Poisons List Amendment Order (No. 2) 2003
I make the following order under section 15(1) of the Poisons Act 1971 .
25 August 2003D. E. Llewellyn
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 2) 2003 .
This order takes effect on the day on which its making is notified in the Gazette or on 1 September 2003, whichever is later.
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 2011 the following:
2011M.
Beclomethasone in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.
(b) by omitting item 2036 and substituting the following:
2036.
Dextromethorphan when supplied in a pack containing 600mg or less of dextromethorphan –
(a) in divided preparations containing 30mg or less of dextromethorphan per dosage unit and with a recommended daily dose not exceeding 30mg of dextromethorphan; or
(b) in undivided preparations containing 0.6% or less of dextromethorphan with a recommended daily dose not exceeding 120mg of dextromethorphan.
(c) by omitting item 2073 and substituting the following:
2073.
Iron compounds (excluding iron oxides when present as an excipient in divided preparations containing 10mg or less of total iron oxides per dosage unit or in undivided preparations containing 1% or less of total iron oxides) for human internal use except –
(a) when included in Schedule 4 ; or
(b) when labelled with a recommended daily dose not exceeding 24mg of iron –
(i) in undivided preparations supplied in packs each containing 750mg or less of iron; or
(ii) in divided preparations –
(A) containing more than 5mg of iron per dosage unit in packs each containing 750mg or less of iron; or
(B) containing 5mg or less of iron per dosage unit.
(d) by omitting item 2077 ;(e) by omitting item 2081 and substituting the following:
2081.
Lithium (excluding when present as an excipient at 0.25% or less of lithium) in preparations for therapeutic dermal use containing 1% or less of lithium except in preparations containing 0.01% or less of lithium.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3002 and substituting the following:
3002.
Alclometasone as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of alclometasone in packs containing 30g or less of such preparations.
(b) by omitting item 3006 ;(c) by omitting item 3014M and substituting the following:
3014M.
Clobetasone (clobetasone-17-butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of clobetasone in packs containing 30g or less of such preparations.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40065 ;(b) by omitting item 40137 and substituting the following:
40137.
Avoparcin.
(c) by omitting item 40150 and substituting the following:
40150.
Bacitracin.
(d) by omitting item 40161 and substituting the following:
40161.
Beclomethasone except when included in Schedule 2 .
(e) by omitting item 40172 ;(f) by inserting after paragraph (e) in item 40207 the following:
40207M.
Bosentan.
(g) by omitting item 40395 and substituting the following:
40395.
Collagen in preparations for injection or implantation –
(a) for tissue augmentation; or
(b) for cosmetic use.
(h) by inserting after item 40404 the following:
40404S.
Cuprimyxin.
(i) by inserting after item 40550 the following:
40550M.
Dutasteride.
(j) by omitting item 40586 and substituting the following:
40586.
Erythromycin.
(k) by inserting after item 40620 the following:
40620M.
Etoricoxib.
(l) by omitting item 40760 and substituting the following:
40760.
Hyaluronic acid and its polymers in preparations for injection or implantation for –
(a) tissue augmentation; or
(b) cosmetic use; or
(c) the treatment of animals.
(m) by omitting item 40775 and substituting the following:
40775.
Hygromycin.
(n) by omitting item 40836 and substituting the following:
40836.
Ketoprofen except –
(a) in preparations for dermal use; or
(b) when included in Schedule 3 .
(o) by omitting item 40875 and substituting the following:
40875.
Lithium (excluding when present as an excipient at 0.25% or less of lithium) for therapeutic use, except –
(a) when included in Schedule 2 ; or
(b) in preparations containing 0.01% or less of lithium.
(p) by inserting after item 40894 the following:
40894M.
Marbofloxacin.
(q) by omitting item 41038 and substituting the following:
41038.
Nalidixic acid.
(r) by omitting item 41122 ;(s) by inserting after item 41133 the following:
41133M.
Oxedrine for human internal use except in preparations labelled with a recommended daily dose not exceeding 30mg of oxedrine.
(t) by inserting after item 41165 the following:
41165M.
Pegfilgrastim.
(u) by omitting item 41242M and substituting the following:
41242M.
Polylactic acid in preparations for injection or implantation for –
(a) tissue augmentation; or
(b) cosmetic use.
(v) by omitting item 41404 and substituting the following:
41404.
Spiramycin.
(w) by inserting after item 41456 the following:
41456M.
Tadalafil.
(x) by inserting after item 41466 the following:
41466M.
Telithromycin.
(y) by inserting after item 41606 the following:
41606E.
Valdecoxib.
(z) by omitting item 41628 and substituting the following:
41628.
Virginiamycin.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5042 ;(b) by omitting items 5048 and 5049 and substituting the following:
5049.
Chlorinating compounds containing 20% or less of available chlorine except –
(a) when separately specified in these Schedules; or
(b) sodium hypochlorite; or
(c) in liquid preparations containing not less than 2%, but not more than 4%, of available chlorine when labelled with the statement –
"WARNING: Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products."; or
(d) in liquid preparations containing less than 2% of available chlorine; or
(e) in other preparations containing 4% or less of available chlorine.
(c) by omitting item 5073 ;(d) by omitting item 5098 and substituting the following:
5098.
Dichloroisocyanuric acid containing 40% or less of available chlorine except in –
(a) liquid preparations containing not less than 2%, but not more than 4%, of available chlorine when labelled with the statement –
"WARNING: Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products."; or
(b) liquid preparations containing less than 2% of available chlorine; or
(c) other preparations containing 4% or less of available chlorine.
(e) by inserting after item 5130 the following:
5130M.
Fenbuconazole.
(f) by omitting item 5177 and substituting the following:
5177.
Ivermectin for use in animals –
(a) in preparations for the prophylaxis of heartworm in cats and dogs; or
(b) in intraruminal implants containing 160mg or less of ivermectin; or
(c) in preparations containing 3.5% or less of ivermectin when packed in a container fitted with a child-resistant closure; or
(d) in other preparations containing 2% or less of ivermectin.
(g) by inserting after item 5215 the following:
5215M.
Morantel tartrate in preparations containing 25% or less of morantel except in preparations containing 10% or less of morantel.
(h) by omitting item 5300 ;(i) by omitting item 5348 ;(j) by omitting item 5362 .
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6027 ;(b) by omitting item 6049 ;(c) by inserting after paragraph (b) in item 6063 the following:
6063M.
Cadusafos in aqueous preparations containing 20% or less of microencapsulated cadusafos.
(d) by inserting after item 6075 the following:
6075M.
Chlorinating compounds except –
(a) when included in Schedule 5 ; or
(b) when separately specified in these Schedules; or
(c) sodium hypochlorite; or
(d) in liquid preparations containing not less than 2%, but not more than 4%, of available chlorine when labelled with the statement –
"WARNING: Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products."; or
(e) in liquid preparations containing less than 2% of available chlorine; or
(f) in other preparations containing 4% or less of available chlorine.
(e) by inserting after item 6125 the following:
6125M.
Dichloroisocyanuric acid except –
(a) when included in Schedule 5 ; or
(b) in liquid preparations containing not less than 2%, but not more than 4%, of available chlorine when labelled with the statement –
"WARNING: Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products."; or
(c) in liquid preparations containing less than 2% of available chlorine; or
(d) in other preparations containing 4% or less of available chlorine.
(f) by omitting item 6163 ;(g) by omitting item 6225 ;(h) by inserting after item 6272 the following:
6272M.
Morantel tartrate except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 10% or less of morantel.
(i) by omitting item 6277 ;(j) by omitting item 6376 .
9. Schedule 7 amended (Dangerous Poisons)
Part 1 of Schedule 7 to the Principal Order is amended as follows:(a) by omitting item 7036 and substituting the following:
7036.
Cadusafos except when included in Schedule 6 .
(b) by omitting item 7219 .
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 3 September 2003
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. 18, Amendment No. 1.