Pursuant to section 106 (1) of the Medicines Act 1981,
I, G. R. Boyd, Chief Advisor, Safety and Regulation, acting under delegated authority, hereby declare the following:
1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.
Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.
Unless specific reference is made otherwise, every reference applies also to medicines that are:
(a) Preparations and admixtures containing any substance listed in the notice;
(b) Salts and esters of any substance listed in the notice;
(c) Preparations or extracts of biological materials listed in the notice;
(d) Salts or oxides of elements listed in the notice.
Unless specific reference is made otherwise, every reference to a medicine also applies:
(i) in the case of medicines which are injections or
eye preparations, to any concentration of that medicine; or
(ii) in the case of medicines which are not injections or eye preparations, when the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.
Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.
Schedule 1
Prescription Medicines
Abrus precatorius; at all strengths
Acetylcholine; except in medicines containing 1 milligram or less per litre or per kilogram
Aldosterone; except in medicines containing 10 micrograms or less per litre or per kilogram
Allylisopropylacetylurea; at all strengths
Aminophenazone; at all strengths
Aminophylline; except in liquid form for oral use in medicines containing 2% or less
Anchusa officinalis; at all strengths
Antimony; except in medicines containing 1 milligram or less per litre or per kilogram
Apomorphine; except in medicines containing 1 milligram or less per litre or per kilogram
Aristolochia spp; at all strengths
Arsenic; except in medicines containing 1 milligram or less per litre or per kilogram
Atropine; for ophthalmic use; for injection except when used as an antidote in a device designed for
self-injection; except in medicines containing
100 micrograms or less per litre or per kilogram
Bithionol; at all strengths
Buclosamide; at all strengths
Buniodyl sodium; at all strengths
Cacalia spp; at all strengths
Clioquinol; at all strengths
Colecalciferol; in medicines for internal use containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Coniine; at all strengths
Cotarnine; at all strengths
Crotalaria spp; at all strengths
Croton tiglium; except in medicines containing 1 milligram or less per litre or per kilogram
Cynoglossum spp; at all strengths
Dulcin; at all strengths
Erysimum; except in medicines containing 1 milligram or less per litre or per kilogram
Ethylhexanediol; at all strengths
Etofenamate; except for external use
Farfugium japonicum; at all strengths
Fluorides; for internal use in medicines containing more than 2.2 milligrams per dose form except in parenteral nutrition replacement preparations; for external use in medicines containing more than 2.5% of elemental fluorine
Follicle stimulating hormone; except in medicines containing 100 micrograms or less per litre or per kilogram
Gemifloxacin
Haloperidol; except in medicines containing 1 milligram or less per litre or per kilogram
Heliotropium spp; at all strengths
Hydrocyanic acid; except in medicines containing
1 microgram or less per litre or per kilogram
Indomethacin; except for external use in medicines containing 1% or less; except in medicines containing
1 milligram or less per litre or per kilogram
Iron; for injection except in parenteral nutrition replacement preparations
Isopropamide; except for dermal use in preparations containing 2% or less
Ligularia dentata; at all strengths
Lopinavir
Methylene blue; for injection
Mifepristone
Oestradiol; except in medicines containing 10 micrograms or less per litre or per kilogram
Oestrone; except in medicines containing 1 milligram or less per litre or per kilogram
Omalizumab
Oxyphenisatin; at all strengths
Oxytocin; except in medicines containing 1 microgram or less per litre or per kilogram
Phenolphthalein
Podophyllum; in medicines containing more than 20%; except in medicines containing 1 milligram or less per litre or per kilogram
Progesterone; except in medicines containing 1 milligram or less per litre or per kilogram
Propranolol; except in medicines containing 1 milligram or less per litre or per kilogram
Pulmonaria spp; at all strengths
Safrole; for internal use except in preparations containing 0.1% or less
Sibutramine
Silicones; for injection
Telithromycin
Testosterone; except in medicines containing 1 milligram or less per litre or per kilogram
Theophylline; except in liquid form for oral use in medicines containing 2% or less
Thyroxine; except in medicines containing 10 micrograms or less per litre or per kilogram
Trichodesma africana; at all strengths
Triparanol; at all strengths
Tryptophan; in medicines containing more than
100 milligrams per recommended daily dose except in parenteral nutrition replacement preparations
Vitamin A; in preparations containing more than
3000 micrograms of retinol equivalents per recommended daily dose except in parenteral nutrition replacement preparations
Vitamin D; in medicines for internal use containing more than 25mcg per recommended daily dose except in parenteral nutrition replacement preparations
Zinc; for internal use in medicines containing more than
25 milligrams per recommended daily dose except in parenteral nutrition preparations
Schedule 2
Restricted Medicines
Aminophylline; in liquid form for oral use in medicines containing 2% or less
Atropine; in liquid form for oral use; in solid dose form containing more than 0.3 milligrams per dose or more than 1 milligram per recommended daily dose; except in medicines containing 100 micrograms or less per litre or per kilogram
Glucagon; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container
Macrogols; in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures
Nicotine; in lozenges except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
Oxiconazole; for vaginal use
Podophyllum; in medicines containing 20% or less; except in medicines containing 1 milligram or less per litre or per kilogram
Strychnine; except in medicines containing 1 milligram or less per litre or per kilogram
Theophylline; in liquid form for oral use in medicines containing 2% or less
Schedule 3
Pharmacy-only Medicines
Atropine; in solid dose form containing 0.3 milligrams or less per dose and 1 milligram or less per recommended daily dose; except in medicines containing
100 micrograms or less per litre or per kilogram; except when used as an antidote in a device designed for self-injection; except when sold by licensees under the Toxic Substances Regulations
Desloratadine
Dibromopropamidine; for ophthalmic use
Etofenamate; for external use
Fluorides; for internal use in medicines containing
2.2 milligrams or less per dose form except in parenteral nutrition replacement preparations; for external use in medicines containing 2.5% or less but more than 0.1% of elemental fluorine
Folic acid; in medicines containing more than
500 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Formaldehyde; in medicines containing more than 5%
Gelsemium; except in medicines containing 1 milligram or less per litre or per kilogram
Glyceryl trinitrate; except for injection; except in medicines containing 100 micrograms or less per litre or per kilogram
Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 0.5% or less by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container
Indomethacin; for external use in medicines containing
1% or less; except in medicines containing 1 milligram or less per litre or per kilogram
Injectable medicines; except when specified elsewhere in the schedule; except for contrast media or plasma volume expanders
Isopropamide; for dermal use in preparations containing
2% or less
Paraformaldehyde; in medicines containing more than 5%
Potassium; except when specified elsewhere in the schedule; for internal use in slow release or enteric coated forms; in medicines containing more than 100 milligrams per recommended dose except in medicines for oral rehydration therapy, parenteral nutrition replacement or dialysis
Propamidine; for ophthalmic use
Staphisagria; except in medicines containing 0.2% or less
Zinc chloride; for dermal use in medicines containing more than 5%
Medicines for General Sale
Please note that the following medicines are no longer classified as prescription medicines, restricted medicines or pharmacy-only medicines. As such, they are now available for general sale.
Acetomenaphthone
Bentiromide
Bromelains
Broxaldine
Broxyquinoline
Calcium hypochlorite
Calcium salicylate
Camphor, ammoniated
Capsicum oleo-resin
Chromium oxide
Colecalciferol; in medicines for internal use containing
25 micrograms or less per recommended daily dose; in parenteral nutrition replacement preparations
Copper
Cyanocobalamin
Deoxyribonuclease; for external use
Dextranomer
Dextrans
Diamthazole
Dibromopropamidine; except for ophthalmic use
Fluorides; in parenteral nutrition replacement preparations; for external use in medicines containing 0.1% of elemental fluorine
Folic acid; in medicines containing 500 micrograms or less per recommended daily dose; in parenteral nutrition replacement preparations
Formic acid
Hetastarch
Hexamidine
Hippuric acid
Hydrogen peroxide
Hydroiodic acid
Hydroxocobalamin
Ichthammol
Injectable medicines which are contrast media or plasma volume expanders
Iodic acid
Iron; in medicines containing 24 milligrams or less per recommended daily dose; in parenteral nutrition replacement preparations
Irrigation medicines
Isopropyl alcohol
Jaborandi
Krameria
Magenta
Menadiol
Methylene blue; except for injection
Monoacetin
Nitrous ether spirit
Oxerutins
Pentastarch
Phenoxyethanol
Phytomenadione
Picric acid
Piroctone
Polygeline
Potassium; for external use; for internal use except when specified in the First Schedule to the Medicines Regulations 1984 or amendments; for oral rehydration therapy, parenteral nutrition replacement or dialysis.
Propamidine; except for ophthalmic use
Ribonuclease
Salsalate
Scillarins
Sodium hydroxide
Sodium iodide
Sodium salicylate
Solcoseryl
Stannous chloride
Stannous oxide
Staphisagria; in medicines containing 0.2% or less
Sucralfate
Tannic acid
Theobromine
Thiomersal
Thioxolone
Tryptophan; in medicines containing 100 milligrams or less per recommended daily dose; in parenteral nutrition replacement preparations
Vitamin A; in preparations containing 3000 micrograms or less of retinol equivalents per recommended daily dose; in parenteral nutrition replacement preparations
Vitamin D; in medicines for internal use containing more than 25 micrograms per recommended daily dose except in parenteral nutrition replacement preparations
Zinc; for external use except zinc chloride in medicines containing more than 5%; for internal use in medicines containing 25 milligrams or less per recommended daily dose or in parenteral nutrition preparations
Dated this 22nd day of February 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).