Poisons List Amendment Order 2006

Poisons List Amendment Order 2006

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

24 January 2006

D. E. LLEWELLYN

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order 2006 .

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 warning statements to the following effect:
	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
	In children 12-16 years of age with, or recovering from, chickenpox, influenza or fever
	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
	(c) in tablets or capsules each containing no other therapeutically active constituent other than 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 warning statements to the following effect:
	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
	In children 12-16 years of age with, or recovering from, chickenpox, influenza or fever
	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
	(d) in tablets or capsules each containing no other therapeutically active constituent other than 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:
	For use under medical supervision only.

(b) by omitting item 2017 and substituting the following:

2017.	Bifonazole in preparations for dermal use, except in preparations –
	(a) containing 1% or less of bifonazole for the treatment of the scalp; or
	(b) for the treatment of tinea pedis.

(c) by omitting item 2030 and substituting the following:

2030.

Clotrimazole for human use in dermal preparations, except in preparations for the treatment of tinea pedis.

(d) by omitting item 2037 ;

(e) by omitting item 2042 ;

(f) by omitting item 2046 and substituting the following:

2046.

Econazole for human use in dermal preparations, except in preparations for the treatment of tinea pedis.

(g) by omitting item 2051 and substituting the following:

2051.

Famotidine when sold in the manufacturer's original pack containing not more than 14 days' supply.

(h) by omitting item 2076 and substituting the following:

2076.	Ketoconazole in preparations for dermal use, except in preparations –
	(a) containing 1% or less of ketoconazole for the treatment of the scalp; or
	(b) for the treatment of tinea pedis.

(i) by omitting item 2094 and substituting the following:

2094.

Miconazole for human use in dermal preparations except in preparations for the treatment of tinea pedis.

(j) by omitting items 2098 and 2098M and substituting the following:

2098.	Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for inhalation.
2098M.	Nizatidine when sold in the manufacturer's original pack containing not more than 14 days' supply.

(k) by omitting item 2118 and substituting the following:

2118.

Prilocaine in preparations for dermal use containing 10% or less of total local anaesthetic substances.

(l) by omitting item 2122 ;

(m) by omitting item 2125 and substituting the following:

2125.

Ranitidine when sold in the manufacturer's original pack containing not more than 14 days' supply.

(n) by omitting item 2136 ;

(o) by omitting item 2138 and substituting the following:

2138.

Tioconazole in preparations for dermal use, except in preparations for the treatment of tinea pedis.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting items 3013 and 3014 and substituting the following:

3013.

Cimetidine when sold in the manufacturer's original pack containing not more than 14 days' supply.

(b) by omitting item 3026 ;

(c) by omitting item 3032 ;

(d) by omitting item 3033 and substituting the following:

3033.

Fluorides in pastes, powders or gels, for use on teeth, containing more than 1 000mg/kg of fluoride ion.

(e) by omitting items 3061 and 3062 ;

(f) by omitting item 3067M and substituting the following:

3067M.	Pseudoephedrine in preparations (other than preparations for stimulant, appetite suppression or weight-control purposes) in a primary pack with a recommended daily dose of 240mg or less of pseudoephedrine –
	(a) in undivided preparations containing 60mg or less of pseudoephedrine per recommended dose; or
	(b) when in combination with other therapeutically active substances; or
	(c) in slow-release preparations; or
	(d) in other divided preparations, where pseudoephedrine is the only therapeutically active substance, containing 60mg or less of pseudoephedrine per recommended dose in a pack containing 30 or less dosage units.

(g) by omitting item 3076 .

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40007 and substituting the following:

40007.

Acetanilide and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.

(b) by inserting after item 40121 the following:

40121E.

Articaine.

(c) by inserting after item 40190 the following:

40190V.

Bevacizumab.

(d) by omitting item 40194 and substituting the following:

40194.	Bifonazole except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for dermal use containing 1% or less of bifonazole for the treatment of the scalp; or
	(c) in preparations for dermal use for the treatment of tinea pedis.

(e) by inserting after item 40229 the following:

40229M.	Butoconazole.
40229S.	Butraconazole.

(f) by inserting after item 40266 the following:

40266E.

Carbuterol.

(g) by inserting after item 40308 the following:

40308E.

Cetuximab.

(h) by inserting after item 40346 the following:

40346S.

Cinacalcet.

(i) by omitting item 40358 and substituting the following:

40358.

Clemastine.

(j) by omitting item 40384 and substituting the following:

40384.	Clotrimazole –
	(a) except when included in Schedule 2 , 3 or 6 ; or
	(b) in preparations for dermal use for the treatment of tinea pedis.

(k) by inserting after item 40432H the following:

40432M.

Darifenacin.

(l) by inserting after item 40469 the following:

40469M.

Dichlorophen for internal human therapeutic use.

(m) by inserting after item 40501 the following:

40501M.

Dimethothiazine.

(n) by omitting item 40517 and substituting the following:

40517.

Diphenylpyraline.

(o) by omitting item 40552 and substituting the following:

40552.	Econazole –
	(a) except when included in Schedule 2 , 3 or 6 ; or
	(b) in preparations for dermal use for the treatment of tinea pedis.

(p) by omitting item 40608 and substituting the following:

40608.

Ethyl chloride for human therapeutic use.

(q) by inserting after item 40621 the following:

40621M.

Everolimus.

(r) by omitting item 40658 and substituting the following:

40658.

Flunisolide.

(s) by inserting after item 40744 the following:

40744E.

Halofuginone in preparations containing 0.1% or less of halofuginone for the treatment of animals.

(t) by inserting after item 40756 the following:

40756E.

Hexoprenaline.

(u) by omitting item 40762 and substituting the following:

40762.

Hydrargaphen.

(v) by inserting after item 40788H the following:

40788S.

Imidapril.

(w) by omitting item 40835 and substituting the following:

40835.	Ketoconazole except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for dermal use containing 1% or less of ketoconazole for the treatment of the scalp; or
	(c) in preparations for dermal use for the treatment of tinea pedis.

(x) by inserting after item 40846 the following:

40846M.

Laronidase.

(y) by inserting after item 40933 the following:

40933M.

Mequitazine.

(z) by omitting item 40997 and substituting the following:

40997.	Miconazole –
	(a) except when included in Schedule 2 , 3 or 6 ; or
	(b) in preparations for dermal use for the treatment of tinea pedis.

(za) 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) for sublingual use; or
	(e) in preparations for transdermal use.

(zb) by inserting after item 41089 the following:

41089S.

Norelgestromin.

(zc) by omitting item 41135 and substituting the following:

41135.

Oxiconazole except in preparations for dermal use for the treatment of tinea pedis.

(zd) by inserting after item 41170 the following:

41170E.

Pentaerythritol tetranitrate.

(ze) by omitting items 41206 and 41207 and substituting the following:

41206.	Phenylpropanolamine.
41207.	Phenyltoloxamine.

(zf) by inserting after item 41246 the following:

41246M.

Poractant alfa.

(zg) by inserting after item 41260 the following:

41260S.

Pregabalin.

(zh) by omitting item 41305 and substituting the following:

41305.

Pseudoephedrine except when included in Schedule 3 .

(zi) by omitting item 41490 and substituting the following:

41490.

Thenyldiamine.

(zj) by omitting item 41530 and substituting the following:

41530.	Tioconazole –
	(a) except when included in Schedule 2 or 3 ; or
	(b) in preparations for dermal use for the treatment of tinea pedis.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after paragraph (b) in item 5003 the following:

5003E.

Acriflavine in preparations for veterinary use containing 2.5% or less of acriflavine.

(b) by inserting after item 5011 the following:

5011S.

Aminacrine in preparations for veterinary use containing 2.5% or less of aminacrine.

(c) by inserting after paragraph (c) in item 5043 the following:

5043S.

Carbamide peroxide in preparations containing 18% or less of carbamide peroxide, except in preparations containing 9% or less of carbamide peroxide.

(d) by inserting after item 5117 the following:

5117M.

Emodepside in preparations for external treatment of animals containing 2.5% or less of emodepside.

(e) by inserting after item 5187 the following:

5187S.

Malachite green in preparations for veterinary use containing 10% or less of malachite green.

(f) by inserting after paragraph (b) in item 5210 the following:

5210M.

Methylene blue in preparations for veterinary use containing 50% or less of methylene blue.

(g) by inserting after item 5214 the following:

5214S.

Milbemectin in preparations containing 1% or less of milbemectin.

(h) by omitting item 5250 and substituting the following:

5250.	Permethrin in preparations –
	(a) containing 25% or less of permethrin; or
	(b) for external use, for the treatment of dogs, containing 50% or less of permethrin when packed in single-use containers having a capacity of 4mL or less –
	except in preparations containing 2% or less of permethrin.

(i) by omitting item 5258M and substituting the following:

5258M.	Pine oils in preparations containing 25% or less of pine oils when packed and labelled as a herbicide.
5258S.	Pinoxaden in preparations containing 10% or less of pinoxaden.

(j) by inserting after item 5282S the following:

5282V.

Quinine in preparations for veterinary use containing 1% or less of quinine.

(k) by omitting item 5307 and substituting the following:

5307.

Spinosad except in aqueous suspensions containing 25% or less of spinosad.

(l) by omitting item 5329 and substituting the following:

5329.	Thiabendazole –
	(a) for the treatment of animals; or
	(b) when packed and labelled for use as a fungicide, except in preparations containing 50% or less of thiabendazole.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by inserting after item 6016 the following:

6016E.

Aminopyralid.

(b) by inserting after item 6068 the following:

6068S.	Carbamide peroxide except –
	(a) when included in Schedule 5 ; or
	(b) in other preparations containing 9% or less of carbamide peroxide.

(c) by inserting after item 6121 the following:

6121S.

Dichlobenil.

(d) by omitting item 6127 and substituting the following:

6127.	Dichlorophen except –
	(a) when included in Schedule 4 or 5 ; or
	(b) in fabrics other than when –
	(i) for human therapeutic use; or
	(ii) as part of a registered pesticidal product.

(e) by inserting after item 6160 the following:

6160E.

Emodepside for the treatment of animals except when included in Schedule 5 .

(f) by omitting item 6211 and substituting the following:

6211.	Glycolic acid (including its salts and esters) in cosmetic products or when packed and labelled for use as an agricultural chemical, except –
	(a) in cosmetic preparations for salon use only which are labelled in accordance with the National Occupational Health and Safety Commission's National Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)] or its successors; or
	(b) in preparations containing 5% or less of glycolic acid; or
	(c) in preparations containing 20% or less of glycolic acid with a pH of 3.5 or greater.

(g) by inserting after item 6270 the following:

6270E.

Milbemectin except when included in Schedule 5 .

(h) by omitting item 6273 and substituting the following:

6273.	Moxidectin for external use –
	(a) in preparations containing 2.5% or less of moxidectin when packed in single-dose tubes for the treatment of cats and dogs; or
	(b) in preparations containing 2% or less of moxidectin for the treatment of animals –
	except when included in Schedule 5 .

(i) by inserting after paragraph (b) in item 6295 the following:

6295M.

N-tallow alkyl-1,3-propanediamine diacetate and tallow alkylamine acetates.

(j) by omitting item 6320 and substituting the following:

6320.	Phenylenediamines and alkylated phenylenediamines not elsewhere specified in these Schedules –
	(a) in preparations packed and labelled for photographic purposes; or
	(b) in preparations packed and labelled for testing water except tablets containing 10mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging, provided the directions for use include the statement, "Do not discard testing solutions into the pool"; or
	(c) in hair dye preparations except when the immediate container and primary pack are labelled with the following statements written in letters not less than 1.5mm in height:
	"KEEP OUT OF REACH OF CHILDREN";
	"WARNING – This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye." ; or
	(d) in eyelash and eyebrow-tinting products when the immediate container and primary pack are labelled with the following statement written in letters not less than 1.5mm in height:
	"WARNING – This product contains ingredients which may cause skin irritation to certain individuals and, when used for eyelash and eyebrow-tinting, may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use."

(k) by omitting item 6326M and substituting the following:

6326M.	Pine oils when packed and labelled as a herbicide, except when included in Schedule 5 .
6326S.	Pinoxaden except when included in Schedule 5 .

(l) by omitting item 6404 and substituting the following:

6404.	Toluenediamine –
	(a) in hair dye preparations except when the immediate container and primary pack are labelled with the following statements written in letters not less than 1.5mm in height:
	"KEEP OUT OF REACH OF CHILDREN";
	"WARNING – This product contains ingredients which may cause skin irritation to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye." ; or
	(b) in eyelash and eyebrow-tinting products when the immediate container and primary pack are labelled with the following statement written in letters not less than 1.5mm in height:
	"WARNING – This product contains ingredients which may cause skin irritation to certain individuals and when used for eyelash and eyebrow-tinting may cause injury to the eye. A preliminary test according to the accompanying directions should be made before use."

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended as follows:

(a) by inserting after item 7002M in Part 1 the following:

7002V.

Acriflavine for veterinary use, except when included in Schedule 5 .

(b) by inserting after item 7010 in Part 1 the following:

7010S.

Aminacrine for veterinary use, except when included in Schedule 5 .

(c) by omitting item 7123 from Part 1 and substituting the following:

7123.

Halofuginone except when included in Schedule 4 .

(d) by inserting after paragraph (b) in item 7143 in Part 1 the following:

7143M.

Malachite green for veterinary use, except when included in Schedule 5 .

(e) by inserting after paragraph (c) in item 7158M in Part 1 the following:

7158S.

Methylene blue for veterinary use except when included in Schedule 4 or 5 .

(f) by omitting item 7167 from Part 1 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) for sublingual use; or
	(e) in preparations for transdermal use; or
	(f) in tobacco prepared and packed for smoking.

(g) by inserting after item 7192 in Part 1 the following:

7192M.

Quinine for veterinary use except, when included in Schedule 5 .

(h) by omitting item 7536 from Part 2 and substituting the following:

7536.

Phenylenediamines in preparations for skin colouration and dyeing of eyelashes or eyebrows, except when included in Schedule 6 .

(i) by inserting after item 7542 in Part 2 the following:

7542S.

Toluenediamine in preparations for skin colouration and dyeing of eyelashes or eyebrows, except when included in Schedule 6 .

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

Notified in the Gazette on 1 February 2006

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. 20, Amendment No. 2.