Poisons List Amendment Order (No. 3) 2004

Poisons List Amendment Order (No. 3) 2004

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

20 December 2004

D. E. Llewellyn

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 3) 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 2009 and substituting the following:

2009.	Atropine (excluding atropine methonitrate) –
	(a) for oral use –
	(i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
	(ii) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
	(b) in preparations containing atropine sulfate when packed and labelled for the treatment of organophosphorus poisoning –
	(i) in tablets each containing 0.6mg or less of atropine sulfate in packs of 20 tablets; or
	(ii) in preparations for injection each containing 0.6mg per mL or less of atropine sulfate in packs of 5.

(b) by omitting item 2067 and substituting the following:

2067.	Hyoscyamus niger for oral use –
	(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
	(b) in divided preparations containing 0.3mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.

(c) by inserting after item 2087 the following:

2087J.

Meclozine in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

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

2098.

Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for inhalation or sublingual use.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended by omitting item 3055 .

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by inserting after item 40037 the following:

40037S.

Alefacept.

(b) by inserting after item 40116E the following:

40116J.

Aprepitant.

(c) by inserting after item 40125 the following:

40125M.

Atazanavir.

(d) by inserting after item 40127 the following:

40127S.

Atomoxetine.

(e) by inserting after item 40341 the following:

40341J.

Ciclesonide.

(f) by omitting item 40603 and substituting the following:

40603.

Ethoheptazine.

(g) by inserting after item 40642 the following:

40642M.

Firocoxib.

(h) by omitting item 40908 and substituting the following:

40908.

Meclozine except when included in Schedule 2 .

(i) 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
	(b) in chewing gum; or
	(c) in lozenges; or
	(d) in preparations for transdermal use.

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

41158.	Paracetamol –
	(a) when combined with aspirin, caffeine or salicylamide or any derivative 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.

(k) by inserting after item 41220 the following:

41220E.	Piper methysticum (Kava) in preparations for human use except –
	(a) in preparations for oral use containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome when labelled with a recommended daily dose of 250mg or less of kavalactones –
	(i) containing more than 25mg of kavalactones per dose, labelled with the statement:
	WARNING – Not for prolonged use. Not recommended for use by pregnant or lactating women. May harm the liver.
	(ii) in tablet or capsule form containing 125mg or less of kavalactones per tablet or capsule; or
	(iii) in the form of a teabag when the amount of dried whole or peeled rhizome does not exceed 3g; or
	(b) in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or
	(c) in dermal preparations.

(l) by omitting item 41309 and substituting the following:

41309.	Pyridoxine, pyridoxal or pyridoxamine for human therapeutic use except –
	(a) in oral preparations containing 200mg or less but more than 50mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when labelled with the warning statement –
	WARNING – this medication may be dangerous when used in large amounts or for a long time; or
	WARNING – this product contains [insert pyridoxine, pyridoxal or pyridoxamine as applicable] which may be dangerous when used in large amounts or for a long time.
	(b) in oral preparations containing 50mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.

(m) by inserting after item 41355 the following:

41355S.

Rosuvastatin.

(n) by inserting after item 41439 the following:

41439S.

Sulfaquinoxaline.

(o) by omitting item 41445 and substituting the following:

41445.	Sulfonamides except –
	(a) when separately specified in this Schedule; or
	(b) when included in Schedule 3 , 5 or 6 .

(p) by inserting after item 41559 the following:

41559S.

Treprostinil.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after paragraph (c) in item 5282 the following:

5282S.

Quinclorac.

(b) by omitting item 5314 .

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by omitting item 6243 and substituting the following:

6243.

Mafenide when packed and labelled for the treatment of ornamental fish only.

(b) by omitting item 6271 ;

(c) by inserting after paragraph (d) in item 6296 the following:

6297.

1-octen-3-ol except in preparations containing 5% or less of 1-octen-3-ol.

(d) by omitting item 6419 .

9.    Schedule 7 amended (Dangerous Poisons)

Part 1 of Schedule 7 to the Principal Order is amended as follows:

(a) by inserting after item 7162 the following:

7162S.

Molinate.

(b) by omitting item 7167 and substituting the following:

7167.	Nicotine except –
	(a) when included in Schedule 2 , 4 or 6 ; or
	(b) in chewing gum; or
	(c) in lozenges; or
	(d) in preparations for transdermal use; or
	(e) in tobacco prepared and packed for smoking.

(c) by inserting after item 7222 the following:

7222S.

Vinclozolin.

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

Notified in the Gazette on 29 December 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 1971 by incorporating changes recommended by the National Drugs and Poisons Schedule Committee in the Standard for the Uniform Scheduling of Drugs and Poisons No. 19, Amendment No. 2.