(1)
The Minister responsible for finance may, by statutory instrument, with the approval of Cabinet, amend Schedule 1 to this Act.
(2)
The Minister may, after consulting the Drug Authority, by statutory order, amend Schedules 2, 3, 4, 5, 6, 7, 8 and 9 to this Act.
Schedule 1 (Sections
1
,
62(1)
)
Currency point A currency point is equivalent to twenty thousand shillings.
Class A drugs or narcotics The drugs included in this class may only be imported, or exported, manufactured or used, under authority. They may be sold by retail only on the prescription of a duly qualified medical practitioner, dentist, and veterinary surgeon but only for medical, dental or veterinary purposes and may be supplied only by a licensed person.
Acetyl-Alpha-Methylfentanyl
Acetyldihydrocodeine, except as specified in group II of class B
Beta-Hydroxy-3-Methylfentanyl
Cannabis (the flowering and fruiting tops ofthe Cannabis plant)
Cannabis Resin, Extracts and Tinctures of Cannabis
Codeine, except as specified in group II of class B
Concentrate of Poppy Straw
Cyprenorphine hydrochloride
Dihydrocodeine, except as specified in group II of class B
Meperidine and its intermediates
Methadone, its salts, intermediates and derivatives
Norcodeine, except as specified in class B, group II
Opium (all preparations made direct from opium are considered to be opium)
Pepap (l-phenethyl-4-phenyl-4-piperidinol acetate (ester))
Pethidine, its salts, intermediates and derivatives
Pholcodine, except as specified in class B group II or in class C
All substances referred to in this Schedule include, unless expressly excluded or unless listed in another Schedule, the following-
(a)
the isomers of such substances, where the existence of such isomers is possible within the specific chemical designation;
(b)
the esters and ethers of such substances and of the isomers referred to in paragraph (a), as well as the isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible;
(c)
the salts of such substances and of the isomers referred to in paragraph (a), as well as the salts of the esters, ethers and isomers referred to in paragraph (b), where the existence of such salts is possible;
(d)
the isomers of any of the salts referred to in paragraph (c), where the existence of such isomers is possible; and
(e)
all preparations and mixtures of any of the above.
Class B drugs or controlled drugs
Group I The following drugs may be supplied by retail, by a licensed person only on the prescription of a duly qualified medical practitioner, dentist or veterinary surgeon, but only for medical, dental or animal treatment respectively.
4-Aminosalicylic acid (p-aminosalicylic acid) and its salts
5-Fluorouracil its salts derivatives and metabolites
5-Aminosalicylic acid (Mesalazine or Mesalamine)
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts
6-Mercaptopurine and its derivatives, except if listed in another schedule Abamectin V
Acamprosate, and its salts carbose, and its salts
Acebutolol, and its salts
Acepromazine, and its salts V
Acetanilide; alkyl acetanilides (except as provided in Group II ofthis class)
Acetazolamide and its salts
Acocanthera, glycosides of
Allylisopropyl-acetylurea
Amidopyrine, its salts; amidopyrine sulphonates, their salts
Acetylcholine, when intended for ophthalmic use
Acetylcysteine except as specified in group II ofthis class
Acetylpromazine maleate V
Acetylsalicylic acid except as specified in group II ofthis class and class C
Acitrelin, its salts and derivatives
Aconiazide, and its salts
Acyclovir, and its salts, except when intended for topical application
Adapalene, its salts and derivatives
Adefovir, its salts and derivatives
Adenosine and its salts (for parenteral use)
Alendronic acid, and its salts
Allylisopropyl-acetylurea
Almotriptan and its salts
Alphadolone and its salts
Alteplase, its salts and derivatives
Alverine, and its salts (for parenteral use)
Amantadine, and its salts
Amifostine, and its salts
Amikacin, its salts and derivatives
Amino acids, in preparations intended for parenteral use
Aminopromazine (proquamezine) and its salts
Aminopterin, and its salts
Aminopyrine and its derivatives V
Amitriptyline, and its salts
Amlexanox, its salts and derivatives
Amlodipine, and its salts
Ammonium chloride, in preparations intended for parenteral use
Ammonium tetrathiomolybdate V
Amodiaquine, except as specified in group II ofthis class
monolevulinic acid, its salts and derivatives
Amphomycin, and its salts, its esters and salts ofsuch esters
Amphotericin, its salts and derivatives
Amprolium, its salts and derivatives
Anagrelide, and its salts
Anakinra, its salts and derivatives
Androgenic, oestrogenic and progestational substances and their derivatives, with either hormonal, prohormonal or anti-hormonal activitY (except as specified elsewhere in the schedules) such as:
Hydroxyprogesterone hexanoate
Stilbenes such as Diethylstibesterol (Stilbesrol)
Aprepitant and its derivatives
Argatroban, its salts and derivatives
Arsenic and its compounds, including Arsenic trioxide, except as specified in class C
Arterolane, and its salts
Artesunate, except as specified in group II of this class and in class C
Astemizole, and its salts
Atipamezole, and its salts V
Atomoxetine, and its salts
Atorvastatin, and its salts
Atovaquone and its salts, except as specified in group II of this class
Atracurium, and its salts
Atropine, and its salts, preparations intended for parenteral use
Avian coccidiosis vaccine V
Avian Infectious bronchitis vaccine V
Azacyclonol acid, and its salts
Azathioprine, and its salts
Azithromycin, its salts and derivatives
Azlocillin, its salts and dervatives
Aztreonam, its salts and derivatives
Bacillus Calmette-Guerin (BCG) vaccine V
Bacitracin, its salts and derivatives except as specified in group II of this class
Barbituric acid, its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; their salts; their derivatives, such as:
Methylphenobarbital (Mephobarbital)
Bambuterol, and its salts
Beclomethasone, except as specified in group II of this class
Benactyzine, and its salts
Benazepril, and its salts
Bendrofluazide (Bendroflumethiazide)
Benoxaprofen, and its salts
Benserazide, and its salts
Benzhexol (Trihexyphenidyl) and its salts
Benzocaine and its salts; except as specified in group II of this class and in class C
Benzodiazepines, and salts or derivatives thereof (except as listed elsewhere in the schedules), such as:
Benzoyl Peroxide except as specified in group II of this class
Benztropine, its homologues; their salts
Betahexol and its derivatives
Betahistine, and its salts
Bismuth and its salts, except as specified in group II of this class and in class C Bivalirudin
Blood, its components and products derived from blood
Bonsetan, its salts and derivatives
Bordetella bronchiseptica (Infectious tracheobronchitis) vaccine V
Boric acid in preparations intended for parentral use
Bovine ephemeral fever vaccine V
Bovine mastitis vaccine V
Bovine Tuberculin vaccine V
Bromocriptine, and its salts
Buparvaquone, for parenteral use V
Bupivacaine, and its salts (for parenteral use)
Cabergoline and its salts.
Caffeine, except as specified in group II of this class or in class C
Calcium gluconate in injectable form for parenteral use.
Candesartan, its salts and derivatives Canine coronavirus vaccineV
Canine distemper virus vaccine V
Canine parvovirus vaccine V
Capreomycin and its salts, deravatives, its esters and salts of such esters
Captodiamine and its salts
Carbachol, its ophthalmic preparations when intended for glaucoma
Carprofen, its salts and derivatives V
Carvedilol, and its salts
C-C chemokine receptor type 5 (CCR5) antagonists such as maraviroc Celiprolol
Cephalosporins, their derivatives and salts (except as specified in group II of this class), such as:
Cefprozil, its salts and derivatives
Chlamydophiliosis vaccineV
Chlorambucil, its salts and derivatives
Chloramphenicol, its salts and derivatives except as specified in class C
Chlordiazepoxide and its salts
Chloroquine and its salts, except as specified in group II of this class
Chlorpheniramine, and its salts, in preparations intended for injection
Chlorphenoxmine, and its salts
Chlorphentermine; and its salts
Chlorothiazide and other derivatives of Benzol 2:4-thiadiazine -7-sulphonamide 1:1-dioxide, whether hydrogenated or not
Chlorpromazine, and its salts
Chlorpropamide, and its salts
Chlorprothixene, and other derivatives of 9-methylenethiazane-ther, their salts
Chlorthalidone, and other derivatives of o-chlorobenzene sulphonamide
Cimetidine, and its salts
Cinchocaine except as specified in group II of this class
Cisapride and its salts Cisatracurium and its salts Cisplatin
Clavulanic acid, except as specified in group II of this class Clazuril V
Clenbuterol and its salts V
Clindamycin, its salts and derivatives.
Clofazimine Clofibrate Clomethiazole Clomipramine and its salts Clonidine and its salts. Clopidogrel and its salts Cloprostenol, its salts and derivatives, V Clorexolone, its salts Clorsulon V Closantel and its salts V Clostridial infections vaccineV Clostridium botulinum toxins type A & B Clozapine, and its salts Cobicistat Colchicine Colecalciferol Colesevelam Colestipol Colestyramine
Colistin (Polymyxin E), its salts and derivatives Conivaptan
Contagious Caprine Pleuropneumonia vaccine V
Copper salts, when intended for injection for parenteral nutrition, V Corticosteroids; their salts and derivatives; whether natural or synthetic, (except as specified elsewhere in the schedules); such as:
Desoxycorticosterone PivalateV
Coumarin and its derivatives, such as:
Cromoglycic acid and its salts; except as specified in group II of this class
Cyclizine, except as specified in group II of this class
Cyclopentolate and its salts in preparations for parenteral use
Cycloserine and its salts
Cytarabine and its salts,
Dabigatran, its salts and derivatives
Dalteparin and its salts.
Danaparoid, its salts and derivatives
Dapiprazole and its salts
Dapoxetine, and its salts
Daunorubicin and its salts.
Debrisoquine and its salts
Deferoxamine and its salts.
Desimipramine and its salts
Despramine, and its salts
Detomidine and its salts V
Dextrose in solutions for parenteral use
Diaminazene and its salts V
Dimenhydrinate and its salts except as specified in group II of this class
Dichlorvos V in preparations intended for oral use
Diclofenac, and its salts; except as specified in group II of this class
Dictyocaulus viviparus vaccine
Dicycloverine (Dicyclomine) except as specified in group II of this class.
Diethylcarbamazine and its salts
Digitalis, its glycosides, derivatives and their salts
Dihydrostreptomycin, its salts and derivatives
Diiodohydroxyquinoline (lodoquinol)
Dimethicone and its salts, except as specified in group II of this class
Dimetridazole injection V
Diminazene and its salts V
Dinitolmide, V except as specified in class C
Disodium hydrogen citrate
Disopyramide and its salts
Dorzolamide and its salts
Doxercalciferol and its derivatives
Doxorubicin (Adriamycin) and its salts
East Coast Fever vaccineV
Echinocandins, their salts and derivatives, such as Caspofungin,
Anidulafungin and Micafungin
Ecothiophate and its salts V
Eflomithine, its salts and derivatives
Electrolyte solutions for parenteral use
Enalapril, its salts and derivatives
Enilconazole except when intended for application to the skin
Enteric red mouth disease vaccine V
Ephedrine and its salts, except as specified in group II of this class
Epinephrine (adrenaline) and its salts
Epirubicinesc and its salts
Epoprostenol and its salts
Eprosartan, its salts and derivatives
Eptifibatide and its salts
Equine anti-human thymocyte globulin
Equine chorionic gonadotrophin, V
Equine herpesvirus vaccine V
Equine influenza virus vaccine V
Ergot, alkaloids of, whether hydrogenated or not; their homologues; any salt of any substance falling within this item (except as provided in Group II of this class) such as Ergotamine, Ergometrine, Cabergoline, Nicergoline
Escitalopram and its salts
Esomeprazole and its salts, except as specified in group II of this class
Etamiphylline, its salts and derivatives
Ethacrycin acid, its salts
Ethambutol, and its salts.
Ethionamide, and its salts
Ethoheptazine, and its salts
Ethopropazine hydrochloride (profenamine), and its salts
Etodolac, its salts and derivatives
Etoposide and its derivatives
Etymemazine and its salts
Famciclovir and its salts.
Famotidine, except as specified in group II of this class
Feline Chlamydial vaccine V
Feline leukaemia vaccine V
Feline panleucopenia vaccine V
Feline viral respiratory disease complex vaccine V
Feline viral rhinotracheitis vaccine V
Fenfluramine and its salts
Fenoprofen, except as specified in group II of this class
Fexofenadine and its salts
Fipronil V, when used in preparations intended for cutaneous spray
Florfenicol and its derivatives
Fluconazole, except as specified in group II of this class Flucytosine
Fludarabine, its salts and derivatives Flufenamic acid Flumazenil
Flunarizine and its salts
Flunixin, its salts and derivatives V
Fluorescein, except when intended for ophthalmic use by the topical route only
Flupentixol, its salts and derivatives.
Fluphenazine and its salts.
Flurbiprofen, except as specified in group II of this class
Fluvastatin, its salts and derivatives
Fluvoxamine and its salts
Formoterol, and its salts
Fosphenytoin and its salts
Furadantin Furaltadone and its salts V
Furazolidone and its salts
Fusidic acid and its salts, its esters and salts or such esters
Fusion inhibitors and their salts such as enfurvitide
Gabapentin, its salts and derivatives
Galantamine, its salts and derivatives
Gallamine; its salts, derivatives and quaternary compounds
Gamma-aminobutyric acid, its derivatives and salts there of
Ganciclovir and its salts and derivatives
Gemcitabine and its salts and derivatives
Gemfibrozil and its salts
Gemifloxacin, its salts and derivatives
Gentamycin and its salts, its esters and salts of such esters
Glucosamine, substances, preparations and mixtures when intended for the treatment of primary and secondary osteoarthritis, osteochondrosis and spondylosis
Glutethimide, and its salts.
Glyburide, and its salts and derivatives.
Glyceryl trinitrate (Nitroglycerin)
Glycopyrrolate and its salts
Glycopyrronium and its salts
Gramicidin, except as specified in group II of this class
Granisetron and its salts
Grepafloxacin, its salts and derivatives
Guanethidine, and its salts
Halofantrine and its salts
Haloperidol and its salts
Hepatitis B immunoglobulin
Homatropine and its salts, except as specified in group II of this class
Homidium bromide (ethidium bromide) V
Human anti-D immunoglobulin
Human anti-thymocyte rabbit immunoglobulin
Human menopausal gonadotrophin (Menotrophin)
Human normal immunoglobulins
Hyaluronic acid and its salts, except as specified in group II of this class and class C
Hydralazine and its salts
Hydroxycarbamide (Hydroxyurea)
Hydroxychloroquin and its salts
Hydroxyethyl starch, and its derivates intended for parentral use
Hydroxyzine, and its salts
Hyoscine and its salts, except as provided in group II of this class
Hyoscyamine, except as provided in class C
Ibandronic acid and its salts
Ibuprofen, except as specified in group II of this class and in class C
Idoxuridine, except when intended for application to the skin
Imidocarb, and its salts V
Imipenem, its salts and derivatives
Imipramine, and its salts
Indapamide, and its salts
Indomethacin, and its salts, except as specified in group II of this class
Infectious Bovine Rhinotracheitis (IBR) vaccines V
Infectious bursal disease (Gumboro) vaccine V
Infectious canine hepatitis vaccine V
Infectious Coryza vaccine V
Infectious tracheobronchitis vaccine V
Integrase inihibitors, and their salts such as;
Interferons, such as Interferon-alpha, Interferon-beta, Interferon-gamma, Interferon-omega and their corresponding subtypes.
Intra uterine devices; whether hormonal or copper based lohexol lopanoic acid lopromide lopamidol
Ipratropium, and its salts
soniazid, and its salts, derivatives and their salts
Isocarboxazid and its salts Isoconazole and its salts,
Isometamidium and its salts V
Isopropamide and its salts
Isosorbide, its salts and derivatives
Isotretinoin, its salts and derivatives
Isoxsuprine and its salts
Itraconazole and its salts
Lincomycins, their salts, their esters and salts of such esters
Ketoconazole and its salts, except as specified in group II of this class and class C
Ketoprofen and its salts, except as specified in group II of this class
Lamotrigine and its salts
Lansoprazole except as specified in group II of this class
Levamisole and its salts, for injection V
Levocabastine, except as specified in group II of this class
Levosalbutamol, except as specified in group II of this class lidocaine, except as specified in group II of this class and class C
Lincomycin, and its salts and derivatives
Lisinopril, and its salts
Lithium, and its salts except as specified in group II of this class
Lomoxicam (Chlortenoxicam)
Lumefantrine except as specified in class C
Lungworm disease vaccine V
Macrogol (polyethylene glycol), when used for faecal impaction, or for the purposes of bowel cleansing prior to surgery or diagnostic procedures, except when intended for the treatment of constipation.
Magnesium glutamate hydrobromide
Marmomustine, and its salts
Mebezonium, and its salts V
Meclofenokate, and its salts
Marek's disease vaccine V
Mebezonium and its salts V
Meclofenamic acid, and its salts
Meclofenokate, and its salts
Mefenamic acid, its salts and derivatives, except as specified in group II of this class.
Mefloquine, its salts and derivatives; in oral preparations intended for treatment of malaria infection
Melatonin, except as specified as specified in group II of this class
Meloxicam, its salts and derivatives except as specified in group II of this class.
Melphalan and its derivatives
Mephenesin, and its derivatives
Mepivacaine and its salts, in preparations intended for parenteral use
Meropenem, its salts and derivatives
Metaproterenol (Orciprenaline) when intended for the prevention or delay of labour and its preparations for injection, or when contained in respirator solutions
Metaraminol, and its salts
Metaxalone, and its salts
Metformin, its salts and derivatives
Methaqualone, and its salts
Methohexital and its salts
Methotrexate, and its salts
Methylene blue (Methylthioninium chloride), when used for treatment of methemoglobinemia
Methylpentynol; its esters and other derivatives
Metoclopramide and its salts
Metronidazole except as specified in group II of this class
Miconazole, and its salts except as specified in group II of this class.
Milbemycin and its derivatives V
Mineral salts either alone or in combination,
(a)
in preparations intended for parenteral use
(b)
except as listed elsewhere in the schedules; when intended for correction of pH of body fluids or correction of electrolyte imbalances; except as specified in group II of this class and class C.
Minoxidil, except as specified in group II of this class
Mirtazapine and its salts
Monensin V except as specified in class C
Montelukast and its salts
Mupirocin, except as specified in group II of this class
Mustine and any other N-substituted derivatives of di-(2-chloroethyl) amine; their salts
Mycophenolate mofetil, its derivatives and salts there of
Nalorphine, and its salts
Naphthalene-1-yl (1-Pentyl-1h-Indol-3-yl) Methanone
Naproxen, and its salts, except as specified in group II of this class.
Nateglinide, its salts and derivatives.
Neomycin and its salts; except as specified in group II of this class
Neostigmine and its salts
Niacin (Nicotinic acid) when intended for hypercholesterolaemia
Nicotine, except as specified in group II of this class.
Nitrofurazone (Nitrofural)
Nitroxynil and its salts V
Non-Nucleoside Reverse Transcriptase Inihibitors, and their salts such as;
Norepinephrine (Noradrenaline)
Nortryptyline; and its salts
Nucleoside and Nucleotide Reverse Transcriptase Inihibitors, and their salts such as;
Oleandomycin and its salts; its esters and their salts
Olmesartan, and its salts
Omeprazole and its salts, except as specified in group II of this class.
Ondansetron and its salts
Orf (Contagious ecthyma) vaccine V
Orlistat, except as specified in group II of this class
Ormetoprim, and its salts V
Oxaprozin, its salts and derivatives.
Oxethazaine (oxetacaine) except as specified in group II of this class
Oxybuprocaine, and its salts
Paclitaxel, and its derivatives
Paliperidone, its salts and derivatives
Pancreatic enzymes such as amylase, lipase and proteases
Pancuronium and its salts
Pantoprazole and its salts
Papaverine, except as specified in group II of this class
Paracetamol, except as specified in group II of this class and class C
Paromomycin and its salts, its esters and salts of such esters
Paroxetine, and its salts
Penciclovir and its salts, except as specified in group II of this class.
Penicillin antibiotics, their salts and derivatives (except as specified elsewhere in the schedules), such as:
Penethamate (hydroiodide) V
Procaine fortified penicillin
Pentamidine, and its salts
Pentazocine, and its salts
Pentoxifylline and its salts
Pericyazine and its salts
Peritoneal and haemoldialysis preparations
Perphenazine and its salts
Pestes des petits ruminants virus vaccine V
Phenazopyridine Phenbutrazate
Phentolamine and its salts
Phenylbutazone and its salts
Phenylephrine, except as specified in group II of this class and class C
Phenylpropanolamine (norephedrine), except as specified in group II of this class
Physostigmine, its salts and derivatives
Pioglitazone and its salts
Piperacetazine and its salts
Pirlimycin and its salts V
Piroxicam, its salts and derivatives except as specified in group II of this class
Pituitary gland, the active principles of, whether natural or synthetic, such as:
Adrenocorticotrophic hormone
Follicle-stimulating hormone
Gonadorelin (Gonadotropin Releasing Hormone)
Melanocyte-stimulating hormone
Thyroid-stimulating hormone
Polymyxin B, and its salts
Polysulfated glycosaminoglycan V
Porcine parvovirus (PPV) Vaccine V
Porcine pneumonia Vaccine V
Pralidoxime and its salts
Pravastatin and its salts
Pregabalin, its salts and derivatives
Pregnant Mare's Serum Gonadotropin V
Procainamide and its salts
Procarbazine, and its salts
Procyclidine and its salts
Proguanil and its salts, except as specified in group II of this class
Promethazine, and its salts; except as specified in group II of this class
Propafenone, and its salts
Propranolol, and its salts
Propylhexedrine; its salts
Protease inihibitors, and their salts such as;
Prothipendyl, and its salts
Proxymetacaine, and its salts
Pseudoephedrine, except as specified in group II of this class and class C
Purines, their salts and derivatives, whether natural or synthetic (except as specified elsewhere in the schedules)
Pyrantel, its salts and derivatives
Pyridostigmine Pyrimethamine
Pyrimidines, their salts and derivatives, whether natural or synthetic (except as specified elsewhere in the schedules)
Pyronaridine and its salts
Quetiapine, its salts and derivatives
Quinapyramine V, its salts derivatives
Quinolones and fluoroquinoles, and their salts such as;
Rabeprazole and its salts
Racecadotril (acetorphan)
Radiopharmaceuticals, being radio compounds and radio-active labelled compounds, when used for diagnostic or therapeutic purposes, unless listed elsewhere in the schedules
Ramipril, its salts and derivatives
Ranitidine, and its salts except as specified in group II of this class
Rauwolfia alkaloids, salts and derivatives
Remoxipride and its salts
Repaglinide, its salts and derivatives
Rifamycins, their salts, their esters and salts of such esters, including:
Risperidone and its salts
Romifidine, and its salts V
Ronidazole, its salts and derivatives V
Rosiglitazone and its salts
Rosuvastatin and its salts
Salbutamol, except as specified in group II of this class and in class C
Salmonellosis/Fowl Typhoid vaccine V
Sertaconazole and its salts
Sheep pox virus vaccine V
Simethicone, except as specified in group II of this class
Sodium chloride when formulated alone in preparations intended for parenteral or oral use
Sodium nitroprusside and its salts
Solutions for parentral nutrition (glucose, protein hydrolysates, aminoacids or lipid/fat emulsions)
Solutions of carbohydrates or proteins, synthetic or natural substances used for injection as plasma volume expanders
Sorbitol, in preparations intended for parenteral administration
Spectinomycin, its salts and derivatives
Streptomycin, its salts, its derivatives and their salts
Fosfomycin (Sulphomycin), its derivatives and their salts
treptogramins their salts, derivatives and their salts; including:
Strontium and its salts, when indicated for oral use for the treatment of osteoporosis in adults
Substances commonly known as vaccines, sera, toxins, anti-toxins and antigens; if not listed anywhere in the schedules
Sulconazole and its salts
Sulfonamide antibiotics, their salts, derivaties and salts thereof; (except as specified elsewhere in the schedules) such as:
Sulphinpyrazone and its salts
Sulphones; their salts and derivatives such as Dapsone
Sumatriptan and its salts
Suxamethonium and its salts
Syrosingopine, and its salts
Telithromycin, its salts and derivatives and salts thereof
Telmisartan, its salts and derivatives and salts thereof
Terbinafine, except as specified in group II of this class
Terbutaline, and its salts except as specified in group II of this class
Terconazole and its salts
Terdecamycin V Terfenadine and its salts
Teriparatide and its salts.
Tetrabenazine, and its salts
Tetracaine (Amethocaine), and its salts, except as specified in group II of this class and class C
Tetracyclines, their salts, derivatives and their salts, (except as listed anywhere else in the schedules), including:
Demeclocycline (Demethylchlortetracycline)
Oxytetracycline Rolitetracycline
Thalidomide, and its salts
Theophylline, and its salts
Thiacetazone, its salts; its derivatives and salts thereof
Thiocarlide, and its salts
Thioctic acid (thioctacid)
Thiopropazate and its salts
Thioproperazine and its salts
Thyroid gland; its active principles, their salts and derivatives thereof;
whether natural or synthetic, such as:
Tiaprofenic acid and its salts
Timepidium, except as specified in group II of this class
Tioconazole, except as specified in group II of this class
Tirofiban, its salts and derivatives
Tobramycin, its salts and derivatives
Tolfenamic acid, its salts and derivatives
Tolperisone and its salts
Mercaptopurine, and its salts, derivatives of mercaptopurine, their salts Mescaline, and other derivatives of phenethylamine formed by substitution in the aromatic ring, their salts
Torasemide (torsemide) and its salts
Trandolapril, its salts and derivatives
Tretinoin, its salts and derivatives
Triamterene, and its salts
Trifluoperazine and its salts
Triflupromazine, and its salts
Trimeprazine (Alimemazine) its salts and derivatives V
Trimethadione (Troxidone)
Trimipramine and its salts
Tryptan blue solution for opthalamic use
Vasopressin, its analogues, whether natural or synthetic; such as Desmopressin and Terlipressin
Tyrothricin, except as specified in group II of this class.
Unoprostone, its salts and derivatives
Uracil, salts of, when sold for treatment of cancer
Ursodeoxycholic acid and its salts
Valacyclovir and its salts
Valganciclovir, its salts and derivatives
Valrubicin and its derivatives
Valsartan, its salts and derivatives
Vancomycin, its salts and derivatives
Varicella-zoster virus vaccine
Vasoactive intestinal polypeptide
Vedaprofen, its salts and derivatives
Venlafaxine and its salts
Verapamil (Iproveratril) and its salts
Vinca alkaloids, their salts and derivatives; such as:
Vinblastine and its salts
Vincristine and its salts
Viomycin, its salts and derivatives
Viral neuraminidase enzyme inhibitors, the following-
Laninamivir, and its salts and derivatives
Oseltamivir, and its salts and derivatives
Peramivir, and its salts and derivatives
Zanamivir, and its salts and derivaties
Vitamins either alone or in combination, in preparations intended for injection
Yersinia ruckeri vaccine V
Zafirlukast and its salts
Zinc sulphate in preparations intended for ophthalmic use
Zoledronic acid and its salts
Zuclopenthixol and its salts
Any drugs derived from any of the drugs referred to in this schedule, unless expressly excluded or unless listed in another schedule.
Any drug or preparation not listed in the schedules.
Herbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (unless expressly excluded or unless listed in another schedule) in preparations intended for parenteral administration.
The following drugs and preparations containing such drugs may be supplied by retail only by a licensed person.
Acetylcysteine, in preparations intended for oral use when labelled with a recommended daily dose not exceeding 1000 milligrams.
^cetyldihydrocodeine - oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodiene (calculated as base) per dosage unit; and liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 0.4 percent w/v of acetyldihydrocodeine (calculated as base).
Acetylsalicylic acid and its salts, in preparations intended for rectal application in strengths of more than 150 milligrams per dosage unit, but not exceeding 600 milligrams per dosage unit
Alginic acid and its salts
Amidines acaricides V such as Amitraz and Cymiazole
Amino acids, in preparations intended for oral use, in concentrations exceeding the recommended dietary allowances
Amodiaquine, when contained in preparations intended for oral use
Amoxicillin and its salts, when combined with Clavulanic acid and its salts; in preparations intended for oral use, for a treatment period not below 5 days and not exceeding 7 days
Amylocaine and its salts, in preparations intended for topical use Antazoline and its salts
Artesunate, in preparations intended for oral administration
Atovaquone and its salts, in oral preparations intended for use in malaria prophylaxis
Atropine; except as specified in group I of this class
Bacitracin and its salts and derivatives, in preparations intended for application to the skin
Beclomethasone dipropionate, when intended for nasal administration as an aqueous spray for use in adults and children over 12 years of age, subject to-
(a)
maximum dose of 100 micrograms per nostril and a maximum daily dose of 200 micrograms of beclomethasone per nostril; and
(b)
a maximum pack size of 200 doses
Benfotiamine and its salts
Benzocaine and its salts, when intended for topical application
Benzoyl peroxide, when intended for topical application
Benzydamine, and its salts
Betamethasone valerate either alone or in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.5 percent w/w in preparations intended for topical administration
Beta-sitosterol in preparations intended for topical application
Bifonazole, when intended for application to the skin
Bufexamac, in preparations intended for topical use Butinoline
Butoconazole in preparations intended for topical administration
(a)
in combination with one or more other drugs listed in this group; in concentrations not exceeding 65 milligrams per dosage unit.
(b)
in combination with one or more other drugs listed in class C; in concentrations exceeding 65 milligrams per dosage unit.
Cantharidin and its derivatives
Carbinoxamine and its salts
Cefalexin, in preparations intended for oral use, for a maximum treatment duration of 7 days.
Clioquinol, in preparations intended for ophthalamic and topical administration Chlorcyclizine and its salts
"hloroquine, in oral preparations intended for malaria prophylaxis ilorpheniramine, and its salts in preparations intended for oral or topical use
Chondroitin and its salts
Cinchocaine when contained in preparations intended for rectal administration Cinnarizine
Clobetasol and its salts, either alone or in combination with one or more drugs listed in this group or in class C; in concentrations not exceeding 0.05 percent w/w in preparations intended for application to the skin
Clobetasone and its salts, either alone or in combination with one or more drugs listed in this group or in class C; in concentrations not exceeding 0.05 percent w/w in preparations intended for application to the skin
Codeine (methylmorphine):
(a)
in oral solid preparations, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 10 milligrams (calculated as base) per dosage unit; in pack sizes not exceeding 10 dosage units.
(b)
In liquid oral preparations and mixtures, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.2 percent w/w, in pack sizes not exceeding 100 millilitres.
Cromoglycic acid and its salts in solutions of sodium cromoglycate in concentrations not exceeding 2 percent w/v or less, for ophthalmic or intranasal use
Cyclizine, in preparations intended for oral use
Cyproheptadine and its salts
Dehydroemetine; its salts
Desloratadine and its salts
(a)
either alone or in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 1 percent w/w in preparations intended for topical or ophthalmic use or in concentrations not exceeding 0.01 percent w/v in preparations intended for oral use
(b)
as the only active therapeutic substance when contained in oral solid dosage forms not exceeding 0.5 milligrams per dosage unit Dexchlorpheniramine
Dextromethorphan, and its salts except as specified in class C
Dextroiphan, and its salts
Diclofenac when contained in:
(a)
preparations intended for topical use in concentrations exceeding 1.16 percent w/w
(b)
preparations intended for rectal administration
(c)
oral solid dosage, immediate release preparations containing not more than 50 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.
(d)
oral solid dosage, modified release preparations containing not more than 100 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.
Dicycloverine (Dicyclomine) and its salts, intended for topical use
(a)
oral solid preparations, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 20 milligrams (calculated as base) per dosage unit; or
(b)
liquid oral preparations and mixtures, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.4 percent w/w (calculated as base).
Dimenhydrinate and its salts for oral use
Dimethicone, its salts and derivatives when contained in oral liquid, oral solid or topical preparations
Diphenhydramine and its salts
Doxylamine melilotus officinalis extract
Ephedrine, and its salts in:
(a)
concentrations not exceeding 1 percent w/v in preparations intended for nasal administration for a maximum treatment period of 5 days.
(b)
concentrations not exceeding 0.15 percent w/v in liquid preparations intended for oral use, with daily doses not exceeding 50 milligrams.
Ergotamine tartarate, in oral preparations in concentrations not exceeding 2 milligrams per dosage unit, with a maximum daily dose of 6 milligrams and no more than 10 milligrams per week
Esomeprazole and its salts, in oral preparations in concentrations not exceeding 20 milligrams per dosage unit when intended for a treatment period not exceeding 10 days
Euphorbia prostata extract
Famotidine, in oral solid dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in packs containing not more than 30 dosage units.
Fexofenadine in preparations intended for oral use
Fluconazole in single dose oral preparations containing 150 milligrams or less of Fluconazole for the treatment of vaginal candidiasis
(a)
in preparations intended for topical use
(b)
when intended for oral use in concentrations not exceeding 100 milligrams per dosage unit, and a maximum daily dose not exceeding 300 milligrams for a maximum treatment period of 5 days
Fluticasone propionate, when intended for nasal administration as an aqueous spray for use in adults and children over 12 years, subject to a maximum daily dose of 100 micrograms per nostril and a maximum pack size of 120 dosage units.
Gentamycin sulphate in concentrations not exceeding 0.1 percent w/w in preparations intended for application to the skin and in concentrations not exceeding 0.3 percent w/v in preparations intended for application to the eye
Gramicidin, its salts and derivatives in preparations intended for application to the skin
Griseofulvin, in preparations intended for oral or topical use
Heparin and its salts, when intended for topical use
Homatropine and its salts when intended for oral use in concentrations not exceeding 2 milligrams per dosage unit
Hormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action:
(a)
as Levonorgestrel in concentrations of 1.5 milligrams or less per oral dosage unit, intended for emergency postcoital contraception, in pack sizes containing not more than 1.5 milligrams of levonorgestrel
(b)
in oral preparations, either alone or in combination; when intended for emergency postcoital contraception
(c)
when intended for oral contraception, except as specified in class C
Hyaluronic acid and its salts when intended for ophthalmic use in concentrations not exceeding 0.1 percent w/v
Hydroquinone; preparations and mixtures containing 2 percent or less thereof, when intended for application to the skin, and indicated foi management of melanin hyperpigmentation.
Hydroxyethylcellulose, in preparations intended for ophthalmic use Hydroxyethyl starch, and its derivates in preparations intended foi ophthalamic use
Hydroxypropylmethylcellulose (Hypromellose), in preparations intended for ophthalmic use
Hyoscine and its salts; when contained in transdermal preparations or oral preparations
Ibuprofen when contained in oral medicinal preparations in combination with one or more drugs listed in this group or in class C, in packs not exceeding 100 millilitres in volume or in solid preparations in packs not exceeding 10 dosage units, where the recommended daily dose of ibuprofen in the case of adults and children over 12 years does not exceed 1200 milligrams and in children from the age of 6 months up to 12 years does not exceed 20 milligrams per kilogramme of body weight.
Indomethacin, when intended for topical or rectal application Ipecacuanha tincture Ispaghula husk Isoaminile, and its salts
Ketoconazole, in preparations intended for application on the skin in concentrations not exceeding 2 percent w/w
(a)
in preparations intended for topical use
(b)
when intended for oral use in concentrations not exceeding 25 milligrams per dosage unit, in pack sizes not exceeding 30 dosage units.
Lansoprazole and its salts, in oral solid dosage forms in concentrations not exceeding 30 miligrams per dosage unit, in packs containing not more than 10 dsage units.
Levocabastine, in preparations intended for ophthalmic application or nasal administration
Levocetirizine and its salts
Levosalbutamol when contained in pressurized aerosol preparations in concentrations not exceeding 50 micrograms per dosage unit, in pack sizes not exceeding 200 metered doses
Lidocaine in preparations for topical use other than eye drops
Lithium salts, when intended for application to the skin
Macrogol (polyethylene glycol), when contained in preparations intended for oral or vaginal administration.
Magnesium citrate, intended for oral use as a purgative
Magnesium sulphate, in preparations intended for oral use, use as a laxative Mebeverine
Meclizine (Meclozine) and its salts
Mefenamic acid as the only therapeutically active substance in oral formulations, when intended for use in adults and children over the age of 12 years, subject to a maximum daily dose of 1500 millligrams and a maximum treatment period of 5 days.
Mefloquine, its salts and derivatives; in oral preparations intended for prophylaxis against Malaria infection
Melatonin, when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6 milligrams daily
Meloxicam, its salts and derivatives, in preparations intended for oral use, for a maximum treatment period of 5 days in adults and children aged 12 years and above, where the maximum daily dose does not exceed 15 milligrams.
Mepivacaine and its salts when intended for topical use
Mercury, preparations and mixtures that contain mercury metal and that are intended for external use in concentrations not exceeding 0.5 percent of mercury
Metaproterenol (orciprenaline), except as specified in group 1 of this class.
Metronidazole when contained in preparations:
(a)
. intended for topical application
(b)
intended for oral administration as solid dosage forms, in concentrations not exceeding 400 milligrams per dosage unit, and supplied for a treatment duration not exceeding 7 days
(c)
intended for oral administration as liquid dosage forms, in concentrations not exceeding 4 percent w/v, in pack sizes not exceeding 100 millilitres.
Methylprednisolone and its salts, in concentrations not exceeding 0.25 percent w/w when contained in preparations intended for application to the skin
Miconazole, when contained in preparations:
(a)
intended for application to the skin; and
(b)
intended for human vaginal use, specifically for the treatment of vaginal candidiasis; and
(c)
intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis).
Mineral salts except as listed elsewhere in the schedules, either alone or in combination with vitamins, amino acids or other micronutrients as specified in this group, in preparations intended for oral use in concentrations above the recommended dietary allowances
Minoxidil, when contained in topical preparations, in concentrations not exceeding 5 percent w/v
Mometasone furoate, when intended for nasal administration as an aqueous spray for use in adults and children above the age of 2 years, subject to: (a) a maximum dose of 200 micrograms per nostril in adults and 50 micrograms per nostril in children; and
(b)
a maximum pack size of 200 doses.
Mupirocin, in preparations intended for application to the skin
Naphazoline except as specified in class C
(a)
in preparations intended for application to the skin
(b)
in oral solid dosage forms, in concentrations not exceeding 500 milligrams per dosage unit, and in packs containing not more than 20 dosage units.
Neomycin and its salts, in concentrations not exceeding 0.5 percent w/w in preparations intended for topical or opthalamic administration.
Nicotine when intended for human medicinal use as an aid to smoking
cessation, and presented:
(a)
as nicotine gum or lozenges containing not more than 4 milligrams of Nicotine per piece,
(b)
as metered sprays containing 1 milligram per dose or less, as nicotine transdermal patches for continuous application to the skin in strengths not exceeding 25 milligrams per 24 hours,
(c)
as oral solid dosage forms containing 2 milligrams or less, or (d) as inhalers containing 10 milligrams or less per cartridge.
Norcodeine-oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of Norcodeine (calculated as base) per dosage unit; or liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 0.4 percent w/v or less of norcodeine (calculated as base).
Octatropine methylbromide Olopatadine and its salts omeprazole and its salts, in oral solid dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in packs containing not more than 10 dosage units.
Orlistat, in oral preparations containing not more than 60 milligrams per doage unit, and indicated for weight loss in overweight adults with a body mass index greater or equal to 28 kilogrammes per square meter, in doses not exceeding 180 milligrams per day.
Oxethazaine when contained in antiacid or antihemorroidal preparations Oxymetazoline and its salts, in preparations intended for nasal administration Oxyphencyclimine Oxyphenonium
Papain (Papaya proteinase 1)
Papaverine; substances, preparations and its mixtures for oral use Paracetamol:
(a)
as the only active therapeutic substance in immediate release oral or rectal formulations containing more than 500 milligrams per dosage unit, where the recommended cumulative daily dose does not exceed 4000 milligrams
(b)
as the only active therapeutic substance in modified release formulations
(c)
in combination with one or more drugs listed in this group or in class C, in a solid dosage form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the cumulative daily dose of Paracetamol does not exceed 3250 milligrams.
(d)
in combination with one or more drugs listed in this group or in class C in oral liquid preparations containing Paracetamol in a strength of not more than 5 percent w/v, in packs not exceeding 100 millilitres, intended for use in children aged 3 months and above.
Penciclovir and its salts, in preparations intended for topical use for the treatment of herpes simplex virus infections of the lips and face (Herpes labialis) in adults and children over 12 years of age.
Peppermint (Mentha piperita) including leaf and oil when intended for oral or topical use
Phenylephrine, either alone or in combination with any other drug listed in this schedule or in class C; when contained in: (a) preparations for topical or rectal application
(b)
solid preparations intended for oral use, in concentrations not exceeding 20 milligrams per dosage unit
(c)
when contained in oral liquid preparations not exceeding 0.4 percent w/v
Phenylpropanolamine (norephedrine), preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when intended for the symptomatic relief of nasal and sinus congestion
Phenyltoloxamine and its salts
Pholcodine, either alone or in combination with one or more drugs listed in this schedule or in class C in oral preparations in concentrations not exceeding 20 milligrams per dosage unit or 0.4 percent w/v.
Pimethixene, preparations and mixtures thereof when used solely as an antihistamine
Piperaquine and its salts
Piroxicam, its salts and derivatives in oral dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.
Pizotifen, preparations and mixtures, when intended for prophylaxis of migraine
Podophyllum resin, preparations and mixtures containing 20 percent or less.
Povidone iodine, for ophthalmic use
Probiotics, containing microrganisms such as; Lactobacillus acidophilus, Bifidobacterium infantis, enterococcus faecium and Saccharomyces boulardii
Proguanil, in oral preparations intended for malaria prophylaxis
Promethazine, when intended for use:
(a)
in preparations for application to the skin
(b)
in preparations for oral use containing not more than 25 milligrams per dosage unit for solid formulations, and not more than 0.1 percent w/v for liquid formulations.
Pseudoephedrine, either alone or in combination with one or more drugs listed in this group or in class C, when contained in:
(a)
oral solid dosage forms in concentrations not exceeding 120 milligrams per dosage unit
(b)
oral liquid dosage forms in concentrations not exceeding 1.2 percent w/v.
Pyrethrins V, their salts and derivaties such as;
Ranitidine and its salts, when contained in oral solid dosage forms at a concentration not exceeding 150 milligrams per dosage unit in pack sizes containing not more than 30 dosage units.
Retapamulin, when intended for topical application to the skin, nares and external ear
(a)
when contained in pressurized aerosol preparations in concentrations not exceeding 200 micrograms per dosage unit, in pack sizes not exceeding 200 metered doses
(b)
either alone or in combination with any drug listed in this group or in class C, in oral liquid preparations in concentrations not exceeding 0.04 percent w/v
Silver nitrate, when intended for topical application
Simethicone, its salts and derivatives when contained in oral liquid, oral solid or topical preparations
Sodium bisphosphate when contained in oral and rectal preparations, and intended for use as a purgative
Sodium chloride when formulated at a concentration on 0.9 percent w/v, in preparations intended for ocular irrigation
Sodium phosphate when contained in oral and rectal preparations, and intended for use as a purgative
Sorbitol, except as specified in group II of this class
Terbinafine and its salts, in preparations intended for topical administration
Terbutaline, either alone or in combination with any drug listed in this group or in class C, in oral liquid preparations in concentrations not exceeding 0.05 percent w/v
Tetracaine when contained in preparations intended for oral, rectal or topical application to the skin
Tetracycline and its salts, in preparations intended for topical administration Tetrahydrozoline for ophthalamic use
Thiethylperazine, in oral preparations for relief of nausea and vomiting Tiaprofenic acid, in concentrations not exceeding 300 milligrams per dosage unit when intended for a maximum treatment period of 5 days
Timepidium in preparations intended for oral use
Tioconazole and its salts in preparations intended for application to the skin and in preparations intended for intra-vaginal use
Triamcinolone acetonide when contained in nasal spray formulations delivering not more than 55 micrograms per spray, intended for use by adults and children over the age of 12 years.
Tribenoside when contained in preparations intended for rectal administration Tricholine
Triprolidine, except as specified in class C
Tyrothricin, when used in oral preparations for symptomatic relief of soar throat
Urea when contained in preparations intended for application on the skin
Vaccines, sera, toxins, antitoxins and antigens for human use; except as specified elsewhere in the schedules; the following:
Diphtheria toxoid vaccine
Haemophilus influenza vaccine
Human papillomavirus vaccine
Pneumococcal vaccine, conjugated
Pneumococcal vaccine, polysaccharide
Rotavirus, live attenuated vaccine
Tuberculosis (Bacillus Calmette-Guerin) vaccine
Vaccines, sera, toxins, antitoxins and antigens for veterinary use; except as specified elsewhere in the schedules; the following:
Bovine Contagious Pleuropneumonia vaccine V
Foot and Mouth disease vaccines V
Lumpy Skin disease vaccine V
Newcastle disease vaccine V
Vitamin Bl (Thiamine), and its derivatives; in preparations intended for oral use
Vitamin B2 (Riboflavin), and its derivatives; in preparations intended for oral use
Vitamin B3 (Niacin), and its derivatives; in preparations intended for oral use
Vitamin B5 (Pantothenic acid), and its derivatives; in preparations intended for oral use
Vitamin B6 (Pyridoxine), and its derivatives; in preparations intended for oral use
Vitamin B12 (Cobalamin), and its derivatives; in preparations intended for oral use
Vitamins (except as specified elsewhere in the schedules), either alone or in combination, in preparations intended for oral use, in concentrations above the recommended dietary allowances.
Xylometazoline; in preparations intended for nasal administration
Yohimbe, alkaloids of, such as Yohimbine
Zinc pyrithione, in preparations intended for topical use
Herbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (unless expressly excluded or unless listed in another schedule) in preparations intended for topical or oral use; except as specified in class C. Any substances derived from any of the medicines referred to in this schedule, unless expressly excluded.
Class C drugs The following drugs, except such as are in a form suitable for administration by injection are the drugs included in this Schedule. They may be sold by retail only by a person or company operating as a licensed person or a licensed seller, but in the case of the latter only in accordance with the terms of his or her license.
Group I Acetylsalicylic acid and its salts:
(a)
in preparations intended for application on the skin
(b)
either alone or in combination with one or more drugs listed in this class, intended for oral use in concentrations ranging from 300 milligrams to 600 milligrams per dosage unit subject to a maximum daily dose of 2400 milligrams subject to a maximum treatment period of 5 days.
Acyclovir and its salts, in preparations intended for topical use
Albendazole in preparations intended for oral use
Ammonium chloride, except as specified in group I of this class Amoxicillin, its salts; in preparations intended for oral use Amylmetacresol
Antacid preparations containing compounds such as;
Anti histamines as listed in class B group II but only when contained in preparations for external application only other than for the eyes or nose and in preparations containing not less than 1 percent
Antibiotics, when contained in preparations or concentrates for animal feedstuffs
Arsenic, in preparations containing less than the equivalent of 0.01 percentof arsenic trioxide, and dentifrices containing less than 0.5 percent of acetarsol
Artemether in combination with Lumefantrine, in oral preparations for parasitologically diagnosed uncomplicated malaria
Artesunate, in preparations intended for rectal administration
Benzalkonium, and its salts
Benzocaine, when contained in lozenge preparations
Benzyl benzoate for topical use
Boric acid for topical use
Brucine, when contained in surgical spirit containing not more than 0.2 percent of brucine
Caffeine, in combination with one or more other drugs listed in this class; in concentrations not exceeding 65 milligrams per dosage unit.
Camphor oils in preparations intended for topical use
Cetalkonium, and its salts
Chlorhexidine and its salts
Chloramphenicol in preparations formulated as eye/ear drops
Chloroform, in preparations containing not more than 0.5 percent w/v of chloroform
Dexpanthenol in preparations intended for topical use
Dextromethorphan when contained in oral preparations in concentrations not exceeding 10 milligrams per dosage unit or 0.2 percent w/v 2, 4 dichlorobenzyl alcohol
Diazepam, in preparations intended for rectal administration
Diclofenac when contained in preparations intended for topical use in concentrations not exceeding 1.16 percent w/w
Didecyl dimethyl ammonium chloride
Dioctyl dimethyl ammonium chloride enilconazole, for topical use
Erythromycin and its salts, in preparations intended for oral use
Ethanol, in concentrations exceeding 70 percent w/v in preparations intended for oral or topical use
Ethinyl estradiol when used in combination with levonorgestrel in oral preparations intended for contraception
Ethylenediamine dihydroiodide V
Ferric and ferrous salts, and their combinations when contained in preparations for oral use
Fipronil V when used in spot-on solutions for topical use in concentrations not exceeding 10 percent w/v
Glutaraldehyde, when contained in topical preparations in concentrations not exceeding 10 percent w/w
Guaifenesin (Glyceryl guaiacolate)
Hyaluronic acid and its salts, when contained in topical preparations
Hydrocortisone either alone or in combination with one or more drugs in this class, in concentrations not exceeding 1 percent w/w in preparations intended for application to the skin.
Hydrogen peroxide solution for topical use
Hyoscyamine, in preparations containing less than 0.15 percent of hyoscyamine in preparations intended for topical use
(a)
when contained in preparations intended for application to the skin
(b)
as the only active therapeutic substance, in a solid dose form contained in packs not exceeding 20 dosage units for use in adults and children over 12 years of age where the recommended daily dose of ibuprofen does not exceed 1200 milligrams
(c)
when contained in oral liquid preparations as the only active therapeutic substance in packs not exceeding 100 millilitres in volume when intended for children over the age of 1 year but not exceeding 12 years; where the recommended daily dose of ibuprofen does not exceed 20 milligrams per kilogramme of body weight
(d)
in combination with one or more drugs listed in this Schedule, in a solid dose form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the recommended daily dose of ibuprofen does not exceed 1200 milligrams
Idoxuridine, when intended for application to the skin
Iodine tincture, for topical use
Ketoconazole, in preparations for topical use as shampoos in concentrations not exceeding 2 percent w/v
Levamisole and its salts for oral use
Lidocaine when contained in oral lozenges
Lindane for topical use liquid Paraffin
Liquorice root extact (Glycyrrhiza glabra) in preparations intended for use in the relief of the symptoms of mucus coughs and colds
Loperamide 2 milligrams oral formulations intended for short-term relief of non-infectious diarrhea.
Lozenges for common cold and cough
Malathion for topical use
Medroxyprogesterone acetate
Metacresol sulphonic acid for topical use
Methyl nicotinate for topical use
Methy salicylate in preparations for topical use
Methylated spirit (Denatured alcohol)
Moxidectin for topical use V
Multivitamin preparations intended for oral use, containing a combination of two or more of the following vitamins or their derivatives;
Naphazoline for nasal use
(a)
when intended for vaginal application in the initial treatment of vaginal candidiasis
(b)
when intended for application to the skin, nares, and external ear
(c)
when contained in preparations intended for oral administration Octyl 2-cyanoacrylate, when used as a wound barrier and closure adhesive.
Paracetamol in preparations intended for oral or rectal use:
(a)
as the only active substance in immediate release formulations containing not more than 500 milligrams per dosage unit, in pack sizes not exceeding 20 dosage units or in liquid preparations containing not more than 5 percent w/v in pack sizes not exceeding 100 millilitres
(b)
in combination with one or more drugs listed in this Schedule, in a solid dosage form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the cumulative daily dose of Paracetamol does not exceed 2000 milligrams
Phenylephrine, either alone or in combination with any other drug listed in this Schedule:
(a)
when contained in solid preparations intended for oral use, in concentrations not exceeding 10 milligrams per dosage unit
(b)
when contained in oral liquid preparations not exceeding 0.2 percent w/v
Pholcodine in preparations containing not more than 1 percent w/v of pholcodine
Povidone iodine, in topical preparations
Pseudoephedrine, either alone or in combination with one or more drugs listed in this Schedule, when contained in:
(a)
oral solid dosage forms in concentrations not exceeding 60 milligrams per dosage unit
(b)
oral liquid dosage forms in concentrations not exceeding 0.6 percent w/v
(a)
as the only active therapeutic substance contained in oral liquid preparations in concentrations not exceeding 0.04 percent w/v when used for relief of bronchospasm in bronchial asthma
(b)
when contained in oral solid preparations in concentrations not exceeding 4 milligrams per unit dose, when used for relief of bronchospasm in bronchial asthma
Salicylic acid, in preparations for topical application
Selenium Sulphide in topical preparations in concentrations not exceeding 2.5 percent w/v
Senna and its preparations
Sodium citrate when contained in oral cough preparations as a mucolytic agent
Sodium chloride when formulated alone in preparations intended for nasal administration
Sulfadiazine silver when intended for application to the skin in the shortterm treatment of minor bums, subject to a maximum pack size of 30 grams
Sulphur contained in preparations for topical administration
Syzygium aromaticum (clove oil) in preparations intended for topical use
Tetracaine when contained in lozenges in concentrations not exceeding 0.2 milligrams per dosage unit
Tetracycline ointment for ophthalmic use, in adults and children above 12 years of age
Tibezonium and its salts in preparations for topical use
Tolnaftate, intended for topical application
Triprolidine, either alone or in combination with any other drug listed in this Schedule when contained in:
(a)
oral solid dosage forms in concentrations not exceeding 2.5 milligrams per dosage unit
(b)
oral liquid dosage forms in concentrations not exceeding 0.025 percent w/v
Turpentine oils in preparations intended for application on the skin undecyclenic acid for topical application.
Vitamin A, in preparations for oral use
Vitamin C, in preparations intended for oral use
Wintergreen oil in preparations intended for topical use.
Zinc sulphate in preparations intended for oral administration
Herbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (except as specifically listed in the schedules) in preparations intended for -
(a)
topical application, where not indicated or otherwise associated with the management of any condition specified in Schedule 6 of this Act;
(b)
oral administration specifically intended for relief of mild to moderate coughs, flu, colds, pains and fever; and where not indicated or otherwise associated with the management of any condition specified in Schedule 6 of this Act.
Exempted drugs and articles The following drugs and articles are known as exempted drugs and articles.
Ammonia, substances containing less than five percent of ammonia, refrigerators.
Antimony, chlorides of, when contained in polishes
Batteries and accumulators
Chemicals not included in Class A, B or C when packed and labelled for culinary and cooking purposes
Creasote, obtained from coal tar
Dressings on seeds or bulbs
Fitters, fire extinguishers
Formaldehyde, when in photographic glasing or hardening solution
Laundry materials; blue, bleaches and starch
Motor fuels and lubricants
Nitrobenzene, when contained in polishes
Oxalic acid and metallic ozalates when contained in polishes and cleaning powders
Paints (other thin pharmaceutical paints)
Phenylmercuric salts, when used in a concentration not exceeding 0.01 percent in toilet and cosmetic preparations as a preservative or in textiles or antiseptic dressings as a bacteriostat or fungicide
Diseases as to which publication of descriptive matter is restricted or prohibited
