Poisons List Amendment Order (No. 3) 1998
I make the following order under the section 15(1) of the Poisons Act 1971 .
8 December 1998J. L. JACKSON
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 3) 1998 .
This order takes effect on the day on which its making is notified in the Gazette.
In this order, the Poisons List Order 1998 is referred to as the Principal Order.
4. Schedule 2 amended (Medicinal Poisons)
Schedule 2 to the Principal Order is amended by inserting after subparagraph (iv) in paragraph (c) of item 2092 the following item:
2092M.
Penciclovir in preparations for dermal use containing 1% or less of penciclovir.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3004 ;(b) by inserting after paragraph (b) in item 3021 the following:
3021M.
Diphenoxylate in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1% of the dose of diphenoxylate.
(c) by inserting after paragraph (b) in item 3039 the following:
3039E.
Minoxidil in preparations for dermal use containing 2% or less of minoxidil.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40090 and substituting the following:
40090.
Astemizole.
(b) by inserting after item 40181 the following:
40181S.
Candesartan cilexetil.
(c) by omitting item 40259 and substituting the following:
40259.
Chlortetracycline except when included in Schedule 5 .
(d) by inserting after item 40264 the following:
40264E.
Cidofovir.
(e) by omitting item 40306 and substituting the following:
40306.
Codeine when compounded with one or more other therapeutically active substances –
(a) in divided preparations containing 30mg or less of codeine per dosage unit; or
(b) in undivided preparations containing 1% or less of codeine.
except when included in Schedules 2 or 3 .
(f) by omitting item 40419 and substituting the following:
40419.
Diphenoxylate in preparations containing, per dosage unit, 2.5mg or less of diphenoxylate, and a quantity of atropine sulfate equivalent to at least 1% of the dose of diphenoxylate, except when included in Schedule 3 .
(g) by inserting after item 40463 the following:
40463E.
Eprosartan mesylate.
(h) by omitting item 40790 and substituting the following:
40790.
Minoxidil except when included in Schedule 3 .
(i) by inserting after item 40802 the following:
40802M.
Montelukast.
(j) by inserting after paragraph (b) in item 40818 the following:
40818E.
Naratriptan.
(k) by omitting item 40900 and substituting the following:
40900.
Oxytetracycline except when included in Schedule 5 .
(l) by omitting item 40915 and substituting the following:
40915.
Penciclovir except when included in Schedule 2 .
(m) by omitting item 41137 and substituting the following:
41137.
Tetracycline except when included in Schedule 5 .
(n) by inserting after item 41188 the following:
41188S.
Tramadol.
(o) by omitting item 41244 and substituting the following:
41244.
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 in each dosage unit of a divided preparation or 100 IU or less of vitamin A in each gram of an undivided preparation; or
(c) in other preparations for internal use labelled –
(i) with a recommended daily amount of 5 000 IU or less of vitamin A; and
(ii) where the preparation is labelled for adult use, in bold-face letters not less than 1.5mm high, with a statement to the following effect:
The recommended daily amount of vitamin A from all sources is 2 500 IU; and
(iii) where the preparation is labelled for adult use, in bold-face letters not less than 1.5mm high at the beginning of the directions for use, with a statement to the following effect:
WARNING – Taking more than 2 500 IU a day during pregnancy may cause birth defects.
7. Schedule 5 amended (Domestic Poisons)
Schedule 5 to the Principal Order is amended as follows:(a) by omitting item 5006 and substituting the following:
5006.
Alkaline salts, being the carbonate, silicate or phosphate salts of sodium or potassium, alone or in any combination –
(a) in solid orthodontic device cleaning preparations, the pH of which as an in-use aqueous solution is more than 11.5; or
(b) in solid automatic dishwashing preparations the pH of which, in a 500 g/l aqueous solution or mixture is more than 11.5; or
(c) in other solid preparations, the pH of which in a 10g/l aqueous solution is more than 11.5; or
(d) in liquid or semisolid preparations, the pH of which is more than 11.5.
(b) by inserting after item 5023 the following:
5023S.
Benzofenap.
(c) by omitting item 5044 and substituting the following:
5044.
Chlortetracycline in preparations –
(a) for topical application to animals for ocular use only; or
(b) containing not more than 100 000 international units of chlortetracycline in each dose, for intramammary infusion in animals; or
(c) containing 40% or less of chlortetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.
(d) by omitting item 5149 and substituting the following:
5149.
Imazapic except in preparations containing 25% or less of imazapic.
(e) by inserting after item 5205 the following:
5205M.
Nonoxinol 9 in preparations containing 25% of nonoxinol 9 except –
(a) when labelled with the statements –
(i) Irritant; and
(ii) Avoid contact with eyes; or
(b) in preparations containing 12.5% or less of nonoxinol 9; or
(c) in preparations for human use.
(f) by omitting item 5216 and substituting the following:
5216.
Oxytetracycline in preparations –
(a) for topical application to animals for ocular use only; or
(b) containing not more than 100 000 international units of oxytetracycline in each dose, for intramammary infusion in animals; or
(c) containing 40% or less of oxytetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.
(g) by omitting item 5229 and substituting the following:
5229.
Phosphoric acid (excluding its salts and derivatives) in preparations containing 35% or less of phosphoric acid (H3PO4) except –
(a) in preparations containing 15% or less of phosphoric acid (H3PO4); or
(b) in solid or semi-solid preparations; or
(c) in professional dental kits.
(h) by inserting after item 5235 the following:
5235M.
Potassium peroxomosulfate triple salt in preparations containing 5% or less of potassium peroxomosulfate triple salt as –
(a) solid preparations the pH of which in a 10 g/l aqueous solution is less than 2.5; or
(b) liquid or semi-solid preparations the pH of which is less than 2.5.
(i) by inserting after item 5236 the following:
5236M.
Sodium percarbonate (CAS No. 15630-89-4) in preparations containing 35% or less of sodium percarbonate except in preparations containing 15% or less of sodium percarbonate.
(j) by omitting item 5275 and substituting the following:
5275.
Symphytum spp. (comfrey) for dermal use.
(k) by omitting item 5286 and substituting the following:
5286.
Tetracycline in preparations –
(a) for topical application to animals for ocular use only; or
(b) containing not more than 100 000 international units of tetracycline in each dose, for intramammary infusion in animals; or
(c) containing 40% or less of tetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by inserting after item 6013 the following:
6013E.
1-Aminomethanamide dihydrogen tetraoxosulfate
(b) by omitting item 6078 ;(c) by inserting after paragraph (b) in item 6271 the following:
6271M.
Nonoxinol 9 except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 25% of nonoxinol 9 when labelled with the statements –
(i) Irritant; and
(ii) Avoid contact with eyes; or
(c) in preparations containing 12.5% or less of nonoxinol 9; or
(d) in preparations for human use.
(d) by omitting item 6279 ;(e) by omitting item 6295 and substituting the following:
6295.
Phosphoric acid (excluding its salts and derivatives) except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 15% or less of phosphoric acid (H3PO4); or
(c) in solid or semi-solid preparations; or
(d) in professional dental kits.
(f) by omitting item 6306 and substituting the following:
6306.
Potassium peroxomonosulfate triple salt except –
(a) when included in Schedule 5 ; or
(b) when in solid orthodontic device cleaning preparations, the pH of which as an in-use aqueous solution is neutral; or
(c) in preparations containing 5% or less of potassium peroxomonosulfate triple salt as –
(i) solid preparations the pH of which in a 10 g/l aqueous solution is 2.5 or more; or
(ii) liquid or semi-solid preparations the pH of which is 2.5 or more.
(g) by omitting item 6339 and substituting the following:
6339.
Sodium percarbonate (CAS No. 15630-89-4) except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 15% or less of sodium percarbonate.
(h) by omitting item 6358 .
9. Schedule 8 amended (Narcotic Substances)
Schedule 8 to the Principal Order is amended by omitting item 8026 and substituting:
8026.
Diphenoxylate except when included in Schedule 3 or 4 .
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 16 December 1998
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 1998 (S.R. 1998, No. 121) so as to adopt changes recommended by the National Drugs and Poisons Schedule Committee.