Poisons List Amendment Order 2012

Poisons List Amendment Order 2012

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

2 May 2012

MICHELLE O'BYRNE

Minister for Health

1.   Short title

This order may be cited as the Poisons List Amendment Order 2012 .

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 2011 and substituting the following:

2011.	Azelastine –
	(a) in preparations for nasal use; or
	(b) in topical eye preparations containing 0.05% or less of azelastine.

(b) by omitting item 2037M and substituting the following:

2037M.	Diclofenac when –
	(a) in divided preparations for oral use containing 12.5mg or less of diclofenac per dosage unit in a pack containing 20 or fewer dosage units and labelled with a recommended daily dose of 75mg or less of diclofenac; or
	(b) in preparations for dermal use containing 4% or less of diclofenac, except in preparations for dermal use containing 1% or less of diclofenac or for the treatment of solar keratosis.

(c) by omitting item 2085 and substituting the following:

2085.

Loperamide in divided preparations for oral use in packs of 20 dosage units or fewer, except in preparations containing 2mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or fewer.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3006 ;

(b) by inserting after item 3030 the following:

3030M.

Famciclovir for oral use, in divided preparations, containing a total dose of 1 500mg or less of famciclovir for the treatment of herpes labialis (cold sores).

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by inserting after item 40029B the following:

40029D.

Aflibercept.

(b) by omitting item 40145 and substituting the following:

40145.

Azelastine except when included in Schedule 2 .

(c) by inserting after item 40161 the following:

40161M.

Belatacept.

(d) by inserting after item 40287 the following:

40287M.

Ceftaroline fosamil.

(e) by inserting after item 40431 the following:

40431E.

Dapagliflozin.

(f) by omitting item 40471 and substituting the following:

40471.	Diclofenac except –
	(a) when included in Schedule 2 or 3 ; or
	(b) in preparations for dermal use unless –
	(i) for the treatment of solar keratosis; or
	(ii) containing more than 4% of diclofenac.

(g) by inserting after item 40584 the following:

40584B.

Eribulin mesylate.

(h) by omitting item 40623 and substituting the following:

40623.

Famciclovir except when included in Schedule 3 .

(i) by inserting after item 40681 the following:

40681M.

Follistatin.

(j) by inserting after paragraph (b) in item 40800 the following:

40800M.

Ingenol mebutate.

(k) by inserting after paragraph (c) in item 40875 the following:

40875M.

Lixisenatide.

(l) by omitting item 40880 and substituting the following:

40880.	Loperamide except –
	(a) when included in Schedule 2 ; or
	(b) in divided oral preparations containing 2mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or fewer.

(m) by inserting after item 41232 the following:

41232M.

Pitavastatin.

(n) by inserting after item 41338K the following:

41338KA.

Rifaximin.

(o) by inserting after item 41456T the following:

41456W.

Taliglucerase alfa.

(p) by inserting after item 41613 the following:

41613M.	Velaglucerase alfa.
41613T.	Vemurafenib.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

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

5090.	Deltamethrin –
	(a) when impregnated in plastic resin strip material containing 4% or less of deltamethrin; or
	(b) in aqueous preparations containing 5% or less of deltamethrin when no organic solvent other than a glycol is present; or
	(c) in wettable granular preparations containing 25% or less of deltamethrin when packed in child-resistant packaging each containing 3g or less of the formulation; or
	(d) in water-dispersible tablets each containing 500mg or less of deltamethrin in child-resistant packaging; or
	(e) in other preparations containing 0.5% or less of deltamethrin –
	except in preparations containing 0.1% or less of deltamethrin.

(b) by omitting item 5117M and substituting the following:

5117M.	Emodepside in preparations –
	(a) containing 2.5% or less of emodepside for the external treatment of animals; or
	(b) containing 30mg or less of emodepside per dosage unit for the oral treatment of animals.

(c) by inserting after item 5146 the following:

5146E.

Fluxapyroxad.

(d) by inserting after item 5248 the following:

5248M.

Penthiopyrad except in preparations containing 20% or less of penthiopyrad.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by inserting after paragraph (b) in item 6228 the following:

6228M.

Indaziflam.

(b) by omitting item 6238M and substituting the following:

6238M.	Laureth carboxylic acids (excluding their salts and derivatives) except –
	(a) in leave-on preparations containing 1.5% or less of laureth carboxylic acids; or
	(b) in wash-off preparations containing 30% or less of laureth carboxylic acids and, if containing more than 5% of laureth carboxylic acids, when labelled with a warning to the following effect:
	IF IN EYES WASH OUT IMMEDIATELY WITH WATER; or
	(c) in other preparations containing 30% or less of laureth carboxylic acids and, if containing more than 5% of laureth carboxylic acids, when labelled with warnings to the following effect:
	IF IN EYES WASH OUT IMMEDIATELY WITH WATER; and
	IF SKIN OR HAIR CONTACT OCCURS, REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN OR HAIR WITH RUNNING WATER.

(c) by inserting after item 6347M the following:

6347T.

Prosulfuron.

(d) by inserting after item 6413 the following:

6413M.

Triclosan in cosmetic preparations for human use containing more than 0.3% of triclosan.

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

Notified in the Gazette on 9 May 2012

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 No. 2, Amendment No. 4.