Poisons List Amendment Order (No. 4) 2006
I make the following order under section 15(1) of the Poisons Act 1971 .
29 August 2006Lara Giddings
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 4) 2006 .
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 inserting after item 2002 the following:
2003.
Aconitum spp. for therapeutic use in adults –
(a) in preparations for oral use in packs each containing 0.2mg or less of total alkaloids except in packs containing 0.02mg or less of total alkaloids; or
(b) in preparations for dermal use containing 0.02% or less of total alkaloids, in packs each containing 0.2mg or less of total alkaloids except in packs containing 0.02mg or less of total alkaloids.
(b) by omitting item 2006 and substituting the following:
2006.
Amorolfine for topical use in preparations containing 0.25% or less of amorolfine except in preparations for the treatment of tinea pedis.
(c) by omitting item 2011M and substituting 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 for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
(d) by omitting items 2019 and 2019M 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 –
except in preparations for the treatment of children under 2 years of age.
2019M.
Budesonide in aqueous nasal sprays delivering 50 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
(e) 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 –
except in preparations for the treatment of children under 2 years of age.
(f) 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 –
except in preparations for the treatment of children under 2 years of age.
(g) by omitting items 2041 and 2043 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 –
except in preparations for the treatment of children under 2 years of age.
2042.
Diphenylpyraline 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 diphenylpyraline in the bed-time dose –
except in preparations for the treatment of children under 2 years of age.
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 –
except in preparations for the treatment of children under 2 years of age.
(h) by omitting item 2054J and substituting the following:
2054J.
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 for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
(i) by inserting after item 2088 the following:
2088M.
Mepyramine for dermal use.
(j) by omitting item 2090 and substituting the following:
2090.
Mercury for external use in preparations containing 0.5% or less of mercury.
(k) by omitting item 2094R and substituting the following:
2094R.
Mometasone in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
(l) by inserting after item 2101 the following:
2101M.
Oxiconazole for dermal use except in preparations for the treatment of tinea pedis.
(m) 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 –
except in preparations for the treatment of children under 2 years of age.
(n) by omitting item 2120 and substituting the following:
2120.
Promethazine in oral preparations –
(a) in primary packs of 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 –
except in preparations for the treatment of children under 2 years of age.
(o) by omitting items 2139M , 2140 and 2141 and substituting the following:
2139M.
Triamcinolone in aqueous nasal sprays delivering 50 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
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 –
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 –
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 3004 and substituting the following:
3004.
Amorolfine for topical use except –
(a) when included in Schedule 2 ; or
(b) in preparations for the treatment of tinea pedis.
(b) by inserting after item 3005 the following:
3006.
Azelastine in topical eye preparations containing 0.05% or less of azelastine.
(c) by inserting after subparagraph (ii) in paragraph (b) of item 3016 the following:
3016M.
Cyclizine in preparations for oral use.
(d) by inserting after subparagraph (ii) in paragraph (b) of item 3041 the following:
3041M.
Ibuprofen in divided preparations, each containing 400mg or less of ibuprofen, in a primary pack containing not more than 50 dosage units when labelled –
(a) with a recommended daily dose of 1 200mg or less of ibuprofen; and
(b) not for the treatment of children under 12 years of age –
except when included in or expressly excluded from Schedule 2 .
(e) by inserting after item 3045 the following:
3045E.
Ketotifen for ophthalmic use in preparations containing 0.025% or less of ketotifen.
(f) by omitting item 3045M and substituting the following:
3045M.
Levonorgestrel for emergency post-coital contraception.
(g) by omitting item 3051 and substituting the following:
3051.
Metoclopramide when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units.
(h) by inserting after item 3059M the following:
3059R.
Oxiconazole in preparations for vaginal use.
(i) by omitting item 3081 and substituting the following:
3081.
Trimeprazine –
(a) in solid oral preparations except when included in Schedule 2 ; or
(b) in liquid oral preparations containing 10mg or less of trimeprazine per 5mL.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40022 and substituting the following:
40022.
Aconitum spp. except –
(a) when included in Schedule 2 ; or
(b) in preparations for oral use in adults in packs containing 0.02mg or less of total alkaloids; or
(c) in preparations for dermal use in adults containing 0.02% or less of total alkaloids in packs containing 0.02mg or less of total alkaloids.
40022M.
Acrivastine.
(b) by inserting after item 40037S the following:
40037V.
Alemtuzumab.
(c) by inserting after paragraph (b) in item 40061 the following:
40061M.
Amidopyrine.
(d) by omitting item 40084 and substituting the following:
40084.
Amorolfine except –
(a) when included in Schedule 2 or 3 ; or
(b) in preparations for the treatment of tinea pedis.
(e) by inserting after item 40105 the following:
40105M.
Anecortave.
(f) by omitting item 40112 and substituting the following:
40112.
Antimony for therapeutic use except when separately specified in these Schedules.
(g) by inserting after item 40128 the following:
40128M.
Atosiban.
(h) by omitting item 40145 and substituting the following:
40145.
Azelastine except when included in Schedule 3 .
(i) by omitting item 40242 and substituting the following:
40242.
Camphorated oil for therapeutic use.
(j) by omitting item 40407 and substituting the following:
40407.
Cyclizine except when included in Schedule 3 .
(k) by omitting item 40422 and substituting the following:
40422.
Cysteamine for human therapeutic use.
(l) by inserting after item 40572 the following:
40572M.
Entecavir.
(m) by inserting after item 40584 the following:
40584E.
Erlotinib.
(n) by inserting after item 40693 the following:
40693M.
Fulvestrant.
(o) by omitting item 40782 and substituting the following:
40782.
Ibuprofen except –
(a) when included in or expressly excluded from Schedule 2 or 3 ; or
(b) in preparations for dermal use.
(p) by omitting item 40838 and substituting the following:
40838.
Ketotifen except when included in Schedule 3 .
(q) by inserting after item 40846 the following:
40846F.
Lanthanum.
(r) by omitting item 40933 and substituting the following:
40933.
Mepyramine except when included in Schedule 2 or 3 .
(s) by inserting after item 41028 the following:
41028M.
Muraglitazar.
(t) by inserting after item 41055 the following:
41055M.
Nesiritide.
(u) by inserting after item 41110 the following:
41110F.
Olmesartan.
(v) by omitting item 41135 and substituting the following:
41135.
Oxiconazole except –
(a) when included in Schedule 2 or 3 ; or
(b) in preparations for the treatment of tinea pedis.
(w) by inserting after item 41150 the following:
41150M.
Palifermin.
(x) by inserting after item 41151 the following:
41151M.
Palonosetron.
(y) by inserting after item 41165 the following:
41165F.
Pegaptanib.
(z) by inserting after item 41165M the following:
41165Q.
Pegvisomant.
(za) by inserting after item 41246M the following:
41246S.
Posaconazole.
(zb) by inserting after item 41247 the following:
41247M.
Potassium chloride in slow-release oral preparations for human therapeutic use except when containing 100mg or less of potassium chloride per dosage unit.
(zc) by inserting after item 41328 the following:
41328F.
Rasagiline.
(zd) by omitting item 41389 and substituting the following:
41389.
Sodium polystyrene sulphonate for human therapeutic use.
(ze) by inserting after item 41395 the following:
41395M.
Solifenacin.
(zf) by inserting after item 41477M the following:
41477S.
Terlipressin.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5006 and substituting the following:
5006.
Alkaline salts, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination –
(a) in solid orthodontic device-cleaning preparations, the pH of which as an "in-use" aqueous solution is more than 11.5; or
(b) in solid automatic dishwashing preparations, the pH of which in a 500g/L aqueous solution or mixture is more than 11.5 but less than or equal to 12.5; or
(c) in other solid preparations, the pH of which in a 10g/L aqueous solution is more than 11.5; or
(d) in liquid or semi-solid preparations, the pH of which is more than 11.5 –
except when separately specified in these Schedules.
(b) by inserting after item 5047 the following:
5048.
Chlorhexidine in preparations containing 3% or less of chlorhexidine except –
(a) in preparations containing 1% or less of chlorhexidine; or
(b) in solid preparations.
(c) by inserting after item 5085 the following:
5085M.
Cysteamine in cosmetic preparations containing 6% or less of cysteamine except in preparations containing 1% or less of cysteamine.
(d) by inserting after item 5139 the following:
5139M.
Florasulam.
(e) by inserting after paragraph (b) in item 5268 the following:
5268M.
Prohexadione calcium.
(f) by inserting after item 5304 the following:
5304M.
Sodium polystyrene sulphonate in preparations for cosmetic use except in preparations containing 10% or less of sodium polystyrene sulphonate.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by inserting after item 6008 the following:
6008M.
Alkaline salts, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination for non-domestic use –
(a) in solid automatic dishwashing preparations, the pH of which in a 500g/L aqueous solution or mixture is more than 12.5; or
(b) in liquid or semi-solid automatic dishwashing preparations, the pH of which is more than 12.5.
(b) by inserting after paragraph (b) in item 6011 the following:
6011M.
Amicarbazone.
(c) by inserting after item 6075 the following:
6075F.
Chlorhexidine in preparations containing 7% or less of chlorhexidine except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 1% or less of chlorhexidine; or
(c) in solid preparations.
(d) by inserting after item 6114 the following:
6114M.
Cysteamine for cosmetic use except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 1% or less of cysteamine.
9. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended by inserting after item 7048 in Part 1 the following items:
7048M.
Chlorhexidine except –
(a) when included in Schedule 5 or 6 ; or
(b) in preparations containing 1% or less of chlorhexidine; or
(c) in solid preparations.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 6 September 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. 21, Amendment No. 1.