Poisons List Amendment Order (No. 3) 2008
I make the following order under section 15(1) of the Poisons Act 1971 .
18 December 2008LARA GIDDINGS
Minister for Health
This order may be cited as the Poisons List Amendment Order (No. 3) 2008 .
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 2054 and substituting the following:
2054.
Fluorides for human use –
(a) in preparations for ingestion containing 0.5mg or less of fluoride ion per dosage unit; or
(b) in liquid preparations for topical use containing 1 000mg/kg or less of fluoride ion, in a container with a child-resistant closure –
(i) for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels (September 2008), except in preparations containing 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride, when fitted with a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(ii) for non-therapeutic use when 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 –
except in preparations containing 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride, when 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 –
except in preparations containing 15mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority.
(b) by omitting item 2058 .
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3033 and substituting the following:
3033.
Fluorides for human topical use –
(a) in liquid preparations containing 5 500mg/kg or less of fluoride ion, in a container with a child-resistant closure, except when included in or expressly excluded from Schedule 2 ; or
(b) in non-liquid preparations containing 5 500mg/kg or less of fluoride ion except –
(i) in preparations for therapeutic use containing 1 500mg/kg or less of fluoride ion and, when containing more than 1 000mg/kg of fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(ii) in preparations for non-therapeutic use containing 1 500mg/kg or less of fluoride ion and, when containing more than 1 000mg/kg of fluoride ion, 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; or
(iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority.
(b) by omitting item 3039 and substituting the following:
3039.
Glyceryl trinitrate in preparations for –
(a) oral use; or
(b) rectal use.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by inserting after item 40041 the following:
40042.
Alglucosidase.
(b) by omitting item 40207 and substituting the following:
40207.
Boron, including boric acid and borax, for human therapeutic use except –
(a) in preparations for internal use containing 6mg or less of boron per recommended daily dose; or
(b) in preparations for dermal use containing 0.35% or less of boron, which are not for paediatric or antifungal use; or
(c) when present as an excipient.
(c) by inserting after item 40432 the following:
40432E.
Daptomycin.
(d) by omitting item 40722 and substituting the following:
40722.
Glyceryl trinitrate except when included in Schedule 3 .
(e) by inserting after item 40786 the following:
40786M.
Idursulfase.
(f) by inserting after paragraph (b) in item 40830 the following:
40830M.
Ixabepilone.
(g) by inserting after item 40846M the following:
40846R.
Laropiprant.
(h) by inserting after item 40853 the following:
40853M.
Lenalidomide.
(i) by inserting after item 40894 the following:
40894E.
Maraviroc.
(j) by inserting after item 40894M the following:
40894R.
Maropitant.
(k) by inserting after item 41076 the following:
41077.
Nitric oxide for human therapeutic use.
(l) by omitting item 41220E and substituting the following:
41220E.
Piper methysticum (Kava) in preparations for human use, except when included on the Australian Register of Therapeutic Goods in preparations –
(a) for oral use when present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250mg or less of kavalactones and –
(i) the tablet or capsule form contains 125mg or less of kavalactones per tablet or capsule; or
(ii) the amount of dried whole or peeled rhizome in the teabag does not exceed 3g –
and, where containing more than 25mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(b) in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or
(c) in dermal preparations.
(m) by inserting after item 41324 the following:
41324M.
Raltegravir.
(n) by inserting after item 41355S the following:
41355V.
Rotigotine.
(o) by inserting after item 41469 the following:
41469M.
Temsirolimus.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5087 and substituting the following:
5087.
2,4-D in preparations containing 20% or less of 2,4-D.
(b) by omitting item 5090 and substituting the following:
5090.
Deltamethrin –
(a) in aqueous preparations containing 5% or less of deltamethrin when no organic solvent other than a glycol is present; or
(b) in wettable granular preparations containing 25% or less of deltamethrin when packed in child-resistant packaging each containing 3g or less of the formulation; or
(c) in water-dispersible tablets each containing 500mg or less of deltamethrin in child-resistant packaging; or
(d) in other preparations containing 0.5% or less of deltamethrin.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6001 and substituting the following:
6001.
Abamectin –
(a) in preparations for pesticidal use containing 2% or less of abamectin, except when included in Schedule 5 ; or
(b) in slow-release plastic matrix ear tags for livestock use containing 1g or less of abamectin.
(b) by omitting item 6070 and substituting the following:
6070.
Carbendazim except in paints, jointing compounds and sealants containing 0.5% or less of carbendazim.
(c) by omitting item 6103 and substituting the following:
6103.
Coumaphos –
(a) in slow-release plastic matrix ear tags for livestock use containing 6g or less of coumaphos; or
(b) in other preparations containing 5% or less of coumaphos.
(d) by inserting after item 6115 the following:
6115M.
2,4-D except when included in Schedule 5 .
(e) by omitting item 6211 and substituting the following:
6211.
Glycolic acid (including its salts and esters) in cosmetic products or when packed and labelled for use as an agricultural chemical except –
(a) in cosmetic preparations for salon use only which are labelled in accordance with the National Occupational Health and Safety Commission'sNational Code of Practice for the Labelling of Workplace Substances [NOHSC:2012(1994)]; or
(b) in preparations containing 5% or less of glycolic acid; or
(c) in preparations containing 20% or less of glycolic acid with a pH of 3.5 or greater.
(f) by omitting item 6263 and substituting the following:
6263.
Methomyl in fly-baits containing 1% or less of methomyl and not less than 0.002% of denatonium benzoate as a bittering agent.
(g) by omitting item 6268M and substituting the following:
6268M.
Methylnorbornylpyridine.
(h) by omitting item 6298 and substituting the following:
6298.
Octhilinone except in paints, jointing compounds and sealants containing 1% or less of octhilinone calculated on the non-volatile content.
(i) by omitting item 6325 ;(j) by inserting after item 6375 the following:
6376.
Spirotetramat.
9. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended as follows:(a) by inserting after paragraph (c) in item 7063 in Part 1 the following:
7063M.
Cyanogen.
(b) by inserting after item 7513 in Part 2 the following:
7513M.
1,4-butanediol (excluding its derivatives) in non-polymerised form in preparations for domestic use.
(c) by inserting after item 7523 in Part 2 the following:
7523M.
Diethylene glycol for use in toothpastes or mouthwashes, except in preparations containing 0.25% or less of diethylene glycol.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 31 December 2008
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. 23, Amendment No. 2.