Poisons List Amendment Order (No. 2) 2001

Poisons List Amendment Order (No. 2) 2001

I make the following order under section 14 of the Poisons Act 1971 .

22 May 2001

JUDY JACKSON

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 2) 2001 .

2.   Commencement

This order takes effect on the day on which its making is notified in the Gazette or on 1 June 2001, whichever is the later.

3.   Principal Order

In this order, the Poisons List Order 1998 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 2001 the following:

2001G.

Acetylcysteine in preparations for oral use.

(b) by inserting after item 2047B the following:

2047C.

Famotidine for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.

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

2051.

Glyceryl trinitrate except when included in Schedule 3 or 4 .

(d) by omitting item 2066 ;

(e) by omitting item 2069M and substituting the following:

2069M.

Lithium for dermal use in preparations containing 1% or less of lithium except in preparations containing 0.01% or less of lithium.

(f) by inserting after paragraph (b) in item 2111 the following:

2111D.

Ranitidine for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3001 ;

(b) by omitting item 3003 and substituting the following:

3003.

Aminophylline in liquid oral preparations containing 2% or less of aminophylline.

(c) by omitting item 3025 ;

(d) by inserting after item 3028 the following:

3029.

Fluticasone in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms and when packed in a primary pack containing 200 actuations or less, for the short-term prophylaxis or treatment of seasonal allergic rhinitis in adults and children 12 years and over.

(e) by inserting after item 3031M the following:

3031P.

Glyceryl trinitrate in oral preparations.

(f) by inserting after item 3035 the following:

3035E.

Isosorbide dinitrate in oral preparations containing 10mg or less of isosorbide dinitrate per dosage unit.

(g) by omitting item 3050 ;

(h) by omitting item 3056 and substituting the following:

3056.

Theophylline in liquid oral preparations containing 2% or less of theophylline.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40003 ;

(b) by omitting item 40009 and substituting the following:

40009.

Acetylcysteine except when included in Schedule 2 .

(c) by inserting after item 40030 the following:

40030M.

Alosetron.

(d) by inserting after item 40059 the following:

40059M.

Amisulpride.

(e) by inserting after item 40068 the following:

40068C.

Amprenavir.

(f) by inserting after item 40075 the following:

40075F.	Androstanolone.
40075M.	Androstenediol.
40075Q.	Androstenedione.

(g) by inserting after item 40088 the following:

40088F.

Artemether.

(h) by inserting after paragraph (b) in item 40099 the following:

40099F.

Aviptadil.

(i) by inserting after item 40111 the following:

40111M.

Balsalazide.

(j) by inserting after paragraph (b) in item 40112 the following:

40112C.

Bambuterol.

(k) by inserting after item 40143E the following:

40143M.

Bivalirudin.

(l) by inserting after item 40154 the following:

40154M.

Brinzolamide.

(m) by inserting after item 40166 the following:

40166C.

Bupropion.

(n) by inserting after item 40231 the following:

40231R.

Cetrorelix.

(o) by omitting item 40252 ;

(p) by inserting after item 40347M the following:

40347R.

Dehydrochloromethyltestosterone.

(q) by inserting after item 40366 the following:

40366M.

Dexmedetomidine.

(r) by inserting after item 40452 the following:

40452F.

Eletriptan.

(s) by inserting after item 40469 the following:

40469M.

Esomeprazole.

(t) by inserting after item 40496 the following:

40496T.

Exemestane.

(u) by omitting item 40498 and substituting the following:

40498.

Famotidine except when included in Schedule 2 .

(v) by inserting after item 40513M the following:

40513P.

Florfenicol.

(w) by omitting item 40540 and substituting the following:

40540.

Fluticasone except when included in Schedule 3 .

(x) by inserting after item 40561 the following:

40561F.	Ganirelix.
40561Q.	Gatifloxacin.

(y) by inserting after item 40631 the following:

40631F.

Interleukins except when separately specified in these Schedules.

(z) by omitting item 40643 and substituting the following:

40643.

Isoetarine.

(za) by omitting item 40649 and substituting the following:

40649.

Isosorbide dinitrate except when included in Schedule 3 .

(zb) by inserting after item 40676 the following:

40676E.

Lercanidipine.

(zc) by inserting after item 40681 the following:

40681F.

Levobupivacaine.

(zd) by inserting after item 40688 the following:

40688M.

Linezolid.

(ze) by omitting item 40691 and substituting the following:

40691.	Lithium for therapeutic use, except –
	(a) when included in Schedule 2 ; or
	(b) in preparations containing 0.01% or less of lithium.

(zf) by inserting after item 40701 the following:

40701M.

Lumefantrine.

(zg) by inserting after item 40745 the following:

40745P.

Metenolone.

(zh) by omitting item 40749 and substituting the following:

40749.

Methandienone (metandienone).

(zi) by omitting item 40761 and substituting the following:

40761.

Methoxyflurane.

(zj) by inserting after item 40804X the following:

40804Y.

Moxifloxacin.

(zk) by inserting after item 40820 the following:

40820E.

Nateglinide.

(zl) by inserting after item 40849 the following:

40849M.	19-Norandrostenediol.
40849P.	19-Norandrostenedione.

(zm) by inserting after item 40882 the following:

40882M.

Oseltamivir.

(zn) by inserting after item 40886 the following:

40886M.

Oxaliplatin.

(zo) by inserting after item 40888 the following:

40888F.

Oxcarbazepine.

(zp) by inserting after item 40958 the following:

40958M.

Pioglitazone.

(zq) by inserting after item 41034E the following:

41034M.

Rabeprazole.

(zr) by omitting item 41037 and substituting the following:

41037.	Ranitidine except when included in Schedule 2 .
41038.	Rapacuronium bromide.

(zs) by inserting after item 41058 the following:

41058G.

Salcatonin.

(zt) by inserting after item 41067 the following:

41067M.

Sertindole.

(zu) by inserting after item 41070 the following:

41070M.

Sialoepoetin.

(zv) by inserting after item 41075 the following:

41075M.

Sirolimus.

(zw) by inserting after item 41123 the following:

41123M.

Tasonermin.

(zx) by inserting after item 41124M the following:

41124P.	Tegafur.
41124T.	Tegaserod.

(zy) by inserting after item 41126E the following:

41126M.

Tenecteplase.

(zz) by omitting item 41135M and substituting the following:

41135M.

Tetanus antitoxin except when used for short-term protection or treatment of tetanus in animals.

(zza) by omitting item 41188S ;

(zzb) by inserting after item 41189 the following:

41189M.

Tramadol.

(zzc) by inserting after item 41192 the following:

41192C.

Trastuzumab.

(zzd) by inserting after item 41214S the following:

41214V.

Trometamol in preparations for injection.

(zze) by inserting after item 41222 the following:

41222M.	Unoprostone.
41222Q.	Uracil.

(zzf) by inserting after item 41235 the following:

41235M.

Verteporfin.

(zzg) by omitting item 41244 and substituting the following:

41244.	Vitamin A for human therapeutic or cosmetic use, except –
	(a) in preparations for topical use containing 1% or less of vitamin A; or
	(b) in preparations for internal use, containing 100 IU or less of vitamin A per dosage unit of a divided preparation, or 100 IU or less of vitamin A per gram of an undivided preparation; or
	(c) in other preparations for internal use labelled –
	(i) with a recommended daily amount of 5 000 IU or less of vitamin A; and
	(ii) where the preparation is labelled for adult use, in bold-face letters not less than 1.5mm high, with a statement to the following effect:
	The recommended adult daily amount of vitamin A from all sources is 2 500 IU.
	(iii) where the preparation is labelled for adult use, in bold-face letters not less than 1.5mm high at the beginning of the directions for use, with a warning statement to the following effect:
	WARNING – When taken in excess of 8 000 IU vitamin A can cause birth defects. If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.
	or
	WARNING – Taking more than 2 500 IU a day during pregnancy may cause birth defects.

(zzh) by inserting after item 41251 the following:

41251C.

Zaleplon.

(zzi) by inserting after paragraph (b) in item 41254 the following:

41254F.

Ziprasidone.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after paragraph (b) in item 5024 the following:

5024G.	Bergamot oil except –
	(a) when steam distilled; or
	(b) in preparations containing 0.4% or less of bergamot oil; or
	(c) in soaps or bath and shower gels that are washed off the skin; or
	(d) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(b) by inserting after item 5031 the following:

5031G.

Butroxydim.

(c) by omitting item 5108 ;

(d) by inserting after item 5162 the following:

5162M.	Lemon oil except –
	(a) when steam distilled; or
	(b) in preparations containing 0.05% or less of lemon oil; or
	(c) in soaps or bath and shower gels that are washed off the skin; or
	(d) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(e) by inserting after item 5163 the following:

5163M.	Lime oil except –
	(a) when steam distilled; or
	(b) in preparations containing 0.5% or less of lime oil; or
	(c) in soaps or bath and shower gels that are washed off the skin; or
	(d) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(f) by omitting item 5190 and substituting the following:

5190.

2-methylthio-4-(2-methylprop-2-yl) amino-6-cyclopropylamino-5-triazine.

(g) by inserting after item 5208 the following:

5208G.	Orange oil (bitter) except –
	(a) when steam distilled; or
	(b) in preparations containing 1.4% or less of orange oil (bitter); or
	(c) in soaps or bath and shower gels that are washed off the skin; or
	(d) when packed in containers labelled with the statement:
	Application to skin may increase sensitivity to sunlight.

(h) by inserting after item 5229J the following:

5229M.

Polihexanide except in preparations containing 5% or less of polihexanide.

(i) by omitting item 5231 ;

(j) by inserting after item 5245 the following:

5245M.

Pyridaben in preparations containing 25% or less of pyridaben.

(k) by omitting item 5248 and substituting the following:

5248.	Quaternary ammonium compounds in preparations containing 20% or less of quaternary ammonium compounds except –
	(a) when separately specified in these Schedules; or
	(b) dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or
	(c) in preparations containing 5% or less of such quaternary ammonium compounds.

(l) by omitting item 5282 .

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by omitting item 6010 and substituting the following:

6010.	Alpha-cypermethrin –
	(a) in aqueous preparations containing 25% or less of alpha-cypermethrin except when included in Schedule 5 ; or
	(b) in other preparations containing 10% or less of alpha-cypermethrin except when included in Schedule 5 .

(b) by omitting item 6033 ;

(c) by omitting item 6037 and substituting the following:

6037.

Bifenthrin in preparations containing 10% or less of bifenthrin except in preparations containing 0.5% or less of bifenthrin.

(d) by omitting item 6070 ;

(e) by inserting after item 6085 the following:

6085P.

Closantel.

(f) by omitting item 6115 ;

(g) by omitting item 6133 and substituting the following:

6133.	Dimethyl sulfoxide –
	(a) when not for therapeutic use; or
	(b) for the treatment of animals –
	(i) when combined with no other therapeutic substance or substances; or
	(ii) in liquid preparations containing copper salicylate and 1% or less of methyl salicylate as the only other therapeutic substances; or
	(iii) in clay poultices containing 2% or less of dimethyl sulfoxide.

(h) by omitting item 6144 ;

(i) by inserting after item 6231M the following:

6231P.

Mecoprop-p.

(j) by inserting after item 6249 the following:

6249P.

Metosulam.

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

6273.

Octhilinone except in paints containing 1% or less of octhilinone calculated on the non-volatile content of the paint.

(l) by inserting after subparagraph (ii) in paragraph (c) of item 6306 the following:

6306H.

Prallethrin (cis:trans=20:80).

(m) by inserting after item 6320 the following:

6320P.

Pyridaben except when included in Schedule 5 .

(n) by omitting items 6321A and 6322 and substituting the following:

6321A.	Pyrithione zinc except –
	(a) when included in Schedule 2 ; or
	(b) in semi-solid hair preparations; or
	(c) in shampoos containing 2% or less of pyrithione zinc when labelled with the statement, "Keep out of eyes" or "If in eyes, rinse well with water".
6322.	Quaternary ammonium compounds except –
	(a) when separately specified in these Schedules; or
	(b) when included in Schedule 5 ; or
	(c) dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or
	(d) in preparations containing 5% or less of such quaternary ammonium compounds.

(o) by omitting item 6355 .

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended by omitting item 7027 and substituting:

7027.

Bifenthrin except –

(a) when included in Schedule 6 ; or

(b) in preparations containing 0.5% or less of bifenthrin.

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

Notified in the Gazette on 30 May 2001

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 1998 to incorporate changes recommended by the National Drugs and Poisons Schedule Committee.