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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Schedules

Schedule 4

 

Schedule 4

 

(a) All substances referred to in this Schedule are excluded when specifically packed, labelled, sold and used for—
(i) industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose; and
(ii) analytical laboratory purposes.
(b) All preparations of substances or mixtures of such substances containing or purporting to contain any substance referred to in this Schedule and includes the following:
(ii) The salts and esters of such substances, where the existence of such salts and esters is possible; and
(iii) all preparations and mixtures of such substances where such preparations and mixtures are not expressly excluded.
(c) In terms of section 22A(5)(f) of the Act, a practitioner, nurse or a person registered  under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances and medicines and to the conditions determined by the Authority, to patients under his/her care, the Schedule 4 substances and medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.

 

(i) Annexure 1A: Emergency Care Provider (Paramedic);

Annexure 1B: Emergency Care Provider (Emergency Care Practitioner;

Annexure 1C: Basic Ambulance Assistant

Annexure 1D: Ambulance Emergency Assistant

Annexure 1E: Emergency Care Technician

Annexure 1F: Emergency Care Assistant

(ii) Annexure 2: Dental Therapist.
(iii) Annexure 3: Optometrist.
(iv) Annexure 4: Podiatrist.

 

 

Abacavir.

 

Abatacept.

 

Abciximab.

 

Abemeciclib.

 

Abiraterone.

 

Acalabrutinib.

 

Acarbose.

 

Acediasulfone.

 

Acetarsone diethylamine salt, when intended for injection.

 

Acyclovir, except when intended for application to the lips in the early treatment of recurrent Herpes simplex virus infections. (S1)

 

Adalimumab.

 

Adenosine.

 

Adrenaline, when intended for injection. (S2, S3)

 

Afatinib.

 

Agalsidase Alfa.

 

Agalside beta.

 

Aglepristone.

 

Alatrofloxacin.

 

Albendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Alclometasone.

 

Alcuronium.

 

Aldesleukin.

 

Alectinib

 

Alefacept.

 

Alemtuzumab.

 

Alfacalcidol.

 

Alfuzosin.

 

Alglucosidase alfa.

 

Alginic Acid, its salts and complexes thereof, when intended for use in gastric regurgitation, gastro-oesophageal reflux and reflux associated with hiatus hernia in infants and young children under the age of 6 years. (S0)

 

Alirocumab.

 

Alizapride.

 

Almitrine.

 

Alosetron.

 

Alpelisib.

Alphachymotrypsin (-chymotrypsin), when intended for ophthalmic use.

 

Alprostadil.

 

Alteplase (recombinant human tissue-type plasminogen activator) (r-tPA).

 

Altrenogest for use in animals.

 

Amantadine.

 

Ambrisentan.

 

Amethocaine - see Tetracaine.

 

Amifostine.

 

Amikacin.

 

Aminoacridine.

 

Aminoglutethimide.

 

Aminolevulinic.

 

Aminophenazone.

 

Aminopyrine (amidopyrine).

 

Aminosalicylic acid.

 

Amiodarone.

 

Amiphenazole.

 

Amodiaquine.

 

Amoxicillin.

 

Amphotericin B.

 

Ampicillin except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. (Act 36 of 1947)

 

Apremilast.

 

Amprenavir.

 

Amprolium, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947. (Act 36 of 1947)

 

Amrinone.

 

Amsacrine.

 

Anagrelide.

 

Anastrozole.

 

Anecortave.

 

Anidulafungin.

 

Anticoagulants, except preparations intended for application to the skin. (S1)

 

Antihemophilic factor.

 

Antimalarials, unless listed elsewhere in the Schedules.

 

Antimicrobial substances, natural or synthetic including substances purporting to be suitable for the treatmentof microbial infections unless listed elsewhere in the Schedules, and except—

(a) the following substances when intended for topical application to the epidermis, nares and external ear:
(i) bacitracin; (S1)
(ii) gramicidin; (S1)
(iii) griseofulvin; (S2)
(iv) mupirocin; (S2)
(v) natamycin; (S2)
(vi) polymyxin B; (S1)
(vii) tyrothricin: (S1)
(b) when intended for use as—
(i) disinfectants, being topical agents or preparations used to treat inanimate objects materials or surfaces, and that destroys or inhibits the growth of pathogenic micro-organisms so treated in the non-sporting or vegetative state, rendering them harmful to netierhhelath nor the quality of perishable goods; (S0)
(ii) antiseptics, being topical agents or preparations used on skin and other living tissues, and that destroys or inhibits the growth of pathogenic micro-organisms so treated in the non-sporing or vegetative state, protecting health and preventing infection; (S0) and
(iii) germicides, being topical agents or preparations used to treat inanimate objects, materials or surfaces and/or on skin and other living tissues, destroying or killing pathogenic micro-organisms so treated in the non-sporing or vegetative state, thereby protecting health, the quality of perishable goods, and preventing infection. (S0)

 

Antisera, unless listed elsewhere in the Schedules when intended for veterinary use, except antisera registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Apalutamide.

 

Apixaban.

 

Apomorphine, when indicated for the treatment of erectile dysfunction. (S2)

 

Apraclonidine.

 

Apramycin.

 

Apremilast.

 

Aprepitant.

 

Α-β arteether.

 

Aprotinin.

 

Arabinosylcytosine.

 

Arprinocid, except when intended and registered as an anticoccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Arsenamide, when intended for injection.

 

Arsenic:

(a) when intended for injection;
(b) except in oral dosage form. (S1, S2)

 

Artemether and its derivatives.

 

Artemisinin.

 

Artemotil.

 

Artensuate.

 

Atezolizumab.

 

Asciminib.

 

L-Asparaginase.

 

Astemizole.

 

Atanzanavir.

 

Atipamizole.

 

Atorvastatin.

 

Atosiban.

 

Atovaquine.

 

Atracurium besilate.

 

Atropine,

(a)        when intended for use in injections. (S2)

(b)        except when intended for use in ophthalmic preparations. (S3)

 

Auranofin.

 

Avilamycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947(Act 36 of 1947).

 

Avoparcin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947(Act 36 of 1947).

 

Axitinib.

 

Azacitidine.

 

Azathioprine.

 

Azithromycin.

 

Azlocillin.

 

Aztreonam.

 

Bacampicillin.

 

Bacitracin, except when intended for topical application to the epidermis, nares and external ear. (S1) and except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Baclofen.

 

Baloxavir.

 

Bambermycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Baricitinib.

 

Barium sulfate.

 

Basiliximab.

 

Bazedoxifene.

 

Beclomethasone dipropionate, except when intended for inhalation, or nasal administration. (S3)

 

Bedaquiline.

 

Bedinvetmab

 

Bee venom, except preparations intended for application to the skin. (S1)

 

Belatacep.

 

Belimumab.

 

Bemegride.

 

Bemiparin.

 

Bendamustine.

 

Benethamine penicillin.

 

Benralizumab.

 

Benzathine benzylpenicillin.

 

Benzathine phenoxymethylpenicillin.

 

Benzocaine,

(a) when intended for ophthalmic or parenteral use;
(b) except in lozenges containing 30 mg or less of benzocaine, per dosage unit; (S1)
(c) except when intended for topical use; (S1)
(d) except in preparations containing 2 % or less of benzocaine. (S1)

 

Benzylpenicillin.

 

Besifloxacin.

 

Betamethasone.

 

Bethanechol.

 

Betiatide.

 

Bevacizumab.

 

Bicalutamide.

 

Bictegravir.

 

Bifonazole, except when intended for application to the skin. (S1)

 

Bimatoprost.

 

Biolimus.

 

Biological medicines, injectable preparations thereof, when intended for human use and unless listed elsewhere in the Schedules,

(a) except vaccines, when listed elsewhere in the Schedules and vaccines registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
(b) but specifically including the following—
(i) Equine anti-human thymocyte globulin;
(ii) Equine gamma globulin;
(iii) Human anti-D immunoglobulin;
(iv) Human anti-thymocyte rabbit immunoglobulin;
(v) Hepatitis A vaccine;
(vi) Hepatitis B immunoglobulin;
(vii) Human normal immunoglobulin, possibly polyvalent or possibly including IgG, IgA, or IgM;
(viii) Human plasmaalbumin;
(ix) Neiserria meningitides vaccine;
(x) Pneumococcal vaccine, polysaccharide;
(xi) Rabies immunoglobulin;
(xii) Rabies vaccine;
(xiii) Recombinant cholera toxin B subunit;
(xiv) rhDNase-dornase alfa;
(xv) Snake antivenom;
(xvi) Tetanus immunoglobulin;
(xvii) Varicella immunoglobulin;
(xviii) Varicella-zoster virus vaccine;
(xix) Yellow Fever virus, attenuated.

 

Biperiden.

 

Bleomycin.

 

Boceprevir.

 

Bortezomib.

 

Botulinum toxin.

 

Brentuximab.

 

Bretylium tosylate.

 

Brigatinib.

 

Brolucizumab.

 

Bromocriptine.

 

Budesonide,

(a) except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S2)
(b) except when intended for inhalation or nasal administration, unless listed in another Schedule. (S3)

 

Bufenoide.

 

Bumadizone.

 

Bupivicaine.

 

Buserelin.

 

Busulphan.

 

Butoconazole, except—

(a) when intended for application to the skin; (S1) and
(b) when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

 

Cabazitaxel.

 

Cabergoline.

 

Cabotegravir.

 

Cabozantinib.

 

Calcitonin.

 

Calcitriol.

 

Calcium,

(a) when indicated for the treatment of hyperphospatemia; (S0)
(b) except in oral preparations or mixtures containing more than1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
(c) except in preparations thereof for injection; (S3)
(d) except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Cambendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Canakinumab.

 

Candicidin.

 

Cannabidiol, except—

(a) in complementary medicines containing no more than 600 mg cannabidiol per sales pack, providing a maximum daily dose of 20mg of cannabidiol, and making a general health enhancement, health maintenance or relief of minor symptoms (low-risk) claim, (S0) or
(b) processed product made from cannabis raw plant material intended for ingestion containing 0,00075 percent of less of cannabidiol where only the naturally occurring quantity of cannabinoids found in the source material are contained in the product. (S0)

 

Capecitabine.

 

Capreomycin.

 

Capsaicin, when intended for transdermal application.

 

Carbachol, except ophthalmic preparations thereof, when intended for glaucoma. (S3)

 

Carbadox, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Carbenicillin, when intended for therapeutic purposes. (S7).

 

Carbetocin.

 

Carbidopa.

 

Carboplatin.

 

Carbuterol, when intended for injection. (S2, S3)

 

Carfilzomib.

 

Carglumic.

 

Carmustine.

 

Carnidazole, except when listed elsewhere in the Schedules and except injections thereof intended for use in pigeons and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Casirivimab.

 

Casopitant.

 

Caspofungin.

 

Catridecacog.

 

Cefaclor.

 

Cefadroxil.

 

Cefalexin.

 

Cefaloridine.

 

Cefalosporin.

 

Cefalotin.

 

Cefamandole.

 

Cefazolin.

 

Cefepime.

 

Cefixime.

 

Cefmetazole.

 

Cefodizime.

 

Cefonicid.

 

Cefoperazone.

 

Cefotaxime.

 

Cefotetan.

 

Cefovecin.

 

Cefoxitin.

 

Cefpirome.

 

Cefpodoxime.

 

Cefprozil.

 

Cefquinome.

 

Cefradine.

 

Cefsulodin.

 

Ceftaroline.

 

Ceftazidime.

 

Ceftibuten.

 

Ceftiofur.

 

Ceftizoxime.

 

Ceftobiprole.

 

Ceftolozane.

 

Ceftriaxone.

 

Cefuroxime.

 

Cefalotin.

 

Ceritinib.

 

Cerivastatin.

 

Certoparin.

 

Ceruletide.

 

Cetrorelix.

 

Cetuximab.

 

Chlorambucil.

 

Chloramphenicol.

 

Chlormadinone.

 

Chloroquine.

 

Choriogonadotropin alfa.

 

Chlorquinaldol.

 

Chlortetracycline, except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Chorionic gonadotrophin

 

Chymopapain, when intended for injection.

 

Ciclacillin.

 

Ciclosporin.

 

Cilastatin.

 

Cinacalcet.

 

Cinoxacin.

 

Ciplofloxacin.

 

Ciprofloxacin

 

Cisapride.

 

Cisatracurium.

 

Cisplatin.

 

Cladribine.

 

Clanobutin.

 

Clarithromycin.

 

Clavulanic acid.

 

Clazuril, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Clemizole penicillin.

 

Clenbuterol.

 

Clioquinol.

 

Clindamycin.

 

Clobetasol.

 

Clobetasone.

 

Clodantoin.

 

Clofazimine.

 

Clomifene.

 

Cloprostenol, when intended for veterinary use.

 

Closantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Clotrimazole, except when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of the current vaginal candidiasis. (S1)

 

Cloxacillin, except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Cobicistat.

 

Cobimetinib.

 

Colfosceril.

 

Colistimethate.

 

Colistin,

(a) when presented as a finished pharmaceutical product; and
(b) except when compounded by a pharmacist in terms of Section 14(4) of the Act, by a veterinarian, or by a holder of a Section 22C(1)(a) licence, or presented as the raw material. (S6)

 

Contrast media, unless listed elsewhere in the Schedules.

 

Copper,

(a) in preparations thereof for injection; (S0)
(b) except in oral preparations or mixtures containing more than 4 mg of Copper per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1)

 

Corifollitropin alfa.

 

Corticosteroids (natural or synthetic), unless listed elsewhere in the Schedules, except—

(a) hydrocortisone and hydrocortisone acetate when used as a single active ingredient in a maximum concentration of 1,0 per cent in preparations intended for application to the skin; (S2)
(b) triamcinolone when intended for application to oral lesions; (S2) and
(c) when contained in preparations intended for nasal administration. (S2, S3)

 

Co-tetroxazine.

 

Co-trifamole.

 

Co-trimoxazole.

 

Crisaborole.

 

Crizotinib.

 

Crisanlizumab.

 

Cyclofenil.

 

Cyclophosphamide and its derivatives, unless listed in another Schedule.

 

Cycloserine.

 

Cyprenorphine.

 

Cyproterone acetate.

 

Cytarabine.

 

Dabigatran

 

Dabrafenib.

 

Dacarbazine.

 

Dacliximab.

 

Dacomitinib.

 

Daclizumab.

 

Dactinomycin.

 

Dalteparin.

 

Danaparoid.

 

Danofloxacin.

 

Dantrolene.

 

Dapagliflozin.

 

Dapivirine

 

Dapsone and its derivatives, unless listed in another Schedule.

 

Daptomycin.

 

Darbepoetin Alfa

 

Darolutamide.

 

Darunavir.

 

Dasatinib.

 

Daunorubicin.

 

Decitabine.

 

Deconexent (DHA) 380, when indicated for the treatment of hypertriglyceridaemia.

 

Decoquinate, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Deferasirox.

 

Deferipone.

 

Deferoxamine.

 

Degarelix.

 

Demecarium.

 

Demeclocycline.

 

Denosumab.

 

Desirudin.

 

Deslorelin.

 

Desonide.

 

Desmopressin.

 

Desoximetasone.

 

Dexamethasone.

 

Dexlansoprazole.

 

Diatrizoic acid.

 

Diazoxide.

 

Dichlorophen,

(a) except in preparations and mixtures when intended for application to the skin; (S0)
(b) except in preparations containing 0,5 percent or less of dichlorophen when intended for when intended for use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act 54 of 1972);
(c) except when intended for use and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Diclazuril, except when intended registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Diclodronic acid.

 

Dicloxacillin.

 

Didanosine.

 

Diethylcarbamazine.

 

Diflorasone.

 

Difloxacin.

 

Diflucortolone.

 

Dihydralazine.

 

Dihydrostreptomycin except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Dihydrotachysterol.

 

Diiodohydroxyquinoline, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Di-isopropyl fluorophosphate.

 

Dilazep.

 

Diloxanide furoate.

 

Dimethyl fumarate.

 

Dimethyl sulphoxide.

 

Dimetridazole, except when listed elsewhere in the Schedules and except when intended for use in pigeons, as an anti-spirochaete preparation for pigs and to promote growth in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Diminazene, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Dinitolmide, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Dinitrophenol.

 

Dinoprostone.

 

Diphemethoxidine.

 

Diphenidol.

 

Disophenol, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Disopyramide.

 

Distigmine.

 

Ditazole.

 

Dobutamine.

 

Docetaxol.

 

Dolasetron.

 

Dolutegravir.

 

Domperidone.

 

Dopa.

 

Dopamine.

 

Doravirine.

 

Doripenem.

 

Doxapram.

 

Doxepin, when intended for application to the skin. (S5)

 

Doxorubicin.

 

Doxycycline, except

(a) when intended and labelled for the chemoprophylaxis of malaria in those aged 8 years and older; (S2)
(b) in preparations thereof for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Dronedarone.

 

Drospirenone,

(a) when intended for hormone replacement therapy;
(b) except when intended for oral contraception. (S3)

 

Drotrecognin.

 

Dulaglutide.

 

Durvalumab.

 

Dutasteride.

 

Dydrogesterone.

 

Econazole, except—

(a) when intended for application to the skin; (S1) and
(b) when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis (S1)

 

Edoxudine.

 

Edrophonium.

 

Efalizumab.

 

Efavirenz.

 

Efraloctocog alfa.

 

Eicosapent (EPA) 460, when indicated for the treatment of hypertriglyceridaemia.

 

Eletriptan.

 

Eltrombopag.

 

Elvitegravir.

 

Emetine, except substances, preparations and mixtures containing less than 0,2 percent of alkaloids, calculated as emetine.

 

Empagliflozin.

 

Emtricitabine

 

Encainide.

 

Enilconazole, except when intended for application to the skin. (S1)

 

Enoxacin.

 

Enoxaparin.

 

Enramycin, except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Enrofloxacin.

 

Entacapone.

 

Entecavir.

 

Entrectinib.

 

Enzalutamide.

 

Epicillin.

 

Epinephrine, when intended for injection. (S2, S3)

 

Epirizole.

 

Epirubicin (4-epidoxorubicin).

 

Eplerenone.

 

Epoetin beta, polyethylene glycol.

 

Eptacog alfa.

 

Eptifibatide.

 

Erenumab.

 

Ergometrine maleate.

 

Ergot alkaloids (natural or synthetic); except preparations and mixtures thereof when intended for the treatment of migraine. (S2)

 

Eribulin.

 

Erlotinib.

 

Ertapenem.

 

Etravirine.

 

Erythromycin

 

Esomeprazole.

 

Estriol,

(a) when intended for hormone replacement therapy;
(b) when intended for veterinary use;
(c) except when intended for oral contraception; (S3)
(d) except when intended for human vaginal use; (S2)

 

Estramustine.

 

Etamiyan.

 

Etanercept.

 

Etelcalcetide.

 

Etidronic acid.

 

Etiproston.

 

Ethambutol.

 

Ethionamide.

 

Ethopabate, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Etofamide.

 

Etoglucid.

 

Etoposide.

 

Everolimus.

 

Evolocumab.

 

Exemestane.

 

Ezetimibe.

 

Famciclovir.

 

Famotidine, except when intended for the short term symptomatic relief of heartburn caused by excess acid, where the maximum dose is 10 milligrams, the maximum daily dose (per 24 hours) is 20 milligrams and the maximum treatment period is 2 weeks. (S2)

 

Fampridine.

 

Faricimab.

 

Fazadinium.

 

Febantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Fenchlorphos, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Fenoldopam.

 

Fenoterol, when intended for the prevention or delay of labour and preparations thereof for injection. (S2, S3)

 

Fenticonazole.

 

Fertirelin.

 

Ferucarbitran.

 

Fidaxomicin.

 

Filgrastim.

 

Finasteride.

 

Fingolimod.

 

Flecainide.

 

Florfenicol.

 

Flosequinan.

 

Flucloxacillin.

 

Fluconazole.

 

Flucytosine.

 

Fludarabine.

 

Fludrocortisone acetate.

 

Flugestone.

 

Flumethasone.

 

Flunisolide, except when intended for inhalation or nasal administration. (S2, S3)

 

Fluocinolone.

 

Fluocinonide.

 

Fluocortolone.

 

Fluorides,

(a) except in oral medicinal preparations or mixtures intended for ingestion containing not more than 0,25 milligrams of fluorine per dosage unit; (S1)
(b) except in toothpaste containing nor more than 0,15 percent fluoride; (S0) and
(c) except in mouth rinses containing not more than 0,15 percent fluoride. (S0)

 

Fluorometholone.

 

5-Fluorouracil.

 

Fluprednidene.

 

Flurbiprofen,

(a) when intended for ophthalmic use; (S4)
(b) except when in the form of lozenges, indicated for the relief of pain associated with sore throats, subject to:
(i) a maximum of 8.75 milligrams per lozenge;
(ii) a maximum treatment period of 3 days; and
(iii) a maximum pack size of 15 lozenges. (S1)
(c) except when intended for application to the skin, provided that in the case of application by transdermal patch:
(i) use is restricted to adults and children 12 years and older; and
(ii) the treatment period is limited to a maximum of 4 weeks. (S0)
(d) except when intended for the treatment of post-traumatic conditions, for a maximum period of 5 days; (S2).

 

FIutamide.

 

Fluticasone furoate, except

(a) when intended for nasal administration, as an aqueous spray, in the short-term (less than 6 months) prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to—

(i)        a maximum daily dose of 55 micrograms per nostril; and

(ii)        a maximum pack size limit of 120 doses. (S2.)

(b)        when intended for inhalation or nasal administration. (S3)

 

Fluticasone propionate, except

(a) when intended for nasal administration as an aqueous spray, in the short-term (less than 6 months prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and  children over 12 years of age, subject to—

(i)        a maximum daily dose of 100 micrograms per nostril; and

(ii)        a maximum pack size of 120 doses. (S2)

(b)        when intended for inhalation or nasal administration. (S3)

 

Fluvastatin.

 

Follitropin alfa.

 

Follitropin delta.

 

Fondaparinux.

 

Formoterol.

 

Fosamprenavir.

 

Fosaprepitant.

 

Fosfomycin.

 

Fosphenytoin sodium.

 

Fotemustine.

 

Framycetin.

 

Fremanezumab.

 

Frovatriptan.

 

Ftorafur.

 

Fulvestrant.

 

Furaltadone, except when listed elsewhere in the Schedules and except when intended as a single oral dosage for gastro-intestinal infections and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Furazolidone.

 

Fusidic acid, except when intended for topical application. (S2)

 

Gadobutrol.

 

Gadodiamide.

 

Gadofosveset.

 

Gadoversetamide.

 

Galactose, when used as a contrast agent.

 

Galantamine.

 

Galcanezumab.

 

Gallamine.

 

Gamithromycin.

 

Gamma benzene hexachloride, except when intended to be used for the second line treatment of lice in a pack size not exceeding 60ml. (S2)

 

Ganciclovir.

 

Ganirelix.

 

Gatifloxacin.

 

Gefitinib.

 

Gemcitabine.

 

Gemifloxacin.

 

Gemtuzumab.

 

Gentamicin.

 

Gestrinone.

 

Glatiramer.

 

Glucagon.

 

Glycosaminoglycan polysulphate (previously mucopolysaccharide poly-sulphuric acid ester), except when intended for application to the skin. (S1)

 

Golimumab.

 

Gonadorelin.

 

Goserelin.

 

Gramicidin except when intended for topical application to the epidermis, nares and external ear. (S1)

 

Granisetron.

 

Granulocyte Colony Stimulating Factor (G-CSF).

 

Grepafloxacin.

 

Griseofulvin except when intended for topical application to the epidermis, nares and external ear. (S2)

 

Guselkumab.

 

Halcinonide.

 

Halofantrine.

 

Halofenate.

 

Halofuginone, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Halogenated hydroxyquinolines, except when intended for application to the skin (S2).

 

Halometasone.

 

Halquinol.

 

Hemin.

 

Heparin.

 

Heptaminol.

 

Hexoprenaline, when intended for the prevention or delay of labour and preparations thereof for injection. (S2, S3)

 

Histrelin.

 

Hormones (natural or synthetic, including recombinant forms), with either hormonal or anti-hormonal action, unless listed in another Schedule, except—

(a) when specifically intended for emergency postcoital contraception (S2);
(b) when intended for oral contraception; (S3);
(c) insulin (S3);
(d) epinephrine (S2, S3, S4);
(e) corticotrophin (adrenocorticotrophichormone; ACTH) (S5);
(f) Human growth hormone (human somatotropin) - all forms (S5);
(g) zeranol, natural estrogen, and progesterone, when intended and registered as a veterinary production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947);
(h) BST (Bovine somatotropin), when intended and registered as a production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Human coagulation factors.

 

Human fibrinogen, when indicated for use as a haemostatic.

 

Human normal immunoglobulin

 

Human Plasma.

 

Human thrombin, when indicated for use as a haemostatic.

 

Hyaluronidase.

 

Hyaluronic acid and its salts,

(a) when intended for parenteral use;
(b) except when intended for use with contact lens solutions or as an ophthalmic lubricant in concentrations of not more than 0,1 percent; (S0)
(c) except when intended for topical application to the skin; (S1)
(d) except when intended for ophthalmic use in preparations (except injectables) containing more than 0,1 percent; (S2)
(e) except in preparations containing less than 2,5 percent when intended for topical use in terms of the provisions of the Foodstuffs, Cosmetics and Disinfectants Act. 1972 (Act 54 of 1972).

 

Hycanthone.

 

Hydroxycarbamide. (Hydroxyurea)

 

Hydroxychloroquine.

 

lbandronic acid.

 

Ibuprofen,

(a) when intended for the treatment of haemodynamically significant patent ductus arteriosus in infants less than 34 weeks of gestational age;
(b) except when contained in preparations intended for application to the skin; (S1)
(c) except when contained in oral medicinal preparations supplied in a solid dose form as divided doses contained in packs not exceeding 24 dosage units or divided doses and containing ibuprofen as the only active therapeutic substance, intended for the treatment of mild to moderate pain or fever of inflammatory origin or for the treatment of post-traumatic conditions in adults and children over 12 years of age when the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children 12 years and older does not exceed 20 milligrams per kilogram of body weight; (S1)
(d) except when contained in oral medicinal preparations intended for human use only, in combination with one or more other active therapeutic substances and intended for the treatment of mild to moderate pain or fever of inflammatory origin for a maximum treatment period of days the recommended daily dose of ibuprofen in the case of adults does not exceed 1,2 grams and in children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
(e) except when contained in oral medicinal preparations, intended for human use only, as the only active therapeutic substance in oral liquid preparations in packs not exceeding 100 millilitres in volume or in oral solid preparations in packs exceeding 24 dosage units or divided doses, when intended for adults and children over the age of 1 year; for the treatment of mild to moderate pain of inflammatory origin for a maximum treatment period of 10 days, or for the treatment of fever of inflammatory origin or for the treatment of post- traumatic conditions where the recommended daily dose of ibuprofen for adults does not exceed 1,2 grams and for children over the age of 1 year and up to and including the age of 12 years does not exceed 20 milligrams per kilogram of body weight; (S2)
(f) except for the emergency treatment of acute gout attacks for a maximum treatment period of 5 days; (S2)

(g)        except when intended for veterinary use. (S3)

 

Ibutilide.

 

Ibritumomab.

 

Ibrutinib.

 

Icatibant.

 

ldarubicin.

 

Idarucizumab.

 

Idebenone.

 

Idoxuridine, except when intended for application to the skin. (S1)

 

Idursulfase.

 

Ifosfamide.

 

Iloprost.

 

Imdevimab.

 

Imatinib.

 

Imidocarb, except when intended and registered as an antibabesial for the treatment of babesiosis in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Imiglucerase.

 

Imiquimod.

 

Imipenem.

 

Inclisiran.

 

Indacaterol.

 

Indinavir.

 

Indium chloride pentetreotide.

 

Infliximab.

 

Ingenol mebutate.

 

Inosine pranobex.

 

Interferon alpha.

 

Interferon beta.

 

Interferon gamma.

 

Intra-uterine devices.

 

Intra-uterine systems, drug eluting, unless listed elsewhere in the Schedules.

 

Intrifiban.

 

Iobitridol.

 

Iocarmic acid.

 

Iodamide sodium.

 

Iodised oil, when used as a contrast agent.

 

Iodixanol.

 

Iofendylate.

 

Ioglicic acid.

 

Iohexol.

 

Iomeprol.

 

Iopamidol.

 

Iopanoic acid.

 

Iopromide.

 

Iotalamate sodium.

 

Iotrolan.

 

Ioversol.

 

Ioxitalamic acid.

 

Ioxoglate sodium.

 

Ipilimumab.

 

Irinotecan.

 

lsepamicin.

 

Isoconazole, except when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

 

Isoniazid

 

Isopirin.

 

Isoprenaline (isoproterenol), when intended for injection. (S2, S3)

 

Isoxsuprine.

 

Itopride.

 

Itraconazole.

 

Ixabelipone.

 

Ixekizumab.

 

Josamycin.

 

Kanamycin.

 

Ketoconazole, except—

(a) preparations and mixtures containing not more than 1,0 per cent of ketaconazole, when intended for the prevention and treatment of dandruff; (S0) or
(b) except when intended for application to the skin. (S0, S1)

 

Ketorolac, except when intended for ophthalmic use (S3)

 

Lamivudine.

 

Lanreotide.

 

Lansoprazole, except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to—

(a) a maximum daily dose of 15mg (S2); and
(b) a maximum treatment period of 14 days. (S2).

 

Lanthanum.

 

Lapatinib.

 

Laronidase.

 

Laropiprant.

 

Lasalocid, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Latamoxef.

 

Latanoprost.

 

Ledipasvir.

 

Leflunomide.

 

Lenalidomide.

 

Lenograstim.

 

Lenvatinib.

 

Lepirudin.

 

Lesinurad.

 

Letermovir.

 

Letrozole.

 

Leuprolide acetate.

 

Levallorphan.

 

Levamisole, except when intended and registered as an anthelmintic and an immunomodulator in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Levobupivacaine.

 

Levodopa.

 

Levofloxacin.

 

Levonorgestrel,

(a) when administered via an Intra-Uterine System;
(b) except when intended for oral contraception; (S3)
(c) except when intended for emergency post coital contraception. (S2)

 

Levosimendan.

 

Liarozole.

 

Lidocaine,

(a) when intended for ophthalmic or parenteral use;
(b) when intended for the treatment of neuropathic pain associated with previous herpes zoster infection;
(c) except when intended for topical use; (S1)
(d) except in oral preparations containing 2% or less of lidocaine per dosage form. (S1)

 

Lignocaine, see Lidocaine.

 

Linagliptin.

 

Lincomycin.

 

Linezolid.

 

Lipegfilgrastim.

 

Liraglutide.

 

Lixisenatide.

 

Local anaesthetics, when intended for ophthalmic and parenteral use—

(a) when intended for topical use; (S1)
(b) oxybuprocaine, proxymetacaine and tetracaine, when contained in eye drops intended for emergency treatment of "arc eyes"

 

Lokivetmab.

 

Lomefloxacin.

 

Lomustine.

 

Lopinavir.

 

Loracarbef.

 

Loteprednol.

 

Lovastatin.

 

Lumefantrine.

 

Luprositol, when intended for veterinary use.

 

Lutropin alfa.

 

Lymecycline.

 

Lysozyme, except preparations and mixtures when intended for application to the skin.  (S1)

 

Macitentan.

 

Maduramicin, except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Mafenide.

 

Mangafodipir trisodium.

 

Mandelic acid.

 

Maraviroc.

 

Marbofloxacin.

 

Maropitant, when intended for veterinary use.

 

Mavacoxib.

 

Mecamylamine.

 

Mecillinam.

 

Medical gases, when used in combination with nitrous oxide, but excluding such medical gasses when used alone or in combinations that exclude nitrous oxide. (S0)

 

Medroxyprogesterone.

 

Mefloquine.

 

Meglumine diatrizoate.

 

Meglumine gadobenate.

 

Meglumine gadoterate.

 

Meglumine iodipamide.

 

Meglumine ioglycamate.

 

Meglumine iotalamate.

 

Meglumine iotroxate.

 

Meglumine pentetate.

 

Melagatran.

 

Melarsoprol.

 

Melatonin, except when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6 mg daily. (S2)

 

Melphalan and its derivatives, unless listed in another Schedule.

 

Memantine.

 

Menotrophin.

 

Mepacrine.

 

Mephentermine.

 

Mepirizole.

 

Mepivicaine.

 

Meropenem.

 

6-mercaptopurine and its derivatives, unless listed in another Schedule.

 

Mercury; preparations and mixtures that contain mercury metal and that are intended for medicinal use.

 

Mesna, when intended for injection. (S2)

 

Metaproterenol (orciprenaline), when intended for the prevention or delay of labour, and preparations thereof for injection. (S2, S3)

 

Metergoline.

 

Methacholine.

 

Methampyrone (dipyrone).

 

Methenamine (hexamine), except when intended for application to the skin. (S1)

 

Methotrexate.

 

Methoxsalen.

 

Methyl-5-aminolevulinate.

 

Methylnaltrexone.

 

Methylprednisolone.

 

Methysergide.

 

Metoclopramide.

 

Metomidate.

 

Metrizoic acid.

 

Metronidazole, except when

(a) intended and registered for use in pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947) and
(b) intended for human vaginal use, specifically for the treatment of recurrent bacterial vaginosis. (S2)

 

Mexiletine.

 

Mezlocillin.

 

Micafungin.

 

Miconazole,

(a) except when intended for application to the skin; (S1) and
(b) except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1)
(c) except when 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) (S2).

 

Mifamurtide.

 

Mifepristone.

 

Miglitol.

 

Miglustat.

 

Milrinone.

 

Miltefosine.

 

Minocycline.

 

Minoxidil, except when intended for application to the scalp in preparations containing not more than 2 percent (m/v) and which are registered in terms of the Act. (S2)

 

Misoprostol.

 

Mitomycin C.

 

Mitoxantrone.

 

Mivacurium.

 

Mizolastine.

 

Mofebutazone.

 

Molgramostim.

 

Molnupiravir.

 

Mometasone furoate, except when intended for inhalation or nasal administration. (S2, S3)

 

Monensin, except when listed elsewhere in the Schedules and except when intended and registered as a anti-coccidial preparation and as a feed additive for growth promotion in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Moracizine.

 

Morazone.

 

Morinamide promolate.

 

Morphethylbutyne.

 

Moxifloxacin.

 

Mucoglucuronan.

 

Mupirocin, except when intended for topical application to the epidermis, nares and external ear. (S2)

 

Muromonab.

 

Mycophenolic acid.

 

Mycoplasma gailisepticum (Strain F) vaccine, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Nadroparin.

 

Nalidixic acid.

 

Nalorphine.

 

Naloxone.

 

Naltrexone.

 

Narasin except when listed elsewhere in the Schedules and except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Naratriptan.

 

Natalizumab.

 

Natamycin, except when intended for topical application to the epidermis, nares and external ear. (S2)

 

Nefopam.

 

Nelfinavir.

 

Neomycin, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Neostigmine.

 

Neotizide.

 

Neratinib.

 

Netilmicin.

 

Netupitant.

 

Nevirapine.

 

Niacin (Nicotinic Acid) and derivatives thereof,

(a) when intended for hypercholesterolaemia and for the management of dyslipidaemias; (S0)
(b) except in oral preparations or mixtures containing more than 35 mg of Niacin per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S1)

 

Nicarbazin, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Nicorandil.

 

Nifuratel.

 

Nifuroxazide.

 

Nifurtoinol.

 

Nikethamide.

 

Nilotinib.

 

Nilutamide.

 

Nimesulide.

 

Nimorazole.

 

Nimotuzumab.

 

Nimustine.

 

Nintedanib.

 

Niridazole.

 

Nitrofurantoin, except preparations thereof intended for application to the skin. (S1)

 

Nitrofurazone, except when intended for application to the skin. (S1)

 

Nitrofural, except preparations thereof intended for application to the skin. (S1)

 

Nitrous oxide, alone or in combination with other gases.

 

Nitrovin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Nitroxoline.

 

Nitroxnil, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Nivolumab.

 

Nizatidine, except when intended for oral administration for short-term symptomatic relief of heartburn and hyperacidity, where the maximum dose is 150 milligrams, the maximum daily dose is 300 milligrams and the maximum treatment period is two weeks. (S2)

 

Nomegestrol.

 

Noradrenaline (norepinephrine)

 

Norethisterone,

(a) when intended for parenteral use as a contraceptive;
(b) when intended for hormone replacement therapy;
(c) except when intended for oral contraception. (S3)

 

Norfloxacin.

 

Norgestrel,

(a) when intended for hormone replacement therapy;
(b) except when intended for oral contraception. (S3)

 

Novobiocin.

 

Nystatin,

(a) when intended for systemic use or the initial treatment of vaginal candidiasis;
(b) except when presented as oral drops containing not more than 100 000 I.U. per millilitre; (S2)
(c) except when intended for application to the skin, (S1) and
(d) except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, (S1)
(e) except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Obidoxime.

 

Obinutuzumab.

 

Ocrelizumab.

 

Ocriplasmin.

 

Octogog alfa.

 

Octreotide.

 

Ofloxacin.

 

Olaquindox, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Olaratumab.

 

Oleandomycin.

 

Olodaterol.

 

Oloparib.

 

Omeprazole, except when intended for the temporary, short-term relief of heartburn and hyperacidity, subject to:

(a) a maximum daily dose of 20 mg;
(b) a maximum treatment period of 14 days. (S2)

 

Ondansetron.

 

Oprelvekin.

 

Orbifloxacin.

 

Ornidazole, except when intended for application to the skin. (S1)

 

Ornipressin.

 

Osaterone, when intended for veterinary use.

 

Oseltamivir.

 

Osimertinib.

 

Oxacillin.

 

Oxaliplatin.

 

Oxamniquine.

 

Oxetacaine (Oxethazaine),

(a) when intended for ophthalmic or parenteral use;
(b) except in oral preparations containing an antacid. (S1)

 

Oxolinic acid.

 

Oxybuprocaine,

(a) when intended for ophthalmic or parenteral use;
(b) except when contained in eye drops intended for emergency treatment of "arc eyes". (S2)

 

Oxyclozanide, except when intended and registered as an anthelmintic  in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies Stock and Remedies Act, 1947.

 

Oxyphenbutazone, except when intended and registered for the synchronization of oestrus in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Oxytetracycline, except when listed elsewhere in the Schedules and except preparations thereof for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Oxytocin.

 

Paclitaxel.

 

Palivizumab.

 

Palonosetron.

 

Pamidronate disodium.

 

Pamidronic acid.

 

Pancuronium.

 

Panituzumab.

 

Panobinostat.

 

Pantoprazole, except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:

(a) a maximum daily dose of 20 milligrams (S2); and
(b) a maximum treatment period of 14 days. (S2)

 

Paricalcitrol.

 

Pasireotide.

 

Pazopanib.

 

Pegfilgrastim.

 

Peginterferon alpha.

 

Peginterferon beta 1a.

 

Pembrolizumab.

 

Pemetrexed.

 

Penciclovir, except when intended for application to the lips in the early treatment of recurrent Herpes simplex virus infections. (S1)

 

Penethamate hydriodide, except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Penicillamine.

 

Pentamidine.

 

Pentostatin.

 

Perfluorooctane, when intended for intraocular use. (S2)

 

Pergolide.

 

Perhexiline.

 

Pertuzumab.

 

Phenacetin, except preparations and mixtures intended for external use and containing not more than 0,1 percent phenacetin as stabilizer.

 

Phenamidine, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Pheneticillin.

 

Phenindione.

 

Phenopyrazone.

 

Phenoxybenzamine.

 

Phenoxymethylpenicillin, except when intended for the prophylaxis of rheumatic fever. (S3)

 

Phenylephrine

(a) when intended for injection;
(b) except ophthalmic preparations containing 0,2 percent or less. (S0)
(c) except for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent (S1).

 

Phospholipids when intended for parenteral administration. (S0)

 

Phthalylsulfathiazole.

 

Physostigmine, except ophthalmic preparations thereof when intended for glaucoma.  (S3)

 

Picrotoxin.

 

Pilocarpine, except ophthalmic preparations thereof intended for glaucoma. (S3)

 

Pimecrolimus

 

Pimobendan.

 

Pipemidic acid.

 

Piperacillin, anhydrous.

 

Pirenzepine.

 

Pirfenidone.

 

Piribedil.

 

Pirlimycin.

 

Piromidic acid.

 

Pivampicillin.

 

Pivmecillinam.

 

Pixantrone.

 

Plerixafor.

 

Podophyllum resin; preparations and mixtures containing more than 20 per cent of podophyllum resin. (S1)

 

Polatuzumab.

 

Polydimethysiloxane, see Silicone oil.

 

Polyglycerylene-dextran.

 

Polymixin B, except when intended for topical application to the epidermis, nares and external ear. (S1)

 

Polynoxylin.

 

Polysterene sulfonic acid when intended for therapeutic purposes.

 

Pomalidomide.

 

Poractant alpha.

 

Posaconazole.

 

Potassium dichromate, except preparations and mixtures containing not more than 15 micrograms of potassium dichromate per dosage unit.

 

Pradofloxacin, when intended for veterinary use.

 

Pralidoxime.

 

Pralsetinib.

 

Pramipexole.

 

Prasugrel

 

Pravastatin.

 

Praziquantel, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Prednisolone.

 

Pretomanid.

 

Prilocaine,

(a) when intended for ophthalmic or parenteral use; (S4)
(b) except in topical preparations containing 10% or less of prilocaine. (S1)

 

Primaquine.

 

Procainamide.

 

Procaine benzylpenicillin, except when listed elsewhere in the Schedules and except intra-mammary preparations thereof, containing tracer dye(s) and intended for the treatment of mastitis in cattle and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Procarbazine.

 

Progesterone.

 

Proguanil.

 

Propafenone.

 

Propentofylline, except when intended for veterinary use. (S1)

 

Propylhexedrine, except when used as a vasoconstrictor and decongestant in nose preparations and inhalants. (S1)

 

Protein C (isolated from human plasma).

 

Proyliodone.

 

Proteolytic (fibrinolytic) enzymes, when intended for injection, and unless listed elsewhere in the Schedules. (S1)

 

Protionamide.

 

Proxymetacaine, except when contained in eye drops intended for emergency treatment of arc eyes. (S2)

 

Prucalopride.

 

Pyrazinamide.

 

Pyricarbate.

 

Pyridostigmine.

 

Pyrimethamine.

 

Quinagolide.

 

Quinine, except preparations and mixtures containing not more than 1 percent. (S2)

 

Quinoronium, except when intended and registered as an antibabesial in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Quinupristin.

 

Rabeprazole,except when intended for the temporary short term relief of heartburn and hyperacidity, subject to—

(a) maximum daily dose of 10 milligrams;
(b) maximum treatment period of 14 days. (S2).

 

Ractopamine, when used as a  veterinary production improver.

 

Radiopharmaceuticals, being radioactive compounds and radio-active labelled compounds when used for diagnostic or therapeutic purposes, unless listed elsewhere in the Schedules, and including the following radioisotopes:

(i) Chromium-51;
(ii) 14 C – Urea;
(iii) 18F – Fludeoxyglucose (2 - deoxy – 2 - fluoro- D- glucose
(iv) Gallium-67;
(v) Indium-111;
(vi) Iodine-123;
(vii) Iodine-125;
(viii) Iodine-131;
(ix) Phosphorous-32;
(x) Radium – 223;
(xi) Strontium-89;
(xii) Technetium-99;
(xiii) Thallium-201;
(xiv) Xenon-133;
(xv) Yttrium-90;
(xvi) Gold – 198

 

Rafoxanide, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Raltegravir.

 

Raltitrexid.

 

Ranibizumab.

 

Ranolazine.

 

Rapacurunium.

 

Rasagiline.

 

Rasburicase.

 

Recombinant human epidermal growth factor (rhEGF)

 

Regorafenib.

 

Remdesivir.

 

Resorantel, except when intended and registered as an anthelmintic in  terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Retapamulin.

 

Ribavirin.

 

Ribociclib.

 

Rifabutin.

 

Rifampicin.

 

Rifapentine.

 

Rifaximin.

 

Rilpivirine.

 

Riluzole.

 

Rimiterol, when intended for injection. (S2, S3)

 

Riociguat.

 

Risdiplam.

 

Ritodrine.

 

Ritonavir.

 

Rituximab.

 

Rivaroxaban.

 

Rizatriptan.

except when in oral solid dosage forms providing 5mg or less and presented as packs of no more than 2 oral solid dosage forms, indicated for the acute relief of migraine attacks, with or without aura, in patients previously diagnosed by a medical practitioner and initiated on treatment with rizatriptan (S2).

 

Robenacoxib.

 

Rocuronium.

 

Roflumilast.

 

Rolitetracycline except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Romiplostim.

 

Ropinirole.

 

Ropivacaine.

 

Rosoxacin.

 

Rosuvastatin.

 

Rotigotine.

 

Roxatidine.

 

Roxithromycin.

 

Ruxolitinib.

 

Safinamide.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine.

 

Salbutamol, when intended for injection. (S2, S3)

 

R-salbutamol, except when intended and registered as a stock remedy in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Salinomycin, except when listed elsewhere in the Schedules and except when intended as an anti-coccidial preparation and to promote growth and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Salmefamol, when intended for injection. (S2, S3)

 

Salmeterol.

 

Saquinavir.

 

Sarafloxacin.

 

Saroglitazar magnesium.

 

Sarolaner, except when intended and registered for the control of ticks and fleas in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Satralizumab.

 

Secukinumab.

 

Selegiline.

 

Selenium,

(a) in preparations thereof for injection, when intended for veterinary use;
(b) except in oral preparations or mixtures containing more than 200 µg of Selenium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)

 

Selexipag.

 

Semaglutide.

 

Semuloparin.

 

Serelaxin.

 

Sermorelin.

 

Sertaconazole, except when intended for application to the skin. (S1)

 

Sertindole.

 

Sevelamer.

 

Sildenafil.

 

Silicone oil (polydimethylsiloxane) when intended for intraocular use.

 

Silodosin.

 

Simvastatin.

 

Simoctogog alfa.

 

Siponimod.

 

Sirolimus.

 

Sisomicin.

 

Sodium aurothiomalate.

 

Sodium cromoglycate, when intended for veterinary use. (S2)

 

Sodium dihydroazapentacene  polysulphonate.

 

Sodium fluoride; except oral medicinal preparations and mixtures thereof containing 40 milligrams or more per daily dose. (S1)

 

Sodium nitroprusside.

 

Sodium polystyrine sulphonic acid, when indicated for therapeutic use.

 

Sofosbuvir.

 

Solcoseryl, except preparations intended for application to the skin, to the mucous membranes of the mouth and to the lips and except ophthalmic preparations thereof. (S0, S3).

 

Sorafenib.

 

Sparfloxacin.

 

Spectinomycin

 

Stavudine.

 

Stents, Drug Eluting, unless listed elsewhere in the Schedules.

 

Streptokinase

 

Strychnine, except—

(a) preparations and mixtures containing 0,2 per cent or less of strychnine; (S2) and
(b) subject thereto that it shall only be supplied for the control of problem predatory mammals—
(i) on a written prescription issued by a State Veterinarian, for use in the particular State Veterinarian’s area of jurisdiction, and in a quantity not exceeding 5 grams; and
(ii) subject to the State Veterinarian obtaining prior written approval for such use from the Director of the concerned provincial conservation institution or authority in his area of jurisdiction, a copy of such written approval being attached to the written prescription

 

Styramate.

 

Sugammadex

 

Sulbactam.

 

Sulfabenzamide.

 

Sulfacetamide.

 

Sulfadiazine, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfadiazine silver, except when intended for application to the skin in the short term treatment of minor burns, provided that the pack size is limited to a maximum of 50 grams; (S2)

 

Sulfadimidine (sulfadimethoxine) except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfamethazine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfadoxine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfafurazole (sulfisoxazole).

 

Sulfaguanidine except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfamethizole.

 

Sulfamethoxazole except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfametopyrazine.

 

Sulfamoxole.

 

Sulfanilamide.

 

Sulfathiazole, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sulfisomidine.

 

Sulfamerazine.

 

Sulfapyridine.

 

Sulfasalazine.

 

Sulphonamides, unless listed elsewhere in the Schedules, and except—

(a) substances, preparations and mixtures intended for application to the eyes, nares and vagina; (S2) and
(b) when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Sultamicillin.

 

Sumatriptan.

 

Sunitinib.

 

Suramin.

 

Surfactant associated proteins.

 

Suxamethonium.

 

Suxethonium.

 

Streptokinase.

 

Streptomycin.

 

Tacrine.

 

Tacrolimus.

 

Tadalafil.

 

Tafamidis.

 

Tafluprost.

 

Talampicillin.

 

Tamoxifen.

 

Tamsulosin.

 

Tasonermin.

 

Taurolidine.

 

Tazobactam.

 

Tedizolid.

 

Tegafur.

 

Tegaserod.

 

Teicoplanin.

 

Telaprevir.

 

Telbivudine.

 

Telithromycin.

 

Temozolomide.

 

Temsirolimus.

 

Tenecteplase.

 

Teniposide.

 

Tenofovir.

 

Terbinafine, except when intended for application to the skin. (S1)

 

Terconazole.

 

Terfenadine.

 

Teriflunomide.

 

Terizidone.

 

Teriparatide.

 

Terlipressin.

 

Tetrabenazine.

 

Tetracaine,

(a)        when intended for ophthalmic or parenteral use;

(b)        except when intended for topical use; (S1)

(c)        except in oral preparations containing 2% or less of Tetracaine; (S1)

(d)        except when contained in eye drops intended for the emergency treatment of "arc eyes ". (S2)

 

Tetracosactrin (Tetracosactide).

 

Tetracycline, except when listed elsewhere in the Schedules and except injections thereof intended for the treatment of animals and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Tetramisole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural  Remedies and Stock Remedies Act, 1947.

 

Thalidomide.

 

Theophylline and its derivatives, unless listed in another Schedule, preparations intended for injection. (S2)

 

Thiabendazole, except when intended for application to the skin (S1) and except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Thiamphenicol.

 

Thioacetazone.

 

Thioguanine.

 

Thiostrepton.

 

Thymopentin.

 

Thyrotropin alfa.

 

Tiamulin, except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Tibolone.

 

Ticarcillin.

 

Tigecycline.

 

Tildipirosin, when intended for veterinary use.

 

Tilmicosin.

 

Tiludronic Acid.

 

Tin fluoride, when intended for injection

 

Tinidazole.

 

Tinzaparin.

 

Tioconazole, except when intended for application to the skin and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)

 

Tiopronin.

 

Tipranavir.

 

Tirilazad.

 

Tivoznib.

 

Tobramycin.

 

Tocainide.

 

Tocilizumab.

 

Tolcapone.

 

Tolrestat.

 

Toltrazuril, except when intended and registered as an anti-coccidial preparation in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Topotecan.

 

Toremifene.

 

Tozinameran.

 

Trabectedin.

 

Trametinib.

 

Tranexamic acid.

 

Trastuzumab ematansine.

 

Travoprost.

 

Treosulfan.

 

Triclabendazole, except when intended and registered as an anthelmintic in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Thiotepa.

 

Trametinib.

 

Trifluridine.

 

Trimetaphane.

 

Trimethoprim, except when specifically intended and registered in combination with sulphonamides for the treatment of gastro-enteritis and pneumonia in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Trimetrexate.

 

Trioxysalen.

 

Triptorelin.

 

Tromantadine.

 

Trometamol.

 

Tropisetron.

 

Tuberculin.

 

Tubocurarine.

 

Turoctocog Alpha.

 

Tylosin, except when listed elsewhere in the Schedules and except when intended for addition to drinking water and feedstuff for administration to poultry and pigs and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Tyropanoic acid.

 

Tyrothricin, except when intended for topical application to the epidermis, nares and external ear. (S1)

 

Unoprostone.

 

Upadacitinib.

 

Urapidil.

 

Urethane.

 

Urofollitropin.

 

Urokinase.

 

Ustekinumab.

 

{Vaccines, see – Biologicals}

 

Valaciclovir.

 

Valganciclovir.

 

Valnemulin.

 

Vancomycin.

 

Vardenafil.

 

Vasoactive intestinal polypeptide.

 

Vecuronium.

 

Velaglucerase alfa.

 

Velpatasvir.

 

Vemurafenib.

 

Venetoclax.

 

Vernakalant.

 

Verteporfin.

 

Vidarabine.

 

Vilanterol.

 

Vinblastine.

 

Vincristine.

 

Vindesine.

 

Vinorelbine.

 

Virginiamycin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Vismodegib.

 

Voriconazole.

 

Vorinostat.

 

Vorozole.

 

Warfarin.

 

Zalcitabine.

 

Zanamivir.

 

Zidovudine.

 

Zinc bacitracin, except when listed elsewhere in the Schedules and except when intended and registered to promote growth as a feed additive in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

 

Ziv-aflibercept.

 

Zofenopril.

 

Zolmitriptan.

 

Zoledronic acid.

 

Zotarolimus.

 

 

ANNEXURE 1A: EMERGENCY CARE PROVIDER (PARAMEDIC)

 

PARAMEDIC (National Diploma in Emergency Medical Care graduates only) registered with the Health Professions Council of South Africa

PARAMEDIC (National Diploma in Emergency Medical Care graduates)

ANTI-ARRHYTHMICS


Substance

: Adenosine

Indication

: Endogenous Purine Nucleoside/Supraventricular Anti-arrhythmic

Route of Administration

: Parenteral

ANTI-ARRHYTHMICS

 

Substance

: Amiodarone

Indication

: Class III anti-arrhythmic/Atrial & Ventricular

Route of Administration

: Parenteral

ANTI-ARRHYTHMICS

 

Substance

: Lignocaine Hydrochloride (systemic)

Indication

: Class I B- Ventricular Anti-arrhythmic

Route of Administration

: Parenteral

*ANTI-FIBRINOLYTIC

 

Substance

: Tranexamic acid

Indication

: Major haemorrhage in trauma

Route of Administration

: Parenteral

ANTI-CHOLINERGIC

 

Substance

: Atropine

Indication

: Competitive Anti-Cholinergic, Bradycardia, Anti-arrhythmic

Route of Administration

: Parenteral

ADRENERGIC

 

Substance

: Adrenaline/Epinephrine

Indication

: Sympathomimetic catecholamine

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Salbutamol

Indication

: Bronchodilator

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

CORTICOSTEROID

 

Substance

: Glucagon

Indication

: agent

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Hydrocortisone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Prednisolone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

HYPERGLYCAEMIC AGENT

 

Substance

: Methylprednisolone

Indication

: Hyperglycaemic

Route of Administration

: Oral

ANTI-EMETIC

 

Substance

: Metoclopramide Monohydrochloride

Indication

: Propulsive Anti-emetic/ Dopamine Antagonist

Route of Administration

: Parenteral

LOCAL ANAESTHETIC

 

Substance

: Lignocaine hydrochloride

Indication

: Local anaesthesia

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Naloxone Hydrochloride

Indication

: Opioid Antagonist/Narcotic Antagonist

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Nitrous Oxide

Indication

: Analgesic Gas

Route of Administration

: Inhalant

**OXYTOCIN

 

Substance

: Oxytocin

Indication

: Post-partum haemorrhage

Route of Administration

: Parenteral

 

 

ANNEXURE 1B: EMERGENCY CARE PROVIDER (EMERGENCY CARE PRACTITIONER)

 

EMERGENCY CARE PRACTITIONER (Bachelor of Technology Degree in Emergency Medical Care) registered with the Health Professions Council of South Africa

EMERGENCY CARE PRACTITIONER (B Tech: Emergency Medical Care)

ANTI-ARRHYTHMICS


Substance

: Adenosine

Indication

: Endogenous Purine Nucleoside/Supraventricular Anti-arrhythmic

Route of Administration

: Parenteral

ANTI-ARRHYTHMICS

 

Substance

: Amiodarone

Indication

: Class III Anti-arrhythmic/ Atrial & Ventricular

Route of Administration

: Parenteral

ANTI-ARRHYTHMICS

 

Substance

: Lignocaine Hydrochloride (Systemic)

Indication

: Class I B- Ventricular Anti-arrhythmic

Route of Administration

: Parenteral

ANTI-CHOLINERGIC

 

Substance

: Atropine

Indication

: Competitive Anti-Cholinergic, Bradycardia, Anti-arrhythmic

Route of Administration

: Parenteral

*ANTICHOLINESTERASE

 

Substance

: Neostigmine

Indication

: Reversal of neuromuscular blockade

Route of Administration

: Parenteral

ADRENERGIC

 

Substance

: Adrenaline/ Epinephrine

Indication

: Sympathomimetic catecholamine

Route of Administration

: Parenteral

**ADRENERGIC

 

Substance

: Dobutamine

Indication

: Haemodynamic support

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Salbutamoi

Indication

: Bronchodilator

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

*CHOLINESTERASE INHIBITOR

 

Substance

: Sugammadex

Indication

: Reversal of neuromuscular blockade

Route of Administration

: Parenteral

**CORTICOSTEROID

 

Substance

Betamethasone

Indication

Pre-term birth

Route of Administration

Parenteral

**CORTICOSTEROID

 

Substance

Dexamethasone

Indication

Pre-term birth

Route of Administration

Parenteral

CORTICOSTEROID

 

Substance

Prednisolone

Indication

Glucocorticold/Steroidal anti-inflammatory

Route of Administration

Parenteral

CORTICOSTEROIDS

 

Substance

: Hydrocortisone

Indication

: Glucocorticoid / Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Methylprednisolone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Oral

**DIRECT THROMBIN INHIBITOR

 

Substance

: Bivalirudin

Indication

: Adjunct in percutaneous coronary angioplasty

Route of Administration

: Parenteral

**DOPAMINERGIC

 

Substance

: Dopamine

Indication

: Haemodynamic support

Route of Administration

: Parenteral

HYPERGLYCAEMIC AGENT

 

Substance

: Glucagon

Indication

: Hyperglycaemic agent

Route of Administration

: Parenteral

ANTI-EMETIC

 

Substance

: Metoclopramide Monohydrochioride

Indication

: Propulsive Anti-emetic/Dopamine Antagonist

Route of Administration

: Parenteral

*ANTI-FIBRINOLYTIC

 

Substance

: Tranexamic acid

Indication

: Major haemorrhage in trauma

Route of Administration

: Parenteral

LOCAL ANAESTHETIC

 

Substance

: Lignocaine hydrochloride

Indication

: Local anaesthesia

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Naloxone Hydrochloride

Indication

: Opioid Antagonist/Narcotic Antagonist

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Nitrous Oxide

Indication

: Analgesic Gas

Route of Administration

: Inhalant (50:50 combination with Medical Oxygen)

OXYTOCIN

 

Substance

: Oxytocin

Indication

: Post-partum haemorrhage

Route of Administration

: Parenteral

*SEROTONIN ANTAGONIST

 

Substance

: Ondansetron

Indication

: Post-operative nauses and vomiting

Route of Administration

: Parenteral

THROMBOLYTIC AGENTS

 

Substance

: Streptokinase

Indication

: Enzymes

Route of Administration

: Parenteral

THROMBOLYTIC AGENTS

 

Substance

: Tenecteplase

Indication

: Enzymes

Route of Administration

: Parenteral

ANTITHROMBOTIC AGENTS

 

Substance

: Heparin Sodium

Indication

: Anticoagulant

Route of Administration

: Parenteral

ANTITHROMBOTIC AGENT

 

Substance

: Enoxaparin

Indication

: Anticoagulant

Route of Administration

: Parenteral

MUSCLE RELAXANTS (NEURO BLOCKING AGENTS)

Substance

: Suxamethonium Chloride

Indication

: Depolarizing Muscle Relaxant

Route of Administration

: Parenteral

MUSCLE RELAXANTS (NEURO BLOCKING AGENTS)

Substance

: Vecuronium

Indication

: Competitive Muscle Relaxant

Route of Administration

: Parenteral

MUSCLE RELAXANTS (NEURO BLOCKING AGENTS)

Substance

: Rocuronium

Indication

: Non-Depolarizing Muscle Relaxants

Route of Administration

: Parenteral

 

 

ANNEXURE 1C: BASIC AMBULANCE ASSISTANT

 

BASIC AMBULANCE ASSISTANT registered with the Health Professions Council of South Africa

BASIC AMBULANCE ASSISTANT registered with the Health Professions Council of South Africa

*SELECTIVE β2 AGONISTS


Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

 

 

ANNEXURE 1D: AMBULANCE EMERGENCY ASSISTANT

 

AMBULANCE EMERGENCY ASSISTANT registered with the Health Professions Council of South Africa

AMBULANCE EMERGENCY ASSISTANT registered with the Health Professions Council of South Africa

*ADRENERGIC


Substance

: Adrenaline/Epinephrine

Indication

: Sympathomimetic catecholamine

Route of Administration

: Parenteral

*CORTICOSTEROIDS

 

Substance

: Methylprednisolone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Oral

*CORTICOSTEROIDS

 

Substance

: Hydrocortisone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

*HYPERGLYCAEMIC AGENT

 

Substance

: Glucagon

Indication

: Hyperglycaemic agent

Route of Administration

: Parenteral

*OPIOID ANTAGONIST

 

Substance

: Naloxone hydrochloride

Indication

: Opioid Antagonist/Narcotic Antogonist

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Nitrous oxide

Indication

: Analgesic Gas

Route of Administration

: inhalant (50:50 combination with Medical Oxygen)

SELECTIVE β2 AGONISTS

 

Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

LOCAL ANAESTHETIC

 

Substance

: Lignocaine hydrochloride

Indication

: Local anaesthesia

Route of Administration

: Parenteral

 

 

ANNEXURE 1E:  EMERGENCY CARE TECHNICIAN

 

EMERGENCY CARE TECHNICIAN registered with the Health Professions Council of South Africa

EMERGENCY CARE TECHNICIAN registered with the Health Professions Council of South Africa

ADRENERGIC


Substance

: Adrenaline/Epinephrine

Indication

: Sympathomimetic catecholamine

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Hydrocortisone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

HYPERGLYCAEMIC AGENT

 

Substance

: Glucagon

Indication

: Hyperglycaemic agent

Route of Administration

: Parenteral

ANTI-ARRHTHMICS

 

Substance

: Amiodarone

Indication

: Class III Anti-arrhythmic/Atrial & Ventricular

Route of Administration

: Parenteral

*ANTI-EMETIC

 

Substance

: Metoclopramide monohydrochloride

Indication

: Propulsive Anti-emetic/Dopamine Antagonist

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Salbutamol

Indication

: Bronchodilator

Route of Administration

: Parenteral

ANTI-CHOLINERIGIC

 

Substance

: Atropine

Indication

: Competitive Anti-Cholinergic, Bradycardia, Anti-arrhythmic

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Naloxone hydrochloride

Indication

: Opioid Anagonist/Narcotic Antagonist

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Nitrous oxide

Indication

: Analgesic Gas

Route of Administration

: Inhalant (50:50 combination with Medical Oxygen)

**OXYTOCIN

 

Substance

: Oxytocin

Indication

: Post-partum haemorrhage

Route of Administration

: Parenteral

CORTICOSTEROID

 

Substance

: Prednisolone

Indication

: Glucocorticoid/Steroidal anti-inflammatory

Route of Administration

: Parenteral

LOCAL ANAESTHETIC

 

Substance

: Lignocaine hydrochloride

Indication

: Local anaesthesia

Route of Administration

: Parenteral

 

ANNEXURE 1F:  EMERGENCY CARE ASSISTANT

 

EMERGENCY CARE ASSISTANT registered with the Health Professions Council of South Africa

EMERGENCY CARE ASSISTANT registered with the Health Professions Council of South Africa

*ADRENERGIC


Substance

: Adrenaline/Epinephrine

Indication

: Sympathomimetic catecholamine

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Hydrocortisone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

CORTICOSTEROIDS

 

Substance

: Methylprednisolone

Indication

: Glucocorticoid/Steroidal Anti-Inflammatory

Route of Administration

: Parenteral

HYPERGLYCAEMIC AGENT

 

Substance

: Glucagon

Indication

: Hyperglycaemic agent

Route of Administration

: Parenteral

ANTI-CHOLINERGIC

 

Substance

: Atropine

Indication

: Competitive Anti-Cholinergic, Bradycardia, Anti-arrhythmic

Route of Administration

: Parenteral

SELECTIVE β2 AGONISTS

 

Substance

: Fenoterol

Indication

: Bronchodilator

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Naloxone hydrochloride

Indication

: Opioid Anagonist/Narcotic Antagonist

Route of Administration

: Parenteral

OPIOID ANTAGONIST

 

Substance

: Nitrous oxide

Indication

: Analgesic Gas

Route of Administration

: Inhalant (50:50 combination with Medical Oxygen)

 

 

ANNEXURE 2: DENTAL THERAPIST

 

DENTAL THERAPIST (Bachelors degree in Dental Therapy) registered with Health Professions Council of South Africa

DENTAL THERAPIST (Bachelors degree in Dental Therapy)

LOCAL ANAESTHETIC


Substance

: Lignocaine/ Lidocaine Hydrochloride 2% with Vasoconstrictor (Adrenaline)

Indication

:  Dental local anaesthesia

Route of Administration

:  Oral

LOCAL ANAESTHETIC


Substance

: Lignocaine/Lidocaine Hydrochloride 3% without a Vasoconstrictor (Adrenaline)

Indication

:  Dental local anaesthesia

Route of Administration

:  Parenteral

LOCAL ANAESTHETIC


Substance

: Mepivacaine Hydrochloride 2% with a Vasoconstrictor (Adrenaline)

Indication

:  Dental local anaesthesia

Route of Administration

:  Parenteral

LOCAL ANAESTHETIC

Substance

: Mepivacaine Hydrochloride 3% without a Vasoconstrictor (Adrenaline)

Indication

: Dental local anaesthesia

Route oo Administration

: Parenteral

ANTI-MICROBIALS (Beta-Lactams)

 

Substance

: Penicillins

Indication

: Dental orofacial and odontogenic infections (Non prophylactic)

Route of Administration

: Oral

ANTI-PROTOZOAL

 

Substance

: Metronidazole

Indication

: Dental orofacial and odontogenic infections (Non prophylactic)

Route of Administration

: Oral

AUTONOMIC SYMPATHOMIMETICS

Substance

:  Adrenaline

Indication

: Emergency medicine for drug related anaphylactic shock

Route of Administration

: Parenteral

 

 

ANNEXURE 3: OPTOMETRIST

 

OPTOMETRIST (Bachelors degree in Optometry – B OPTOM) registered with the Health Professions Council of South Africa in terms of the Health Professions Act, 1974 (Act 56 of 1974) and recognised by the Health Professions Council of South Africa as an authorised prescriber.

OPTOMETRISTS

ANTIBACTERIAL


Substance

: Chloramphenicol

Indication

: Bacterial conjunctivitis; Anterior blepharitis; Posterior blepharitis

Route of Administration

: Topical Application

ANTIBACTERIAL

 

Substance

: Tetracycline

Indication

: Chlarnydieai conjunctivitis; Biepharitis

Route of Administration

: Topical Application

ANTIBACTERIAL

 

Substance

: Erythromycin

Indication

: Chlamydial conjunctivitis; Blepharitis; Impetigo
(Not to be used as 1st Line Treatment)

Route of Administration

: Topical Application

ANTIBACTERIAL

 

Substance

: Aciclovir

Indication

: Conjunctivitis; Herpes simplex blepharitis: Epithelial keratitis

Route of Administration

: Topical Application

ANTIBACTERIAL

 

Substance

: Tetracycline

Indication

: Trachoma

Route of Administration

: Oral

ANTIBACTERIAL


Substance

: Doxycycline

Indication

: Trachoma

Route of Administration

: Oral

ANTIBACTERIAL


Substance

: Azithromycin

Indication

: Trachoma

Route of Administration

: Oral

ANTIBIOTICS

 

Substance

Fuscidic acid

Indication

For Blepharitis and stye

Route of Administration

Topical drops or ointment

ANTIBIOTICS

 

Substance

Neomycin

Indication

For Blepharitis only

Route of Administration

Topical drops or ointment

ANTIBIOTICS

 

Substance

Bacitracin

Indication

For Blepharitis only

Route of Administration

Ointment

ANTIBIOTICS

 

Substance

Polymyxin B

Indication

For Blepharitis only

Route of Administration

Ointment

LOCAL ANAESTHETIC

 

Substance

: Tetracaine

Indication

: Diagnostic Aide

Route of Administration

: Topical Application (Drops)

LOCAL ANAESTHETIC

 

Substance

: Oxybuprocaine and other equivalent local anaesthetics

Indication

: Diagnostic Aide

Route of Administration

: Topical Application (Drops)

PROSTAGLANDIN ANALOGUES (PGAs)

 

Substance

: Latanoprost, Travoprost, Bimatoprost

Indication

: Glaucoma

Route of Administration

: Drops

 

 

ANNEXURE 4: PODIATRIST

 

PODIATRIST registered with the Health Professions Council of South Africa in terms of the Health Professions Act, 1974 (Act 56 of 1974)

 

 

[Schedule 4 substituted by Notice No. 2685, GG47373, dated 28 October 2022]