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 proportion of 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.
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
acetanilides
acetylmethyldimethyloximidophenylhydrazine
acokanthera
adonis
adrenaline; in medicines containing more than 1%
aldesleukin
ambenonium
amfebutamone
ammi visnaga
amyl nitrite; except when sold from outlets licensed under the Toxic Substances Regulations 1983 to sell sodium cyanide paste for the purpose of vertebrate pest control
ancestim
antithrombin III
apocynum
aviptadil
azelastine; for ophthalmic use
bambuterol
becaplermin
benzoyl metronidazole
bivalirudin
bufexamac; except in suppositories or medicines for dermal use containing 5% or less
bupropion
butyl nitrite
calotropis
camphorated oil
camphotamide
capecitabine
celecoxib
cetirizine; except for oral use
cetrorelix
cholera vaccine
cidofovir
clenbuterol
clioquinol
clorprenaline
convallaria
coronilla
cymarin
cysteamine
dalfopristin
debrisoquine
delavirdine
demecarium
diethazine
dihydralazine
di-iodohydroxyquinoline; except for vaginal use
dipivefrin
diphemanil; except for dermal use
dofetilide
efavirenz
eletriptan
entacapone
eptifibatide
erysimum
ethopropazine
etilefrine
felypressin
fencamfamin
fenproporex
fexofenadine; except for oral use
fluticasone; except when specified elsewhere in the Schedule
fosfestrol
fosphenytoin
galanthus
glibornuride
glimepiride
hemerocallus
hylan polymer
hydroxyephedrine
hydroxyprogesterone
imiglucerase
interleukins
isoamyl nitrite
isobutyl nitrite
isometheptene
isopropamide; except for dermal use
khellin
laudexium
leflunomide
lepirudin
leptazol
levocabastine; except for nasal or ophthalmic use
lidoflazine
lindane; except in medicines for external use containing
2% or less
liothyronine
loratadine; except for oral use
luteinising hormone
mangafodipir
mefenorex
megestrol
mepacrine
mephenisin
mometasone; except when specified elsewhere in the Schedule
naratriptan
nicotine; for nasal administration except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner; in medicines other than for smoking cessation
nikethamide
noradrenaline
normethandrone
octyl nitrite
oestriol
oleander
oleandrin
orthopterin
oseltamivir
palivizumab
pamaquine
penciclovir; except for the topical treatment of herpes labialis
pentamethonium
phenazone; except for external use
phenylephrine; except when specified elsewhere in the Schedule
pilocarpine; except in medicines containing 0.025% or less
potassium perchlorate
practolol
pramipexole
procyclidine; except in medicines for dermal use containing 5% or less progesterone
propylhexedrine
pseudoephedrine; except when specified elsewhere in the Schedule
quinupristin
rabeprazole
reboxetine
repaglinide
rofecoxib
rosiglitazone
sodium phosphate; in oral laxative preparations
solasadine
sontoquine
stilboestrol
strophanthin-k
strophanthus
tanacetum vulgare; in medicines containing more than
0.8% of oil of tansy
telmisartan
thevetia
thevetin
thyroid
tirofiban
tolfenamic acid
troglitazone
tulobuterol
visnadine
yohimbine
zafirlukast
zanamivir
ziprasidone
Schedule 2
Restricted Medicines
adrenaline; in medicines containing 1% or less and more than 0.02%
chlorbutol; in medicines containing more than 5%
*fluticasone; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is no greater than
200 micrograms
glucagon
*mometasone; in aqueous nasal sprays delivering up to
50 micrograms per actuation when the maximum recommended daily dose is no greater than
200 micrograms
nicotine; for inhalation or in sublingual tablets except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
sodium phosphate; in oral bowel preparations for bowel cleansing prior to diagnostic, medical or surgical procedures
Schedule 3
Pharmacy-only Medicines
cetirizine; for oral use
chlorbutol; in medicines containing 5% or less and more than 0.5%
fexofenadine; for oral use
ibuprofen; in solid dose form containing 200 milligrams or less per dose form and in packs containing not more than 100 tablets or capsules
isopropamide; for dermal use
levocabastine; for nasal or ophthalmic use
lindane; in medicines for external use containing 2% or less
lobelia; except in medicines for smoking or burning
loratadine; for oral use
mefenamic acid; in solid dose form in packs containing not more than 30 tablets or capsules for the treatment of dysmenorrhoea
mebendazole
naproxen; in solid dose form containing 250 milligrams or less per dose form and in packs of not more than
30 tablets or capsules
nicotine; for transdermal use or in chewing gum except when sold from a smoking cessation clinic run under the auspices of a registered medical practitioner, nurse, pharmacist or psychologist
phenazone; for external use
phenylephrine; for oral use in medicines containing more than 0.5%; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing
5% or less and more than 1%
procyclidine; in medicines for dermal use containing
5% or less
psedoephedrine; in cough or decongestant preparations in either slow release form or in preparations containing
not more than 60 milligrams per dose, and when
the recommended daily dose is not more than
240 milligrams.
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.
adrenaline; in medicines containing 0.02% or less
bufexamac; in suppositories; in medicines for dermal use containing 5% or less
diphemanil; for dermal use
idoxuridine; for dermal use in medicines containing 0.5% or less
lobelia; in medicines for smoking or burning
pilocarpine; in medicines containing 0.025% or less
pregnancy test kits
tanacetum vulgare; in medicines containing 0.8% or less of oil of tansy
*Regulation 20 of the Medicines Regulations 1984 requires that all medicines sold without a practitioner's prescription must include a consumer information panel on the label. Further, all material changes to a medicine (including changes to labelling), must be notified to the Director-General of Health in accordance with section 24 of the Medicines Act 1981.
Dated this 4th day of April 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation.