Poisons List Amendment Order (No. 2) 2008 (TAS)

Poisons List Amendment Order (No. 2) 2008

I make the following order under section 15(1) of the Poisons Act 1971 .1 September 2008

LARA GIDDINGS

Minister for Health and Human Services

1Short titleThis order may be cited as the Poisons List Amendment Order (No. 2) 2008 . 2CommencementThis order takes effect on the day on which its making is notified in the Gazette. 3Principal OrderIn this order, the Poisons List Order 2001 is referred to as the Principal Order. 4Schedule 2 amended (Medicinal Poisons) Schedule 2 to the Principal Order is amended as follows: (a) by omitting item 2036 and substituting the following:

2036.  Dextromethorphan (excluding its stereoisomers) when supplied in a pack containing 600mg or less of dextromethorphan and with a recommended daily dose of 120mg or less of dextromethorphan.

(b) 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 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 supplied to registered dental professionals or by approval of an appropriate authority.

(c) by omitting item 2091 and substituting the following:

2091.  Methoxamine in preparations for external use except in preparations containing 1% or less of methoxamine.

5Schedule 3 amended (Potent Substances) Schedule 3 to the Principal Order is amended as follows: (a) by omitting item 3007 and substituting the following:

3007.	Brompheniramine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(b) by omitting item 3011 and substituting the following:

3011.	Chlorpheniramine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(c) by omitting item 3018 and substituting the following:

3018.	Dexchlorpheniramine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(d) by omitting item 3024 and substituting the following:

3024.	Diphenhydramine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(e) by omitting item 3028 and substituting the following:

3028.	Doxylamine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(f) 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 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 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 supplied to registered dental professionals or by approval of an appropriate authority.

(g) by omitting item 3060 and substituting the following:

3060.	Pheniramine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

(h) by omitting item 3082 and substituting the following:

3082.	Triprolidine in oral preparations except –
(a) when included in Schedule 2 ; or
(b) for the treatment of children under 2 years of age.

6Schedule 4 amended (Restricted Substances) Schedule 4 to the Principal Order is amended as follows: (a) by omitting item 40462 and substituting the following:

40462.  Dextromethorphan (excluding its stereoisomers) except when included in Schedule 2 .

(b) by omitting item 40464 and substituting the following:

40464.  Dextrorphan (excluding its stereoisomers).

(c) by inserting after item 40521 the following:

40521M.  Dirlotapide.

(d) by omitting item 40664 and substituting the following:

40664.  Fluorides in preparations for human use except when included in or expressly excluded from Schedule 2 or 3 .

(e) by omitting item 40693 ; (f) by inserting after item 40696 the following:

40696M.  Furosemide (frusemide).

(g) by inserting after item 40865 the following:

40865M.  Levomepromazine.

(h) by omitting item 40965 ; (i) by inserting after item 41155 the following:

41155M.  Panitumumab.

(j) 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; or
(e) for injection.

(k) 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 –
(a) in preparations for oral use when –
(i) present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250mg or less of kavalactones and –
(A)  the tablet or capsule form contains 125mg or less of kavalactones per tablet or capsule; or
(B)  the amount of dried whole or peeled rhizome in the teabag does not exceed 3g; and
(ii) 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.

7Schedule 5 amended (Domestic Poisons) Schedule 5 to the Principal Order is amended as follows: (a) by inserting after item 5121 the following:

5121F.  Esfenvalerate in preparations containing 0.1% or less of esfenvalerate.

(b) by omitting item 5145 and substituting the following:

5145.	Fluorides in preparations containing 3% or less of fluoride ion except in preparations –
(a) for human use; or
(b) containing 15mg/kg or less of fluoride ion.

(c) by omitting item 5214 ; (d) by inserting after item 5281 the following:

5281M.  Pyrithione zinc in paints containing 0.5% or less of pyrithione zinc calculated on the non-volatile content of the paint.

(e) by inserting after item 5306 the following:

5306M.  Spinetoram.

8Schedule 6 amended (Agricultural and Industrial Poisons) Schedule 6 to the Principal Order is amended as follows: (a) by omitting item 6165 and substituting the following:

6165.  Esfenvalerate except when included in Schedule 5 .

(b) by omitting item 6199 and substituting the following:

6199.	Fluorides except –
(a) when included in Schedule 5 ; or
(b) in preparations for human use; or
(c) in preparations containing 15mg/kg or less of fluoride ion.

(c) by omitting item 6240 and substituting the following:

6240.	Lead compounds except –
(a) when included in Schedule 4 or 5 ; or
(b) in zinc-based paints or tinters containing 0.2% or less of lead as an impurity in the zinc and calculated on the non-volatile content of the paint or tinter; or
(c) in other paints or tinters containing 0.1% or less of lead calculated on the non-volatile content of the paint or tinter; or
(d) in preparations for cosmetic use containing 100mg/kg or less of lead; or
(e) in pencil cores, finger colours, showcard colours, pastels, crayons, poster paints/colours or coloured chalks containing 100mg/kg or less of lead; or
(f) in ceramic glazes when labelled with the warning statement:
CAUTION – Harmful if swallowed. Do not use on surfaces which contact food or drink.
written in letters not less than 1.5mm in height.

(d) by inserting after item 6269 the following:

6269M.  Metribuzin.

(e) by omitting item 6354 and substituting the following:

6354.	Pyrithione zinc except –
(a) when included in Schedule 2 or 5 ; or
(b) for human use 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) in semi-solid hair preparations for animal use; or
(d) in shampoos for animal use containing 2% or less of pyrithione zinc when labelled with the statement "Keep out of eyes" and "If in eyes rinse well with water"; or
(e) when immobilised in solid preparations containing 0.5% or less of pyrithione zinc.
6354M.	Pyroxsulam.

9Schedule 7 amended (Dangerous Poisons) Schedule 7 to the Principal Order is amended as follows: (a) by omitting item 7098 from Part 1 and substituting the following:

7098.  Epidermal growth factor except in preparations for human therapeutic use.

(b) by inserting after item 7532 in Part 2 the following:

7532M.  Lead compounds in inks or ink additives except preparations containing 0.1% or less of lead calculated on the non-volatile content of the ink or ink additive.

Displayed and numbered in accordance with the Rules Publication Act 1953.

Notified in the Gazette on 10 September 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