Poisons List Amendment Order (No. 2) 2007
I make the following order under section 15(1) of the Poisons Act 1971 .
6 September 2007LARA GIDDINGS
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 2) 2007 .
This order takes effect on the day on which its making is notified in the Gazette.
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 2015 and substituting the following:
2015.
Benzydamine in preparations for topical use, except in preparations for dermal use.
(b) by omitting item 2019 and substituting the following:
2019.
Brompheniramine when combined with one or more other therapeutically active substances in oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing brompheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(c) by omitting item 2026 and substituting the following:
2026.
Chlorpheniramine when combined with one or more other therapeutically active substances in oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing chlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(d) by omitting item 2035 and substituting the following:
2035.
Dexchlorpheniramine when combined with one or more other therapeutically active substances in oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(e) by omitting item 2041 and substituting the following:
2041.
Diphenhydramine in oral preparations –
(a) in a primary pack containing 10 dosage units or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when –
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing diphenhydramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(f) by omitting item 2043 and substituting the following:
2043.
Doxylamine when combined with one or more other therapeutically active substances in oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(g) by omitting item 2109 and substituting the following:
2109.
Pheniramine –
(a) in eye drops; or
(b) when combined with one or more other therapeutically active substances in oral preparations when –
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing pheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(h) by omitting item 2120 and substituting the following:
2120.
Promethazine in oral preparations –
(a) in a primary pack containing 10 dosage units or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances when –
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing promethazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
(i) by inserting after item 2123 the following:
2123F.
Pyrethrins, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, for human therapeutic use in preparations containing more than 10% of such substances.
(j) by omitting items 2124 and 2125 and substituting the following:
2124.
Pyrithione zinc for human therapeutic use, except in preparations for the treatment of the scalp containing 2% or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.
2125.
Ranitidine in preparations supplied in the manufacturer's original pack containing not more than 14 days' supply, except when supplied as divided preparations for oral use containing 150mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units.
(k) by omitting item 2126F and substituting the following:
2126F.
Selenium in preparations for human therapeutic use, except –
(a) for topical use containing 3.5% or less of selenium sulfide; or
(b) when included in Schedule 4 ; or
(c) for oral use with a recommended daily dose of 150 micrograms or less.
(l) by omitting items 2140 and 2141 and substituting the following:
2140.
Trimeprazine when combined with one or more other therapeutically active substances in solid oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing trimeprazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
2141.
Triprolidine when combined with one or more other therapeutically active substances in oral preparations when –
(a) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(b) in a day-night pack containing triprolidine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper –
except in preparations for the treatment of children under 2 years of age.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3056 and substituting the following:
3056.
Nicotinic acid for human therapeutic use in divided preparations containing 250mg or less of nicotinic acid per dosage unit, except –
(a) in preparations containing 100mg or less of nicotinic acid per dosage unit; or
(b) nicotinamide.
(b) by omitting item 3072 ;(c) by omitting item 3079 .
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by inserting after item 40027 the following:
40027M.
Adrafinil.
(b) by omitting item 40182 and substituting the following:
40182.
Benzydamine except –
(a) when included in Schedule 2 ; or
(b) in preparations for dermal use.
(c) by omitting item 40548H and substituting the following:
40548H.
Drotrecogin.
(d) by inserting after item 40622 the following:
40622M.
Exenatide
(e) by inserting after item 40711 the following:
40711G.
GHRH injectable plasmid.
(f) by inserting after item 40829 the following:
40829K.
Ivabradine.
(g) by inserting after item 40932 the following:
40932F.
Meptazinol.
(h) by omitting item 40971 and substituting the following:
40971.
Methylandrostanolone.
(i) by inserting after item 40978 the following:
40978F.
Methyl salicylate in preparations for internal therapeutic use.
(j) by inserting after item 41045 the following:
41045N.
Natalizumab.
(k) by omitting item 41063 and substituting the following:
41063.
Nicotine in preparations for human therapeutic use, except –
(a) when included in Schedule 2 ; or
(b) for use as an aid in withdrawal from tobacco smoking in chewing gum, lozenges or preparations for sublingual or transdermal use.
(l) by omitting item 41117 and substituting the following:
41117.
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 malathion for external use.
(m) by omitting item 41158 and substituting the following:
41158.
Paracetamol –
(a) when combined with aspirin, caffeine or salicylamide or any derivative of these substances, except when separately specified in these Schedules; or
(b) in slow-release tablets or capsules containing more than 665mg of paracetamol; or
(c) in non-slow-release tablets or capsules containing more than 500mg of paracetamol; or
(d) in individually wrapped powders or sachets of granules each containing more than 1 000mg of paracetamol.
(n) by omitting item 41327 and substituting the following:
41327.
Ranitidine except –
(a) when included in Schedule 2 ; or
(b) in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit when supplied in the manufacturer's original pack containing not more than 14 dosage units.
(o) by omitting item 41368 and substituting the following:
41368.
Selenium –
(a) for human oral use with a recommended daily dose of more than 300 micrograms; or
(b) for the treatment of animals, except –
(i) when included in Schedule 6 or 7 ; or
(ii) in solid, slow-release bolus preparations each weighing 100g or more and containing 300mg or less of selenium per dosage unit; or
(iii) in other divided preparations containing 30 micrograms or less of selenium per dosage unit; or
(iv) as elemental selenium, in pellets containing 100g/kg or less of selenium; or
(v) in feeds containing 1g/tonne or less of selenium.
(p) by inserting after item 41382 the following:
41382F.
Sitagliptin.
(q) by inserting after item 41399 the following:
41399F.
Sorafenib.
(r) by inserting after item 41450 the following:
41450F.
Sunitinib.
(s) by inserting after item 41466 the following:
41466H.
Telbivudine.
(t) by omitting item 41554 and substituting the following:
41554.
Tranexamic acid.
(u) by inserting after item 41580 the following:
41580F.
Trinitrophenol (excluding its derivatives) in preparations for human therapeutic use.
(v) by inserting after item 41609M the following:
41609R.
Varenicline.
(w) by omitting item 41630 and substituting the following:
41630.
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 3 000 micrograms retinol equivalents or less of vitamin A per daily dose; or
(c) in preparations for parenteral nutrition replacement.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5031F and substituting the following:
5031F.
Betacyfluthrin –
(a) in aqueous preparations containing 2.5% or less of betacyfluthrin; or
(b) in solid preparations containing 8% or less of betacyfluthrin in a plastic matrix.
(b) by inserting after item 5108 the following:
5108M.
Dimethicodiethylbenzalmalonate except when included in preparations containing 10% or less of dimethicodiethylbenzalmalonate.
(c) by omitting item 5169M and substituting the following:
5169M.
Indoxacarb (includes the R and S enantiomers) in preparations containing 1% or less of indoxacarb.
(d) by omitting item 5188 and substituting the following:
5188.
Malathion in preparations containing 10% or less of malathion, except –
(a) for human therapeutic use; or
(b) in dust preparations containing 2% or less of malathion.
(e) by omitting item 5209 and substituting the following:
5209.
Methyl salicylate in preparations containing 25% or less of methyl salicylate, except –
(a) in preparations for therapeutic use; or
(b) in preparations containing 5% or less of methyl salicylate.
(f) by omitting item 5278 and substituting the following:
5278.
Pyrethrins, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids, except –
(a) in preparations for human therapeutic use; or
(b) in preparations containing 10% or less of such substances.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6029M and substituting the following:
6029M.
Basic orange 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) except in hair dye preparations containing 1% or less of basic orange 31 when the immediate container and primary pack are labelled with the following statements:
KEEP OUT OF REACH OF CHILDREN;
If in eyes wash out immediately with water;
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.
written in letters not less than 1.5mm in height.
(b) by omitting item 6042 and substituting the following:
6042.
Bifenthrin in preparations containing 25% or less of bifenthrin, except in preparations containing 0.5% or less of bifenthrin.
(c) by inserting after item 6138 the following:
6138F.
5,6-Dihydroxyindoline.
(d) by omitting item 6244 and substituting the following:
6244.
Malathion except –
(a) when included in Schedule 5 ; or
(b) for human therapeutic use; or
(c) in dust preparations containing 2% or less of malathion.
(e) by inserting after item 6265 the following:
6265M.
Methyl methacrylate (excluding its derivatives) except in preparations containing 1% or less of methyl methacrylate as residual monomer in a polymer.
(f) by omitting item 6267 and substituting the following:
6267.
Methyl salicylate except –
(a) when included in Schedule 5 ; or
(b) in preparations for therapeutic use; or
(c) in preparations containing 5% or less of methyl salicylate.
(g) by omitting item 6354 and substituting the following:
6354.
Pyrithione zinc except –
(a) when included in Schedule 2 ; or
(b) in preparations for the treatment of the scalp containing 2% or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(c) when immobilised in solid preparations containing 0.5% or less of pyrithione zinc.
(h) by inserting after item 6416 the following:
6416M.
Trinitrophenol (excluding its derivatives) except –
(a) in preparations for human therapeutic use; or
(b) in preparations containing 5% or less of trinitrophenol.
9. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended as follows:(a) by omitting item 7167 from Part 1 and substituting the following:
7167.
Nicotine except –
(a) when included in Schedule 6 ; or
(b) in preparations for human therapeutic use; or
(c) in tobacco prepared and packed for smoking.
(b) by inserting after paragraph (b) in item 7204 in Part 1 the following:
7204F.
Sulfentrazone.
(c) by inserting after item 7508H in Part 2 the following:
7508M.
Basic orange 31 (2-[(4-aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride) in preparations for skin colouration and dyeing of eyelashes or eyebrows.
(d) by inserting after item 7524 in Part 2 the following:
7524M.
5,6-Dihydroxyindoline for cosmetic use in preparations containing more than 2% of 5,6-dihydroxyindoline.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 12 September 2007
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. 22, Amendment No. 1.