Poisons List Amendment Order (No. 3) 2003
I make the following order under section 15(1) of the Poisons Act 1971 .
19 December 2003D. E. LLEWELLYN
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 3) 2003 .
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 2002 and substituting the following:
2002.
Acetylcysteine in preparations for oral use except when labelled with a recommended daily dose of 1g or less of acetylcysteine.
(b) by inserting after paragraph (d) in item 2019 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 and over.
(c) by omitting item 2036 and substituting the following:
2036.
Dextromethorphan when supplied in a pack containing 600mg or less of dextromethorphan and with a recommended daily dose of 120mg or less of dextromethorphan.
(d) by omitting item 2068 and substituting the following:
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 4g 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 a warning statement to the following effect:
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; or
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, do not use [this product / name of the product]:
For more than a few days at a time;
With other medicines containing aspirin 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].
(e) by inserting after item 2094M 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 short-term prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.
(f) by omitting item 2098 and substituting the following:
2098.
Nicotine for use as an aid in withdrawal from tobacco smoking –
(a) in chewing gum; or
(b) in lozenges; or
(c) in preparations for –
(i) inhalation; or
(ii) transdermal use.
(g) by inserting after item 2126 the following:
2126F.
Selenium in preparations for human topical therapeutic use except in preparations containing 3.5 per cent or less of selenium sulfide.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3009 ;(b) by omitting item 3016 and substituting the following:
3016.
Codeine when compounded with –
(a) a single non-opiate analgesic substance in divided preparations containing 10mg or less of codeine per dosage unit and with a recommended daily dose not exceeding 60mg of codeine; or
(b) paracetamol in divided preparations containing 12mg or less of codeine per dosage unit and with a recommended daily dose greater than 60mg but not exceeding 100mg of codeine when –
(i) packed in blister or strip packaging or in a container with a child-resistant closure; and
(ii) in a primary pack containing 12 or less dosage units –
except when included in Schedule 2 .
(c) by inserting after item 3031 the following:
3031M.
Fluconazole in single-dose oral preparations containing 150mg or less of fluconazole for the treatment of vaginal candidiasis.
(d) by inserting after item 3045 the following:
3045M.
Levonorgestrel in tablets each containing 0.75mg of levonorgestrel, in a primary pack containing 2 such tablets, for emergency post-coital contraception.
(e) by omitting item 3054 ;(f) by omitting item 3055 and substituting the following:
3055.
Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for sublingual use.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by inserting after item 40116 the following:
40116E.
Apramycin.
(b) by omitting item 40220 and substituting the following:
40220.
Budesonide except when included in Schedule 2 .
(c) by inserting after item 40437 the following:
40437M.
Deferiprone.
(d) by omitting item 40650 and substituting the following:
40650.
Fluconazole except when included in Schedule 3 .
(e) by omitting item 40782 and substituting the following:
40782.
Ibuprofen except –
(a) when included in or expressly excluded from Schedule 2 ; or
(b) in preparations for dermal use.
(f) by omitting item 40866 and substituting the following:
40866.
Levonorgestrel except when included in Schedule 3 .
(g) by inserting after item 40970 the following:
40970F.
Methyl aminolevulinate.
(h) by omitting item 41015 and substituting the following:
41015.
Mometasone except when included in Schedule 2 .
(i) by omitting item 41209 and substituting the following:
41209.
Pholcodine –
(a) in divided preparations containing 100mg or less of pholcodine per dosage unit; or
(b) in undivided preparations containing 2.5% or less of pholcodine –
except when included in Schedule 2 .
(j) by omitting item 41309 and substituting the following:
41309.
Pyridoxine, pyridoxal or pyridoxamine in preparations for human use containing more than the equivalent of 50mg of pyridoxine per recommended daily dose except when labelled with the warning statement –
WARNING – this medication may be dangerous when used in large amounts or for a long time; or
WARNING – this product contains [insert pyridoxine, pyridoxal or pyridoxamine as applicable] which may be dangerous when used in large amounts or for a long time.
(k) by omitting item 41368 and substituting the following:
41368.
Selenium for therapeutic use except –
(a) when included in Schedule 2 , 3 , 6 or 7 ; or
(b) in preparations for human oral use where the sum of the organic selenium expressed in micrograms and half the inorganic selenium expressed in micrograms, contained in the recommended daily dose of the preparation, does not exceed 26 micrograms; or
(c) in preparations for human topical use containing 3.5% or less of selenium sulfide; or
(d) for the treatment of animals –
(i) in solid, slow-release bolus preparations each weighing 100g or more and containing 300mg or less of selenium per dosage unit; or
(ii) in other divided preparations containing 30 micrograms or less of selenium per dosage unit; or
(iii) as elemental selenium, in pellets containing 100g/kg or less of selenium; or
(iv) in feeds containing 1g/tonne or less of selenium.
(l) by inserting after item 41477 the following:
41477M.
#Teriparatide.
(m) by inserting after item 41505 the following:
41505M.
Thiostrepton.
(n) by inserting after item 41609 the following:
41609M.
Vardenafil.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5045 and substituting the following:
5045.
Cassia oil except –
(a) in food additives; or
(b) in preparations for dermal use as a rubefacient containing 5% or less of cassia oil; or
(c) in other preparations containing 2% or less of cassia oil.
(b) by inserting after item 5056 the following:
5056P.
Cinmethylin.
(c) by inserting after item 5150 the following:
5150G.
Gamma-cyhalothrin in aqueous preparations containing 15% or less of microencapsulated gamma-cyhalothrin.
(d) by omitting item 5161 and substituting the following:
5161.
Hydrogen peroxide (excluding its salts and derivatives) –
(a) in hair dye preparations containing 12% or less of hydrogen peroxide except in hair dyes containing 6% or less of hydrogen peroxide; or
(b) in other preparations containing 6% (20 volume) or less of hydrogen peroxide except in preparations containing 3% (10 volume) or less of hydrogen peroxide.
(e) by omitting item 5199 and substituting the following:
5199.
Metalaxyl in preparations containing 35% or less of metalaxyl.
(f) by omitting items 5215M and 5216 and substituting the following:
5215M.
Morantel in preparations containing 25% or less of morantel except in preparations containing 10% or less of morantel.
5216.
Moxidectin –
(a) in preparations for external use for the treatment of non-companion animals containing 0.5 per cent or less of moxidectin; or
(b) 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.
(g) by omitting item 5222 and substituting the following:
5222.
Nitric acid (excluding its salts and derivatives) in preparations containing 10% or less of nitric acid (HNO3) except in preparations containing 0.5% or less of nitric acid.
(h) by omitting item 5266 and substituting the following:
5266.
Potassium sulfide in preparations for metal treatment in containers each containing 50g or less of potassium sulfide.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6011 and substituting the following:
6011.
Alpha-cypermethrin –
(a) in aqueous preparations containing 25% or less of alpha-cypermethrin; or
(b) in other preparations containing 10% or less of alpha-cypermethrin –
except when included in Schedule 5 .
(b) by inserting after item 6138 the following:
6138M.
Dimethenamid-P.
(c) by omitting item 6144 and substituting the following:
6144.
Dimethyl sulfoxide –
(a) when not for therapeutic use; or
(b) for the treatment of animals –
(i) when combined with no other therapeutic substance(s); or
(ii) in liquid preparations containing copper salicylate and 1% or less of methyl salicylate as the only other therapeutic substances; or
(iii) in clay poultices containing 2% or less of dimethyl sulfoxide.
(d) by omitting item 6210 and substituting the following:
6210.
Glyceryl thioglycollate in hair-waving preparations except when labelled with directions for use that include the statement –
"Wear protective gloves when using. Keep out of eyes.".
(e) by omitting item 6222 and substituting the following:
6222.
Hydrogen peroxide (excluding its salts and derivatives) except –
(a) when included in Schedule 5 ; or
(b) in hair dye preparations containing 6% or less of hydrogen peroxide; or
(c) in other preparations containing 3% (10 volume) or less of hydrogen peroxide.
(f) by omitting items 6272M and 6273 and substituting the following:
6272M.
Morantel except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 10% or less of morantel.
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; or
(b) in preparations containing 2% or less of moxidectin for the treatment of animals –
except when included in Schedule 5 .
(g) by omitting item 6320 and substituting the following:
6320.
Phenylenediamines and alkylated phenylenediamines not elsewhere specified in these Schedules –
(a) in preparations packed and labelled for photographic purposes; or
(b) in preparations packed and labelled for testing water except tablets containing 10mg or less of diethyl-para-phenylenediamine or dimethyl-para-phenylenediamine in opaque strip packaging, provided the directions for use include the statement, "Do not discard testing solutions into the pool"; or
(c) in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
"KEEP OUT OF REACH OF CHILDREN";
"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." –
written in letters not less than 1.5mm in height.
(h) by inserting after item 6360 the following:
6360M.
Rotenone except in solid or semi-solid preparations containing 2% or less of rotenone.
(i) by omitting item 6404 and substituting the following:
6404.
Toluenediamine in hair dye preparations except when the immediate container and primary pack are labelled with the following statements:
"KEEP OUT OF REACH OF CHILDREN";
"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." –
written in letters not less than 1.5mm in height.
9. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended by inserting after item 7122 in Part 1 the following item:
7122E.
Gamma-cyhalothrin except when included in Schedule 5 .
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 31 December 2003
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 to incorporate changes recommended by the National Drugs and Poisons Schedule Committee.