Poisons List Amendment Order 2004

Poisons List Amendment Order 2004

I make the following order under section 15(1) of the Poisons Act 1971 .

28 April 2004

D. E. LLEWELLYN

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order 2004 .

2.   Commencement

This order takes effect on the day on which its making is notified in the Gazette.

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 omitting item 2008 and substituting the following:

2008.	Aspirin except –
	(a) when included in Schedule 4 , 5 or 6 ; or
	(b) in individually wrapped powders or sachets of granules each containing 650mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when enclosed in a primary pack that –
	(i) contains 12 or less such powders or sachets of granules; and
	(ii) is labelled with –
	(A) a warning statement to the following effect (permitted until 30 April 2005):
	WARNING - This medication may be dangerous when used in large amounts or for a long period; or
	CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful; or
	(B) warning statements to the following effect (mandatory from 1 May 2005):
	Don’t use [this product / name of the product]:
	If you have a stomach ulcer
	In the last 3 months of pregnancy
	If you are allergic to aspirin or anti-inflammatory medicines;
	Unless a doctor has told you to, don’t use [this product / name of the product]:
	For more than a few days at a time
	With other medicines containing aspirin or other anti-inflammatory medicines
	If you have asthma
	In children under 12 years of age
	If you are pregnant;
	See a doctor before taking [this product / name of the product] for thinning the blood or for your heart. [Can be omitted in products for inhibition of platelet aggregation or with additional active ingredients.]; and
	(iii) includes in the directions for use, in capital letters not less than 1.5mm in height, the warning statements:
	CONSULT A DOCTOR BEFORE GIVING THIS MEDICATION TO CHILDREN OR TEENAGERS WITH CHICKENPOX, INFLUENZA OR FEVER.
	CAUTION - DO NOT GIVE TO CHILDREN UNDER TWO YEARS OF AGE EXCEPT ON DOCTOR’S ADVICE; or
	(c) in tablets or capsules each containing no other therapeutically active constituent except an effervescent agent when –
	(i) packed in blister or strip packaging or in a container with a child-resistant closure; and
	(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500mg or less of aspirin; and
	(iii) the primary pack is labelled with –
	(A) a warning statement to the following effect (permitted until 30 April 2005):
	WARNING - This medication may be dangerous when used in large amounts or for a long period; or
	CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful; or
	(B) warning statements to the following effect (mandatory from 1 May 2005):
	Don’t use [this product / name of the product]:
	If you have a stomach ulcer
	In the last 3 months of pregnancy
	If you are allergic to aspirin or anti-inflammatory medicines;
	Unless a doctor has told you to, don’t use [this product / name of the product]:
	For more than a few days at a time
	With other medicines containing aspirin or other anti-inflammatory medicines
	If you have asthma
	In children under 12 years of age
	If you are pregnant;
	See a doctor before taking [this product / name of the product] for thinning the blood or for your heart. [Can be omitted in products for inhibition of platelet aggregation or with additional active ingredients.]; and
	(iv) the directions for use include, in capital letters not less than 1.5mm in height, the warning statements:
	CONSULT A DOCTOR BEFORE GIVING THIS MEDICATION TO CHILDREN OR TEENAGERS WITH CHICKENPOX, INFLUENZA OR FEVER.
	CAUTION - DO NOT GIVE TO CHILDREN UNDER TWO YEARS OF AGE EXCEPT ON DOCTOR’S ADVICE; or
	(d) in tablets or capsules each containing no other therapeutically active constituent except an effervescent agent when –
	(i) packed in blister or strip packaging or in a container with a child-resistant closure; and
	(ii) in a primary pack containing 100 or less tablets or capsules, each containing 100mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and
	(iii) the primary pack is labelled with the warning statement to the following effect:
	For use under medical supervision only.

(b) by inserting after item 2054F the following:

2054J.

Fluticasone in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.

(c) by omitting item 2098 and substituting the following:

2098.	Nicotine for use as an aid in withdrawal from tobacco smoking –
	(a) in lozenges; or
	(b) in preparations for inhalation.

(d) by omitting item 2104 and substituting the following:

2104.	Paracetamol for therapeutic use except –
	(a) when included in Schedule 4 ; or
	(b) in individually wrapped powders or sachets of granules each containing 1 000mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –
	(i) in a primary pack containing not more than 12 such powders or sachets; and
	(ii) labelled with –
	(A) a statement to the following effect (permitted until 30 April 2005):
	WARNING - This medication may be dangerous when used in large amounts or for a long period; or
	CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful; or
	(B) statements to the following effect (mandatory from 1 May 2005):
	Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to do so by a doctor;
	Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to do so by a doctor;
	If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 131 126; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage;
	Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist; and
	(iii) not labelled for the treatment of children 6 years of age or less; or
	(c) in tablets or capsules each containing 500mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –
	(i) packed in blister or strip packaging or in containers with child-resistant closures; and
	(ii) in a primary pack containing not more than 25 such tablets or capsules; and
	(iii) the primary pack is labelled with –
	(A) a statement to the following effect (permitted until 30 April 2005):
	WARNING - This medication may be dangerous when used in large amounts or for a long period; or
	CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful; or
	(B) statements to the following effect (mandatory from 1 May 2005):
	Adults: Keep to the recommended dose. Don’t take this medicine for longer than a few days at a time unless advised to do so by a doctor;
	Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to do so by a doctor;
	If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 131 126; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage;
	Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist; and
	(iv) not labelled for the treatment of children 6 years of age or less.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3035 ;

(b) by inserting after item 3059 the following:

3059M.

Orlistat in oral preparations for weight-control purposes containing 120mg or less of orlistat per dosage unit.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by inserting after item 40097 the following:

40097G.

Anakinra.

(b) by inserting after item 40119 the following:

40119M.

Aripiprazole.

(c) by inserting after item 40274 the following:

40274M.

Cefadroxil.

(d) by omitting item 40296 ;

(e) by inserting after item 40622 the following:

40622M.

Ezetimibe.

(f) by inserting after item 40631 the following:

40631M.

Fenofibrate.

(g) by omitting item 40678 and substituting the following:

40678.

Fluticasone except when included in Schedule 2 .

(h) by inserting after item 40704 the following:

40704M.

Gefitinib.

(i) by inserting after item 40922 the following:

40922M.

Memantine.

(j) by omitting item 41063 and substituting the following:

41063.	Nicotine for use as an aid in withdrawal from tobacco smoking (including preparations for nasal administration) except –
	(a) when included in Schedule 2 or 3 ; or
	(b) in chewing gum; or
	(c) in preparations for transdermal use.

(k) by omitting item 41067 ;

(l) by omitting item 41072 ;

(m) by omitting item 41077 ;

(n) by omitting item 41118 and substituting the following:

41118.

Orlistat except when included in Schedule 3 .

(o) by omitting item 41158 and substituting the following:

41158.	Paracetamol –
	(a) when combined with aspirin, caffeine or salicylamide or any derivatives of these substances except when separately specified in these Schedules; or
	(b) in tablets or capsules containing more than 665mg of paracetamol; or
	(c) in individually wrapped powders or sachets of granules each containing more than 1 000mg of paracetamol.

(p) by inserting after item 41169 the following:

41169M.

Penethamate.

(q) by omitting item 41210 and substituting the following:

41210.

Phthalylsulfathiazole.

(r) by inserting after item 41213 the following:

41213E.

Pimecrolimus.

(s) by inserting after item 41568 the following:

41568M.

Trichloroacetic acid for human dermal use except when in preparations containing 12.5% or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after item 5121 the following:

5121M.

1,2-Ethanediamine polymer with (chloromethyl)oxirane and N-methylmethanamine.

(b) 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 preparations containing 3.5% or less of ivermectin when packed in child-resistant packaging or in packaging approved by the relevant registration authority; or
	(d) in other preparations containing 2% or less of ivermectin.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) 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 wettable granular preparations containing 25% or less of deltamethrin; or
	(c) in water-dispersible tablets each containing 500mg or less of deltamethrin; or
	(d) in emulsifiable concentrates containing 11% or less of deltamethrin in a solvent containing 40% or less of acetophenone and 45% or less of liquid hydrocarbons; or
	(e) in other preparations containing 3% or less of deltamethrin –
	except when included in Schedule 5 .

(b) by inserting after item 6160 the following:

6160M.

Endosulfan in aqueous preparations containing 33% or less of microencapsulated endosulfan.

(c) by omitting item 6409 and substituting the following:

6409.	Trichloroacetic acid except –
	(a) when included in Schedule 4 or 5 ; or
	(b) in human dermal preparations containing 12.5% or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended as follows:

(a) by omitting item 7042 from Part 1 and substituting the following:

7042.

Carbon tetrachloride except in chlorinated rubber-based paint containing 1% or less of carbon tetrachloride.

(b) by omitting item 7094 from Part 1 and substituting the following:

7094.

Endosulfan except when included in Schedule 6 .

(c) by omitting item 7541 from Part 2 and substituting the following:

7541.

Silicones for tissue augmentation by injection or implantation.

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

Notified in the Gazette on 5 May 2004

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 by incorporating changes recommended by the National Drugs and Poisons Schedule Committee in the Standard for the Uniform Scheduling of Drugs and Poisons No. 18, Amendment No. 3.