Poisons List Amendment Order (No. 2) 2010

Poisons List Amendment Order (No. 2) 2010

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

6 October 2010

MICHELLE O'BYRNE

Minister for Health

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 2) 2010 .

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 2006 and substituting the following:

2006.

Amorolfine in preparations for topical use, except in preparations for the treatment of tinea pedis.

(b) by omitting item 2054F and substituting the following:

2054F.	Flurbiprofen in preparations for topical oral use when –
	(a) in divided preparations containing 10mg or less of flurbiprofen per dosage unit; or
	(b) in undivided preparations containing 0.25% or less, or 10mg or less per dose, of flurbiprofen.

(c) 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) –
	except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

(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 phenylephrine and/or guaiphenesin or when combined with effervescent agents) when –
	(i) enclosed in a primary pack that contains not more than 12 such powders or sachets of granules; and
	(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; and
	(iii) not labelled for the treatment of children 6 years of age or less; and
	(iv) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or
	(c) in tablets or capsules each containing 500mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin or when combined with effervescent agents) when –
	(i) packed in blister or strip packaging or in a container with a child-resistant closure; and
	(ii) in a primary pack containing not more than 25 such tablets or capsules; and
	(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; and
	(iv) not labelled for the treatment of children 6 years of age or less; and
	(v) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3004 ;

(b) by inserting after item 3045 the following:

3045E.

Lansoprazole in oral preparations containing 15mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

(c) by inserting after item 3059 the following:

3059E.

Omeprazole in oral preparations containing 20mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

(d) by omitting item 3059X and substituting the following:

3059X.

Pantoprazole in oral preparations containing 20mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

(e) by omitting item 3067S and substituting the following:

3067S.

Rabeprazole in oral preparations containing 10mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40084 and substituting the following:

40084.	Amorolfine except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for the treatment of tinea pedis.

(b) by inserting after item 40305 the following:

40305M.

Certolizumab pegol.

(c) by inserting after item 40368 the following:

40368M.

Clofarabine.

(d) by inserting after paragraph (c) in item 40397H the following:

40397M.

Corifollitropin alfa.

(e) by inserting after item 40438 the following:

40438M.

Degarelix.

(f) by inserting after item 40444 the following:

40444M.

Denosumab.

(g) by inserting after item 40546 the following:

40546M.

Dronedarone.

(h) by inserting after item 40561 the following:

40561M.

Eltrombopag.

(i) by inserting after item 40780 the following:

40780F.

Ibogaine.

(j) by inserting after item 40784 the following:

40784M.

Icatibant.

(k) by inserting after item 40793 the following:

40793M.

Indacaterol.

(l) by omitting item 40846 and substituting the following:

40846.

Lansoprazole except when included in Schedule 3 .

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

41063.	Nicotine in preparations for human therapeutic use, except –
	(a) when included in Schedule 2 ; or
	(b) for use as an aid in withdrawal from tobacco smoking in chewing gum, lozenges or preparations for sublingual, transdermal or oromucosal spray use.

(n) by inserting after item 41093 the following:

41093M.

Noribogaine.

(o) by inserting after item 41111M the following:

41111S.

Omega-3-acid ethyl esters (excluding salts and derivatives) for human therapeutic use for the treatment of post-myocardial infarction and/or hypertriglyceridaemia.

(p) by omitting item 41112 and substituting the following:

41112.

Omeprazole except when included in Schedule 3 .

(q) by inserting after item 41163 the following:

41163M.

Pazopanib.

(r) by omitting item 41209M and substituting the following:

41209M.	Phosphodiesterase type-5 inhibitors, except –
	(a) when separately specified in these Schedules; or
	(b) when present as an unmodified, naturally occurring substance.

(s) by inserting after item 41235 the following:

41235M.

Plerixafor.

(t) by inserting after item 41364 the following:

41364M.

Saxagliptin.

(u) 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 ; or
	(c) when packed and labelled solely for use as a herbicide.

(v) by inserting after item 41631M the following:

41631R.

Vorinostat.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by omitting item 5006 and substituting the following:

5006.	Alkaline salts, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination –
	(a) in solid orthodontic device-cleaning preparations, the pH of which as an "in-use" aqueous solution is more than 11.5; or
	(b) in solid automatic dishwashing preparations, the pH of which in a 500g/L aqueous solution or mixture is more than 11.5 but less than or equal to 12.5; or
	(c) in other solid preparations, the pH of which in a 10g/L aqueous solution is more than 11.5; or
	(d) in liquid or semi-solid preparations, the pH of which is more than 11.5, unless –
	(i) in food additive preparations for domestic use; or
	(ii) in automatic dishwashing preparations for domestic use with a pH of more than 12.5 –
	except when separately specified in these Schedules.

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

5090.	Deltamethrin –
	(a) in aqueous preparations containing 5% or less of deltamethrin when no organic solvent other than a glycol is present; or
	(b) in wettable granular preparations containing 25% or less of deltamethrin when packed in child-resistant packaging each containing 3g or less of the preparation; or
	(c) in water-dispersible tablets each containing 500mg or less of deltamethrin in child-resistant packaging; or
	(d) in other preparations containing 0.5% or less of deltamethrin –
	except in preparations containing 0.1% or less of deltamethrin.

(c) by inserting after item 5146 the following:

5146M.

Foramsulfuron.

(d) by inserting after item 5189 the following:

5189M.

Mandipropamid.

(e) by inserting after item 5213 the following:

5214.

Metrafenone in preparations containing 50% or less of metrafenone.

(f) by omitting item 5264 and substituting the following:

5264.	Potassium hydroxide (excluding its salts and derivatives) in preparations containing 5% or less of potassium hydroxide, being –
	(a) solid preparations, the pH of which in a 10g/L aqueous solution is more than 11.5; or
	(b) liquid or semi-solid preparations, the pH of which is more than 11.5, except in food additive preparations for domestic use.

(g) by omitting item 5299 and substituting the following:

5299.	Sodium hydroxide (excluding its salts and derivatives) in preparations containing 5% or less of sodium hydroxide, being –
	(a) solid preparations, the pH of which in a 10g/L aqueous solution is more than 11.5; or
	(b) liquid or semi-solid preparations, the pH of which is more than 11.5, except in food additive preparations for domestic use.

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 concentrations 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 or in preparations containing 0.1% or less of deltamethrin.

(b) by inserting after item 6269 the following:

6269E.

Metrafenone except when included in Schedule 5 .

(c) by omitting item 6333 and substituting the following:

6333.	Potassium hydroxide (excluding its salts and derivatives), except –
	(a) when included in Schedule 5 ; or
	(b) in preparations containing 5% or less of potassium hydroxide, being –
	(i) solid preparations, the pH of which in a 10g/L aqueous solution is 11.5 or less; or
	(ii) liquid or semi-solid preparations, the pH of which is 11.5 or less; or
	(c) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5, for domestic use.

(d) by omitting item 6372 and substituting the following:

6372.	Sodium hydroxide (excluding its salts and derivatives), except –
	(a) when included in Schedule 5 ; or
	(b) in preparations containing 5% or less of sodium hydroxide, being –
	(i) solid preparations, the pH of which in a 10g/L aqueous solution is 11.5 or less; or
	(ii) liquid or semi-solid preparations, the pH of which is 11.5 or less; or
	(c) liquid or semi-solid food additive preparations, the pH of which is more than 11.5, for domestic use.

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended as follows:

(a) by omitting item 7068 from Part 1 and substituting the following:

7068.	Deltamethrin except –
	(a) when included in Schedule 5 or 6 ; or
	(b) when in preparations containing 0.1% or less of deltamethrin.

(b) by inserting after item 7501 in Part 2 the following:

7501M.	Alkaline salts, being the carbonate, silicate or phosphate salts of sodium or potassium, alone or in any combination for domestic use –
	(a) in liquid or semi-solid food additive preparations, the pH of which is more than 11.5; or
	(b) in solid automatic dishwashing preparations, the pH of which in a 500g/L aqueous solution or mixture is more than 12.5; or
	(c) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.

(c) by inserting after item 7536 in Part 2 the following:

7536M.

Potassium hydroxide (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

(d) by inserting after item 7541 in Part 2 the following:

7541M.

Sodium hydroxide (excluding its salts and derivatives), in liquid or semi-solid food additive preparations, for domestic use, the pH of which is more than 11.5.

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

Notified in the Gazette on 13 October 2010

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 Medicines and Poisons.