Poisons List Amendment Order 2007
I make the following order under section 15(1) of the Poisons Act 1971 .
28 April 2007LARA GIDDINGS
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order 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 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 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 of age and over.
(b) by omitting item 2019M and substituting the following:
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 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 of age and over.
(c) by omitting item 2027 and substituting the following:
2027.
Ciclopirox in preparations for dermal use containing 2% or less of ciclopirox except in preparations for dermal use for the treatment of tinea pedis.
(d) by omitting item 2038 ;(e) by omitting item 2054 and substituting the following:
2054.
Fluorides for human use (except in preparations containing 15mg/kg or 15mg/L or less of fluoride ion) –
(a) as sodium fluoride, in preparations for ingestion containing 2.2mg or less of sodium fluoride per dosage unit; or
(b) in preparations for topical use containing 2.5% or less of fluoride ion except –
(i) when included in Schedule 3 ; or
(ii) dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing 1 000mg/kg or less of fluoride ion; or
(iii) other dental hygiene, whitening or bleaching products that are therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(iv) other dental hygiene, whitening or bleaching products that are not therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:
(A) Do not swallow;
(B) Do not use [this product / name of product] in children 6 years of age or less.
(f) 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 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 of age and over.
(g) by omitting item 2081 and substituting the following:
2081.
Lithium in preparations for dermal use containing 1% or less of lithium except –
(a) when present as an excipient at 0.25% or less of lithium; or
(b) in preparations containing 0.01% or less of lithium.
(h) by omitting item 2089 ;(i) by omitting item 2127 and substituting the following:
2127.
Silver for therapeutic use except –
(a) in solutions for human oral use containing 0.3% or less of silver when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(b) in other preparations containing 1% or less of silver.
(j) by omitting item 2133 and substituting the following:
2133.
Terbinafine for dermal use except in preparations for the treatment of tinea pedis.
(k) by omitting item 2139M and substituting the following:
2139M.
Triamcinolone in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation, when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by inserting after item 3008 the following:
3009.
Butoconazole in preparations for vaginal use.
(b) by omitting items 3012 and 3013 and substituting the following:
3012.
Ciclopirox in preparations for dermal use except –
(a) when included in Schedule 2 ; or
(b) in preparations for the treatment of tinea pedis.
3013.
Cimetidine in a primary pack containing not more than 14 days' supply.
3014.
Clemastine in preparations for oral use.
(c) by omitting item 3033 and substituting the following:
3033.
Fluorides in dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing more than 1 000mg/kg of fluoride ion.
(d) by omitting item 3040 and substituting the following:
3040.
Glycopyrronium except when included in Schedule 4 .
(e) by omitting items 3046 and 3047 and substituting the following:
3046.
Macrogols in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.
3047.
Malathion in preparations for human external use except in preparations containing 2% or less of malathion.
(f) by omitting item 3056 and substituting the following:
3056.
Nicotinic acid for human therapeutic use in dosage preparations containing 250mg or less of nicotinic acid except –
(a) in preparations containing 100mg or less of nicotinic acid per dosage unit; or
(b) nicotinamide.
(g) by omitting item 3066 and substituting the following:
3066.
Prochlorperazine in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.
(h) by omitting item 3080 and substituting the following:
3080.
Triamcinolone for buccal use in preparations containing 0.1% or less of triamcinolone in a pack of 5g or less.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40023 ;(b) by omitting items 40029F and 40029M and substituting the following:
40029F.
Agalsidase.
(c) by omitting item 40035 and substituting the following:
40035.
Alcuronium.
(d) by omitting item 40038 ;(e) by omitting item 40061M ;(f) by omitting item 40122 ;(g) by omitting item 40175 and substituting the following:
40175.
Benzilonium.
(h) by omitting item 40229M and substituting the following:
40229M.
Butoconazole except when included in Schedule 3 .
(i) by inserting after item 40283 the following:
40283M.
Cefovecin for veterinary use.
(j) by inserting after item 40296H the following:
40296R.
Cephaelis ipecacuanha except in preparations containing 0.2% or less of emetine.
(k) by omitting item 40340 and substituting the following:
40340.
Chymopapain for human therapeutic use.
(l) by omitting item 40358 and substituting the following:
40358.
Clemastine except when included in Schedule 3 .
(m) by inserting after item 40386 the following:
40386M.
Cobalt for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.
(n) by omitting item 40389 and substituting the following:
40389.
Colaspase.
(o) by omitting item 40414 and substituting the following:
40414.
Cyclopropane for therapeutic use.
(p) by inserting after item 40425 the following:
40425M.
Dactinomycin.
(q) by omitting item 40432H and substituting the following:
40432H.
Darbepoetin.
(r) by omitting item 40437 and substituting the following:
40437.
Decamethonium.
40437F.
Deferasirox.
(s) by omitting item 40443 and substituting the following:
40443.
Demecarium.
(t) by inserting after item 40468 the following:
40468M.
Dibotermin.
(u) by omitting item 40469M and substituting the following:
40469M.
Dichlorophen for human therapeutic use.
(v) by omitting item 40473 and substituting the following:
40473.
Dicyclomine.
(w) by inserting after item 40493 the following:
40493M.
Dihydrotachysterol.
(x) by omitting item 40513 and substituting the following:
40513.
Diphemanil except in preparations for dermal use.
(y) by omitting item 40548H and substituting the following:
40548H.
Drotecogin.
(z) by inserting after item 40550 the following:
40550F.
Duloxetine.
(za) by omitting item 40557 and substituting the following:
40557.
Edrophonium.
(zb) by omitting item 40559 ;(zc) by omitting item 40562 and substituting the following:
40562.
Emepronium.
(zd) by omitting item 40566 and substituting the following:
40566.
Enflurane for therapeutic use.
(ze) by inserting after item 40575 the following:
40575M.
Epinastine.
(zf) by omitting items 40577M and 40577S and substituting the following:
40577M.
Epoetins.
(zg) by omitting item 40579 and substituting the following:
40579.
Eprosartan.
(zh) by inserting after item 40600 the following:
40600M.
Ethionamide.
(zi) by inserting after item 40609 the following:
40609M.
Ethylhexanediol.
(zj) by omitting item 40615 and substituting the following:
40615.
Etilefrin.
(zk) by omitting item 40660 and substituting the following:
40660.
Fluocinolone.
(zl) by inserting after item 40663 the following:
40663M.
Fluorescein in preparations for injection.
(zm) by omitting item 40664 and substituting the following:
40664.
Fluorides in preparations for human use except –
(a) when included in Schedule 2 or 3 ; or
(b) dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) other dental hygiene, whitening or bleaching products that are therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(d) other dental hygiene, whitening or bleaching products that are not therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:
(i) Do not swallow;
(ii) Do not use [this product / name of product] in children 6 years of age or less; or
(e) other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(zn) by omitting item 40675 and substituting the following:
40675.
Fluroxene for human therapeutic use.
(zo) by omitting item 40685 and substituting the following:
40685.
Formebolone.
(zp) by inserting after item 40686 the following:
40686K.
Formoterol.
(zq) by omitting item 40690 and substituting the following:
40690.
Fosphenytoin.
(zr) by inserting after item 40707 the following:
40707M.
Gemifloxacin.
(zs) by omitting item 40723 and substituting the following:
40723.
Glycopyrronium in preparations for injection.
(zt) by omitting item 40728 and substituting the following:
40728.
Goserelin.
(zu) by omitting item 40746 and substituting the following:
40746.
Halothane for therapeutic use.
(zv) by omitting item 40748 and substituting the following:
40748.
Heparins for internal use except when separately specified in this Schedule.
(zw) by omitting item 40753 and substituting the following:
40753.
Hexamethonium.
(zx) by omitting item 40756 and substituting the following:
40756.
Hexocyclium.
(zy) by inserting after item 40779K the following:
40779P.
Ibafloxacin for veterinary use.
(zz) by inserting after item 40780 the following:
40780M.
Ibritumomab.
(zza) by omitting item 40817 and substituting the following:
40817.
Isoflurane for therapeutic use.
(zzb) by omitting item 40845 and substituting the following:
40845.
Lanatosides.
(zzc) by omitting items 40849 , 40849H , 40850 and 40851 and substituting the following:
40849.
Laudexium.
40850.
Lauromacrogols in preparations for injection except –
(a) when present as an excipient; or
(b) when separately specified in these Schedules.
40851.
Lead for human therapeutic use.
(zzd) by inserting after item 40866 the following:
40866M.
Levosimendan.
(zze) by omitting item 40872 and substituting the following:
40872.
Liothyronine.
(zzf) by omitting item 40875 and substituting the following:
40875.
Lithium for therapeutic use except –
(a) when included in Schedule 2 ; or
(b) when present as an excipient in preparations for dermal use containing 0.25% or less of lithium; or
(c) in preparations containing 0.01% or less of lithium.
(zzg) by inserting after item 40877 the following:
40877M.
Logiparin for internal use.
(zzh) by inserting after item 40918 the following:
40918M.
Melagatran.
(zzi) by inserting after item 40934 the following:
40934M.
Mercuric oxide for human therapeutic use.
(zzj) by omitting item 40948 and substituting the following:
40948.
Methacholine.
(zzk) by omitting item 40951 and substituting the following:
40951.
Metandienone.
(zzl) by omitting item 40953 and substituting the following:
40953.
Methanthelinium.
(zzm) by inserting after item 40975 the following:
40975M.
Methyl mercury for therapeutic use.
(zzn) by omitting item 40990 ;(zzo) by omitting item 41010 and substituting the following:
41010.
Mitoxantrone.
(zzp) by inserting after paragraph (e) in item 41063 the following:
41063M.
Nicotinic acid for human therapeutic use except –
(a) when contained in other Schedules; or
(b) in preparations containing 100mg or less of nicotinic acid per dosage unit; or
(c) nicotinamide.
(zzq) by inserting after item 41071 the following:
41072.
Nimorazole.
(zzr) by omitting item 41080 and substituting the following:
41080.
Nitrous oxide for therapeutic use.
(zzs) by omitting item 41100 and substituting the following:
41100.
Octatropine.
(zzt) by omitting item 41136 and substituting the following:
41136.
Oxitropium.
(zzu) by omitting item 41147 and substituting the following:
41147.
Oxyphenonium.
(zzv) by omitting item 41155 and substituting the following:
41155.
Pancuronium.
(zzw) by inserting after item 41165M the following:
41165P.
Peginterferon.
(zzx) by omitting item 41170E and substituting the following:
41170E.
Pentaerythrityl tetranitrate.
(zzy) by omitting item 41172 and substituting the following:
41172.
Pentamethonium.
(zzz) by omitting item 41176 and substituting the following:
41176.
Pentolinium.
(zzza) by omitting item 41179 and substituting the following:
41179.
Perhexiline.
(zzzb) by inserting after item 41181 the following:
41181M.
Permethrin for human therapeutic use except in preparations containing 5% or less of permethrin.
(zzzc) by omitting item 41190 and substituting the following:
41190.
Pheneticillin.
(zzzd) by inserting after item 41194 the following:
41194M.
Phenisatin.
(zzze) by omitting item 41202 and substituting the following:
41202.
Phenthimentonium.
(zzzf) by omitting item 41218 and substituting the following:
41218.
Pipecuronium.
(zzzg) by omitting item 41220 and substituting the following:
41220.
Pipenzolate.
(zzzh) by inserting after item 41226 the following:
41226M.
Piracetam.
(zzzi) by omitting item 41246M and substituting the following:
41246M.
Poractant.
(zzzj) by omitting item 41247M and substituting the following:
41247M.
Potassium chloride in oral preparations for human therapeutic use except –
(a) when containing less than 600mg of potassium chloride per dosage unit; or
(b) in preparations for oral rehydration therapy; or
(c) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or
(d) in preparations for enteral feeding.
(zzzk) by omitting item 41253 and substituting the following:
41253.
Prampine.
(zzzl) by omitting item 41261 and substituting the following:
41261.
Pregnenolone.
(zzzm) by omitting item 41298 and substituting the following:
41298.
Protamine.
(zzzn) by omitting item 41301 and substituting the following:
41301.
Protirelin.
(zzzo) by inserting after item 41311 the following:
41311M.
Pyrvinium.
(zzzp) by omitting item 41319 and substituting the following:
41319.
Quinine for human therapeutic use except when the maximum recommended daily dose is 50mg or less of quinine.
(zzzq) by omitting item 41323 and substituting the following:
41323.
Rabies vaccine.
(zzzr) by omitting item 41328 and substituting the following:
41328.
Rapacuronium.
(zzzs) by omitting item 41338 and substituting the following:
41338.
Rifampicin.
41338F.
Rifamycin.
41338K.
Rifapentine.
(zzzt) by omitting item 41339 and substituting the following:
41339.
Rimiterol.
(zzzu) by omitting item 41347 and substituting the following:
41347.
Rocuronium.
(zzzv) by omitting item 41369 ;(zzzw) by omitting item 41392 ;(zzzx) by omitting item 41417 and substituting the following:
41417.
Strophanthins.
(zzzy) by omitting items 41453 and 41454 and substituting the following:
41453.
Suxamethonium.
41454.
Suxethonium.
(zzzz) by omitting item 41475 and substituting the following:
41475.
Terbinafine except –
(a) when included in Schedule 2 ; or
(b) in preparations for dermal use for the treatment of tinea pedis.
(zzzza) by omitting item 41487 and substituting the following:
41487.
Tetraethylammonium.
(zzzzb) by omitting item 41495 ;(zzzzc) by inserting after item 41498 the following:
41498M.
Thioacetazone.
(zzzzd) by omitting item 41506 and substituting the following:
41506.
Thiotepa.
(zzzze) by omitting item 41509 and substituting the following:
41509.
Thiourea for therapeutic use except in preparations containing 0.1% or less of thiourea.
(zzzzf) by omitting item 41512 and substituting the following:
41512.
Thyrotrophin.
(zzzzg) by omitting item 41521 and substituting the following:
41521.
Tiemonium.
(zzzzh) by inserting after item 41522 the following:
41522M.
Tigecycline.
(zzzzi) by inserting after item 41531 the following:
41531M.
Tipranavir.
(zzzzj) by omitting item 41533 and substituting the following:
41533.
Tirofiban.
(zzzzk) by omitting item 41543 and substituting the following:
41543.
Tolonium.
(zzzzl) by omitting item 41546 and substituting the following:
41546.
Tolterodine.
(zzzzm) by omitting item 41557 and substituting the following:
41557.
Trazodone.
(zzzzn) by omitting item 41569 and substituting the following:
41569.
Trichloroethylene for therapeutic use.
(zzzzo) by omitting item 41587 and substituting the following:
41587.
Trometamol in preparations for injection except in preparations containing 3% or less of trometamol.
(zzzzp) by omitting item 41601 and substituting the following:
41601.
Urofollitropin.
(zzzzq) by inserting after item 41607 the following:
41607M.
Valproic acid.
(zzzzr) by omitting item 41612 and substituting the following:
41612.
Vecuronium.
(zzzzs) by omitting item 41626 and substituting the following:
41626.
Vinyl ether for therapeutic use.
(zzzzt) by omitting item 41627 ;(zzzzu) by inserting after item 41634 the following:
41634M.
Ximelagatran.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by inserting after item 5125M the following:
5125T.
Ethyl methacrylate (excluding its derivatives) for cosmetic use except in preparations containing 1% or less of ethyl methacrylate as residual monomer in a polymer.
(b) by omitting item 5145 and substituting the following:
5145.
Fluorides in preparations containing 3% or less of fluoride ion except –
(a) when included in Schedule 2 , 3 or 4 ; or
(b) dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) other dental hygiene, whitening or bleaching products that are therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(d) other dental hygiene, whitening or bleaching products that are not therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:
(i) Do not swallow;
(ii) Do not use [this product / name of product] in children 6 years of age or less; or
(e) other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(c) by omitting item 5250 and substituting the following:
5250.
Permethrin (excluding preparations for human therapeutic use) –
(a) in preparations containing 25% or less of permethrin; or
(b) in preparations for external use, for the treatment of dogs, containing 50% or less of permethrin when packed in single use containers having a capacity of 4mL or less –
except in preparations containing 2% or less of permethrin.
(d) by inserting after item 5267M the following:
5267T.
Profoxydim except in preparations containing 20% or less of profoxydim.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by inserting after paragraph (c) in item 6029 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 written in letters not less than 1.5mm in height:
KEEP OUT OF REACH OF CHILDREN;
If in eyes wash JS6/JT/tr/oc7/Hpd/EN 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.
(b) by inserting after paragraph (f) in item 6095 the following:
6095M.
N-coco-1,3-diaminopropane.
(c) by omitting item 6129 and substituting the following:
6129.
2,4-dichlorprop (including the R and S enantiomers).
(d) by omitting item 6199 and substituting the following:
6199.
Fluorides except –
(a) when included in Schedule 2 , 3 , 4 or 5 ; or
(b) dental hygiene, whitening or bleaching products that are pastes, powders or gels for use on teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) other dental hygiene, whitening or bleaching products that are therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(d) other dental hygiene, whitening or bleaching products that are not therapeutic goods, containing 220mg/kg or 220mg/L or less of fluoride ion, in packs containing not more than 120mg total fluoride, fitted with a child-resistant closure and labelled with warnings to the following effect:
(i) Do not swallow;
(ii) Do not use [this product / name of product] in children 6 years of age or less; or
(e) other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(e) by inserting after paragraph (b) in item 6295 the following:
6295E.
N-oleyl-1,3-diaminopropane.
(f) by omitting item 6315 and substituting the following:
6315.
Permethrin except –
(a) when included in Schedule 4 or 5 ; or
(b) in preparations for human therapeutic use containing 5% or less of permethrin; or
(c) in preparations containing 2% or less of permethrin.
(g) by inserting after paragraph (b) in item 6330H the following:
6330M.
Potassium azeloyl diglycinate except in preparations for cosmetic use containing 1% or less of potassium azeloyl diglycinate.
9. Schedule 7 amended (Dangerous Poisons)
Part 1 of Schedule 7 to the Principal Order is amended as follows:(a) by omitting item 7055 and substituting the following:
7055.
Colecalciferol for use as a rodenticide.
(b) by inserting after item 7157 the following:
7157M.
Methyl methacrylate for cosmetic use except in preparations containing 1% or less of methyl methacrylate as residual monomer in a polymer.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 9 May 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. 21, Amendment No. 3.