Poisons List Amendment Order 2010

Poisons List Amendment Order 2010

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

3 May 2010

MICHELLE O'BYRNE

Minister for Health

1.   Short title

This order may be cited as the Poisons List Amendment Order 2010 .

2.   Commencement

This order takes effect on the day on which its making is notified in the Gazette.

3.   Principal Order

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 by omitting item 2031 and substituting:

2031.

Codeine in preparations for the treatment of coughs and colds when –

(a) not combined with any other opiate substance; and

(b) compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance –

(i) in divided preparations containing 10mg or less of codeine per dosage unit; or

(ii) in undivided preparations containing 0.25% or less of codeine; and

(c) labelled with a recommended daily dose not exceeding 60mg of codeine; and

(d) in packs containing not more than 6 days of supply at the maximum dose recommended on the label.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by inserting after item 3009 the following:

3009M.

Chloramphenicol for ophthalmic use only.

(b) by omitting item 3016 and substituting the following:

3016.	Codeine when –
	(a) not combined with any other opiate substance; and
	(b) compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance –
	(i) in divided preparations containing 12mg or less of codeine per dosage unit; or
	(ii) in undivided preparations containing 0.25% or less of codeine; and
	(c) labelled with a recommended daily dose not exceeding 100mg of codeine; and
	(d) in packs containing not more than 5 days of supply at the maximum dose recommended on the label –
	except when included in Schedule 2 .

(c) by omitting item 3059X and substituting the following:

3059X.

Pantoprazole in oral preparations containing 20mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

(d) by omitting item 3067S and substituting the following:

3067S.

Rabeprazole in oral preparations containing 10mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40314 and substituting the following:

40314.

Chloramphenicol except when included in Schedule 3 .

(b) by inserting after item 40360 the following:

40360M.

Clevidipine.

(c) by inserting after item 40999 the following:

40999M.

Mifepristone.

(d) by inserting after item 41048 the following:

41048M.

Nebivolol.

(e) by inserting after item 41331S the following:

41331W.

Red yeast rice for human therapeutic use.

(f) by inserting after item 41346 the following:

41346M.

Robenacoxib.

(g) by inserting after item 41603 the following:

41603M.

Ustekinumab.

(h) by inserting after paragraph (c) in item 41605 the following:

41605M.

Vaccinia virus vaccine.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after item 5001 the following:

5001M.

Abscisic acid.

(b) by inserting after item 5171 the following:

5171M.

Ipconazole in preparations containing 2% or less of ipconazole.

(c) by inserting after item 5334 the following:

5334M.

Thiophanate-methyl in preparations containing 25% or less of thiophanate-methyl.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by inserting after item 6232 the following:

6232M.

Ipconazole except when included in Schedule 5 .

(b) by inserting after item 6399 the following:

6399M.

Thiophanate-methyl except when included in Schedule 5 .

9.    Schedule 8 amended (Narcotic Substances)

Schedule 8 to the Principal Order is amended by inserting after item 8050 the following item:

8050M.

Nabiximols (botanical extract of Cannabis sativa which includes the following cannabinoids: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90% of the total cannabinoid content) in a buccal spray for human therapeutic use.

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

Notified in the Gazette on 4 May 2010

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. 24, Amendment No. 3.