Poisons List Amendment Order 2003

Poisons List Amendment Order 2003

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

14 April 2003

D. E. LLEWELLYN

Minister for Health and Human Services

1.   Short title

This order may be cited as the Poisons List Amendment Order 2003 .

2.   Commencement

This order takes effect on the day on which its making is notified in the Gazette or on 1 May 2003, whichever is later.

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 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 1 gram or less of acetylcysteine.

(b) by omitting item 2027 and substituting the following:

2027.

Ciclopirox in preparations for dermal use containing 2% or less of ciclopirox.

(c) by inserting after subparagraph (iii) in paragraph (b) of item 2054 the following:

2054F.

Flurbiprofen in divided preparations for topical oral use containing 10mg or less of flurbiprofen per dosage unit.

(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 divided preparations in packs of 100 or less dosage units each containing 200mg or less of ibuprofen; or
	(b) in liquid preparations when sold in the manufacturer's original pack containing 4 grams or less of ibuprofen.

5.    Schedule 3 amended (Potent Substances)

Schedule 3 to the Principal Order is amended as follows:

(a) by omitting item 3009 and substituting the following:

3009.

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.

(b) by omitting item 3034 ;

(c) by omitting item 3046 and substituting the following:

3046.

Macrogol 3350 in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.

(d) by omitting item 3054 and substituting the following:

3054.

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.

(e) by omitting item 3073 and substituting the following:

3073.

Sodium phosphate in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.

6.    Schedule 4 amended (Restricted Substances)

Schedule 4 to the Principal Order is amended as follows:

(a) by omitting item 40013 and substituting the following:

40013.	Acetylcysteine except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for oral use when labelled with a recommended daily dose of 1g or less of acetylcysteine.

(b) by inserting after item 40029 the following:

40029F.

Agalsidase alpha.

(c) by omitting item 40183 and substituting the following:

40183.

Benzylpenicillin.

(d) by inserting after paragraph (b) in item 40194 the following:

40194M.

Bimatoprost.

(e) by omitting item 40493 and substituting the following:

40493.

Dihydrostreptomycin.

(f) by inserting after item 40558 the following:

40558M.

Eflornithine.

(g) by inserting after item 40584 the following:

40584M.

Ertapenem.

(h) by omitting item 40674 and substituting the following:

40674.

Flurbiprofen except when included in Schedule 2 .

(i) by omitting item 40782 and substituting the following:

40782.	Ibuprofen except –
	(a) when included in Schedule 2 ; or
	(b) in preparations for dermal use.

(j) by inserting after item 40800R the following:

40800U.

Insulin-like growth factors except when separately specified in this Schedule.

(k) by omitting item 41096 and substituting the following:

41096.

Novobiocin.

(l) by inserting after item 41111 the following:

41111M.

Omalizumab.

(m) by inserting after item 41161 the following:

41161M.

Parecoxib.

(n) by omitting item 41190 and substituting the following:

41190.

Phenethicillin.

(o) by omitting item 41199 and substituting the following:

41199.

Phenoxymethylpenicillin.

(p) by inserting after item 41241 the following:

41241M.	Polyacrylamide in preparations for injection or implantation –
	(a) for tissue augmentation; or
	(b) for cosmetic use.

(q) by omitting item 41271 and substituting the following:

41271.

Procaine penicillin.

(r) by inserting after item 41328 the following:

41328M.

Rasburicase.

(s) by inserting after item 41338 the following:

41338M.

Riluzole.

(t) by omitting item 41416 and substituting the following:

41416.

Streptomycin.

(u) by inserting after item 41471 the following:

41471M.

Tenofovir.

(v) by inserting after item 41606 the following:

41606M.

Valganciclovir.

(w) by inserting after item 41631 the following:

41631M.

Voriconazole.

7.    Schedule 5 amended (Domestic Poisons)

Schedule 5 to the Principal Order is amended as follows:

(a) by inserting after item 5019 the following:

5019R.

Azadirachta indica extracts (neem extracts), extracted from neem seed kernels using water, methanol or ethanol, in preparations containing 5% or less of total limonoids, for agricultural use.

(b) by inserting after item 5128 the following:

5128M.

Extract of lemon eucalyptus, being acid-modified oil of lemon eucalyptus (Corymbia citriodora), except in preparations containing 40% or less of extract of lemon eucalyptus.

(c) by inserting after item 5326 the following:

5326M.

Tetraconazole in preparations containing 20% or less of tetraconazole.

8.    Schedule 6 amended (Agricultural and Industrial Poisons)

Schedule 6 to the Principal Order is amended as follows:

(a) by inserting after item 6024 the following:

6024M.	Azadirachta indica (neem), including its extracts and derivatives except –
	(a) in preparations for human internal use; or
	(b) when included in Schedule 5 ; 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 labelled with the statements:
	NOT TO BE TAKEN;
	KEEP OUT OF THE REACH OF CHILDREN;
	DO NOT USE IF PREGNANT OR LIKELY TO BECOME PREGNANT; or
	(e) in other preparations for dermal use containing 1% or less of cold-pressed neem seed oil.

(b) by omitting item 6038 ;

(c) by inserting after item 6085 the following:

6085M.

Chlothianidin.

(d) by omitting item 6139 ;

(e) by omitting item 6150 and substituting the following:

6150.

Diquat in preparations containing 20% or less of diquat.

(f) 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; or
	(b) in preparations containing 2% or less of moxidectin for the treatment of animals.

(g) by omitting item 6297 ;

(h) by omitting item 6316 ;

(i) by omitting item 6319 ;

(j) by omitting item 6337 ;

(k) by omitting item 6377 ;

(l) by inserting after paragraph (c) in item 6392 the following:

6392E.

Tetraconazole except when included in Schedule 5 .

9.    Schedule 7 amended (Dangerous Poisons)

Schedule 7 to the Principal Order is amended as follows:

(a) by inserting after item 7088 in Part 1 the following:

7088M.

Diquat except when included in Schedule 6 .

(b) by inserting after item 7117 in Part 1 the following:

7117M.

Flumioxazin.

(c) by inserting after item 7508 in Part 2 the following:

7508H.

Azadirachta indica (neem) including its extracts and derivatives, in preparations for human internal use except debitterised neem seed oil.

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

Notified in the Gazette on 30 April 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 by incorporating changes recommended by the National Drugs and Poisons Schedule Committee in the Standard for the Uniform Scheduling of Drugs and Poisons No. 17, Amendment No. 3.