Poisons List Amendment Order 2008
I make the following order under section 15(1) of the Poisons Act 1971 .
14 May 2008LARA GIDDINGS
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order 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 2027 and substituting the following:
2027.
Ciclopirox in preparations for dermal use and for application to the nails containing 2% or less of ciclopirox, except in preparations for the treatment of tinea pedis.
(b) by omitting item 2055 and substituting the following:
2055.
Formaldehyde (excluding its derivatives) for human therapeutic use except
(a) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or
(b) in other preparations containing 0.2% or less of free formaldehyde.
(c) by omitting item 2091 and substituting the following:
2091.
Methoxamine for external use except in preparations containing 1% or less of methoxamine.
(d) by omitting item 2105 and substituting the following:
2105.
Paraformaldehyde (excluding its derivatives) for human therapeutic use except
(a) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or
(b) in other preparations containing 0.2% or less of free formaldehyde.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3012 and substituting the following:
3012.
Ciclopirox in preparations for dermal use and for application to the nails except
(a) when included in Schedule 2 ; or
(b) in preparations for the treatment of tinea pedis.
(b) by inserting after item 3059R the following:
3059X.
Pantoprazole in oral preparations containing 20mg or less of pantoprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by inserting after item 40030 the following:
40030E.
Agomelatine.
(b) by inserting after item 40233 the following:
40233E.
Cadmium compounds for human therapeutic use.
(c) by inserting after item 40423 the following:
40423E.
Dabigatran.
(d) by omitting item 40966 and substituting the following:
40966.
Methoxamine except
(a) when included in Schedule 2 ; or
(b) in preparations for external use containing 1% or less of methoxamine.
(e) by inserting after item 41000 the following:
41000E.
Miglustat.
(f) by inserting after item 41010 the following:
41010E.
Mitratapide.
(g) by omitting item 41156 and substituting the following:
41156.
Pantoprazole except when included in Schedule 3 .
(h) by omitting item 41158 and substituting the following:
41158.
Paracetamol
(a) when combined with aspirin 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.
(i) by inserting after item 41650 the following:
41650E.
Zonisamide.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5041 ;(b) by inserting after item 5141 the following:
5141E.
Flubendiamide.
(c) by inserting after item 5198 the following:
5198E.
Metaflumizone.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6063 and substituting the following:
6063.
Cadmium compounds except
(a) when included in Schedule 4 ; or
(b) in paints or tinters containing 0.1% or less of cadmium calculated on the non-volatile content of the paint or tinter.
(b) by inserting after item 6071 the following:
6071E.
Castor oil, monomaleate (excluding its salts and derivatives) in preparations for cosmetic use, except in wash-off preparations containing 1% or less of castor oil, monomaleate.
(c) by omitting item 6205 and substituting the following:
6205.
Formaldehyde (excluding its derivatives) in preparations containing 0.05% or more of free formaldehyde except
(a) for human therapeutic use; or
(b) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or
(c) in nail-hardener cosmetic preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
PROTECT CUTICLES WITH GREASE OR OIL; or
(d) in all other preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE.
(d) by inserting after item 6268E the following:
6268M.
Methylnorbornylpyridine except in preparations containing 0.5% or less of methylnorbornylpyridine.
(e) by omitting item 6272 and substituting the following:
6272.
Monensin
(a) in animal feed premixes containing 12.5% or less of antibiotic substances; or
(b) in stockfeed supplements, blocks or licks containing 0.75% or less of antibiotic substances.
(f) by omitting item 6306 and substituting the following:
6306.
Paraformaldehyde (excluding its derivatives) in preparations containing 0.05% or more of free formaldehyde except
(a) for human therapeutic use; or
(b) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or
(c) in nail-hardener cosmetic preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
PROTECT CUTICLES WITH GREASE OR OIL; or
(d) in all other preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE.
9. Schedule 7 amended (Dangerous Poisons)
Part 2 of Schedule 7 to the Principal Order is amended as follows:(a) by inserting after item 7530 the following:
7530M.
Formaldehyde (excluding its derivatives)
(a) in oral hygiene preparations containing more than 0.1% of free formaldehyde; or
(b) in aerosol sprays for cosmetic use containing 0.005% or more of free formaldehyde; or
(c) in nail-hardener cosmetic preparations containing 5% or more of free formaldehyde; or
(d) in all other cosmetic preparations containing 0.05% or more of free formaldehyde except in preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE.
(b) by inserting after item 7534 the following:
7534M.
Paraformaldehyde (excluding its derivatives)
(a) in oral hygiene preparations containing more than 0.1% of free formaldehyde; or
(b) in aerosol sprays for cosmetic use containing 0.005% or more of free formaldehyde; or
(c) in nail-hardener cosmetic preparations containing 5% or more of free formaldehyde; or
(d) in all other cosmetic preparations containing 0.05% or more of free formaldehyde except in preparations containing 0.2% or less of free formaldehyde when labelled with the warning statement:
CONTAINS FORMALDEHYDE.
10. Schedule 8 amended (Narcotic Substances)
Schedule 8 to the Principal Order is amended by omitting item 8041 and substituting:
8041.
Levorphanol (excluding its stereoisomers).
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 21 May 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. 22, Amendment No. 3.