOME

The Committee agreed to exempt Skunkshot from the requirements of scheduling, on thebasis that the expected safety profile of n-butyl mercaptan, isoamyl mercaptan, and crotylmercaptan was consistent with exempt status.

4. OTHER MATTERS FOR CONSIDERATION

(b) JETACAR

The Commonwealth Interdepartmental JETACAR Implementation Group (CIJIG)has requested the NDPSC to consider implementation of recommendation 6 fromthe JETACAR report.

The Committee will give preliminary consideration to Recommendation 6:

“that all antibiotics for use in humans and animals(including fish) be classified as S4 (prescriptiononly)”

within the bounds of the Government view that “antibiotics” should be defined as:

“antibacterial agents (including ionophores) but not includingantiprotozoals, antifungals, antiseptics, disinfectants, antineoplasticagents, antivirals, immunologicals, direct feed microbials or enzymesubstances”.

OUTCOME

The Committee agreed that the following information should be provided for a review ofScheduling in regard to antibiotic resistance:

• Therapeutic class and chemical group of the antibiotic and the range of diseasestreated by both the individual substance and the class.

• Available therapeutic alternatives (human and veterinary) and the relative therapeuticimportance of the antibiotic under consideration..

• Evidence of resistance either potential or in practice and the range of organismsexhibiting this resistance.

• Evidence of any cross-resistance and its scope.

• Mechanism of resistance, the potential for transference and the specificity of anyinterspecies transfer.

• The current and predicted rate of resistance in each country (primarily Australia andNew Zealand)

• Use pattern and target for non-Schedule 4 uses.

The Committee agreed to continue discussion of this item, including further considerationof priorities, at the August 2001 meeting.

The Committee agreed to review the current scheduling of clindamycin, silversulfadiazine, nitrofurazone and sulfacetamide and the relevance of antibiotic resistance toTrans-Tasman Harmonisation at the November 2001 meeting.

The Committee agreed to review the current scheduling in relation to antibiotic resistanceof antibiotics used in ornamental fish and cage birds including the sulfonamides,tetracycline, oxytetracycline, chlortetracycline and nalidixic acid.

5. MATTERS REFERRED BY THE NEW ZEALAND MEDICINESCLASSIFICATION COMMITTEE

(b) Boron, Boric acid and Sodium perborate – Consideration of a proposal toharmonise with New Zealand in regard to the scheduling of boron (to exempt fromscheduling), boric acid and sodium perborate. (from NDPSC 26)

OUTCOME

The Committee agreed that sodium perborate should remain unscheduled.

(c) Alclometasone – Consideration of a proposal to harmonise with New Zealand inregard to the scheduling as a pharmacy medicine (from NDPSC 30).

This item was deferred.

6. PROPOSALS ARISING FROM TRANS-TASMAN WORKINGPARTY ON THE HARMONISATION OF THE SCHEDULING OFDRUGS AND POISONS.

(b) Other substances – scheduling recommendations on the grounds of harmonisation.

Hylan PolymerPolysulphated glycosaminoglycans

OUTCOMES

• The Committee did not agree to the proposal that hylan polymer, when contained inproducts used as replacement material for synovial fluid, be exempted from therequirements of scheduling.

• The Committee confirmed the decision made under item 1.8.1.2.2 of this meeting,and noted the applicability of this decision in relation to hylan polymer.

This outcome was based on the following reasons:

• the product is an injectable and its use required administration by appropriatelyqualified health professionals; and

• there was a potential for inappropriate use, thus the need to regulate the supply anddistribution.

The Committee confirmed that the Schedule 4 entry for polysulphated glycosaminoglycans in the SUSDP remained appropriate.

PART C - RATIFIED DECISIONS

1. VARIATIONS TO PREVIOUS DECISIONS (INCORPORATEDINTO AMENDMENT 1 SUSDP 16)

The variations below were made to clarify the entries for various Datura speciesincluding stramonium.

VARIATIONS

DECISION 2001/30 - 3

Remove ALL entries for DATURA INNOXIA, DATURA TATULA, DATURAMETEL, and STRAMONIUM.

DECISION 2001/30 - 13

Vary the decision to read:


DATURA - amend entry to read:

DATURA spp. for oral use except when separately specified in these Schedules:

(a) in undivided preparations containing 0.025 per cent or lessof the alkaloids of datura and 0.3 mg or less of the alkaloidsof datura per dose, and labelled with a recommended dailydose of 1 mg or less of the alkaloids of datura; or

(b) in divided preparations containing 0.3 mg or less of thealkaloids of datura per dosage unit and labelled with arecommended daily dose of 1 mg or less of the alkaloids ofdatura.

DECISION 2001/30 - 15

Vary the decision to read:


DATURA TATULA (stramonium) except:


(b) for smoking or burning.


STRAMONIUM - amend entry to read:

DATURA STRAMONIUM (stramonium) except:




DATURA TATULA (stramonium):

(a) in undivided preparations containing 0.025 per cent or lessof the alkaloids of stramonium and 0.025 mg or less of thealkaloids of stramonium per dose, and labelled with arecommended daily dose of 0.5 mg or less of the alkaloidsof stramonium; or

(b) in divided preparations containing 0.025 mg or less of thealkaloids of stramonium per dosage unit and labelled with arecommended daily dose of 0.5 mg or less of the alkaloidsof stramonium;

except for smoking or burning.


STRAMMONIUM - amend entry to read:

DATURA STRAMONIUM (stramonium):

(a) in undivided preparations containing 0.025 per cent or lessof the alkaloids of stramonium and 0.025 mg or less of thealkaloids of stramonium per dose, and labelled with arecommended daily dose of 0.5 mg or less of the alkaloidsof stramonium; or

(b) in divided preparations containing 0.025 mg or less of thealkaloids of stramonium per dosage unit and labelled with a

recommended daily dose of 0.5 mg or less of the alkaloidsof stramonium;


The following variations were made to the gazetted decisions to reflect the Committee'sintent:

• to treat all wart treatments the same as for common warts, with the exception ofanogenital wart treatments in Schedule 4;

• to achieve a uniform approach with podophyllotoxin; and

• to retain internal human uses of podophyllum in Schedule 4.

• to harmonise nomenclature with NZ recognising that Podophyllum emodi was theofficial name while P. hexandrum is a synonym for P. emodi.

Overall, the Committee noted that there was a need to clarify and consolidate the entries.

VARIATIONS


Remove all entries for PODOPHYLLUM RESIN and vary the entries forPODOPHYLLUM PELTATUM to read:

Schedule 4 - New Entry

PODOPHYLLUM PELTATUM (podophyllin) for human use:




PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20 per cent orless of podophyllin for human use for the treatment of warts except when inSchedules 2 or 4.



DECISION 2001/30 - 39

Delete decision.

DECISION 2001/30 - 40

Vary decision to read:


PODOPHYLLUM RESIN - amend entry to read:

PODOPHYLLUM EMODI (podophyllin) for human use:





PODOPHYLLUM EMODI (podophyllin) in preparations containing 20 per cent or lessof podophyllin for human use for the treatment of warts except when inSchedules 2 or 4.



PODOPHYLLUM EMODI (podophyllin) in preparations containing 10 per cent or lessof podophyllin for human use for the treatment of warts except when inSchedules 3 or 4.

To exclude veterinary uses from the new entry for tetanus toxoid, the Committee agreedto vary Decision No. 2001/30 - 24 to read:

Schedule 4 - New Entries

PERTUSSIS ANTIGEN.

TETANUS TOXOID for human use.

The following decisions were varied to clarify the actual entries required for the SUSDP.

VARIATIONS


Delete amendments to Schedule 2 for belladonna and hyoscyamus.

Vary the Schedule 7 amendment for brucine to read:


BRUCINE – amend entry to read:

BRUCINE except in alcohol containing 0.02 per cent or less of brucine as a denaturant.

DECISION 2001/30 - 11



BELLADONNA – amend entry to read:

ATROPA BELLADONNA (belladonna):

(a) for external use in preparations containing 0.025 per cent orless of the alkaloids of belladonna; or

(b) for oral use:

(i) in undivided preparations containing 0.025 per centor less of the alkaloids of belladonna and 0.025 mgor less of the alkaloids of belladonna per dose, andlabelled with a recommended daily dose of 0.5 mgor less of the alkaloids of belladonna; or

(ii) in divided preparations containing 0.025 mg or lessof the alkaloids of belladonna per dosage unit, andlabelled with a recommended daily dose of 0.5 mgor less of the alkaloids of belladonna.

DECISION 2001/30 - 12



HYOSCYAMUS – amend entry to read:

HYOSCYAMUS NIGER for oral use:

(a) in undivided preparations containing 0.025 per cent or lessof the alkaloids of hyoscyamus and 0.025 mg of thealkaloids of hyoscyamus per dose and labelled with arecommended daily dose of 0.5 mg or less of the alkaloidsof hyoscyamus; or

(b) in divided preparations containing 0.025 mg of the alkaloidsof hyoscyamus or less per dosage unit and labelled with arecommended daily dose of 0.5 mg or less of the alkaloidsof hyoscyamus.

DECISION 2001/30 – 46

Delete decision.

2. AMENDMENTS

The public consultation process in respect of the substances set out in Part C has beenconcluded. The amendments relating to substances set out in Part C are therefore finalamendments and, as notified in the Commonwealth of Australia Gazette No GN 14, 11April 2001, come into effect on 1 September 2001. The amendments will be published inAmendment 1 to SUSDP 16 which should be available for purchase from AusInfoGovernment Information Shops in August 2001.

Amendments to the Standard for the Uniform Scheduling of Drugs and Poisons

The National Drugs and Poisons Schedule Committee directs that the amendments belowbe applied to the Standard for the Uniform Scheduling of Drugs and Poisons No.16 andrecommends that these amendments be adopted by the States and Territories with effectfrom 1 September 2001. These amendments arise from decisions made by theCommittee at its Februrary 2001 meeting and confirmed at the May 2001 meeting.

PART 1 – INTERPRETATION

AMENDMENTS

Amend “approved name” under sub-paragraph 1(1) to read:

“Approved name” means:

(a) in relation to a poison that is for therapeutic use -

(i) the Australian Approved Name for the poison, not including synonyms,as listed in the publication entitled “Therapeutic Goods Administration

Approved Terminology for Medicines”, July 1999, or its successor,published by the Therapeutic Goods Administration, Canberra; or, if thepoison is not listed in that publication,

(ii) the international non-proprietary name recommended for the poison bythe World Health Organisation; or, if no such name is recommended,

(iii) the English name, not including synonyms, by which the poison isdescribed in the British Pharmacopoeia, the British PharmaceuticalCodex, the Australian Pharmaceutical Formulary and Handbook or theBritish Pharmacopoeia (Veterinary); or, if the poison is not described inany of those publications,

(iv) the approved name given to the poison by the Medicines Commissionof Great Britain; or, if no such name is given,

(v) the accepted scientific name or the name descriptive of the true natureand origin of the poison;

PART 4 - THE SCHEDULES

SCHEDULE 2 – NEW ENTRIES

AMETHOCAINE in preparations for topical use other than eye drops, containing 10 percent or less of total local anaesthetic substances, except in dermal preparationscontaining 2 per cent or less of total local anaesthetic substances.

CICLOPIROX in preparations for dermal use containing 1 per cent or less of ciclopirox.

DATURA TATULA (stramonium) for oral use when:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofstramonium and 0.025 mg or less of the alkaloids of stramonium per dose,and labelled with a recommended daily dose of 0.5 mg or less of the alkaloidsof stramonium; or

(b) in divided preparations containing 0.025 mg or less of the alkaloids ofstramonium per dosage unit and labelled with a recommended daily dose of0.5 mg or less of the alkaloids of stramonium;



SCHEDULE 2 – AMENDMENTS

ATROPINE – amend entry to read:

ATROPINE (excluding atropine methonitrate) :

(a) for oral use:

(i) in undivided preparations containing 0.025 per cent or less of atropine,when labelled with a dose of 0.025 mg or less of atropine and arecommended daily dose of 0.5 mg or less of atropine; or

(ii) in divided preparations containing 0.025 mg or less of atropine perdosage unit and labelled with a recommended daily dose of 0.5 mg orless of atropine; or

(b) in preparations containing atropine sulfate when packed and labelled for thetreatment of organophosphorus poisoning:

(i) in tablets each containing 0.6 mg or less of atropine sulfate in packs of20 tablets; or

(ii) in preparations for injection each containing 0.6 mg per ml or less ofatropine sulfate in packs of 5.


ATROPA BELLADONNA (belladonna):

(a) for external use in preparations containing 0.025 per cent or less of thealkaloids of belladonna; or

(b) for oral use:

(i) in undivided preparations containing 0.025 per cent or less of thealkaloids of belladonna and 0.025 mg or less of the alkaloids ofbelladonna per dose, and labelled with a recommended daily dose of 0.5mg or less of the alkaloids of belladonna; or

(ii) in divided preparations containing 0.025 mg or less of the alkaloids ofbelladonna per dosage unit, and labelled with a recommended dailydose of 0.5 mg or less of the alkaloids of belladonna.

BENZAMINE - delete entry.

BENZOCAINE – amend entry to read:

BENZOCAINE in preparations for topical use other than eye drops:

(a) containing 10 per cent or less of total local anaesthetic substances, except indermal preparations containing 2 per cent or less of total local anaestheticsubstances; or

(b) in divided preparations containing 200 mg or less of total local anaestheticsubstances per dosage unit, except in lozenges containing 30 mg or less oftotal local anaesthetic substances per dosage unit.

BUTYLAMINOBENZOATE - delete entry.

CARBENOXOLONE – delete entry.

CHLORBUTOL – amend entry to read:

CHLORBUTOL for human use in topical preparations containing 5 per cent or less ofchlorbutol, except in preparations containing 0.5 per cent or less of chlorbutol.

CINCHOCAINE – amend entry to read:

CINCHOCAINE in preparations for topical use other than eye drops, containing 0.5 percent or less of total local anaesthetic substances.

DATURA – amend entry to read:

DATURA spp. for oral use except when separately specified in these Schedules:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofdatura and 0.3 mg or less of the alkaloids of datura per dose, and labelled witha recommended daily dose of 1 mg or less of the alkaloids of datura; or

(b) in divided preparations containing 0.3 mg or less of the alkaloids of daturaper dosage unit and labelled with a recommended daily dose of 1 mg or lessof the alkaloids of datura.

DIMETHISOQUIN - delete entry.

DUBOISIA LEICHARDTII – amend entry to read:

DUBOISIA LEICHARDTII for oral use:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofduboisia calculated as hyoscyamine and 0.025 mg or less of the alkaloids ofduboisia calculated as hyoscyamine per dose and labelled with arecommended daily dose of 0.5 mg or less of the alkaloids of duboisiacalculated as hyoscyamine; or

(b) in divided preparations containing 0.025 mg or less of the alkaloids ofduboisia calculated as hyoscyamine per dosage unit and labelled with arecommended daily dose of 0.5 mg or less of the alkaloids of duboisiacalculated as hyoscyamine.

DUBOISIA MYOPOROIDES – amend entry to read:

DUBOISIA MYOPOROIDES for oral use:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofduboisia calculated as hyoscyamine and 0.025 mg or less of the alkaloids ofduboisia calculated as hyoscyamine per dose and labelled with arecommended daily dose of 0.5 mg or less of the alkaloids of duboisiacalculated as hyoscyamine; or

(b) in divided preparations containing 0.025 mg or less of the alkaloids ofduboisia calculated as hyoscyamine per dosage unit and labelled with arecommended daily dose of 0.5 mg or less of the alkaloids of duboisiacalculated as hyoscyamine.

ERYTHRITYL TETRANITRATE – delete entry.

ETHOHEPTAZINE – delete entry.

FLUORIDES - amend entry to read:

FLUORIDES for human therapeutic use (except in preparations containing 15 mg / kg or15 mg / L or less of fluoride ion):

(a) as sodium fluoride, in preparations for ingestion containing 2.2 mg or less ofsodium fluoride per dosage unit; or

(b) in preparations for topical use containing 2.5 per cent or less of fluoride ionexcept:

(i) dentrifices included in Schedule 3;

(ii) dentrifices containing 1000 mg / kg or less of fluoride ion; or

(iii) other dental hygiene products containing 100 mg / kg or 100 mg / l orless of fluoride ion.

GELSEMIUM – amend entry to read:

GELSEMIUM SEMPERVIRENS.

HOMATROPINE – delete entry.

HYOSCINE – amend entry to read:

HYOSCINE (excluding hyoscine butylbromide):

(a) for transdermal use in preparations containing 2 mg or less of hyoscine; or

(b) for oral use:

(i) in undivided preparations containing 0.025 per cent or less of hyoscine,with a dose of 0.3 mg or less of hyoscine and labelled with arecommended daily dose of 1 mg or less of hyoscine; or

(ii) in divided preparations containing 0.3 mg or less of hyoscine perdosage unit and labelled with a recommended daily dose of 1 mg or lessof hyoscine.

HYOSCYAMINE – amend entry to read:

HYOSCYAMINE:

(a) for external use in preparations containing 0.025 per cent or less ofhyoscyamine; or

(b) for oral use:

(i) in undivided preparations containing 0.025 per cent or less ofhyoscyamine, with a dose of 0.025 mg or less of hyoscyamine andlabelled with a recommended daily dose of 0.5 milligrams or less ofhyoscyamine; or

(ii) in divided preparations containing 0.025 mg or less of hyoscyamine perdosage unit and labelled with a recommended daily dose of 0.5 mg orless hyoscyamine.

HYOSCYAMUS – amend entry to read:

HYOSCYAMUS NIGER for oral use:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofhyoscyamus and 0.025 mg of the alkaloids of hyoscyamus per dose andlabelled with a recommended daily dose of 0.5 mg or less of the alkaloids ofhyoscyamus; or

(b) in divided preparations containing 0.025 mg of the alkaloids of hyoscyamusor less per dosage unit and labelled with a recommended daily dose of 0.5 mgor less of the alkaloids of hyoscyamus.

LIGNOCAINE – amend entry to read:

LIGNOCAINE in preparations for topical use other than eye drops:

(a) containing 10 per cent or less of total local anaesthetic substances, except indermal preparations containing 2 per cent or less of total local anaestheticsubstances; or

(b) in divided preparations containing 200 mg or less of total local anaestheticsubstances per dosage unit, except in lozenges containing 30 mg or less oftotal local anaesthetic substances per dosage unit.

LOBELIA – amend entry to read:

LOBELIA INFLATA except for smoking or burning.

OXETHAZAINE – amend entry to read:

OXETACAINE (OXETHAZAINE) in preparations for internal use.

PHENYLENEDIAMINES – delete entry.

PODOPHYLLUM RESIN – amend entry to read:

PODOPHYLLUM EMODI (podophyllin) in preparations containing 10 per cent or lessof podophyllin for human use for the treatment of warts except when in Schedules3 or 4.

PRAMOXINE - delete entry.

PRILOCAINE - amend entry to read:

PRILOCAINE in preparations for topical use other than eye drops, containing 10 per centor less of total local anaesthetic substances.

STRAMONIUM – amend entry to read:

DATURA STRAMONIUM (stramonium) for oral use when:

(a) in undivided preparations containing 0.025 per cent or less of the alkaloids ofstramonium and 0.025 mg or less of the alkaloids of stramonium per dose,and labelled with a recommended daily dose of 0.5 mg or less of the alkaloidsof stramonium; or

(b) in divided preparations containing 0.025 mg or less of the alkaloids ofstramonium per dosage unit and labelled with a recommended daily dose of0.5 mg or less of the alkaloids of stramonium;


STAPHISAGRIA - amend entry to read:

DELPHINIUM STAPHISAGRIA except in preparations containing 0.2 per cent or lessof delphinium staphisagria.


CICLOPIROX in preparations for dermal use except when included in Schedule 2.

ERYTHRITYL TETRANITRATE for therapeutic use.

MANNITYL HEXANITRATE for therapeutic use.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20 per cent orless of podophyllin for human use for the treatment of warts except whenincluded in Schedules 2 or 4.

SALICYLIC ACID in preparations for dermal use except in preparations containing 40per cent of salicylic acid.


CHLORBUTOL – amend entry to read:

CHLORBUTOL in preparations for human use except:


(b) in preparations containing 0.5 per cent or less of chlorbutol.


PODOPHYLLUM EMODI (podophyllin) in preparations containing 20 per cent or lessof podophyllin for human use for the treatment of warts except when included inSchedules 2 or 4.

SODIUM PHOSPHATE in oral preparations for bowel cleansing prior to diagnostic,medical or surgical procedures.

SALBUTAMOL - amend entry to read:

SALBUTAMOL as the only therapeutically active substance:

(a) in metered aerosols delivering 100 micrograms or less of salbutamol permetered dose; or

(b) in dry powders for inhalation delivering 200 micrograms or less of salbutamolper dose.

TERBUTALINE - amend entry to read:

TERBUTALINE as the only therapeutically active substance:

(a) in metered aerosols delivering 250 micrograms or less of terbutaline permetered dose; or

(b) in dry powders for inhalation delivering 500 micrograms or less of terbutalineper dose.


ACOKANTHERA OUABAIO.

AGLEPRISTONE.

#ANABOLIC STEROIDAL AGENTS.

#ANDROGENIC STEROIDAL AGENTS.

ATROPINE METHONITRATE.

BAMBUTEROL HYDROCHLORIDE.

CALOTROPIS GIGANTEA.

CICLOPIROX except when included in Schedule 2 or 3.

CONVALLARIA KEISKI.

DATURA TATULA (stramonium) except:



DIGITALIS LANATA.

EPHEDRA spp. except in preparations containing 0.001 per cent or less of ephedrine.

ESTROPIPATE (piperazine oestrone sulfate).

FENCLOFENAC.

PERTUSSIS ANTIGEN.

PODOPHYLLUM PELTATUM (podophyllin) for human use:



PRAMOCAINE.

QUINISOCAINE (dimethisoquin).

RAUWOLFIA VOMITORIA.

SODIUM PHOSPHATE in preparations for oral laxative use.

SUXETHONIUM BROMIDE.

TEPOXALIN.

TETANUS TOXOID for human use.

TOLONIUM CHLORIDE.


ACONITE – amend entry to read:

ACONITUM spp.

ADONIS - amend entry to read:

ADONIS VERNALIS.

AMETHOCAINE – amend entry to read:

AMETHOCAINE except:


(b) in dermal preparations containing 2 per cent or less of total local anaestheticsubstances.

ANABOLIC AND ANDROGENIC STEROIDAL AGENTS – delete entry.

APOCYNUM – amend entry to read:

APOCYNUM spp.

AZAPETINE - delete entry.


ATROPA BELLADONNA (belladonna) except when included in Schedule 2.

BENZAMINE – amend entry to read:

BENZAMINE.

BENZOCAINE – amend entry to read:

BENZOCAINE except:


(b) in dermal preparations containing 2 per cent or less of total local anaestheticsubstances; or

(c) in lozenges containing 30 mg or less of total local anaesthetic substances perdosage unit.

BRUCINE – delete entry.

BUTYLAMINOBENZOATE – amend entry to read:

BUTYL AMINOBENZOATE.

CALOTROPIS – amend entry to read:

CALOTROPIS PROCERA.

CARBENOXOLONE – amend entry to read:

CARBENOXOLONE for internal use.

CINCHOCAINE – amend entry to read:

CINCHOCAINE except when included in Schedule 2.

COLESTIPOL – amend entry to read:

COLESTIPOL.

CONVALLARIA – amend entry to read:

CONVALLARIA MAJALIS.

CORONILLA – amend entry to read:

CORONILLA spp.

TRANS-4-[(3,5-DIBROMO-2-HYDROXYBENZYL)-AMINO]CYCLOHEXANOLHYDROCHLORIDE MONOHYDRATE – amendentry to read:

DEMBREXINE except when included in Schedule 5.

DIGITALIS – amend entry to read:

DIGITALIS PURPUREA.

DIGOXIN ANTIBODY – amend entry to read:

DIGOXIN-SPECIFIC ANTIBODY FRAGMENT F (Ab).

DIMETHISOQUIN - delete entry.

DUBOISIA LEICHARDTII – amend entry to read:

DUBOISIA LEICHARDTII except when included in Schedule 2.

DUBOISIA MYOPOROIDES – amend entry to read:

DUBOISIA MYOPOROIDES except when included in Schedule 2.

ERYSIMUM – amend entry to read:

ERYSIMUM spp.

ETHOHEPTAZINE – amend entry to read:

ETHOHEPTAZINE CITRATE.

FLUORIDES - amend entry to read:

FLUORIDES in preparations for human therapeutic use except:

(a) when included in Schedule 2 or 3;

(b) dentifrices containing 1000 mg / kg or less of fluoride ion;

(c) other dental hygiene products containing 100 mg / kg or 100 mg / L or less offluoride ion; or

(d) in other substances containing 15 mg / kg or 15 mg / L or less of fluoride ion.

FOLLITROPIN ALPHA – amend entry to read:

FOLLITROPIN ALPHA.

FOLLITROPIN BETA – amend entry to read:

FOLLITROPIN BETA.

GALANTHAMINE –amend entry to read:

GALANTAMINE.

GALANTHUS – amend entry to read:

GALANTHUS spp.

HOMATROPINE – amend entry to read:

HOMATROPINE.

HYOSYCAMUS – amend entry to read:

HYOSCYAMUS NIGER except when included in Schedule 2.

ION-EXCHANGE RESINS – delete entry.

ISOETHARINE – amend entry to read:

ISOETARINE.

LIGNOCAINE – amend entry to read:

LIGNOCAINE except:


(b) in dermal preparations containing 2 per cent or less of total local anaestheticsubstances; or

(c) in lozenges containing 30 mg or less of total local anaesthetic substances perdosage unit.

OLEANDER – amend entry to read:

NERIUM OLEANDER.

NICOUMALONE – amend entry to read:

NICOUMALONE.

NORADRENALINE – amend entry to read:

NORADRENALINE.

OCTATROPINE – amend entry to read:

OCTATROPINE METHYLBROMIDE.

OXETHAZAINE – amend entry to read:

OXETACAINE (oxethazaine) except when included in Schedule 2.

PHENINDIONE – amend entry to read:

PHENINDIONE.


PODOPHYLLUM EMODI (podophyllin) for human use:



PRAMOXINE - delete entry.

PRILOCAINE - amend entry to read:

PRILOCAINE except when included in Schedule 2.

QUEBRACHO – amend entry to read:

ASPIDOSPERMA QUEBRACHO.

RAUWOLFIA – amend entry to read:

RAUWOLFIA SERPENTINA.

SABADILLA – amend entry to read:

SCHOENOCAULON OFFICINALE (sabadilla).

SOMATROPIN - amend entry to read:

#SOMATROPIN (human growth hormone).

STRAMONIUM – amend entry to read:

DATURA STRAMONIUM (stramonium) except:



STROPHANTHUS – amend entry to read:

STROPHANTHUS spp.

STRYCHNOS – amend entry to read:

STRYCHNOS spp.

SULFACETAMIDE - amend entry to read:

SULFACETAMIDE except when included in Schedule 3 or 5.

THEVETIA – amend entry to read:

THEVETIA PERUVIANA.

UROFOLLITROPHIN – amend entry to read:

#UROFOLLITROPHIN.

VERATRUM – amend entry to read:

VERATRUM spp. except when separately specified in this Schedule.


COPPER ACETATE in preparations containing 20 per cent or less of copper acetateexcept when in preparations containing 5 per cent or less of copper acetate.

COPPER COMPOUNDS in animal feed additives containing 5 per cent or less of copperexcept in preparations containing 1 per cent or less of copper.

PHENOL, including cresols and xylenols and any other homologue of phenol boilingbelow 220°C, when in animal feed additives containing 15 per cent or less of suchsubstances, except in preparations containing 3 per cent or less of suchsubstances.

SULFACETAMIDE when packed and labelled for the treatment of ornamental cagedbirds or ornamental fish only.

SCHEDULE 5 - AMENDMENT

TRANS-4-[(3,5-DIBROMO-2-HYDROXYBENZYL)-AMINO]CYCLOHEXANOL HYDROCHLORIDE MONOHYDRATE – amend entry to read:

DEMBREXINE in oral preparations for the treatment of animals.

SCHEDULE 6 - NEW ENTRIES

AMMONIUM PERSULFATE in hair preparations.

COPPER ACETATE except:


(b) when in preparations containing 5 per cent or less of copper acetate.

COPPER COMPOUNDS in animal feed additives except:


(b) in preparations containing 1 per cent or less of copper.

POTASSIUM PERSULFATE in hair preparations.

SODIUM PERSULFATE in hair preparations.

SULFLURAMID.


PHENOL - amend entry to read:

PHENOL, including cresols and xylenols and any other homologue of phenol boilingbelow 220°C, except:


(b) when included in Schedule 5; or

(c) in preparations containing 3 per cent or less of such substances.

PHENYLENEDIAMINES – amend entry to read:

PHENYLENEDIAMINES and alkylated phenylenediamines except when separatelyspecified in this Schedule:

(a) when used in hair dyes;

(b) in preparations packed and labelled for photographic purposes; or

(c) in preparations packed and labelled for testing water except in tabletscontaining 10 mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging provided the directions for useinclude the statement, “Do not discard testing solutions into the pool.”.

SELENIUM - amend entry to read:

SELENIUM

(a) in preparations containing 2.5 per cent or less of selenium when packed andlabelled:

(i) for the blueing of gun barrels;

(ii) for photographic purposes; or

(ii) for the colouring of lead or lead alloys;

(b) in coated granules containing 1 per cent or less of selenium for application topasture except in fertilisers containing 200 g/tonne or less of selenium; or

(c) for the treatment of animals:

(i) in a drench, injection, paste, stocklick or vaccine containing 0.5 per centor less of selenium for the treatment of animals;

(ii) in animal feed premixes containing 2 per cent or less of selenium forthe preparation of feeds containing 1 g/tonne or less of selenium; or

(iii) as barium selenate in preparations for injection containing 5 per cent orless of selenium.

SCHEDULE 7 – AMENDMENT

BRUCINE – amend entry to read:

BRUCINE except in alcohol containing 0.02 per cent or less of brucine as a denaturant.

PART 5 – APPENDICES

APPENDIX C – NEW ENTRY

ARISTOLOCHIC ACID.

APPENDIX C – AMENDMENTS

ARISTOLOCHIA – amend entry to read:

ARISTOLOCHIACEAE and plants of this family containing aristolochic acid.

CONIINE – amend entry to read:

CONIUM MACULATUM (coniine).

APPENDIX D – NEW ENTRIES

SECTION 5:

ANABOLIC STEROIDAL AGENTS, including those separately specified in Schedule 4.

ANDROGENIC STEROIDAL AGENTS, including those separately specified inSchedule 4.

SOMATROPIN (human growth hormone).

APPENDIX D – AMENDMENT

SECTION 5:

ANABOLIC AND ANDROGENIC STEROIDAL AGENTS – delete entry.

APPENDIX E - AMENDMENTS

INTRODUCTION

Amend INTRODUCTION to read:

Directions for First Aid Attention

Under poisons legislation, scheduled substances and their preparations are required to belabelled with appropriate directions for first aid attention in case of poisoning. It is theresponsibility of the manufacturer, packer and supplier of a drug or poison to ensure thatthe first aid instructions included on the label of a poison are appropriate for a specificproduct. The following code has been prepared as a guide for health authorities andmanufacturers in drafting suitable first aid directions for this purpose. Standardstatements specified in this appendix may be varied provided that the intent is notchanged.

The directions listed for any particular substance may require modification to take intoaccount combination of that substance with other substances, both toxic and non toxic, ina formulation, as well as the physical form and presentation of the product. Any suchmodification should be concise and readily understood.

These First Aid Instructions include action to be taken in case of eye contamination fromsubstances recognised as causing direct poisoning via the eye, causing severe eye damageor requiring prolonged flushing to free the absorbed substance from the eye tissue.However, it is recognised that many other substances or preparations will require astatement of varying nature depending on the detailed formulation. While the necessityto flush the eyes in case of accident will be so self-evident as not to justify label space inmany instances, a statement such as “If in eyes rinse well with water” may beappropriate.

Standard Statements – NEW and OLD

Based on a review of the Standard First Aid Instruction Statements undertaken by aWorking Party of the National Drugs and Poisons Schedule Committee, a revised set ofStandard Statements is to be phased in over the transitional period of 1 September 2001to 31 August 2003 where OLD statements b, h, r, and v are to be phased out; and to 31August 2004 for all other OLD statements. These revised Standard Statements are shownin Part 1 of this Appendix as “NEW” Standard Statements. The Standard Statements inforce at the commencement of the transitional period are shown in Part 1 of thisAppendix as “OLD” Standard Statements.

Manufacturers, packers and suppliers are encouraged to switch to use of the NEWStandard Statements as early as possible in the transitional period particularly if theexisting first aid instructions include reference to induction of vomiting. Howeverpoisons labelled with OLD Standard Statements may continue to be sold or supplied until31 August 2004 unless they are labelled with the OLD standard statements b, h, r, or v inwhich case they may not be sold or supplied after 31 August 2003. Poisons labelled withthe NEW standard statement G3 must also be phased in by 31 August 2003.

Because of the transitional period during which poisons may be labelled with either NEWor OLD Standard Statements, Part 2 of this Appendix, which gives the StandardStatements for specific poisons, has been revised to show both NEW and OLD StandardStatements. A mix of NEW and OLD Standard Statements must not be used on labels.

New substances added to this Appendix after the beginning of the transitional period willnot have entries made under the OLD Standard Statements. In such cases there is notransitional period and the specified first aid instructions should be applied by theeffective date of the first document in which they are notified.

T-Values have been retained in Part 2 of this Appendix for use in conjunction with theOLD Standard Statements only.

Conflict between Instructions for Poison and Solvent

This provision does NOT apply to the NEW statements.

Where a preparation contains a scheduled poison dissolved or suspended in a scheduledsolvent, the First Aid Instructions for the poison and the solvent may conflict.

Thus, under the OLD Standard Statements, the poison may call for Instructions “b” or“h”, which prescribe the induction of vomiting, while the solvent may call for Instruction“c”, which specifies not to induce vomiting, due to the risks of aspiration of the solventinto the lungs when vomiting occurs. In such cases the risks of leaving the poison in thedigestive system must be balanced against the risks of aspiration.

As a guide in deciding which Instruction should be adopted, the following rule may beused:-

“Where the First Aid Instruction for a poison and its solvent are in conflict, theInstruction forthe poison is to prevail if its concentration, expressed in grams per litre or grams perkilogramof preparation, is greater than the T-value listed beside the poison in Appendix E. Iftheconcentration is equal to or less than T, then the instruction for the solvent is toprevail,provided that in the case of Instruction ‘h’, the statements on skin absorption are toberetained.

Where two or more poisons are present at concentrations less than their T-value and theirFirst Aid Instructions are in conflict with the solvent calculate, for each poison, theproportion of its T-value which its actual concentration C represents (i.e., the C/Tfraction) and add these fractions. If the total exceeds 1, the first aid for the poisons is toprevail.”

It may be noted that where the solvent concentration is low enough to result in exemptionof the solvent from scheduling, for example at 25 per cent for liquid hydrocarbons, thenno conflict arises and the first aid for the poison automatically prevails.

On the other hand, for certain substances of very low toxicity, the first aid for the solventwill always prevail. In these cases the symbol ‘SVT’ is shown instead of a numericalT-value.

Modified First Aid Instruction on Primary Pack

Where a primary pack contains two or more immediate containers of poisons eachrequiring different first aid instructions:

(a) each immediate container must be labelled with first aid instructionsappropriate for its contents; and

(b) the primary pack must be labelled with the statement:

FIRST AID: See inner packs.

Modified First Aid Instruction for Dilute Preparations

Under the OLD system of Standard Statements, where the concentration of any poison,expressed in grams per litre or grams per kilogram, is less than one tenth of the T-valuelisted beside the poison in Appendix E, then only standard statement “a” need be shown.

This provision does not apply to the NEW Standard Statements.

Exempt Preparations

This Appendix applies only to scheduled poisons. The directions are for substances andtheir preparations at the concentrations at which the schedules apply. If it is thoughtdesirable to show first aid instructions for a substance exempted from the schedules, it isthe responsibility of the manufacturer to ensure they are appropriate.

Poisons Information Centre Telephone Numbers

Companies wishing to use a poisons information centre telephone number other than thenational telephone numbers for Australia and New Zealand in either NEW statement A orOLD statement (a) in Part 1 of this Appendix must meet the following criteria:

1. The poisons information service whose number is used must be attended byadequately trained staff for 24 hour emergency poisons information; and

2. Calls must be logged and submitted for incorporation into the officialcollection of poisoning data.

PART 1

Insert the following heading, preamble and statements after the words “…Sub-paragraph7(p) of this Standard).”:

NEW Standard Statements

Manufacturers, packers and suppliers are encouraged to replace existing first aidinstructions with these New Standard Statements as soon as practical, but no laterthan 31 August 2003 for those substances requiring statement G3 and no later than31 August 2004 for all other statements.

Basic

A For advice, contact a Poisons Information Centre (Phone eg Australia 131126; New Zealand 03 4747 000) or a doctor (at once).

Z First aid is not generally required. If in doubt, contact a Poisons InformationCentre (Phone 131 126) or a doctor.

General

G1 Urgent hospital treatment is likely to be needed. (Note - the words ‘at once’to be added to instruction A).

G2 If swallowed, give activated charcoal if instructed. (Note - the words ‘at once’to be added to instruction A).

G3 If swallowed, do NOT induce vomiting.

G4 Immediately give a glass of water.

G5 Avoid giving milk or oils.

G6 If sprayed in mouth, rinse mouth with water

Eyes

E1 If in eyes wash out immediately with water.

E2 If in eyes, hold eyelids apart and flush the eye continuously with runningwater. Continue flushing until advised to stop by the Poisons InformationCentre or a doctor, or for at least 15 minutes.

Respiratory system

R1 If inhaled, remove from contaminated area. Apply artificial respiration if notbreathing.

R2 If swallowed or inhaled, remove from contaminated area. Apply artificialrespiration if not breathing. Do not give direct mouth-to-mouth resuscitation.To protect rescuer, use air-viva, oxy-viva or one-way mask. Resuscitate in awell-ventilated area.

Skin

S1 If skin or hair contact occurs, remove contaminated clothing and flush skinand hair with running water.

S2 If skin or hair contact occurs, remove contaminated clothing and flush skinand hair with running water. Continue flushing with water until advised tostop by the Poisons Information Centre or a doctor.

S3 If on skin, remove any contaminated clothing, wash skin thoroughly withsoap and water, then methylated spirit if available. Contact the PoisonsInformation Centre or a doctor.

S4 If on skin, immediately remove any contaminated clothing, wash skin withmethylated spirit or PEG (polyethylene glycol) 300 or 400 if available, thenflush under running water until advised to stop by the Poisons InformationCentre or a doctor.

S5 If skin contact occurs, immediately remove contaminated clothing. Flush skinunder running water for 15 minutes. Then apply calcium gluconate gel.Contact the Poisons Information Centre.

Special Purpose

SP1 If swallowed, splashed on skin or in eyes, or inhaled, contact a PoisonsInformation Centre (Phone eg Australia 131 126; New Zealand 03 4747 000)or a doctor at once. Remove any contaminated clothing and wash skinthoroughly. If swallowed, activated charcoal may be advised. Give atropine ifinstructed.

OLD Standard Statements

These Standard Statements are to be phased-out over the period 1 September 2001to 31 August 2003 for statements b, h, r, and v, and to 31 August 2004 for all otherstatements, and replaced by the New Standard Statements given above, with specificrequirements given in Part 2 of this Appendix.

PART 2

Amend Part to read:

FIRST AID INSTRUCTIONS

Standard statements in this Appendix apply to poisons other than agricultural andveterinary chemicals (including pesticides) registered by the National RegistrationAuthority for Agricultural and Veterinary Chemicals. Labelling is not required atconcentrations below scheduled levels (see the INTRODUCTION to this Appendix).

OLD STANDARDSTATEMENTS AND

ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS

OLDSTANDARDSTATEMENTS

T-VALUE

Acetic acid A, G3, E2, S1 a,c,f,sAcetic anhydride A, G3, E2, S1 a,c,f,sAcetone A, G3 a,cAcrolein A,G1,G2,G3,E2, S2,

R2a,b,f,g,s 2

Alkaline salts A, G3, E2, S2 a,c,sAmines for use as curing agentsfor epoxy resins

A, G3, E1, S1 a,c,f

4-Aminopyridine A,G1,G2,E1,S1 a,b,f 4Ammonia

5 per cent or less A aabove 5 per cent A, G3,E1,S1,R1 a,c,f,g

Ammonium bifluoridewhen included in Schedule 5 A a

when included in Schedule 6 A,G3,E2,S5 f,s,c,a,tAmmonium persulfate A,G3,E2 a,c,sAmmonium thiocyanate A a,b 33Anhydrides, organic acid, foruse as curing agents for epoxyresins

A,G3,E1,S1 a,c,f

Aniline A, S1, E2, R1 a,b,f,g 40Anise oil A,G3Antimony chloride A, S2, E2 a,b,sAntimony compounds, exceptAntimony chloride

A a,b


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

Barium salts, except Bariumsulfate

A a,b

Basil oil A,G3Bay oil A,G3Benzalkonium chloride 20when included in Schedule 5 A,G3,E2 a,c

when included in Schedule 6 A,G3,E2,S1 a,c,f,sBenzene A,G3,E1,S1,R1 a,c,f,g 160Benzoyl peroxide 10above 20 per cent A, S1, E2 a,b,f,s

above 10 per cent up to 20 percent

A, E1 a,b,f

10 per cent or less A aBergamot oil A,G3Borax A a,b 100Boric Acid A a,b 100Boron trifluoride A,G3,E2,S1 a,c,f,sBromoform A,G3,E2,R1,S2 a,b,f,g,sBrucine A,G1,G2,G3,R2 a,l 0.12-Butoxyethanol and its acetates A,E2,S1 a,f,sCadmium compounds A a,bCajuput oil A,G3Calcium hypochloritein preparations containing above

4 per cent and below 10 percent of available chlorine

A,G3,E1,S1 a,c,f

in preparations containing 10per cent or more of availablechlorine

A,G3,E2,S1 a,c,f,s

Camphor A,G1,G3,G5 i,c,d 0.5Carbon disulphide A,G3,E2,R1,S2 a,b,e,f,g,sCarbon tetrachloride A,G3,E1,R1,S1 a,b,d,e,f,g,s 0.7Cassia oil A,G3Chlorinated lime


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

in preparations containing above4 per cent and below 10 percent of available chlorine

A,G3,E1,S1 a,c,f


A,G3,E2,S1 a,c,f,s

Chlorinating compounds, exceptwhen separately specified,containingabove 4 per cent and below 10

per cent of availablechlorine

A,G3,E1,S1 a,c,f

10 per cent or more of availablechlorine

A,G3,E2,S1 a,c,f,s

Chlorine (gas) A,R1,E1 a,g,sChlorocresol A,G3,E2,S2 a,b,f,sChloroform A,G3,E1,R1,S1 a,b,f,g,s 80Chromates A,G3,E2,S1 a,b,f,sChromium trioxide A,G3,E2,S1 a,c,f,sCineole A,G1,G3 i,cCinnamon bark oil A,G3Cinnamon leaf oil A,G3Climbazole A a,b 20Clove oil A,G1,G3,E2 i,c,sCopper sulfate A,G3,E2,S1 a,b,f,sCreosote A,G3,E2,S1 a,f,s 70Cresols A,G3,E2,S3 a,c,j,sCresols in pressurised spraypacks

A,E1,S1,G6 o

Cyanides A,G1,E1,R2 a,kCyanoacrylic acid esters A aCyanuric acid A zCyclohexanone peroxide A,E2,G3,S1 a,f,so-Dichlorobenzene A,G3,E1,S1 a,c,e,f,sDichloroethyl ether A,G3,E1,S1,R1 a,f,g,s 7Dichloroisocyanurates A,G3,E1,S1 a,c,fDichloromethane (methylenechloride)

A,G3,G5,E1,S1,R1 a,c,d,e,f,g,s


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

in pressurised spray packs A,S1,G6 oDichromates A,G1,G3,E2,S1 a,b,f,sDidecyldimethyl-ammoniumchloride

A,G3,E2,S1 a,f,p,s 20

Diesel (distillate) A,G3 a,cDiethanolaminewhen included in Schedule 5 A,G3 a,c

when included in Schedule 6 A,G3,E2,S1 a,c,f,sDimethylformamideless than 75 per cent A a,b

75 per cent or more A,E1,R1,S1 a,b,f,g,sDimethyl sulfoxide A,G3,E1,S1 a,f 2000Dinitrocresols A,G1,E1,S1 a,b,f,sDinitrophenols A,G1,E1,S1 a,b,f,sDioxane A,G3,E1,S1,R1 a,f,g 710Distillate A,G3 a,cN-(N-dodecyl)-2-pyrrolidonewhen included in Schedule 5 A,G3,E1 a,c,nwhen included in Schedule 6 A,G3,E2,S1 a,c,sEpoxy resins liquid A,G3,E2,S1 a,c,f,sEssential oils containingcamphor as natural componentunless otherwise specified.

A,G3

Ethanolaminewhen included in Schedule 5 A,G3,E1 a,cwhen included in Schedule 6 A,G3,E2,S1 a,c,f,sEther A,G3,E1,R1 a,b,g 170Ethyl bromide A,E2,S1,R1 a,gEthylene glycol A a,b 30Ethylene glycol monoalkylethers and their acetates, exceptwhen separately specified

A,G3,E2,S1 a,f,s

Ethylene oxide A,E2,R1 a,g,sEucalyptus oil A,G1,G3 i,cEugenol A,G1,G3,E2 i,c,s


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

Fluorides except whenseparately specifiedwhen included in Schedule 5 A a

when included in Schedule 6 A,G1,G3,E2,S1 a,b,sFormaldehyde (see alsoparaformaldehyde)

A,G3,E2,S1,R1

Formic acid A,G3,E2,S1 a,c,f,sGlutaraldehydebelow 5 per cent A,G3,E1 a,p5 per cent or more A,G3,E2,S1 a,p,sGlycolic acid A,G3,E2 a,c,sHexachlorophane whenincluded in Schedule 6

A a

Hydrazine A,G1,G3,E2,R1,S1 a,b,f,g,s 70Hydrocarbons, liquid A,G3 a,cHydrochloric acid A,G3,E2,S1 a,c,f,swhen included in Schedule 5 A,G3 a,cHydrofluoric acidwhen included in Schedule 5 A a

when included in Schedule 6 or7

A,G3,E2,S5 f,s,c,a,t

Hydrogen peroxidemore than 3 per cent up to 20

per centA,G3,E2,S1 a,c,s

more than 20 per cent A,G1,G3,G4,E2,S1 i,w,f,sHydroquinone A,G2,G3,S1,E2,R2 a,b,s 30Hydrosilicofluoric acidwhen included in Schedule 5 A a

when included in Schedule 6 or7

A,G3,E2,S5 f,s,c,a,t

Iodine (excluding salts,derivatives and iodophors)

10

2.5 per cent or more for humanexternal use

A,E2 a,b,s

2.5 per cent or more for otheruses

A,S1,E2 a,b,f,s


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

below 2.5 per cent A aIodophors AIsocyanates, free organic A,E2,S1 a,fIsophorone A,G3,E2,S1 a,c,f,sKerosene A,G3 a,cLauryl isoquinolinium bromide A,E1 a,bLead compoundsin hair cosmetics A a,b

in other preparations A,S1 a,b,fLemon oil A,G3Lime oil A,G3Magnesium chlorate A aMaldison at 20 per cent or less A aMarjoram oil A,G3Melaleuca Oil A,G1,G3 i,cMercuric chloride 0.1for external therapeutic use A a,r

for other uses A,G1,G3,E2,R2,S1 a,f,rMercuric iodide A,G1,G3,E2,R2,S1 a,r 4Mercuric nitrate A,G1,G3,E2,R2,S1 a,rMercuric oxide A,G1,G3 a,rMercuric potassium iodide A,G1,G3,E2,R2,S1 a,rMercuric thiocyanate A,G1,G3,E2,R2,S1 a,rMercurochrome A a,bMercurous chloride A a,bMercury metallic A aMercury, organic compounds A,S1 a,b,f

in preparations for humanexternal use

A a,b

Metaldehyde A,E1,S1 a,b 60Methanol 650above 10% A,G310% or less AMethylated spirit A,G3 a,bMethyl ethyl ketone A,G3


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

Methyl ethyl ketone peroxide A,G3,E2,S1 a,c,f,s 40Methyl iso-amyl ketone A,G3Methyl iso-butyl ketone A,G3N-methyl-2-pyrrolidonewhen included in Schedule 5 A,G3,E1 a,c,n

when included in Schedule 6 A,G3,E2 a,c,sMethyl salicylate liquid whenincluded in Schedule 5 or 6

A,G3,E1 a,b

Naphthalene A,G1,G3 i,b,d 220Nitric acid A,G3,E2,S1 a,c,f,sNitrobenzene A,G3,E1,S1 a,b,fNitrophenol A,G3,E2,S1 a,b,f 90Nonoxinol 9 A,E2 a,s 180Nutmeg oil A,G32-Octyl-4-isothiazolin-3-one(Octhilinone)

A,G3,E2,S1 a,c,f,s

N-(N-octyl)-2-pyrrolidonewhen included in Schedule 5 A,G3,E1 a,c,nwhen included in Schedule 6 A,G3,E2 a,c,sOrange oil (bitter) A,G3Oxalic acid A,G3,E2,S1 a,c,f 50Paraformaldehyde A,G3,E2,R1,S1 a,bPDB (paradichlorobenzene) A a,b,d 50Pennyroyal oil A,G3Peracetic acidwhen included in Schedule 5 A,G3,E1,S1 a,c,f

when included in Schedule 6 A,G3,E2,S1 a,c,f,sPermanganates A,G3,E2,S1 a,c,f,sPetrol A,G3,R1 a,c,gPhenols A,G3,E2,S3 a,c,j,sPhenols in pressurised spraypacks

A,E1 o

Phenylenediamines andalkylated phenylenediaminesin hair dyes A,E1 a,bin other preparations A,G1,G3,E1,S1 a,b,f


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

Phenyl methyl ketoneAs such, or in preparations of

similar viscosityA,G3,E1

N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,5-dimethanamine

A,E2,S1 a,f,s

N,N-bis(phenylmethylene)-bicyclo-(2.2.1)heptane-2,6-dimethanamine

A,E2,S1 a,f,s

ortho-Phenylphenol A,G3,E2,S1 a,b,f 240in pressurised spray packs A,G6,E2,S1 oPhosphonic acid A,G3,E2,S1 a,c,fneutralised to pH 6 (approx) A ain spray packs A,E2,S1 a,o,sPhosphoric acid A,G3,E2,S1 a,c,f,s 150Phosphorus, yellow A,G1,G3,E2,R2,S2 a,b,f 0.01ortho-Phthalaldehydewhen included in Schedule 5 A,E1 a,s

when included in Schedule 6 A,G3,E2,S1 a,c,f,sPicric acid A,G1,G3,E2,R1,S1 a,b,f,g 0.3Polyethanoxy alkylamine2-methyl-1-propanol

A a

Polyethanoxy (15) tallow amine A,E2,S1 a,f,s 120

Poly(Oxy-1,2-ethanediyl), α-[2-[(2-hydroxyethyl)amino]-2-oxoethyl]-ω-hydroxy-. mono-C13-15-alkyl ethers

A,E1 a,n

Potassium bromate A a,bPotassium chlorate A a,bPotassium cyanate A,E1,S1 a,bPotassium hydroxide A,G3,E2,S1 a,c,f,sPotassium metabisulphite A a,cPotassium peroxomonosulfatetriple salt

120

when included in Schedule 5 A,G3,E1 a,c,n


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

when included in Schedule 6 A,G3,E2,S1 a,c,f,sPotassium persulfate A,G3,E2 a,c,sPotassium sulfide A,G3,E2,S1 a,c,f,sPropionic acid A,G3,E1,S1 a,b,s 260d-Pulegone A,G3Pyrithione zinc A,E1 a,b 30Quaternary ammoniumcompounds except whenseparately specifiedabove 20 per cent A,G3,E2 a,p

20 per cent and below A, E2 ain pressurised spray packs A, E2, G6 oSafrole A,G1,G3 i,cSage oil (Dalmatian) A,G3Sassafras oil A,G1,G3 i,cSelenium compounds A,G1,E1,S1Silicofluorideswhen included in Schedule 5 A a

when included in Schedule 6 A,G1,G3,E2,S1 a,b,sSilver salts A,E2 a,sSodium aluminate A,G3,E2,S1 a,c,f,s

Sodium blifluoridewhen included in Schedule 5 A a

when included in Schedule 6 A,G3,E2,S5 f,s,c,a,tSodium bromate A,G1 a,bSodium chlorate A a,bSodium diacetate A,G3,E2,S1 a,c,f,sSodium dichloroisocyanurate A,G3,E1,S1 a,c,f 140Sodium dodecylbenzenesulfonate

A,G3,E2,S1 a,c,f,s 40

Sodium hydrogen sulfate A,G3,E1,S1 a,c,fSodium hydrosulfite A,G3,E2,S1 a,c,sSodium hydroxide A,G3,E2,S1 a,c,f,sSodium hypochlorite


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

in preparations containing above4 per cent and below 10 percent of available chlorine

A,G3,E1,S1 a,c,f


A,G3,E2,S1 a,c,f,s

Sodium laureth-6 carboxylate A aSodium metabisulphite A, G3 a,cSodium nitrite A,G3 a,b 10Sodium percarbonate 240when included in Schedule 5 A,G3,S1 a,c,n

when included in Schedule 6 A,G3,E2,S1 a,c,f,sSodium persulfate A,G3,E2 a,c,sSodium stannate A,E1 a 340Sodium sulfide A,G3,E2,S1 a,c,f,sSodium trichloroacetate A a,b 320Sodium trichloroisocyanurate A,G3,E1,S1 a,c,f 70Strychnine A,G1,G2,G3,R2 a,l 0.5Styrene A,G3,S1,E1 a,c,f 500Sulcofuron A aSulfamic acid A,G3,E2,S1 a,c,f,s 310Sulfuric acid A,G3,E2,S1 a,c,f,s 10Terpenes, chlorinated A,G3 a,bTetrachloroethane A,G3,E1,R1,S1 a,b,d,e,f,g,sTetrachloroethylene A,G3,E2,S1,R1 a,c,d,e,f,g,sThiourea A a,b 0.1Thujone A,G3Thyme oil A,G3ortho-Tolidine A a,b 40Tolueneabove 75 per cent A,G3,E1,S1,R1 a,c,f,g,s75 per cent and below A,G3 a,cin pressurised spray packs A oToluenediaminein hair dyes A,E1 a,b

in other preparations A,G1,G3,E1,S1 a,b,f


ASSOCIATED T-VALUES

POISON NEWSTANDARD

STATEMENTS


T-VALUE

Trichloroacetic acid A,G3,E2,S1 a,c,f,s 40Trichloroacetic acid alkali salts A a,b 3201,1,1-Trichloroethane A,G3,E1,S1,R1 a,c,d,e,f,g,sTrichloroethylene A,G3,E1,S1,R1 a,c,d,e,f,g,s 715Trichloroisocyanuric acid A,G3,E1,S1 a,c,f 70Triethanolamine A,G3,E1,S1 a,c,f,nTriethyl phosphate A,E1 a,bTrifluoromethane-sulphonicacid

A,G3,E2 a,p,s

Triisopropanolamine laurylether sulfate

A,E1,S1 a,f,n

Turpentine (mineral) A,G3 a,cTurpentine oil (vegetable) A,G3,E2 i,c,sWhite spirit A,G3 a,cXyleneabove 75 per cent A,G3,E1,S1,R1 a,c,f,g,s75 per cent and below A,G3 a,cin pressurised spray packs A,G6,E1,S1 oXylenols A,G3,E2,S3 a,c,j,sin pressurised spray packs A,E1 oZinc chloride A,G3,E2,S1 a,c,s 30Zinc sulfate A,G3,E2,S1 a,s

APPENDIX F, PART 1 – NEW ENTRY

89. Application to skin may increase sensitivity to sunlight.

APPENDIX F, PART 2 – NEW ENTRIES

33. Mix strictly according to instructions.

34. May cause fire if it comes into contact with other chemicals, paper or otherflammable materials.

APPENDIX F, PART 3 – NEW ENTRIES

Ammonium persulfate

Warning statements ...............................5,21,25

Safety directions ....................................1,5,23,33,34

Bergamot oil

Warning statement ................................89

Lemon oil


Lime oil


Orange oil (bitter)


Potassium persulfate



Sodium persulfate



APPENDIX F, PART 3 – AMENDMENT

Phenol - amend entry to read:

Phenol and any other homologue of phenol

Safety Directions ...................................1,4

APPENDIX G – AMENDMENTS

GELSEMIUM – amend entry to read:

GELSEMIUM SEMPERVIRENS 1mg

IGNATIA AMARA – amend entry to read:

STRYCHNOS IGNATII 10mg

NUX VOMICA – amend entry to read:

STRYCHNOS NUX VOMICA. 10mg

Appendix H – New entry

Folic Acid.

PART D – OTHER OUTCOMES

The information contained in this Part D relates to outcomes of the May 2001 meeting,other than scheduling decisions, which the NDPSC wishes to advise to interested parties.

NDPSC GUIDELINES

OUTCOME

The Committee confirmed that the AHMAC Guidelines, as currently published on theTGA website, are the current operational guidelines for the NDPSC with the exception ofitems superseded by the legislation.

DIMETHYL PHALATE

OUTCOME

The Committee agreed that there was sufficient evidence to support the exclusion ofDMP and DEP from human use where that use was for repeated application of significantconcentrations to the skin over large areas of the body.

FORESHADOWED

APPENDIX C - New entries

DIMETHYLPHTHALATE in sunscreens or personal insect repellents for human use.

DIETHYLPHTHALATE in sunscreens or personal insect repellents for human use.

SELENIUM

OUTCOME

The Committee agreed that the existing entry for selenium required clarification of thecurrent exemption for oral products contain organic or inorganic selenium. In particularthe exemption required extension to include combination products containing both formsof selenium.

FORESHADOWED


SELENIUM in preparations for human oral use with a recommended daily dose of 100micrograms or less of selenium except where the sum of the organic seleniumexpressed in micrograms and half the inorganic selenium expressed inmicrograms, contained in the recommended daily dose of the preparation, doesnot exceed 26 micrograms.


SELENIUM for therapeutic use except:

(a) when included in Schedule 3, 6 or 7;

(b) in preparations for human oral use where the sum of the organic seleniumexpressed in micrograms and half the inorganic selenium expressed inmicrograms, contained in the recommended daily dose of the preparation,does not exceed 26 micrograms;

(c) for the treatment of animals:

(i) in solid, slow release bolus preparations eachweighing 100 g or more and containing 300 mg orless of selenium per dosage unit;

(ii) in other divided preparations containing 30micrograms or less of selenium per dosage unit;

(iii) as elemental selenium, in pellets containing 100g/kg or less of selenium; or

(iv) in feeds containing 1 g/tonne or less of selenium; or

(d) in preparations for topical use containing 2.5 per cent or lessof selenium sulphide.

31st meeting – may 2001 national drugs …...record of reasons 31st meeting – may 2001 national...

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