Poisons List Amendment Order (No. 3) 1999

Poisons List Amendment Order (No. 3) 1999

I make the following order under the Poisons Act 1971 .

8 September 1999

JUDY JACKSON

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order (No. 3) 1999 .

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 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 omitting item 2002 and substituting the following:

2002.

Aciclovir for external use for the treatment of herpes labialis.

(b) by omitting item 2012 and substituting the following:

2012.

Benzydamine in preparations for topical use.

(c) by omitting item 2017 ;

(d) by inserting after item 2019 the following:

2019E.

Cetirizine in preparations for oral use.

(e) by omitting item 2036 ;

(f) by inserting after paragraph (b) in item 2047 the following:

2047E.

Fexofenadine in preparations for oral use.

(g) by omitting item 2053 and substituting the following:

2053.	Hexachlorophane in preparations for human use containing 3% or less of hexachlorophane except –
	(a) in preparations containing 0.75% or less of hexachlorophane; or
	(b) in preparations for use on infants, as specified in Schedule 4 .

(h) by inserting after item 2054 the following:

2054E.	Hydrocortisone and Hydrocortisone acetate, but excluding other salts and derivatives, in preparations for dermal use containing 0.5 per cent or less of hydrocortisone in packs containing 30g or less of such preparations containing –
	(a) no other therapeutically active substance; or
	(b) an antifungal as the only other therapeutically active substance.

(i) by omitting items 2060 and 2061 and substituting the following:

2060.	Ibuprofen in –
	(a) divided preparations for oral use containing 200mg or less of ibuprofen per dosage unit in a pack containing 100 or less dosage units labelled with a recommended daily dose of not more than 1 200mg of ibuprofen; or
	(b) liquid preparations for oral use which are sold in the manufacturer's original pack having a capacity of 200ml or less and in strengths of 100mg or less of ibuprofen per 5ml; or
	(c) preparations for external use.

(j) by inserting after paragraph (b) in item 2063 the following:

2063C.

Ipratropium in preparations for nasal use.

(k) by omitting item 2067 and substituting the following:

2067.	Ketoconazole in preparations for dermal use, except in preparations containing 1 per cent or less of ketoconazole for the treatment of the scalp.
2067D.	Levocabastine in topical eye or nasal preparations.

(l) by omitting items 2069M , 2070 and 2071 and substituting the following:

2069M.	Lithium for dermal use in preparations containing 1% or less of lithium.
2070.	Lobelia except in preparations for smoking or burning.
2071.	Lobeline except in preparations for smoking or burning.

(m) by inserting after item 2072 the following:

2072C.

Loratadine in preparations for oral use.

(n) by omitting item 2073 ;

(o) by omitting item 2075 and substituting the following:

2075.

Mefenamic acid in divided preparations for oral use in packs of 30 or less dosage units for the treatment of dysmenorrhoea.

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

2085.	Nicotine for use as an aid in withdrawal from tobacco smoking, in preparations –
	(a) for transdermal use; or
	(b) in chewing gum.

(q) by omitting item 2092M and substituting the following:

2092M.

Penciclovir for external use for the treatment of herpes labialis.

(r) by omitting item 2098 and substituting the following:

2098.	Phenylephrine except –
	(a) when included in Schedule 4 ; or
	(b) in oral preparations containing 0.5 per cent or less of phenylephrine; or
	(c) in topical eye or nasal preparations containing 1 per cent or less of phenylephrine.

(s) by omitting item 2109 and substituting the following:

2109.	Pseudoephedrine (other than in preparations for stimulant, appetite-suppression or weight-control purposes) with a recommended daily dose of 240mg or less of pseudoephedrine –
	(a) in preparations containing 60mg or less of pseudoephedrine per recommended dose; or
	(b) in slow-release preparations.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3009 and substituting the following:

3009.	Chlorbutol in preparations for human use except –
	(a) when included in Schedule 2 ; or
	(b) in preparations containing 0.5 per cent or less of chlorbutol as a preservative.

(b) by inserting after paragraph (b) in item 3018 the following:

3018D.

Di-iodohydroxyquinolone (iodoquinol) for vaginal use.

(c) by omitting item 3026 ;

(d) by omitting items 3032 and 3032M and substituting the following:

3031M.	Glucagon.
3031S.	Glycopyrrolate (glycopyrronium) except when included in Schedule 4 .
3032.	Hydrocortisone and Hydrocortisone acetate, but excluding other salts and derivatives in preparations containing 1% or less of hydrocortisone –
	(a) for dermal use in packs containing 30g or less of such preparations and –
	(i) containing no other therapeutically active substance; or
	(ii) containing an antifungal but no other therapeutically active substance; or
	(b) for rectal use, when combined with a local anaesthetic but no other therapeutically active substance –
	(i) in individual preparations, in packs of 35g or less; or
	(ii) in packs containing 12 or less suppositories –
	except when included in Schedule 2 .

(e) by omitting items 3035M and 3036 and substituting the following:

3036.

Maldison (malathion) in preparations for human external use except in preparations containing 2 per cent or less of maldison.

(f) by omitting item 3040 and substituting the following:

3040.

Nicotine for use as an aid in withdrawal from tobacco smoking, in preparations for inhalation or sublingual use.

(g) by omitting item 3049 and substituting the following:

3049.

Quinine in preparations containing 200 milligrams or less of quinine per dosage unit for the treatment of cramp, in packs containing not more than 5 days' supply, except in preparations containing 50mg or less of quinine per recommended daily dose.

(h) by omitting item 3052E and substituting the following:

3052E.	Selenium in preparations for oral human use with a recommended daily dose of 100 micrograms or less of selenium except in preparations for oral human use with a recommended daily dose of –
	(a) 26 micrograms or less of selenium in organic form; or
	(b) 52 micrograms or less of selenium in inorganic form.
3052M.	Sodium phosphate in preparations for oral use for laxative or bowel-cleansing purposes.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by inserting after item 40114 the following:

40114M.

Basiliximab.

(b) by inserting after item 40129 the following:

40129M.

Benzoylmetronidazole.

(c) by omitting item 40192 and substituting the following:

40192.

Carbaryl for human therapeutic use.

(d) by omitting item 40231 and substituting the following:

40231.

Cetirizine except when included in Schedule 2 .

(e) by omitting item 40240 ;

(f) by omitting item 40350 and substituting the following:

40350.

Delavirdine (includes delavirdine mesylate).

(g) by omitting item 40397 and substituting the following:

40397.	Di-iodohydroxyquinoline (iodoquinol) except –
	(a) when included in Schedule 3 ; or
	(b) for human internal use.

(h) by omitting item 40416 and substituting the following:

40416.

Diphemanil methylsulfate except in preparations for dermal use.

(i) by omitting item 40450 and substituting the following:

40450.

Ecothiopate (includes ecothiopate iodide).

(j) by omitting item 40509 and substituting the following:

40509.

Fexofenadine except when included in Schedule 2 .

(k) by omitting item 40573 ;

(l) by omitting item 40576 and substituting the following:

40576.

Glycopyrrolate (glycopyrronium) in preparations for injection.

(m) by inserting after item 40582 the following:

40582M.

Grepafloxacin.

(n) by omitting item 40596 and substituting the following:

40596.	Hexachlorophane in –
	(a) preparations for use on infants; or
	(b) other preparations except –
	(i) when included in Schedule 2 or 6 ; or
	(ii) in preparations containing 0.75% or less of hexachlorophane.

(o) by omitting item 40604 and substituting the following:

40604.

Hydrocortisone, except when included in Schedule 2 or 3 .

(p) by omitting item 40620 and substituting the following:

40620.

Ibuprofen except when included in Schedule 2 .

(q) by omitting item 40622 and substituting the following:

40622.

Idoxuridine except in preparations containing 0.5% or less of idoxuridine for dermal use.

(r) by omitting item 40633 and substituting the following:

40633.

Ipratropium except when included in Schedule 2 .

(s) by omitting item 40659 and substituting the following:

40659.	Ketoconazole except –
	(a) when included in Schedule 2 ; or
	(b) in preparations containing 1% or less of ketoconazole for dermal use for the treatment of the scalp.

(t) by omitting item 40661 and substituting the following:

40661.

Ketorolac (includes ketorolac trometamol).

(u) by omitting item 40682 and substituting the following:

40682.

Levocabastine except when included in Schedule 2 .

(v) by omitting items 40691 , 40692 and 40693 and substituting the following:

40691.

Lithium for therapeutic use except when included in Schedule 2 .

(w) by omitting item 40698 and substituting the following:

40698.

Loratadine except when included in Schedule 2 .

(x) by omitting item 40705 ;

(y) by omitting item 40778 and substituting the following:

40778.

Metronidazole.

(z) by omitting item 40823 and substituting the following:

40823.

Nelfinavir (includes nelfinavir mesylate).

(za) by inserting after item 40830 the following:

40830M.

Nicotine for use as an aid in withdrawal from tobacco smoking (including preparations for nasal administration) except when included in Schedule 2 or 3 .

(zb) by inserting after item 40875 the following:

40875M.

Orbifloxacin.

(zc) by omitting item 40877 and substituting the following:

40877.	Organophosphorus compounds with anticholinesterase activity for human therapeutic use except –
	(a) when separately specified in these Schedules; or
	(b) in preparations containing 2% or less of maldison for external use.

(zd) by omitting item 40930 and substituting the following:

40930.

Phenacetin.

(ze) by inserting after item 40979 the following:

40979M.

Pramipexole.

(zf) by omitting item 41023 and substituting the following:

41023.

Pseudoephedrine (including all preparations for stimulant, appetite-suppression or weight-control purposes) except when included in Schedule 2 .

(zg) by omitting item 41034 and substituting the following:

41034.	Quinine for human internal use except –
	(a) when included in Schedule 3 ; or
	(b) in preparations containing 50 mg or less of quinine per recommended daily dose.

(zh) by inserting after item 41048E the following:

41048M.

Rizatriptan.

(zi) by omitting item 41065 and substituting the following:

41065.	Selenium for therapeutic use except –
	(a) when included in Schedule 3 , 6 or 7 ; or
	(b) in solid, slow-release bolus preparations, for the treatment of animals, each –
	(i) weighing 100g or more; and
	(ii) containing 300mg or less of selenium; or
	(c) as elemental selenium, in pellets containing 100g/kg or less of selenium, for the treatment of animals; or
	(d) in tablets, for the treatment of animals, each –
	(i) weighing 2g or more; and
	(ii) containing 30 micrograms or less of selenium; or
	(e) in animal feeds containing 1g/tonne or less of selenium; or
	(f) in preparations for oral human use with a recommended daily dose of –
	(i) 26 micrograms or less of selenium in organic form; or
	(ii) 52 micrograms or less of selenium in inorganic form; or
	(g) in preparations for topical use containing 2.5% or less of selenium sulphide.

(zj) by omitting item 41082 ;

(zk) by omitting items 41106 and 41107 and substituting the following:

41107.

Strychnos spp. (includes strychnos nux-vomica) except when separately specified in this Schedule.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by omitting item 5034 and substituting the following:

5034.	Carbaryl when –
	(a) in preparations containing 10% or less of carbaryl except when included in Schedule 4 ; or
	(b) impregnated into plastic resin material containing 20% or less of carbaryl.

(b) by inserting after paragraph (b) in item 5054 the following:

5054M.

Coumatetralyl in rodenticides containing 0.05% or less of coumatetralyl.

(c) by omitting item 5168 and substituting the following:

5168.	Maldison (malathion) in preparations containing 10% or less of maldison except –
	(a) for human therapeutic use; or
	(b) in dust preparations containing 2% or less of maldison.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by omitting item 6062 and substituting the following:

6062.

Carbaryl except when included in Schedule 4 or 5 .

(b) by omitting item 6092 and substituting the following:

6092.

Coumatetralyl in rodenticides containing 1% or less of coumatetralyl except when included in Schedule 5 .

(c) by omitting item 6229 and substituting the following:

6229.	Maldison (malathion) except –
	(a) when included in Schedule 5 ; or
	(b) for human therapeutic use; or
	(c) in dust preparations containing 2% or less of maldison.

(d) by inserting after item 6278 the following:

6279.

Paecilomyces lilacinus Strain 251.

(e) by inserting after item 6368 the following:

6368M.

Tolyfluanid.

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended by omitting item 7062 and substituting:

7062.

Coumatetralyl, except when included in Schedule 5 or 6 .

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

Notified in the Gazette on 15 September 1999

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 in force under the Poisons Act 1971 so as to adopt changes recommended by the National Drugs and Poisons Schedule Committee (SUSDP No. 13, Amendment No. 4).