Poisons List Amendment Order (No. 3) 2007

Poisons List Amendment Order (No. 3) 2007

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

17 December 2007

LARA GIDDINGS

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 3) 2007 .

2.   Commencement

This order takes effect on 1 January 2008.

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 2036 the following:

2037.

Dibromopropamidine for ophthalmic use.

(b) by omitting item 2061 and substituting the following:

2061.	Hydrocortisone and Hydrocortisone acetate, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5% or less of hydrocortisone –
	(a) for dermal use, in packs containing 30g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or
	(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except an unscheduled astringent –
	(i) in undivided preparations, in packs of 35g or less; or
	(ii) in packs containing 12 or fewer suppositories.

(c) 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 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; or
	(c) in tablets or capsules each containing 500mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine 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 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.

(d) by inserting after item 2120 the following:

2121.

Propamidine for ophthalmic use.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3041 and substituting the following:

3041.	Hydrocortisone and Hydrocortisone acetate, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1% or less of hydrocortisone –
	(a) for dermal use, in packs containing 30g or less of such preparations, and containing no other therapeutically active constituent other than an antifungal substance; or
	(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except an unscheduled astringent –
	(i) in undivided preparations, in packs of 35g or less; or
	(ii) in packs containing 12 or fewer suppositories –
	except when included in Schedule 2 .

(b) by omitting item 3067 and substituting the following:

3067.	Promethazine in oral preparations except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for the treatment of children under 2 years of age.

(c) by omitting item 3081 and substituting the following:

3081.	Trimeprazine –
	(a) in solid oral preparations except when included in Schedule 2 ; or
	(b) in liquid oral preparations containing 10mg or less of trimeprazine per 5mL –
	except in preparations for the treatment of children under 2 years of age.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by inserting after item 40001 the following:

40001M.

Abatacept.

(b) by omitting item 40042 and substituting the following:

40042M.

Aliskiren.

(c) by inserting after item 40432M the following:

40432R.	Darunavir.
40432V.	Dasatinib.

(d) by inserting after item 40468M the following:

40468U.

Dibromopropamidine for therapeutic use except when included in Schedule 2 .

(e) by omitting item 40475 and substituting the following:

40475.

Dienestrol.

(f) by inserting after item 40686T the following:

40686X.

Fosaprepitant.

(g) by inserting after item 40701 the following:

40701M.

Galsulfase.

(h) by omitting item 40846F and substituting the following:

40846F.	Lanthanum for therapeutic use.
40846J.	Lapatinib.

(i) by omitting item 40934M ;

(j) by inserting after item 41054 the following:

41054M.

Nepafenac.

(k) by inserting after item 41068 the following:

41068M.

Nilotinib.

(l) by inserting after item 41150M the following:

41150T.

Paliperidone.

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

41158.	Paracetamol –
	(a) when combined with aspirin 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.

(n) by inserting after item 41161M the following:

41161U.

Paricalcitol.

(o) by omitting item 41247M and substituting the following:

41247M.	Potassium chloride in oral preparations for human therapeutic use, except –
	(a) when containing less than 550mg of potassium chloride per dosage unit; or
	(b) in preparations for oral rehydration therapy; or
	(c) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or
	(d) in preparations for enteral feeding.

(p) by inserting after item 41283 the following:

41283M.

Propamidine for therapeutic use except when included in Schedule 2 .

(q) by inserting after item 41326 the following:

41326M.

Ranibizumab.

(r) by inserting after item 41338M the following:

41338V.

Rimexolone.

(s) by inserting after item 41339 the following:

41339M.

Rimonabant.

(t) by inserting after item 41358 the following:

41358M.

Ruboxistaurin.

(u) by inserting after item 41382F the following:

41382T.

Sitaxentan.

(v) by inserting after item 41575 the following:

41575M.

Trilostane.

(w) by inserting after item 41619 the following:

41619M.

Vildagliptin.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after item 5063 the following:

5063M.

Clothianidin in preparations containing 20% or less of clothianidin.

(b) by omitting item 5158 and substituting the following:

5158.	Hydrocarbons, liquid, including kerosene, diesel (distillate), mineral turpentine, white petroleum spirit, toluene, xylene and light mineral and paraffin oils (but excluding their derivatives), except –
	(a) toluene and xylene when included in Schedule 6 ; or
	(b) benzene and liquid aromatic hydrocarbons when included in Schedule 7 ; or
	(c) food-grade and pharmaceutical-grade white mineral oils; or
	(d) in solid or semi-solid preparations; or
	(e) in preparations containing 25% or less of designated solvents; or
	(f) in preparations packed in pressurised spray packs; or
	(g) in adhesives packed in containers each containing 50g or less of adhesive; or
	(h) in writing correction fluids, and thinners for writing correction fluids, packed in containers having a capacity of 20mL or less; or
	(i) in other preparations when packed in containers with a capacity of 2mL or less.

(c) by omitting item 5182 and substituting the following:

5182.	Levamisole in preparations containing 15% or less of levamisole for the treatment of animals, except –
	(a) when included in Schedule 4 ; or
	(b) in preparations for the treatment of ornamental birds or ornamental fish, in packs containing 10mg or less of levamisole.

(d) by inserting after item 5277V the following:

5277Y.

Pyrasulfotole.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by omitting item 6093M and substituting the following:

6093M.

Clothianidin except when included in Schedule 5 .

(b) by inserting after item 6353 the following:

6353M.

Pyriprole.

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

Notified in the Gazette on 26 December 2007

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. 22, Amendment No. 2.