POISONS AND DRUGS (AMENDMENT) ACT 1991 (NO. 4 OF 1991)

Australian Capital Territory Numbered Acts

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POISONS AND DRUGS (AMENDMENT) ACT 1991 (NO. 4 OF 1991) - SCHEDULE 2

SCHEDULE 2 Section 3

Acetic acid (excluding its salts and derivatives) in preparations containing more than 80% of acetic acid, for therapeutic use

Aloxiprin

Antazoline in eye drops

Aspirin, except—

(a) when included in Schedule 4 or 6;

(b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent, other than effervescent agents, when enclosed in a primary pack that—

(i) contains not more than 12 such powders or sachets of granules;
(ii) is labelled—
“WARNING—THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD”; or
“CAUTION—THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL”, and
(iii) includes in the directions for use, in capital letters not less than 1.5 mm in height, the warning statements—
“CONSULT A DOCTOR BEFORE GIVING THIS MEDICINE TO CHILDREN OR TEENAGERS WITH CHICKEN POX, INFLUENZA OR FEVER”; and
“CAUTION—DO NOT GIVE TO CHILDREN UNDER 2 YEARS OF AGE EXCEPT ON DOCTOR'S ADVICE”; or

(c) in tablets or capsules each containing 325 mg or less of aspirin as the only therapeutically active constituent, other than effervescent agents, when—

(i) packed in blister or strip packaging or in containers with a child-resistant closure;

(ii) in a primary pack containing not more than 25 such tablets or capsules;
(iii) the pack is labelled—
“WARNING—THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD”; or
“CAUTION—THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL”; and
(iv) includes in the directions for use, in capital letters not less than 1.5 mm in height, the warning statements—
“CONSULT A DOCTOR BEFORE GIVING THIS MEDICINE TO CHILDREN OR TEENAGERS WITH CHICKEN POX, INFLUENZA OR FEVER”; and
“CAUTION—DO NOT GIVE TO CHILDREN UNDER 2 YEARS OF AGE EXCEPT ON DOCTOR'S ADVICE”

Atropine (excluding atropine methonitrate)—

(a) in preparations containing 0.25% or less of atropine; or

(b) atropine sulphate, 0.6 mg tablets in packs of six, when labelled for treatment of organophosphorus poisoning

Belladonna in preparations containing 0.25% or less of the alkaloids of belladonna, calculated as hyoscyamine

Benzamine when included in—

(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of benzamine in each;

(b) suppositories or bougies containing 200 mg or less of benzamine in each; or

Benzocaine when included in—

(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of benzocaine in each;

(b) suppositories or bougies containing 200 mg or less of benzocaine in each; or

Benzoyl peroxide in preparations for external human therapeutic use containing 5% or less of benzoyl peroxide

Benzydamine in preparations for topical use containing 3% or less of benzydamine

Bromhexine

Brompheniramine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive, except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Buclizine in primary packs of 10 doses or less, for the prevention or treatment of motion sickness

Butylaminobenzoate when included in—

(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of butylaminobenzoate in each;

(b) suppositories or bougies containing 200 mg or less of butylaminobenzoate in each; or

Carbaryl in preparations for external human therapeutic use containing 2% or less of carbaryl

Carbenoxolone for topical oral use

Carbetapentane, except in preparations containing 0.5% or less of carbetapentane

Chloroform in preparations for therapeutic use, except—

(a) when included in Schedule 4; or

(b) in preparations containing 0.5% or less of chloroform

Chlorpheniramine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive, except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Cinnamedrine

Clioquinol and other halogenated derivatives of 8-hydroxyquinoline for external human use

Codeine—

(a) when compounded with aspirin, paracetamol or any one of their derivatives, in dosage units each containing 10 mg or less of codeine and no other analgesic substance, and—

(i) in tablets or capsules when packed in blister or strip packaging or in a container with a child-resistant closure; or

(ii) in individually wrapped powders;

and in a primary pack containing 25 or less dosage units; or

(b) when compounded with one or more other therapeutically active substances—

(i) in divided preparations containing 10 mg or less of codeine and with a recommended dose not exceeding 15 mg of codeine; or

(ii) in undivided preparations containing 0.25% or less of codeine and with a recommended dose not exceeding 15 mg of codeine

Creosote derived from wood, for human therapeutic use, except in preparations containing 3% or less of phenols included in this Schedule

Cyanides— see Hydrocyanic acid

DDT— see Dicophane

Dexchlorpheniramine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive, except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Dextromethorphan when compounded with one or more other therapeutically active substances—

(a) in divided preparations containing 30 mg or less of dextromethorphan per dosage unit and with a recommended dose not exceeding 30 mg of dextromethorphan; or

(b) in undivided preparations containing 0.3% or less of dextromethorphan with a recommended dose not exceeding 30 mg of dextromethorphan

Dicophane (DDT) in preparations for human therapeutic use

Dicyclomine in preparations containing 0.1% or less of dicyclomine

Dihydrocodeine when compounded with aspirin and no other therapeutically active substance, in divided preparations containing 5 mg or less of dihydrocodeine per dosage unit and with a recommended dose not exceeding 10 mg of dihydrocodeine when—

(a) packed in blister or strip packaging or in a container with a child-resistant closure; and

(b) in a primary pack containing 25 or less dosage units

Dimenhydrinate in primary packs of 10 doses or less, for the prevention or treatment of motion sickness

Dimethisoquin in preparations for topical use

Diphemanil methylsulphate in preparations for topical use

Diphenhydramine—

(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or

(b) in oral preparations when compounded with one or more of the following medicaments:

(i) an antitussive, except codeine or dihydrocodeine;

(ii) an expectorant;

(iii) a sympathomimetic amine;

except in preparations for the treatment of children under 2 years of age

Diphenylpyraline in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive, except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Doxylamine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive, except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Ephedrine for internal use, for the relief of respiratory tract conditions only, when compounded with one or more other therapeutically active substances in preparations containing 30 mg or less of ephedrine per recommended dose, except in liquid preparations containing 10 mg or less of ephedrine per recommended dose

Erythrityl tetranitrate for therapeutic use

Etafedrine

Ether for therapeutic use, except—

(a) when included in Schedule 4; or

(b) in preparations containing 10% or less of ether

Ethoheptazine in preparations containing 1% or less of ethoheptazine

Ethylmorphine, when compounded with one or more other therapeutically active substances—

(a) in divided preparations containing 10 mg or less of ethylmorphine per dosage unit and with a recommended dose not exceeding 15 mg of ethylmorphine; or

(b) in undivided preparations containing 0.25% or less of ethylmorphine and with a recommended dose not exceeding 15 mg of ethylmorphine

Fluoride for human therapeutic use, being—

(a) sodium fluoride in preparations for ingestion containing 2.2 mg or less of sodium fluoride per dosage unit; or

(b) in preparations for topical use, except—

(i) when included in Schedule 3;

(ii) in dentifrices containing 1,000 mg/kg or less of fluoride ion; or

(iii) in other substances containing 15 mg/kg or less of fluoride ion

Gelsemium

Glutaraldehyde for human therapeutic use

Glyceryl trinitrate for therapeutic use, except when included in Schedule 4

Guaiphenesin—

(a) in liquid preparations containing 2% (200 mg/10 ml) or less of guaiphenesin; or

(b) in divided preparations containing 120 mg or less of guaiphenesin per dosage unit

Hexachlorophane in preparations for human skin cleansing purposes containing 3% or less of hexachlorophane, except in preparations for use on infants as specified in Schedule 4

Homatropine in preparations containing 0.25% or less of homatropine

Human chorionic gonadotrophin or its antibody in pregnancy test kits

Hydroquinone (excluding monobenzone and other alkyl ethers of hydroquinone included in Schedule 4) in preparations for external human therapeutic or cosmetic use containing 2% or less of hydroquinone, except hair preparations containing 1% or less of hydroquinone

8-Hydroxyquinoline and its non-halogenated derivatives for human therapeutic use, except in preparations for external use containing 1% or less of such substances

Hyoscine (excluding hyoscine butylbromide)—

(a) in preparations containing 0.25% or less of hyoscine; or

(b) in transdermal applicators containing 2 mg or less of hyoscine

Hyoscyamine in preparations containing 0.25% or less of hyoscyamine

Hyoscyamus in preparations containing 0.25% or less of the alkaloids of hyoscyamus calculated as hyoscyamine

Iodine—

(a) in preparations for internal human therapeutic use containing 300 mg or more of iodine, except—

(i) when included in Schedule 4; or
(ii) when labelled, in letters not less than 1.5 mm in height—
“CAUTION—TOTAL IODINE INTAKE MAY EXCEED RECOMMENDED LEVEL WHEN TAKING THIS PREPARATION”; and
“WARNING—CONTAINS IODINE—DO NOT TAKE WHEN PREGNANT EXCEPT ON PHYSICIAN'S ADVICE”; or

(b) in preparations for external human therapeutic use containing more than 2.5% of available iodine other than as iodine salts, derivatives or iodophors

Iron compounds for human internal use, except—

(a) when included in Schedule 4;

(b) in divided preparations containing 5 mg or less of iron per dosage unit; or

Isopropamide in preparations containing 2% or less of isopropamide for dermal use

Isosorbide dinitrate for therapeutic use

Lignocaine when included in—

(a) lozenges, pastilles, tablets or capsules containing 30 mg or less of lignocaine in each;

(b) suppositories or bougies containing 200 mg or less of lignocaine in each; or

Lindane in preparations for external human therapeutic use containing 2% or less of lindane

Lobelia—

(a) in divided preparations containing 2.5 mg or less of lobeline per dosage unit; or

(b) in undivided preparations containing 0.05% or less of lobeline;

except in preparations for smoking or burning

Lobeline—

(a) in divided preparations containing 2.5 mg or less of lobeline per dosage unit; or

(b) in undivided preparations containing 0.05% or less of lobeline;

except in preparations for smoking or burning

Luteinising hormone or its antibody in human ovulation test kits

Maldison in preparations for external human therapeutic use containing 2% or less of maldison

Mebendazole for human therapeutic use

Mercuric oxide in ointments for human ocular use

Mercury organic compounds for topical human therapeutic use in preparations containing 0.5% or less of mercury

Methoxamine, except in preparations for external use containing 1% or less of methoxamine

Methoxyphenamine

Methylephedrine

Miconazole for human use in preparations containing 2% or less of miconazole for treatment of fungal infections of the skin

Naphazoline

Naproxen in packs of 12 or less tablets or capsules for treatment of spasmodic dysmenorrhoea

Niclosamide for human therapeutic use

Nitric esters of polyhydric alcohols for therapeutic use, except when separately specified in these Schedules

Noscapine

Oxethazaine in preparations for internal use

Oxymetazoline

Papaverine, except when included in Schedule 4

Paracetamol, except—

(a) when included in Schedule 4;

(b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents when—
(i) the pack is labelled—
“WARNING—THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD”; or
“CAUTION—THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL”; and

(ii) in a primary pack containing not more than 12 such powders or sachets;

unless the pack is labelled for the treatment of children under 7 years of age; or

(c) tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent other than effervescent agents when—

(i) the pack is labelled—

“WARNING—THIS MEDICATION MAY BE DANGEROUS WHEN USED IN LARGE AMOUNTS OR FOR A LONG PERIOD”; or

“CAUTION—THIS PREPARATION IS FOR THE RELIEF OF MINOR AND TEMPORARY AILMENTS AND SHOULD BE USED STRICTLY AS DIRECTED. PROLONGED USE WITHOUT MEDICAL SUPERVISION COULD BE HARMFUL”;

(ii) packed in blister or strip packaging or in containers with a child-resistant closure; and

(iii) in a primary pack containing not more than 25 such tablets or capsules;

unless the pack is labelled for the treatment of children under 7 years of age

Phedrazine

Phenazone for external use

Pheniramine—

(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or

(b) in oral preparations when compounded with one or more of the following medicaments:

(i) an antitussive, except codeine or dihydrocodeine;

(ii) an expectorant;

(iii) a sympathomimetic amine;

except in preparations for the treatment of children under 2 years of age

Phenol, or any homologue of phenol boiling below 220 ^oC, for human therapeutic use, except in preparations containing 3% or less of such substances

Phenylenediamines and alkylated phenylenediamines for therapeutic use

Phenylephrine, except—

(a) when included in Schedule 4;

(b) preparations containing 0.5% or less of phenylephrine; or

Pholcodine when compounded with one or more other therapeutically active substances—

(a) in divided preparations containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine; or

(b) in undivided preparations containing 0.5% or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine

Podophyllotoxin for external human therapeutic use in preparations containing 2% or less of podophyllotoxin

Podophyllum resin (podophyllin) for external human therapeutic use in preparations containing 10% or less of podophyllin

Potassium chlorate for therapeutic use except in preparations containing 10% or less of potassium chlorate

Pramoxine when included in preparations for external use, other than eye drops, containing 1% or less of pramoxine

Procyclidine in preparations containing 5% or less of procyclidine for dermal use

Promethazine—

(a) in primary packs of 10 doses or less, for the prevention or treatment of motion sickness; or

(b) in oral preparations when compounded with one or more of the following medicaments:

(i) an antitussive, except codeine or dihydrocodeine;

(ii) an expectorant;

(iii) a sympathomimetic amine;

except in preparations for the treatment of children under 2 years of age

Propantheline in preparations for topical use

Pseudoephedrine—

(a) in preparations containing 60 mg or less of pseudoephedrine per recommended dose; or

(b) in slow-release preparations containing 120 mg or less of pseudoephedrine per recommended dose, for which approval for the slow-release characteristic has been granted by the Commonwealth Department of Community Services and Health;

except when included in Schedule 4

Pyrantel for human therapeutic use

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 labelled—

“KEEP OUT OF EYES”; or

“IF IN EYES, RINSE WELL WITH WATER”

Salicylamide, except when included in Schedule 4

Silver salts for therapeutic use, except—

(a) chewing tablets containing 5 mg or less of silver per tablet when the pack is labelled—

“WARNING—OVERUSE MAY STAIN THE SKIN OR MOUTH”; or

(b) solutions containing 0.3% or less of silver when the pack is labelled—

“WARNING—OVERUSE MAY STAIN THE SKIN OR MOUTH”

Sodium cromoglycate in nasal preparations for topical use

Sodium nitrite for therapeutic use

Staphisagria, except in preparations containing 0.2% or less of staphisagria

Stramonium in preparations containing 0.25% or less of the alkaloids calculated as hyoscyamine, except preparations for smoking or burning

Tetrahydrozoline

Thenyldiamine—

(a) in nasal preparations for topical use; or

(b) in oral preparations when compounded with one or more of the following medicaments:

(i) an antitussive except codeine or dihydrocodeine;

(ii) an expectorant;

(iii) a sympathomimetic amine;

except in preparations for the treatment of children under 2 years of age

Tramazoline

Trimeprazine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Triprolidine in oral preparations when compounded with one or more of the following medicaments:

(a) an antitussive except codeine or dihydrocodeine;

(b) an expectorant;

except in preparations for the treatment of children under 2 years of age

Tymazoline

Xylometazoline

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