Poisons List Amendment Order (No. 2) 2002
I make the following order under section 15(1) of the Poisons Act 1971 .
4 June 2002JUDY JACKSON
Minister for Health and Human Services
This order may be cited as the Poisons List Amendment Order (No. 2) 2002 .
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 2003;(b) by inserting after item 2008 the following:
2008M.
Atropa Belladonna (belladonna) –
(a) for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or
(b) for oral use –
(i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
(c) by omitting item 2009 and substituting the following:
2009.
Atropine (excluding atropine methonitrate) –
(a) for oral use –
(i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.03mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in preparations containing atropine sulfate when packed and labelled for the treatment of organophosphorous poisoning –
(i) in tablets each containing 0.6mg or less of atropine sulphate in packs of 20 tablets; or
(ii) in preparations for injection each containing 0.6mg per ml or less of atropine sulfate in packs of 5.
(d) by omitting item 2012;(e) by omitting item 2033 and substituting the following:
2033.
Datura spp. for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids –
except when separately specified in these Schedules.
2033D.
Datura stramonium (stramonium) for oral use when –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids –
except for smoking or burning.
2033H.
Datura tatula (stramonium) for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids –
except for smoking or burning.
(f) by omitting items 2044 and 2045 and substituting the following:
2044.
Duboisia leichhardtii for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
2045.
Duboisia myoporoides for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of the alkaloids of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
(g) by omitting item 2064 and substituting the following:
2064.
Hyoscine (excluding hyoscine butylbromide) –
(a) for transdermal use in preparations containing 2mg or less of total solanaceous alkaloids per dosage unit; or
(b) for oral use –
(i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids, when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
(h) by omitting items 2066 and 2067 and substituting the following:
2066.
Hyoscyamine –
(a) for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or
(b) for oral use –
(i) in undivided preparations containing 0.03% or less of total solanaceous alkaloids, when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(ii) in divided preparations containing 0.3mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
2067.
Hyoscyamus niger for oral use –
(a) in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2mg or less of total solanaceous alkaloids; or
(b) in divided preparations containing 0.03mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2mg or less of total solanaceous alkaloids.
(i) by omitting item 2131.
5. Schedule 3 amended (Potent Substances)
Schedule 3 to the Principal Order is amended as follows:(a) by omitting item 3006 and substituting the following:
3006.
Beclomethasone in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone 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 3035 and substituting the following:
3035.
Fluticasone in aqueous nasal sprays delivering 50 micrograms or less of fluticasone 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 3041 and substituting the following:
3041.
Hydrocortisone and Hydrocortisone acetate, but excluding other salts and derivatives in preparations containing 1% or less of hydrocortisone –
(a) for dermal use in packs containing 30g or less of such preparations and –
(i) containing no other therapeutically active substance; or
(ii) containing an antifungal but no other therapeutically active substance; or
(b) for rectal use, when combined with a local anaesthetic but no other therapeutically active substance except unscheduled astringents –
(i) in undivided preparations, in packs of 35 grams or less; or
(ii) in packs containing 12 or less suppositories –
except when included in Schedule 2 .
(d) by omitting item 3055 and substituting the following:
3055.
Nicotine for use as an aid in withdrawal from tobacco smoking –
(a) in lozenges; or
(b) in preparations –
(i) for inhalation; or
(ii) for sublingual use.
6. Schedule 4 amended (Restricted Substances)
Schedule 4 to the Principal Order is amended as follows:(a) by omitting item 40017 and substituting the following:
40017.
Aciclovir except in preparations containing 5% or less of aciclovir for the treatment of Herpes labialis in packs containing 10g or less.
(b) by inserting after item 40130 the following:
40130M.
Atropa Belladonna (belladonna) except when included in Schedule 2 .
(c) by omitting item 40162;(d) by omitting item 40231 and substituting the following:
40231.
Butyl aminobenzoate except in dermal preparations containing 2% or less of total local anaesthetic substances.
(e) by inserting after item 40272 the following:
40272H.
Caspofungin.
(f) by omitting items 40396, 40396H and 40397 and substituting the following:
40396.
Convallaria keiski.
40397.
Convallaria majalis.
40397H.
Copper compounds for human use except –
(a) when separately specified in these Schedules; or
(b) in preparations for human internal use containing 5mg or less of copper per recommended daily dose; or
(c) in other preparations containing 5% or less of copper compound.
(g) by inserting after item 40432 the following:
40432H.
Darbepoetin alfa.
(h) by inserting after item 40433 the following:
40433D.
Datura stramonium (stramonium) except –
(a) when included in Schedule 2 ; or
(b) for smoking or burning.
40433H.
Datura tatula (stramonium) except –
(a) when included in Schedule 2 ; or
(b) for smoking or burning.
(i) by inserting after item 40475 the following:
40475H.
Dienogest.
(j) by inserting after item 40587 the following:
40587B.
Erythropoietins except when separately specified in these Schedules.
(k) by omitting item 40778 and substituting the following:
40778.
Hyoscyamus niger except when included in Schedule 2 .
(l) by inserting after item 40788 the following:
40788H.
Imatinib.
(m) by inserting after item 40849 the following:
40849H.
Laureth-9 in preparations for injection.
(n) by omitting item 40850 and substituting the following:
40850.
Lauromacrogols in preparations for injection except when separately specified in these Schedules.
(o) by omitting after item 41213 the following:
41213H.
Pimobendan.
(p) by omitting items 41238, 41239 and 41240 and substituting the following:
41238.
Podophyllotoxin for human use –
(a) internally; or
(b) in preparations for the treatment of anogenital warts; or
(c) in other preparations except when included in Schedule 2 or 3 .
41239.
Podophyllum emodi (podophyllin) for human use –
(a) internally; or
(b) in preparations for the treatment of anogenital warts; or
(c) in other preparations except when included in Schedule 2 or 3 .
41240.
Podophyllum peltatum (podophyllin) for human use –
(a) internally; or
(b) in preparations for the treatment of anogenital warts; or
(c) in other preparations except when included in Schedule 2 or 3 .
(q) by omitting item 41375;(r) by omitting item 41413.
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 containing 2% or less of cassia oil.
(b) by omitting item 5057 and substituting the following:
5057.
Cinnamon bark oil except –
(a) in food additives; or
(b) in preparations containing 2% or less of cinnamon bark oil.
(c) by inserting after item 5260 the following:
5260H.
Polixetonium salts in preparations containing 60% or less of polixetonium salts except in preparations containing 1% or less of polixetonium salts.
(d) by omitting item 5303 and substituting the following:
5303.
Sodium nitrite in preparations containing 1% or less of sodium nitrite except –
(a) in preparations containing 0.5% or less of sodium nitrite; or
(b) when present as an excipient in preparations for therapeutic use; or
(c) in aerosols.
8. Schedule 6 amended (Agricultural and Industrial Poisons)
Schedule 6 to the Principal Order is amended as follows:(a) by inserting after item 6330 the following:
6330H.
Polixetonium salts except –
(a) when included in Schedule 5 ; or
(b) in preparations containing 1% or less of polixetonium salts.
(b) by inserting after item 6372 the following:
6372D.
Sodium nitrite in preparations containing 40% or less of sodium nitrite except –
(a) when included in Schedule 2 or 5 ; or
(b) in preparations containing 0.5% or less of sodium nitrite; or
(c) when present as an excipient in preparations for therapeutic use; or
(d) in aerosols containing 2% or less of sodium nitrite.
9. Schedule 7 amended (Dangerous Poisons)
Schedule 7 to the Principal Order is amended as follows:(a) by inserting the following heading after the heading to the Schedule:Dangerous poisons: General(b) by inserting after item 7202 the following:
7202H.
Sodium nitrite except –
(a) when included in Schedule 2 , 5 or 6 ; or
(b) in preparations containing 0.5% or less of sodium nitrite; or
(c) when present as an excipient in preparations for therapeutic use; or
(d) in aerosols containing 2% or less of sodium nitrite.
(c) by inserting after Part 1 the following Part:PART 2 - Dangerous poisons for which possession without approval is an offence
7500.
Abrus precatorius (jequirity) seed or root for therapeutic use.
7501.
Acorus calamus (calamus) for human therapeutic use.
7502.
Allylisopropylacetylurea for therapeutic use.
7503.
Aminophenazone (amidopyrine) and its derivatives for human therapeutic use.
7504.
Amygdalin for therapeutic use.
7505.
Anchusa officinalis for therapeutic use.
7506.
Aristolochia ssp. For therapeutic use.
7507.
Aristolochic acid(s) for human therapeutic use.
7508.
Asarum spp. Containing aristolochic acid(s) for human therapeutic use.
7509.
Bithionol for human therapeutic use.
7510.
Borago officinalis (borage) for therapeutic use except the fixed oil derived from the seeds of Borago officinalis.
7511.
Bragantia spp. Containing aristolochic acid(s) for human therapeutic use.
7512.
Buclosamide for therapeutic use.
7513.
Buniodyl sodium for therapeutic use.
7514.
Cacalia ssp. for therapeutic use.
7515.
Cinchophen and its derivatives for therapeutic use.
7516.
Clioquinol and other halogenated derivatives of 8-hydroxyquinoline for human internal use.
7517.
Coal tar for cosmetic use other than in therapeutic goods.
7518.
Conium maculatum (coniine) for therapeutic use.
7519.
Cotarnine for therapeutic use.
7520.
Crotalaria ssp. for therapeutic use.
7521.
Croton tiglium for therapeutic use.
7522.
Cynoglossum ssp. For therapeutic use.
7523.
Dicophane (DDT) for therapeutic use.
7524.
Diethylphthalate in sunscreens or personal insect repellents for human use except in preparations containing 0.5% or less of diethylphthalate.
7525.
Di-iodohydroxyquinoline (iodoquinol) for human internal use.
7526.
Dimethylphthalate in sunscreens or personal insect repellants for human use except in preparations containing 0.5% or less of dimethylphthalate.
7527.
Dulcin for therapeutic use.
7528.
Ethylhexanediol for human use.
7529.
Eupatorium cannabinum (hemp agrimony) for therapeutic use.
7530.
Farfugium japonicum for therapeutic use.
7531.
Heliotropium ssp. for therapeutic use.
7532.
Juniperus sabine (savin(e)) for therapeutic use.
7533.
Ligularia dentata for therapeutic use.
7534.
Oxyphenisatin for therapeutic use.
7535.
Petasites ssp. for therapeutic use.
7536.
Phenylenediamines in preparations for skin colouration.
7537.
Pteridium ssp. for therapeutic use.
7538.
Pulmonaria ssp. For therapeutic use.
7539.
Safrole for internal therapeutic use except in preparations containing 0.1% or less of safrole.
7540.
Senecio ssp. for therapeutic use.
7541.
Silicones for tissue augmentation by injection.
7542.
Symphytum ssp. (comfrey) for therapeutic or cosmetic use except when included in Schedule 5 .
7543.
1,1,1-trichloroethane in pressurised spray packs for therapeutic use.
7544.
Trichodesma africana for therapeutic use.
7545.
Triparanol for therapeutic use.
7546.
Tussilago farfara for therapeutic use.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 12 June 2002
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 –(a) incorporating changes recommended by the National Drugs and Poisons Schedule Committee; and(b) correcting some numerical references in Schedule 4.