Poisons List Amendment Order (No. 3) 2006
I make the following order under section 15(1) of the Poisons Act 1971 .
2 May 2006Lara Giddings
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 3) 2006 .
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. Clause 4 amended (Substances specified in Poisons List)
Clause 4(4) of the Principal Order is amended as follows:(a) by inserting the following definition before the definition of Uniform Standard :Required Advisory Statements for Medicine Labels means the Required Advisory Statements for Medicine Labels published by the Australian Government under the Therapeutic Goods Act 1989 of the Commonwealth, as amended from time to time;(b) by omitting "Publishing Service" from the definition of Uniform Standard and substituting "under the Therapeutic Goods Act 1989 of the Commonwealth".
5. Schedule 2 amended (Medicinal Poisons)
Schedule 2 to the Principal Order is amended as follows:(a) by omitting item 2008 and substituting the following:
2008.
Aspirin except –
(a) when included in Schedule 4 , 5 or 6 ; or
(b) in individually wrapped powders or sachets of granules each containing 650mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when –
(i) enclosed in a primary pack that contains not more than 12 such powders or sachets of granules; and
(ii) compliant with the Required Advisory Statements for Medicine Labels; or
(c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when –
(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and
(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500mg or less of aspirin; and
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels; or
(d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when –
(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and
(ii) in a primary pack containing not more than 100 tablets or capsules, each containing 100mg or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and
(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.
(b) 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 that are therapeutic goods, 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, when compliant with the Required Advisory Statements for Medicine Labels; or
(iv) other dental hygiene products, that are not therapeutic goods, 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.
(c) 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 not more than 100 dosage units except when –
(i) present 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 not more than 25 dosage units; and
(iv) compliant with the Required Advisory Statements for Medicine Labels.
(d) by omitting item 2094 and substituting the following:
2094.
Miconazole for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.
(e) by omitting item 2104 and substituting the following:
2104.
Paracetamol for therapeutic use except –
(a) when included in Schedule 4 ; or
(b) in individually wrapped powders or sachets of granules each containing 1 000mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –
(i) enclosed in a primary pack containing not more than 12 such powders or sachets; and
(ii) compliant with the Required Advisory Statements for Medicine Labels; and
(iii) not labelled for the treatment of children 6 years of age or less; or
(c) in tablets or capsules each containing 500mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents, when –
(i) packed in blister or strip-packaging or in a container with a child-resistant closure; and
(ii) in a primary pack containing not more than 25 such tablets or capsules; and
(iii) compliant with the Required Advisory Statements for Medicine Labels; and
(iv) not labelled for the treatment of children 6 years of age or less.
(f) by omitting item 2111 and substituting the following:
2111.
Phenylephrine except –
(a) when included in Schedule 4 ; or
(b) in oral preparations containing 50mg or less of phenylephrine per recommended daily dose in packs containing 250mg or less of phenylephrine; or
(c) in topical eye or nasal preparations containing 1% or less of phenylephrine.
(g) by omitting item 2124 and substituting the following:
2124.
Pyrithione zinc for human therapeutic use, except –
(a) in semi-solid hair preparations; or
(b) in shampoos containing 2% or less of pyrithione zinc when compliant with the Required Advisory Statements for Medicine Labels.
(h) by omitting item 2127 and substituting the following:
2127.
Silver for therapeutic use except –
(a) in chewing gum each containing 5% or less of silver per dosage unit when compliant with the Required Advisory Statements for Medicine Labels; or
(b) in solutions for human oral use containing 0.3% or less of silver when compliant with the Required Advisory Statements for Medicine Labels; or
(c) in other preparations containing 1% or less of silver.
6. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended by omitting item 3066 and substituting:
3066.
Prochlorperazine in divided preparations in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.
7. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40144 and substituting the following:
40144.
Azelaic acid except –
(a) when included in Schedule 2 ; or
(b) in preparations containing 1% or less of azelaic aid for non-human use.
(b) by inserting after item 40273 the following:
40273T.
Cefacetrile.
(c) by inserting after item 40274M the following:
40274P.
Cefaloridine.
40274S.
Cefamandole.
40274V.
Cefapirin.
40274X.
Cefazolin.
(d) by omitting item 40295 ;(e) by omitting item 40299 and substituting the following:
40299.
Cefaloridine.
(f) by omitting items 40301 , 40302 and 40303 and substituting the following:
40301.
Cefamandole.
40302.
Cefapirin.
40303.
Cefazolin.
(g) by inserting after item 40577 the following:
40577E.
Eplerenone.
(h) 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) 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 that are therapeutic goods, 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 when compliant with the Required Advisory Statements for Medicine Labels; or
(d) in other dental hygiene products that are not therapeutic goods, 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
(e) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(i) by omitting item 41220E and substituting the following:
41220E.
Piper methysticum (Kava) in preparations for human use except –
(a) in preparations for oral use containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome when labelled with a recommended daily dose of 250mg or less of kavalactones and –
(i) if in tablet or capsule form, containing 125mg or less of kavalactones per tablet or capsule; or
(ii) if in the form of a teabag, when the amount of dried whole or peeled rhizome does not exceed 3g –
and, where containing more than 25mg of kavalactones per dose, compliant with 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.
(j) by inserting after item 41227 the following:
41227M.
Pirenoxine.
(k) by omitting item 41230 ;(l) by omitting item 41309 and substituting the following:
41309.
Pyridoxine, pyridoxal or pyridoxamine for human therapeutic use except –
(a) in oral preparations containing 200mg or less, but more than 50mg, of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when compliant with the Required Advisory Statements for Medicine Labels; or
(b) in oral preparations containing less than 50mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.
(m) by inserting after item 41372 the following:
41372M.
Sevelamer.
(n) by inserting after item 41416 the following:
41416M.
Strontium ranelate.
(o) by omitting item 41630 and substituting the following:
41630.
Vitamin A for human therapeutic or cosmetic use, except –
(a) in preparations for topical use containing 1% or less of vitamin A; or
(b) in preparations for internal use, containing 100 IU or less of vitamin A per dosage unit of a divided preparation, or 100 IU or less of vitamin A per gram of an undivided preparation; or
(c) in other preparations for internal use when compliant with the Required Advisory Statements for Medicine Labels.
(p) by omitting item 41646 and substituting the following:
41646.
Zinc compounds for human internal use, except –
(a) in preparations with a recommended daily dose of 25mg or less of zinc; or
(b) in preparations with a recommended daily dose of more than 25mg, but not more than 50mg, of zinc when compliant with the Required Advisory Statements for Medicine Labels.
8. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5017 and substituting the following:
5017.
Anise oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and labelled with the following warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 50% or less of anise oil.
(b) by omitting item 5023 and substituting the following:
5023.
Basil oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and labelled with the following warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 5% or less of methyl chavicol.
(c) by omitting item 5031 and substituting the following:
5031.
Bergamot oil except –
(a) when steam-distilled or rectified; or
(b) in preparations for internal use; or
(c) in preparations containing 0.4% or less of bergamot oil; or
(d) in soaps or bath or shower gels that are washed off the skin; or
(e) in preparations other than medicines for human therapeutic use, when packed in containers labelled with the statement:
Application to the skin may increase sensitivity to sunlight; or
(f) in medicines for human therapeutic use, when packed in containers and compliant with the Required Advisory Statements for Medicine Labels.
(d) by omitting item 5043 and substituting the following:
5043.
Camphor as a natural component in essential oils containing 10% or less of camphor except –
(a) in medicines for human therapeutic use, in essential oils packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, in essential oils packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN
NOT TO BE TAKEN; or
(c) in rosemary oil, sage oil (Spanish) or lavandin oils; or
(d) in preparations containing 2.5% or less of camphor.
(e) by omitting item 5106 and substituting the following:
5106.
Diethyltoluamide (otherwise known as DEET) except –
(a) in medicines for human therapeutic use containing 20% or less of diethyltoluamide, when compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations for human use, other than medicines, containing 20% or less of diethyltoluamide, when labelled with the following warning statement:
WARNING: May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long period; or
(c) in preparations other than for human use, containing 20% or less of diethyltoluamide.
(f) 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) 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 that are therapeutic goods, 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 compliant with the Required Advisory Statements for Medicine Labels; or
(d) in other dental hygiene products that are not therapeutic goods, 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
(e) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(g) by omitting item 5181 and substituting the following:
5181.
Lemon oil except –
(a) when steam-distilled or rectified; or
(b) in preparations for internal use; or
(c) in preparations containing 0.05% or less of lemon oil; or
(d) in soaps or bath or shower gels that are washed off the skin; or
(e) in preparations other than medicines for human therapeutic use, when packed in containers labelled with the statement:
Application to the skin may increase sensitivity to sunlight; or
(f) in medicines for human therapeutic use, when packed in containers and compliant with the Required Advisory Statements for Medicine Labels.
(h) by omitting item 5183 and substituting the following:
5183.
Lime oil except –
(a) when steam distilled or rectified; or
(b) in preparations for internal use; or
(c) in preparations containing 0.5% or less of lime oil; or
(d) in soaps or bath or shower gels that are washed off the skin; or
(e) in preparations other than medicines for human therapeutic use, when packed in containers labelled with the statement:
Application to the skin may increase sensitivity to sunlight; or
(f) in medicines for human therapeutic use, when packed in containers and compliant with the Required Advisory Statements for Medicine Labels.
(i) by omitting item 5191 and substituting the following:
5191.
Marjoram oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and labelled with the following warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 50% or less of marjoram oil.
(j) by omitting item 5230 and substituting the following:
5230.
Nutmeg oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and labelled with the warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 50% or less of nutmeg oil.
(k) by omitting item 5234 and substituting the following:
5234.
Orange oil (bitter) except –
(a) when steam-distilled or rectified; or
(b) in preparations for internal use; or
(c) in preparations containing 1.4% or less of orange oil (bitter); or
(d) in soaps or bath or shower gels that are washed off the skin; or
(e) in preparations other than medicines for human therapeutic use, when packed in containers labelled with the following statement:
Application to the skin may increase sensitivity to sunlight; or
(f) in medicines for human therapeutic use, when packed in containers and compliant with the Required Advisory Statements for Medicine Labels.
(l) by omitting item 5307M and substituting the following:
5307M.
Star anise oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50mL or less fitted with a restricted-flow insert and labelled with the following warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 50% or less of star anise oil.
(m) by omitting item 5335 and substituting the following:
5335.
Thyme oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and labelled with the following warning:
KEEP OUT OF REACH OF CHILDREN; or
(c) in preparations containing 50% or less of thyme oil.
9. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by omitting item 6024M and substituting the following items:
6024M.
Azadirachta indica (Neem), including its extracts and derivatives except –
(a) when included in Schedule 5 ; or
(b) in preparations for human internal use; or
(c) debitterised neem seed oil; or
(d) in preparations for human dermal therapeutic use containing cold-pressed neem seed oil, when in a container fitted with a child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(e) in preparations for dermal use containing 1% or less of cold-pressed neem seed oil.
(b) by omitting item 6030 and substituting the following:
6030.
Bay oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and a child-resistant closure and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of bay oil.
(c) by omitting item 6064 and substituting the following:
6064.
Cajuput oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25ml or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of cajuput oil; or
(f) in oils containing 25% or less of cajuput oil.
(d) by omitting item 6067 and substituting the following:
6067.
Camphor except –
(a) when included in Schedule 4 or 5 ; or
(b) when enclosed in an inhaler device which prevents ingestion of its contents; or
(c) in solid or semi-solid preparations containing 12.5% or less of camphor; or
(d) in liquid preparations containing 2.5% or less of camphor; or
(e) in essential oils when the camphor is present as a natural component of the oil –
(i) in medicines for human therapeutic use, packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(ii) in medicines for human therapeutic use, packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(iii) in essential oils other than medicines for human therapeutic use, packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(iv) in essential oils other than medicines for human therapeutic use, packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and a child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(f) in rosemary oil, sage oil (Spanish) or lavandin oil as such.
(e) by omitting items 6088 and 6089 and substituting the following:
6088.
Cineole except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of cineole; or
(f) in oils containing 25% or less of cineole; or
(g) in rosemary oil or camphor oil (white).
6089.
Cinnamon leaf oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of cinnamon leaf oil.
(f) by omitting item 6095 and substituting the following:
6095.
Clove oil except –
(a) when included in Schedule 5 ; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(f) in preparations containing 25% or less of clove oil.
(g) by omitting items 6178 and 6179 and substituting the following:
6178.
Eucalyptus oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of eucalyptus oil.
6179.
Eugenol except –
(a) when included in Schedule 5 ; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(f) in preparations containing 25% or less of eugenol.
(h) 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 that are therapeutic goods, 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 compliant with the Required Advisory Statements for Medicine Labels; or
(d) in other dental hygiene products that are not therapeutic goods, 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
(e) in other preparations containing 15mg/kg or 15mg/L or less of fluoride ion.
(i) by omitting item 6250 and substituting the following:
6250.
Melaleuca oil (Tea-tree oil) except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(c) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(d) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(e) in preparations containing 25% or less of melaleuca oil.
(j) by inserting after item 6268 the following:
6268E.
Methyleugenol except in preparations containing 1% or less of methyleugenol.
(k) by omitting item 6310 and substituting the following:
6310.
Pennyroyal oil except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(c) in preparations containing 4% or less of d-pulegone.
(l) by omitting item 6354 and substituting the following:
6354.
Pyrithione zinc except –
(a) when included in Schedule 2 ; or
(b) in semi-solid hair preparations; or
(c) in shampoos containing 2% or less of pyrithione zinc when compliant with the Required Advisory Statements for Medicine Labels; or
(d) when immobilised in solid preparations containing 0.5% or less of pyrithione zinc.
(m) by omitting item 6362 and substituting the following:
6362.
Sage oil (Dalmatian) except –
(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and child-resistant closure and compliant with the Required Advisory Statements for Medicine Labels; or
(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 15mL or less fitted with a restricted-flow insert and child-resistant closure, and labelled with the following warnings:
KEEP OUT OF REACH OF CHILDREN;
NOT TO BE TAKEN; or
(c) in preparations containing 4% or less of thujone.
10. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended as follows:(a) by inserting after item 7133 in Part 1 the following:
7133M.
Iodomethane.
(b) by omitting item 7167 from Part 1 and substituting the following:
7167.
Nicotine except –
(a) when included in Schedule 2 , 4 or 6 ; or
(b) in tobacco prepared and packed for smoking; or
(c) for use as an aid in withdrawal from tobacco-smoking in chewing gum, lozenges or preparations for sublingual or transdermal use.
(c) by omitting item 7516 from Part 2 and substituting the following:
7516.
Clioquinol and other halogenated derivatives of 8-hydroxyquinoline for human internal use except when being used solely for experimental purposes in humans and such use is in accordance with –
(a) section 19(4A) of the Therapeutic Goods Act 1989 of the Commonwealth, as amended from time to time, otherwise known as the Clinical Trial Exemption (CTX) scheme; or
(b) section 18(1) of that Act and regulation 12(1A) of the Therapeutic Goods Regulations 1990 of the Commonwealth, as amended from time to time, otherwise known as the Clinical Trial Notification (CTN) scheme.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 10 May 2006
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. 20, Amendment No. 3.