Poisons List Amendment Order (No. 3) 2001

Poisons List Amendment Order (No. 3) 2001

I make the following order under the Poisons Act 1971 .

21 November 2001

JUDY JACKSON

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 3) 2001 .

2.   Commencement

This order takes effect on the day on which its making is notified in the Gazette or on 1 December 2001, whichever is later.

3.   Principal Order

In this order, the Poisons List Order 2001 is referred to as the Principal Order.

4.    Schedule 2 amended (Medicinal Poisons)

Schedule 2 to the Principal Order is amended as follows:

(a) by inserting after item 2034 the following:

2034M.

Desloratadine in preparations for oral use.

(b) by inserting after subparagraph (iii) in paragraph (b) of item 2054 the following:

2044M.	Folic acid for human therapeutic use except in preparations containing 500 micrograms or less of folic acid per recommended daily dose.
2044S.	Folinic acid for human therapeutic use except in preparations containing 500 micrograms or less of folinic acid per recommended daily dose.

(c) by omitting item 2059 ;

(d) by omitting item 2071 and substituting the following:

2071.	Iodine –
	(a) in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or
	(b) in preparations for human external therapeutic use containing more than 2.5% of available iodine (excluding salts, derivatives and iodophors).

(e) by omitting item 2073 and substituting the following:

2073.	Iron compounds (excluding iron oxides when present as an excipient up to 1% in undivided preparations or up to 10mg per dosage unit in divided preparations) for human internal use except –
	(a) when included in Schedule 4 ; or
	(b) in preparations when labelled with a recommended daily dose of more than 5mg but less than 24mg of iron when supplied in a pack containing 600mg or less of iron; or
	(c) in other preparations when labelled with a recommended daily dose of 5mg or less of iron.

(f) by omitting item 2114 and substituting the following:

2114.

Podophyllotoxin in preparations containing 0.5% or less of podophyllotoxin for human use for the treatment of warts except when in Schedule 3 or 4 .

(g) by omitting item 2127 and substituting the following:

2127.	Silver for therapeutic use except –
	(a) in chewing gum each containing 5mg or less of silver per dosage unit when labelled with the statement "Overuse may stain skin or mouth"; or
	(b) in solutions for human oral use containing 0.3% or less of silver when labelled with the statement "Overuse may stain skin or mouth"; or
	(c) in other preparations containing 1% or less of silver.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting items 3036 and 3037 ;

(b) by omitting item 3063 and substituting the following:

3063.

Podophyllotoxin in preparations containing 1% or less of podophyllotoxin for human use for the treatment of warts except when in Schedule 2 or 4 .

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40110 and substituting the following:

40110.

Antigens for human therapeutic use except when separately specified in this Schedule.

(b) by omitting item 40207 and substituting the following:

40207.	Boron for human therapeutic use (excluding when present as an excipient) –
	(a) in preparations for internal use containing more than 3mg per recommended daily dose; or
	(b) in glycerines and honeys of borax or boric acid; or
	(c) in preparations for vaginal use; or
	(d) in preparations for paediatric dermal use, being –
	(i) dusting powders; or
	(ii) other preparations containing more than 0.35% of boron; or
	(e) in other preparations for dermal use containing more than 0.35% of boron except antifungal preparations.

(c) by inserting after item 40296 the following:

40296H.

Cephaelis acuminata (ipecacuanha) except in preparations containing 0.2% or less of emetine.

(d) by inserting after item 40396 the following:

40396H.	Copper compounds for human use except –
	(a) when separately specified in these Schedules; or
	(b) in preparations for human internal use containing 5mg or less of copper per recommended daily dose; or
	(c) in other preparations containing 5% or less of copper compound.

(e) by inserting after item 40451 the following:

40451H.

Desloratadine except when included in Schedule 2 .

(f) by inserting after item 40680 the following:

40680K.	Folic acid in preparations for human use for injection.
40680R.	Folinic acid in preparations for human use for injection.

(g) by omitting item 40734 and substituting the following:

40734.	Guaiphenesin for human therapeutic use except –
	(a) in oral liquid preparations containing 2% or less of guaiphenesin; or
	(b) in divided preparations containing 200mg or less of guaiphenesin per dosage unit.

(h) by omitting item 40760 and substituting the following:

40760.

Hyaluronic acid and its polymers, in preparations for injection.

(i) by inserting after item 40779 the following:

40779K.

Hypromellose in preparations for injection.

(j) by omitting item 40830 and substituting the following:

40830.

Ivermectin for human use.

(k) by inserting after paragraph (b) in item 40861 the following:

40861K.

Levetiracetam.

(l) by omitting item 41001 and substituting the following:

41001.

Milbemycin oxime except when included in Schedule 5 .

(m) by omitting item 41238 and substituting the following:

41238.	Podophyllotoxin for human use –
	(a) for the treatment of anogenital warts; or
	(b) for internal use.

(n) by omitting item 41243 ;

(o) by omitting item 41592 and substituting the following:

41592.

Tryptophan for human therapeutic use except in preparations labelled with a recommended daily dose of 100mg or less of tryptophan.

(p) by omitting item 41595 and substituting the following:

41595.	Tylosin except –
	(a) when included in Schedule 5 ; or
	(b) in animal feeds containing 50mg/kg or less of antibiotic substances –
	(i) for growth promotion; or
	(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 100mg/kg or less of antibiotic substances.

(q) by inserting after item 41648 the following:

41648K.

Zoledronic acid.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by omitting item 5031 and substituting the following:

5031.	Bergamot oil except –
	(a) when steam distilled or rectified; or
	(b) in preparations for internal use; or
	(c) in preparations containing 0.4% or less of bergamot oil; or
	(d) in soaps or bath and shower gels that are washed off the skin; or
	(e) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(b) by omitting items 5065 and 5066 ;

(c) by omitting item 5090 and substituting the following:

5090.	Deltamethrin –
	(a) in aqueous preparations containing 1% or less of deltamethrin, when no organic solvent, other than a glycol, is present; or
	(b) in water-dispersible tablets each containing 500mg or less of deltamethrin in child-resistant packaging; or
	(c) in other preparations containing 0.5% or less of deltamethrin.

(d) by omitting item 5160 and substituting the following:

5160.

Hydrofluoric acid (excluding its salts and derivatives) and admixtures that generate hydrofluoric acid, in preparations containing 0.1% or less of hydrogen fluoride.

(e) by omitting item 5177 and substituting the following:

5177.	Ivermectin for use in animals –
	(a) in preparations for the prophylaxis of heartworm in cats and dogs; or
	(b) in intraruminal implants containing 160mg or less of ivermectin; or
	(c) in other preparations containing 2% or less of ivermectin.

(f) by omitting item 5181 and substituting the following:

5181.	Lemon oil except –
	(a) when steam distilled or rectified; or
	(b) in preparations for internal use; or
	(c) in preparations containing 0.05% or less of lemon oil; or
	(d) in soaps or bath and shower gels that are washed off the skin; or
	(e) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(g) by omitting item 5183 and substituting the following:

5183.	Lime oil except –
	(a) when steam distilled or rectified; or
	(b) in preparations for internal use; or
	(c) in preparations containing 0.5% or less of lime oil; or
	(d) in soaps or bath and shower gels that are washed off the skin; or
	(e) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(h) by inserting after item 5214 the following:

5214M.

Milbemycin oxime for the prophylaxis of heartworm in dogs and cats.

(i) by omitting item 5234 and substituting the following:

5234.	Orange oil (bitter) except –
	(a) when steam distilled or rectified; or
	(b) in preparations for internal use; or
	(c) in preparations containing 1.4% or less of orange oil (bitter); or
	(d) in soaps or bath and shower gels that are washed off the skin; or
	(e) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(j) by omitting item 5360 and substituting the following:

5360.	Tylosin in animal feed premixes containing 5% or less of antibiotic substances –
	(a) for growth promotion; or
	(b) for the prevention of liver abscesses in cattle; or
	(c) for the prevention of ileitis in pigs.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by omitting items 6096 and 6097 and substituting the following:

6096.	Copper compounds except –
	(a) when separately specified in these Schedules; or
	(b) in preparations for human internal use containing 5mg or less of copper per recommended daily dose; or
	(c) in other preparations containing 5% or less of copper compound.

(b) by omitting item 6117 and substituting the following:

6117.	Deltamethrin –
	(a) in aqueous preparations containing 25% or less of deltamethrin, when no organic solvent, other than 10% or less of a glycol, is present; or
	(b) in water-dispersible tablets containing 25% or less of deltamethrin; or
	(c) in other preparations containing 3% or less of deltamethrin –
	except when included in Schedule 5 .

(c) by omitting item 6221 and substituting the following:

6221.

Hydrofluoric acid (excluding its salts and derivatives) and admixtures that generate hydrofluoric acid, in preparations containing 1% or less of hydrogen fluoride except when included in Schedule 5 .

(d) by inserting after item 6376 the following:

6376M.

Spiroxamine.

(e) by inserting after item 6395 the following:

6395M.

Thiacloprid.

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended as follows:

(a) by inserting after paragraph (f) in item 7017 the following:

7017M.

Azafenidin.

(b) by omitting item 7173 .

Displayed and numbered in accordance with the Rules Publication Act 1953.

Notified in the Gazette on 28 November 2001

This order is administered in the Department of Health and Human Services.

EXPLANATORY NOTE

(This note is not part of the order)

This order amends the Poisons List Order 2001 (S.R. 2001, No. 102) to incorporate changes recommended by the National Drugs and Poisons Schedule Committee.