Poisons List Amendment Order (No. 2) 2004 (TAS)

Poisons List Amendment Order (No. 2) 2004

I make the following order under section 15(1) of the Poisons Act 1971 .26 August 2004

D. E. LLEWELLYN

Minister for Health and Human Services

1Short titleThis order may be cited as the Poisons List Amendment Order (No. 2) 2004 . 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 2019 and substituting the following:

2019.	Brompheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(b) by omitting item 2026 and substituting the following:

2026.	Chlorpheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(c) by omitting item 2031 and substituting the following:

2031.	Codeine when –
(a) compounded –
(i) with a single non-opiate analgesic substance in tablets or capsules each containing 10mg or less of codeine when –
(A)  packed in blister or strip packaging or in a container with a child-resistant closure; and
(B)  in a primary pack containing 25 or less dosage units; or
(ii) with a single non-opiate analgesic substance in individually wrapped powders each containing 10mg or less of codeine when in a primary pack containing 25 or less dosage units; or
(iii) with one or more other therapeutically active substances –
(A)  in divided preparations each containing 10mg or less of codeine; or
(B)  in undivided preparations containing 0.25% or less of codeine; and
(b) labelled with a recommended daily dose not exceeding 60mg of codeine.

(d) by omitting item 2035 and substituting the following:

2035.	Dexchlorpheniramine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(e) by omitting items 2041 , 2042 and 2043 and substituting the following:

2041.	Diphenhydramine –
(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.
2042.	Diphenylpyraline when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.
2043.	Doxylamine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(f) 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) pastes, powders or gels for the cleaning of teeth, included in Schedule 3 ; or
(ii) pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or
(iii) other dental hygiene products 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.

(g) by omitting items 2067 and 2068 and substituting the following:

2067.	Hyoscyamus niger for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.03mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids –
except in a pack containing 0.03mg or less of total solanaceous alkaloids.
2068.	Ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1 200mg or less of ibuprofen –
(a) in liquid preparations when sold in the manufacturer’s original pack containing 4 grams or less of ibuprofen; or
(b) in divided preparations, each containing 200mg or less of ibuprofen, in packs of 100 or less dosage units except when –
(i) as the only therapeutically active constituent other than an effervescent agent; and
(ii) packed in blister or strip packaging or in a container with a child-resistant closure; and
(iii) in a primary pack of 25 or less dosage units; and
(iv) the primary pack is labelled with one of the following warning statements:
WARNING – This medication may be dangerous when used in large amounts or for a long time;
CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful;
CAUTION – This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged or excessive use without medical supervision could be harmful; and
(v) the primary pack is labelled with warning statements to the following effect:
Do not use [this product / name of the product]:
If you have a stomach ulcer;
In the last 3 months of pregnancy [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea];
If you are allergic to ibuprofen or other anti-inflammatory medicines.
Unless a doctor has told you to, don’t use [this product / name of the product]:
For more than a few days at a time;
With other medicines containing ibuprofen or other anti-inflammatory medicines or other medicines that you are taking regularly;
If you have asthma;
In children 6 years of age or less;
If you are aged 65 years or over;
If you are pregnant [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea].

(h) 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 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.

(i) by omitting item 2098 and substituting the following:

2098.  Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for inhalation.

(j) 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 for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(k) by omitting item 2120 and substituting the following:

2120.	Promethazine –
(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or
(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

(l) by omitting item 2136 and substituting the following:

2136.	Thenyldiamine –
(a) in nasal preparations for topical use; or
(b) when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza when –
(i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
(ii) in a day-night pack containing thenyldiamine in the bed-time dose –
except in preparations for the treatment of children 2 years of age or less.

(m) by inserting after item 2139 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 and when packed in a primary pack containing 120 actuations or less, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

(n) by omitting items 2140 and 2141 and substituting the following:

2140.	Trimeprazine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.
2141.	Triprolidine when combined with one or more other therapeutically active substances in oral preparations for the treatment of symptoms of coughs, colds or influenza 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 2 years of age or less.

5Schedule 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 in pastes, powders and gels containing more than 1 000mg/kg of fluoride ion.

(b) by omitting item 3068 ; (c) by omitting item 3080 and substituting the following:

3080.  Triamcinolone for the treatment of mouth ulcers, in preparations containing 0.1% or less of triamcinolone in a pack of 5g or less.

6Schedule 4 amended (Restricted Substances) Schedule 4 to the Principal Order is amended as follows: (a) by inserting after item 40023 the following:

40023M.  Adalimumab.

(b) by inserting after item 40024 the following:

40024M.  Adefovir.

(c) by inserting after item 40465 the following:

40465M.  Diaveridine.

(d) by inserting after item 40566 the following:

40566M.  Enfuvirtide.

(e) by inserting after item 40587B the following:

40587H.  Escitalopram.

(f) 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) pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) other dental hygiene products 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
(d) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.

(g) by omitting item 40778 and substituting the following:

40778.	Hyoscyamus niger except –
(a) when included in Schedule 2 ; or
(b) in a pack containing 0.03mg or less of total solanaceous alkaloids.

(h) by omitting item 41053 and substituting the following:

41053.  Neomycin.

(i) by omitting item 41063 and substituting the following:

41063.	Nicotine for use as an aid in withdrawal from tobacco smoking (including preparations for nasal administration) except –
(a) when included in Schedule 2 or 3 ; or
(b) in chewing gum; or
(c) in lozenges; or
(d) in preparations for transdermal use.

(j) by omitting item 41319 and substituting the following:

41319.  Quinine for human internal use except in preparations containing 50mg or less of quinine per recommended daily dose.

(k) by omitting item 41515 and substituting the following:

41515.  Tiamulin.

(l) by omitting item 41564 and substituting the following:

41564.  Triamcinolone except when included in Schedule 2 or 3 .

(m) by omitting item 41628 and substituting the following:

41628.  Virginiamycin except when included in Schedule 5 .

7Schedule 5 amended (Domestic Poisons) Schedule 5 to the Principal Order is amended as follows: (a) by inserting after item 5105 the following:

5105M.  Diethylene glycol monobutyl ether except in preparations containing 10% or less of diethylene glycol monobutyl ether.

(b) by inserting after item 5125 the following:

5125M.  Ethoxysulfuron.

(c) 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) pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) other dental hygiene products 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
(d) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.

(d) by omitting item 5216 and substituting the following:

5216.	Moxidectin –
(a) in preparations for external use for the treatment of animals other than cats and dogs, containing 0.5% or less of moxidectin; or
(b) in preparations for external use for the treatment of cats and dogs, containing 2.5% or less of moxidectin packed in single-dose tubes with a volume of 1mL or less; or
(c) for internal use for the treatment of animals –
(i) in divided preparations for dogs, containing 250 micrograms or less of moxidectin per dosage unit in a pack containing 6 or less dosage units; or
(ii) in other preparations containing 2% or less of moxidectin.

(e) by omitting item 5246 and substituting the following:

5246.  Para-dichlorobenzene.

(f) by inserting after item 5307 the following:

5307M.	Star anise oil except –
(a) when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert, and labelled with the warning –
KEEP OUT OF REACH OF CHILDREN; or
(b) in preparations containing 50% or less of star anise oil.

(g) by omitting item 5336 ; (h) by inserting after item 5361 the following:

5362.  Virginiamycin in animal feed additives containing 1% or less of virginiamycin for the prevention of laminitis in horses when in a pack of 5kg or less.

8Schedule 6 amended (Agricultural and Industrial Poisons) Schedule 6 to the Principal Order is amended as follows: (a) by inserting after item 6172 the following:

6172M.  Ethyl formate when packed and labelled for use as a fumigant.

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

6199.	Fluorides except –
(a) when included in Schedule 2 , 3 , 4 or 5 ; or
(b) in pastes, powders or gels for the cleaning of teeth, containing 1 000mg/kg or less of fluoride ion; or
(c) in other dental hygiene products 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
(d) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.

(c) by omitting item 6273 and substituting the following:

6273.	Moxidectin for external use –
(a) in preparations containing 2.5% or less of moxidectin when packed in single-dose tubes for the treatment of cats and dogs except when included in Schedule 5 ; or
(b) in preparations containing 2% or less of moxidectin for the treatment of animals.

(d) by omitting item 6281 ; (e) by inserting after item 6326 the following:

6326M.  Pine oils (derived from Pinus radiata) when packed and labelled for use as a herbicide.

(f) by inserting after item 6352 the following:

6352M.  Pyridalyl.

9Schedule 7 amended (Dangerous Poisons) Part 1 of Schedule 7 to the Principal Order is amended as follows: (a) by omitting item 7017 and substituting the following:

7017.	Arsenic except –
(a) when separately specified in this Schedule; or
(b) when included in Schedule 4 or 6 ; or
(c) as selenium arsenide in photocopier drums; or
(d) as 10,10’-oxydiphenoxarsine in silicone rubber mastic containing 120mg/kg or less of arsenic; or
(e) as 10,10’-oxydiphenoxarsine contained in polyvinyl chloride and polyurethane extruded and moulded articles containing 160mg/kg or less of arsenic other than when included in articles –
(i) in contact with foodstuffs, animal feeds or potable water; or
(ii) of clothing and footwear in contact with the skin; or
(iii) used as infant wear; or
(iv) intended for use as packaging materials; or
(f) in animal feeds containing 75g/tonne or less of arsenic; or
(g) in paints containing 0.1% or less of arsenic calculated on the non-volatile content of the paint.

(b) by omitting item 7167 and substituting the following:

7167.	Nicotine except –
(a) when included in Schedule 2 , 3 , 4 or 6 ; or
(b) in chewing gum; or
(c) in lozenges; or
(d) in preparations for transdermal use; or
(e) in tobacco prepared and packed for smoking.

(c) by inserting after paragraph (d) in item 7187M the following:

7187R.  Procymidone.

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

Notified in the Gazette on 8 September 2004

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