Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)ScheduleSchedule 6 |
Schedule 6
| (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 (unless expressly excluded or unless listed in another Schedule): |
| (i) | the isomers of such substances, where the existence of such isomers is possible within the chemical designation; |
| (ii) | the esters and ethers of such substances and of the isomers referred to in (i) as well as the isomers of such esters and ethers, where the existence of isomers of such esters or ethers is possible; |
| (iii) | the salts of such substances and of the isomers referred to in (i), as well as the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible; |
| (iv) | the isomers of any of the salts referred to in (ii), where the existence of such isomers is possible; |
| (v) | all preparations and mixtures of any of the above. |
| (vi) | 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 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 Medicines Control Council, to patients under his/her care, the Schedule 6 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); |
| (ii) | Annexure 1B: Emergency Care Provider (Emergency Care Practitioner). |
Acetorphine.
Acetyldihydrocodeine.
Acetylmethadol.
Alfentanil.
Allylprodine.
Alphacetylmethadol.
Alphameprodine.
Alphamethadol.
Alphaprodine.
Amineptine.
Amobarbital.
Anileridine.
Benzethidine.
Benzphetamine.
Benzylmorphine.
Beta-aminopropylbenzene and beta-aminoisopropylbenzene derivatives, being 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);
| (a) | except preparations and mixtures of the above when used as vasoconstrictors and decongestants in antihistamine nose and eye preparations; (S1) and |
| (b) | except when contained in appliances for inhalation in which the substance is absorbed in solid material; (S1) and |
| (c) | excluding cathine ((+)-norpseudoephedrine), ephedrine, etafedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine, prenylamine and preparations and mixtures thereof; (S1, S2, S5) and |
| (d) | except substances listed in Schedule 7. (S1, S2, S5) |
Betacetylmethadol.
Betameprodine.
Betamethadol.
Betaprodine.
Bezitramide.
Buprenorphine.
Butalbital.
Butorphanol
Carfentanil, when intended for veterinary use. (S7)
Cathine ((+)-norpseudoephedrine/D-norpseudoephedrine).
Chlorodyne (Chloroform and Morphine Tincture BP 1980) or any preparation or mixture thereof described as chlorodyne.
Chlorphentermine.
Clonitazene.
Coca leaf and any salt, compound, derivative or preparation of coca leaf and any salt, compound, derivative or preparation thereof that is chemically equivalent or identical to any of these substances, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except decocainized coca leaf and extractions of coca leaf where such extractions contain no cocaine or ecgonine. (S0)
Codeine (methylmorphine),
| (a) | single component codeine preparations; |
| (b) | oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2; S3) |
| (c) | liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3). (S2, S3) |
Codoxime.
Colistin,
| (a) | 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; and |
| (b) | except when presented as a finished pharmaceutical product. (S4) |
Cyclobarbital.
Desomorphine.
Dexamfetamine (Dexamphetamine) in medicines registered in terms of the Act and intended for the treatment of Attention-Deficit Hyperactivity Disorder. (S7)
Dextromoramide.
Dextropropoxyphene, except preparations and mixtures for oral use containing 135 milligrams or less of dextropropoxyphene, calculated as the base, per dosage unit or with a concentration of not more than 2,5 percent in undivided preparations. (S5)
Dextrorphan.
Diampromide.
Diethylpropion (amfepramone).
Diethylthiambutene.
Dihydrocodeine,
| (a) | single component dihydrocodeine preparations; |
| (b) | oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3) |
| (c) | liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3) |
Dihydroetorphine.
Dihydromorphine.
Dimenoxadol.
Dimepheptanol.
Dimethylthiambutene.
Dioxaphethyl butyrate.
Diphenoxin (or diphenoxylic acid), except mixtures containing, per dosage unit, 0,5 milligrams or less of difenoxin, calculated as the base, and a quantity of atropine sulphate equal to at least 5,0 per cent of such quantity of difenoxin, calculated as the base, as is present in the mixture. (S2)
Diphenoxylate, except preparations containing not more than 2,5 milligrams of diphenoxylate, calculated as the base, and not less than 25 micrograms of atropine sulphate per dosage unit.(S1)
Dipipanone.
{D-norpseudoephedrine - see cathine}
Drotebanol.
Ecgonine, and the esters and derivatives thereof that are convertible to ecgonine and cocaine.
Ephedra alkaloids (natural or synthetic), unless listed separately in the Schedules,
| (a) | except products registered in terms of the Act, not intended for export, and being oral preparations and mixtures, in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, containing not more than 30 milligrams of ephedra alkaloids per dose, with a maximum daily dose not exceeding 120 milligrams, subject to a maximum pack size of 360 milligrams and limited to one pack per customer; (S2) |
| (b) | except when intended for application to skin, eyes, ears and nares and containing 1 percent or less of ephedra alkaloids. (S1) |
Ephedrine,
| (a) | except products registered in terms of the Act, not intended for export, and being oral preparations and mixtures, in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, containing not more than 30 milligrams of ephedrine per dose, with a maximum daily dose not exceeding 120 milligrams, subject to a maximum pack size of 360 milligrams and limited to one pack per customer; (S2) |
| (a) | except preparations and mixtures intended for application to the skin, eyes, ears and nares and containing 1 percent or less of ephedrine. (S1) |
Ethylmethylthiambutene.
Ethylmorphine,
| (a) | except oral solid preparations, in combination with one or more therapeutically active substances and containing 20 milligrams or less of ethylmorphine (calculated as base) per dosage unit; (S2) and |
| (b) | except liquid oral reparations and mixtures, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of ethylmorphine (calculated as base) per 5 millilitre dosage unit. (S2) |
Etonitazene.
Etorphine and analogues.
Etoxeridine.
Fenproporex.
Fentanyl, when intended for therapeutic purposes. (S7)
Flunirazepam.
Furethidine.
Glutethimide.
Hydrocodone (dihydrocodeinone).
Hydromorphinol (14-hydroxydihydromorphine).
Hydromorphone (dihydromorphinone).
Hydroxypethidine.
Ibogaine.
Isomethadone.
Ketobemidone.
Levomoramide.
Levophenacylmorphan.
Levorphanol.
Lisdexamfetamine (Lisdexamphetamine), in medicines registered in terms of the Act and intended for the treatment of Attention-Deficit Hyperactivity Disorder. (S7)
Mecloqualone.
Mefenorex.
Meptazinol.
Metazocine.
Methadone.
Methadone-intermediate.
Methorphan, including levomethorphan and racemethorphan, but excluding dextromethorphan. (S2)
Methyldesorphine.
Methyldihydromorphine.
Methylphenidate and its derivatives, unless listed in another Schedule.
Metopon.
Moramide-intermediate.
Morpheridine.
Morphine, except preparations and mixtures of morphine containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S2)
Morphine methobromide and other pentavalent nitrogen morphine derivatives.
Morphine-N-oxide and its derivatives.
Myrophine (myristylbenzylrnorphine).
Nefopam.
Nicocodine.
Nicodicodine.
Nicomorphine.
Noracymethadol.
Norcodeine.
Norlevorphanol.
Normethadone.
Normorphine (demethylmorphine or N-demethylated morphine).
{(+)-Norpseudoephedrine see D-norpseudoephedrine / Cathine}.
Norpipanone.
Opium and opiates and any salt, compound, derivative or preparation of opium or opiates, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis, except mixtures containing 0,2 per cent or less of morphine, calculated as anhydrous morphine.(S2)
Opium-poppy and poppy straw, whether obtained directly or indirectly by extraction from material or substances obtained from plants, or whether obtained independently by chemical synthesis, or by a combination of extraction and chemical synthesis.
Oxycodone (14-hydroxydihydrocodeinone or dihydrohydroxycodeinone).
Oxymorphone (14-hydroxydihydromorphinone or dihydrohydroxymorphinone).
Pentazocine.
Pentobarbital.
Pethidine, pethidine-intermediate A, pethidine-intermediate B and pethidine-intermediate C. (S7)
Phenadoxone.
Phenampromide.
Phenazocine.
Phendimetrazine.
Phenomorphan.
Phenoperidine.
Phenylpropanolamine (norephedrine),
| (a) | except products registered in terms of the Act, not intended for export and oral preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when in combination with another pharmacologically active substance and intended for the symptomatic relief of nasal and sinus congestion, subject to a maximum pack size of 300 milligrams for adults and 150 milligrams for children, limited to one pack per customer. (S2) |
Pholcodine, except when prepared, mixed or compounded
| (a) | containing 20 milligrams or less of pholcodine (calculated as base) per dosage unit; or |
| (b) | containing 20 milligrams or less of pholcodine (calculated as base) per 5 millilitre dosage unit in the case of liquid oral preparations and mixtures. (S2) |
Piminodine.
Piritramide.
Proheptazine.
Properidine.
Propiram.
Pseudoephedrine, except contained in products registered in terms of the Act, and not intended for export, being oral preparations and mixtures containing not more than 60 milligrams or controlled-release oral preparations and mixtures containing not more than 120 milligrams of pseudoephedrine per dose, and not more than 240 milligrams per day, when in combination with another pharmacologically active substance and intended for the symptomatic relief of colds and flu, subject to a maximum pack size of 720 milligrams and limited to one pack per customer. (S2)
Racemoramide.
Racemorphan.
Remifentanil.
Secobarbital.
Sufentanil.
p-Synephrine,
| (a) | except preparations and mixtures registered in terms of the Act and intended for application to the skin, ears and nares containing 1 percent or less of p-synephrine and containing 0,2 percent or less for application to the eyes; (S0) |
| (b) | except oral preparations and mixtures registered in terms of the Act and intended for the symptomatic relief of nasal and sinus congestion, where the recommended daily dose for adults is 50 milligrams or less and for children 6 to 12 years is 25 milligrams or less, with a maximum pack size of 5 days; (S1) |
| (c) | except oral preparations and mixtures registered in terms of the Act and intended for the symptomatic relief of nasal and sinus congestion, where the recommended daily dose for adults is more than 50 milligrams and for children 6 to 12 years is more than 25 milligrams. (S2) |
Tapentadol.
Tetrahydrocannabinol, except
| (a) | in raw cannabis plant material cultivated and possessed in accordance with a permit issued in terms of the Plant Improvement Act (Act 11 of 2018) and processed products manufactured from such material, intended for agricultural or industrial purposes, including the manufacture of consumer items or products which have no pharmacological action or medicinal purpose, or |
| (b) | when raw cannabis plant material is cultivated, possessed and consumed by an adult, in private for personal consumption. |
Thebacon.
Thebaine.
Thiafentanyl.
Tilidine.
Trimeperidine.
Zipeprol.
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) |
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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) |
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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 |
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[Schedule 6 substituted by Notice No. 5181, GG51171, dated 6 September 2024]