Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)SchedulesSchedule 5 and Specified Schedule 5 |
Schedule 5 and Specified Schedule 5
| (a) | All preparations or mixtures of such substances containing or purporting to contain substances that is chemically related and incorporates a structural fragment into its structure that is similar to the structure of a listed substance and/or exhibits pharmacodynamic properties similar to the listed substance referred to in this Schedule include the following: |
| (i) | The salts and esters of such substances, where the existence of such salts and esters is possible; and |
| (ii) | all preparations and mixtures of such substances where such preparations and mixtures are not expressly excluded, |
| (iii) | all homologues of listed substances (being any chemically related substances that incorporate a structural fragment into their structures that is similar to the structure of a listed substance and/or exhibit pharmacodynamic properties similar to the listed substance in the schedules), unless listed separately in the Schedules. |
| (b) | In terms of Section 22A(5)(f) of the Act, a practitioner, nurse or a person registered under the Health Professions Act,1974, other than a medical practitioner or dentist, may prescribe and apply, 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 Medicines Control Council, to patients under his/her care, the Schedule 5 and Specified Schedule 5 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 1E: Emergency Care Technician
| (c) | Specified Schedule 5 substances listed in this schedule are subject to additional control in terms of section 22A of the Act as required under the provisions of the 1971 Convention on Psychotropic Substances and are denoted by **. |
Acitretin.
Agomelatine.
Alprazolam**.
Amisulpride.
Amitryptyline and its derivatives.
Amoxapine.
Anaesthetic preparations containing pregnanedione derivatives.
Androstanolone.
Androstenediol.
Aponal.
Apronalide.
Aripriprazole.
Armodafanil
Recombinant human epidermal growth factor (rhEGF).
Asenapine.
Atomexetine.
Azacyclonol.
Barbituric acid** and its derivatives**, unless listed in another Schedule, excluding—
| (a) | amobarbital, cyclobarbital, pentobarbital and secobarbital (S6), and |
| (b) | preparations and mixtures containing not more than 90 milligrams of phenobarbital** per minimum recommended or prescribed dose when intended for continued use in epilepsy. (S3) |
Benactyzine and its derivatives, unless listed in another Schedule.
Benfluramate.
Benzoctamine.
Benzodiazepines** and their derivatives**, unless listed in another Schedule and except flunitrazepam. (S6)
Benzquinamide.
Beta-aminopropylbenzene and beta-aminoisopropylbenzene:
| (a) | any compound structurally derived from either of these substances by substitution in the side chain or by ring closure therein (or by both such substitution and such ring closure); and |
| (b) | any salt or substance falling under the above; and |
| (c) | except preparations and mixtures of the above when used as vasoconstrictors and decongestants in antihistamine nose and eye preparations; (S1) and |
| (d) | except when contained in appliances for inhalation in which the substance is absorbed onto solid material; (S1, S7) and |
| (e) | excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine and preparations and mixtures thereof; and |
(f) except substances listed in Schedule 7. (S1, S2, S6)
Bolandiol.
Bolasterone.
Boldenone.
Bromides; preparations and mixtures thereof containing 80 milligrams or more of bromine as bromide per recommended daily dose, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetic and Disinfectants Act, 1972 and for anaytical laboratory purposes. (S2)
Bromazepam**.
Bromisovalum.
Brotizolam**.
Bupropion.
Buspirone.
Butriptyline.
Butyrophenones.
Carbromal.
Chloral derivatives, unless listed in another Schedule.
Chlordiazepoxide**.
Chlormethiazole.
Chlormezanone, except mixtures thereof where the maximum recommended or prescribed dose does not exceed 100 milligrams of chlormezanone. (S2)
Chloroform, all substances, preparations and mixtures containing more than 20 percent of chloroform. (S1), except for industrial purposes including the manufacturing and compounding of products not intended for medicinal use. (S0, S1)
Chlorpromazine.
Chlorprothixene.
Citalopram.
Clobazam**
Clomacran.
Clomipramine.
Clonazepam**.
Clopenthixol.
Clorazepic acid**.
Clostebol.
Clothiapine.
Clozapine.
Corticotrophin (adrenocorticotrophic hormone; ACTH).
Cyclobenzaprine.
Cyproheptadine, except when indicated for allergic rhinitis or antipruritic use. (S2)
Danazol.
Dapoxetine.
Deanol and its derivatives, unless listed in another Schedule, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetic and Disinfectants Act, 1972, and for analytical laboratory purposes. (S1)
Dehydrochloromethyltestosterone
Desflurane.
Desipramine.
Desvenlafaxine.
Detomidine
Dexfenfluramine.
Dexmedetomidine.
Dextropropoxyphene; preparations and mixtures for oral use containing not more than 135 milligrams of dextropropoxyphene, calculated as the base, per dosage unit or with a concentration of not more than 2,5 percent in undivided preparations. (S6)
Diazepam**.
Dibenzepin.
Diprenorphine.
Donepezil.
Dosulepin.
Dothiepin.
Doxepin, except when intended for application to the skin. (S4)
Droperidol.
Drostanolone.
Duloxetine.
Ecothiopate.
Emylcamate.
Enflurane.
Epitiostanol.
Escitalopram.
Esketamine
Estazolam**.
Ethchlorvynol**.
Ether (diethyl ether); except substances, preparations and mixtures containing more than 20 per cent of ether. (S1)
Ethinamate** and its derivatives**, unless listed in another Schedule.
Ethylestrenol.
Etifoxine.
Etodroxirine, except preparations and mixtures thereof when used solely as an antihistamine. (S2)
Etomidate.
Etretinate.
Fencamfamine.**
Fenfluramine.
Flumazenil.**
Fluocinolone.
Fluoxetine.
Fluoxymesterone.
Flupenthixol.
Fluphenazine.
Flurazepam**.
Fluspirilene.
Fluvoxamine.
Formebolone.
Furazabol.
Haloperidol.
Halothane.
Hedonal and its esters, except when specifically packaged, labelled and used for industrial purposes including the manufacture or compounding of consumer items or products which have no pharmacological action or medicinal purpose, which are intended to be ingested by man or animals as food or applied to the body as a cosmetic and which are approved for such use in terms of the Foodstuffs, Cosmetic and Disinfectants Act, 1972, and for anaytical laboratory purposes.
Human growth hormone (human somatotropin) - all forms, whether natural or synthetic, including recombinant forms, with either hormonal, prohormonal or anti-hormonal action).
5-Hydroxy Tryptophan,
| (a) | except in oral preparations with a maximum daily dose not exceeding 220 mg of 5-Hydroxy tryptophan, alone or in combination with other active pharmaceutical ingredients; (S1) |
| (b) | except in oral preparation with a maximum daily dose not exceeding 220 mg of 5-Hydroxy tryptophan alone or in combination with other active pharmaceutical ingredients, with general health claims as a health supplement. (S0) |
Hydroxyzine.
Hygromycin B, except when listed elsewhere in the Schedules and except when intended as an anthelmintic for pigs and registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947)
Imipramine and its derivatives, unless listed in another Schedule.
Iproniazid.
Isoflurane.
Isotretinion.
Ketamine.
Ketazolam**.
Lemborexant
Lithium salts, when intended for application to the skin. (S2)
Lofepramine.
Loprazolam**.
Lorazepam**.
Lormetazepam**.
Loxapine.
Maprotiline.
Mazindol**.
Mebolazine.
Mechlorethamine and its derivatives, unless listed in the Schedules.
Meclofenoxate.
Medazepam**.
Medetomidine.
Melitracene.
Mephenoxalone.
Meprobamate**.
Mesterolone
Metandienone
Metenolone.
Methandranone.
Methandriol.
Methoxyflurane.
Methyltestosterone.
Metrifonate.
Mianserin.
Mibolerone.
Midazolam**.
Milnacipran.
Mirtazapine.
Moclobemide.
Modafinil.
Molindone.
Nalbuphine.
Nandrolone.
Nefazodone.
Nitrazepam**.
Nomifensine.
Norclostebol.
Norethandronlone.
Nortriptyline.
Olanzapine.
Oxabolone.
Oxandrolone.
Oxazepam**.
Oxymesterone.
Oxymetholone.
Oxypertine.
Paliperidone.
Paraldehyde.
Pargyline.
Paroxetine.
Pemoline** and its complexes**.
Perampanel.
Phenazepam.
Phenethylhydrazine.
Phenothiazine and its derivatives,
| (a) | unless listed in another Schedule, |
| (b) | except preparations and mixtures containing promethazine or dimethothiazine or their salts when used solely as an antihistaminic (S2), and |
| (c) | except preparations containing promethazine or its salts when intended specifically for the treatment of travel sickness or application to the skin, (S2), and |
| (d) | except phenothiazine 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). |
Phentermine**.
Pimethixene, except preparations and mixtures thereof when used solely as an antihistaminic. (S2)
Pimozide.
Pipradrol**.
Pizotifen, except preparations and mixtures thereof when used solely as an antihistaminic or when intended for the prophylaxis of migraine. (S2)
Prasterone (Dehydroepiandrosterone, DHEA). Prolintane.
Prazepam**.
Prolintane.
Pregabalin.
Prochlorperazine maleate.
Propofol.
Protriptyline.
Quazepam**.
Quetiapine.
Quinbolone.
Quinupramine.
Reboxetine.
Rimonabant.
Risperidone.
Rivastigmine.
Romifidine.
Sertindole
Sertraline.
Sevoflurane.
Sibutramine.
Stanozolol.
Stenbolone.
Sulphonmethane.
Sulpiride.
Temazepam**.
Testolactone.
Testosterone, except subcutaneous implants thereof when specifically 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).
Thioguanosine.
Thiopentone
Thiothixene.
Tiapride.
Tiletamine.
Tizanidine.
Tramadol.
Tranylcypromine.
Trazodone.
Trenbolone, except subcutaneous implants thereof when specifically 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).
Tretinoin, when intended for oral preparation. (S3)
Triazolam**.
Trifluoroperazine.
Trihexyphenidyl.
L-Tryptophan,
| (a) | except in oral preparations with a maximum daily dose not exceeding 220 mg of L-tryptophan, alone or in combination with other active pharmaceutical ingredients; (S1) |
| (b) | except in oral preparation with a maximum daily dose not exceeding 220 mg of L-tryptophan alone or in combination with other active pharmaceutical ingredients, with general health claims as a health supplement; (S0) |
Varenicline.
Venlafaxine.
Viloxazine.
Vortioxetine.
Xylazine.
Zaleplon.
Zimelidine.
Ziprasidone.
Zolazepam.
Zolpidem**.
Zopiclone.
Zotepine.
Zuclopenthixol.
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) |
|||
BENZODIAZEPINE DERIVATIVE |
|||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE ANTAGONIST |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
*INDUCTION AGENTS |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
NON-SELECTIVE ANTIHISTAMINE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
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
PARAMEDIC (National Diploma in Emergency Medical Care graduates) |
|||
BENZODIAZEPINE DERIVATIVE |
|||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE ANTAGONIST |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
NON-SELECTIVE ANTIHISTAMINE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
INDUCTION AGENTS |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
INDUCTION AGENTS |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
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 |
|||
BENZODIAZEPINE DERIVATIVE |
|||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
*BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
*BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE ANTAGONIST |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
NON-SELECTIVE ANTIHISTAMINE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
INDUCTION AGENTS |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
INDUCTION AGENTS |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
EMERGENCY CARE ASSISTANT registered with the Health Professions Council of South Africa
EMERGENCY CARE ASSISTANT registered with the Health Professions Council of South Africa |
|||
BENZODIAZEPINE DERIVATIVE |
|||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
*BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
*BENZODIAZEPINE DERIVATIVE |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
BENZODIAZEPINE ANTAGONIST |
|
||
Substance |
|
||
Indication |
|
||
Route of Administration |
|
||
[Schedule 5 and Specified Schedule 5 substituted by Notice No. 2685, GG47373, dated 28 October 2022]