S6 - Restricted Substance
Restricted substance
About S6 Drugs
Where S6 sits on the scale
Prescription-only, no repeats without a new prescription.
Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Cited: reg 33(3)(f)(i) (General Regulations, 2017)
Who may supply
A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.
Cited: Act s22A(5)(b), s22A(5)(c), s22A(5)(d), s22A(5)(e)
Prescription: Requires a prescription from an authorised prescriber.
Repeats: None. A new prescription is required every time; it cannot be repeated on the same script. The prescription must also be presented for dispensing within 30 days of issue, and the whole course of treatment may not exceed 30 consecutive days.
Cited: Act s22A(6)(d), s22A(6)(i), s22A(6)(o)
Advertising: May be advertised only to health professionals, not the public.
Cited: reg 42(2), reg 42(3) (General Regulations, 2017)
Labelling: Must show the letter S and the number 6 in a square border, immediately before the product's brand name.
Cited: reg 10(1)(a) (General Regulations, 2017)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
S6 Scheduled Drugs
| Name | Variants | Applicant | Number | Schedule |
|---|---|---|---|---|
| Butorphanol (Torbugesic) | 10mg | Zoetis South Africa (Pty) Ltd | 16/11. | S6 |
| Butorphanol (Dolorex) | Not stated | Intervet South Africa (Pty) Ltd | 18-Sep | S6 |
| D-norpseudoephedrine (Relislim) | 20 mg | Loock Pharmaceuticals (Pty) Ltd | 290316 | S6 |
| Cathine (Leanor) Cancelled | Not stated | Acino Pharma (Pty) Ltd | 290526 | S6 |
| Remifentanil (Ultiva, Ultiva ( ), Fortiva) | 1 mg, 2 mg, 5 mg | Pharmacare limited û woodmead | 6 registrations | S6 |
| Pentazocine (Pharma-q Pentazocine) | 30 mg/1 ml | Adcock Ingram Critical Care (Pty) Ltd | 310208 | S6 |
| Buprenorphine (Subutex Sublingual, Sobrixa, Temgesic, +1 more) | 0,4 mg, 2,0 mg, 8,0 mg, 1 ml, tablets | Adcock Ingram Critical Care (Pty) Ltd | 8 registrations | S6 |
| Sufentanil (Pharma-q Sufentanil, Pharma-q Sufentanil Forte) | 10 ug/2 ml, 50 ug/10 ml, 250 ug/5 ml | Pharma-q Holdings (Pty) Ltd | 3 registrations | S6 |
| Methylphenidate (Ralitin, Adaphen) | 5, 10, 20 | Triomed (Pty) Ltd | 4 registrations | S6 |
| Flunitrazepam (Flunitrazepam Biotech) | 1 | Arya Pharma (Pty) Ltd | 350160 | S6 |
| Methylphenidate (Ritalin La, Ritalin) | 20, 30, 40, 10 | Novartis South Africa (Pty) Ltd | 5 registrations | S6 |
| Methylphenidate (Methylphenidate Hcl Douglas) | 10 mg. | Acino Pharma (Pty) Ltd | 360234 | S6 |
| Cathine (Lodenor) | drops | Anmarate (Pty) Ltd | 370006 | S6 |
| Methylphenidate (Concerta, Neucon) | 18 mg, 36 mg, 54 mg, 27 mg | Janssen Pharmaceutica (Pty) Ltd | 8 registrations | S6 |
| Buprenorphine (Sovenor, Butrans) | 5, 10, 20 | Mundipharma (Pty) Ltd | 6 registrations | S6 |
| Sufentanil (Mylan Sufentanil) | 5 ug/ml 2 ml, 5ug/ml 10 ml | Viatris South Africa (Pty) Ltd | 2 registrations | S6 |
| Naloxone (Suboxone, Narbup, Sabax Naloxone) | 2 mg, 8 mg, 0,02 mg/ml | Adcock Ingram Critical Care (Pty) Ltd | 5 registrations | S6 |
| Oxycodone (Oxycontin Prolonged Release, Oxynorm) | 5 mg, 10 mg, 20 mg, 40 mg, 80 mg | Mundipharma (Pty) Ltd | 10 registrations | S6 |
| Hydromorphone (Jurnista) Cancelled | 8 mg, 16 mg, 32 mg, 64 mg, 4 mg | Janssen Pharmaceutica (Pty) Ltd | 5 registrations | S6 |
| Methadone (Equity-methadone, Epatadone) | 2 mg / 1 ml, 10 mg/ml | Equity Pharmaceutical (Pty) Ltd | 2 registrations | S6 |
| Remifentanil (Remifentanil Teva) Cancelled | 1, 2, 5 | Teva Pharmaceuticals (Pty) Ltd | 3 registrations | S6 |
| Remifentanil (Mylan Remifentanil) | 1 mg, 2 mg, 5 mg | Viatris South Africa (Pty) Ltd | 3 registrations | S6 |
| Remifentanil (Remifentanil Adco, Remifentanil Adcoc) | 1 mg, 2 mg, 5 mg | Adcock Ingram Critical Care (Pty) Ltd | 3 registrations | S6 |
| Tapentadol (Palexia, Palexia Sr) | 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 250 mg | Adcock ingram limited | 8 registrations | S6 |
| Methylphenidate (Methylphenidate Biotech, Methylphenidate La Biotech, Lintiral) | 10 mg, 10, 20, 30, 40, 60 | Biotech Laboratories (Pty) Ltd | 7 registrations | S6 |
| Oxycodone (Oxycorrel, Oxycorrell Once Daily) | 5 mg, 10 mg, 20 mg, 40 MG, 80 MG | Austell Pharmaceuticals (Pty) Ltd | 7 registrations | S6 |
| Methylphenidate (Contramyl Xr) | 18 mg, 27 mg, 36 mg, 54 mg | Viatris South Africa (Pty) Ltd | 4 registrations | S6 |
| Methylphenidate (Acerta) | 18, 27, 36, 54 | Teva Pharmaceuticals (Pty) Ltd | 4 registrations | S6 |
| Methylphenidate (Medikinet Mr) | 20 mg | Adcock ingram limited | 511090 | S6 |
| Buprenorphine (Sovetrin, Bupremed, Norbutrin) | 5, 10, 20 | Trinity Pharma (Pty) Ltd | 9 registrations | S6 |
| Methylphenidate (Aterocon La) | 20 mg, 30 mg, 40 mg, 60 mg | Austell Pharmaceuticals (Pty) Ltd | 4 registrations | S6 |
| Methadone (Methadone Adco) | 10mg | Adcock Ingram Critical Care (Pty) Ltd | 540839 | S6 |
| Methadone (Rutrex, Lometasan) | 10 mg, 0,4 mg/mL | Arya Pharma (Pty) Ltd | 2 registrations | S6 |
| Morphine (Oramorph) | 20 mg | Eurolab (Pty) Ltd | 550422 | S6 |
| Methadone (Misyo) | 10 mg/ml | Umsebe healthcare | 550741 | S6 |
| Methylphenidate (Neutif) Cancelled | 18 | Ranbaxy Pharmaceuticals (Pty) Ltd | 550816 | S6 |
| Methylphenidate (Neutif, Satefin, Metheylphenidate Sun) Cancelled | 27, 36, 54, 18 | Ranbaxy Pharmaceutical (Pty) Ltd | 11 registrations | S6 |
| Methylphenidate (Conufen, Mefedinel) | 54, 18, 27, 36, 10 mg | Sandoz South Africa (Pty) Ltd | 5 registrations | S6 |
| Methylphenidate (Phenitab) | 18, 27, 36, 54 | Activo Health (Pty) Ltd | 4 registrations | S6 |
| Methylphenidate (Methylphenidate DRL) | 18, 27, 36, 54 | Dr Reddyæs Laboratories (Pty) Ltd | 4 registrations | S6 |
| Remifentanil (Remifentanil Aspen) | 5 mg | Aspen SA Operations (Pty) Ltd | 570170 | S6 |
| Methylphenidate (Methycap La) | 10 mg, 20 mg, 30 mg, 40 mg | Pharma Dynamics (Pty) Ltd | 4 registrations | S6 |
| Remifentanil (Remivion) | 1 mg, 2 mg, 5 mg | Lamar International (Pty) Ltd | 3 registrations | S6 |
| Phenylbutazone (Fenylbutazone Phenix) | 20% | Phenix SA (Pty) Ltd | 83/284 | S6 |
| Phenylbutazone (Arthridine Nf) Cancelled | Not stated | Virbac Rsa (Pty) Ltd | 83/654 | S6 |
| Phenylbutazone (Oralject P Butazone) Cancelled | - | Rhone-poulenc Animal Health SA (Pty) Ltd | 83/713 | S6 |
| Phenylbutazone (Phenylarthrite) | Not stated | Bayer (Pty) Ltd û Isando | 83/764 | S6 |
| Phenylbutazone (Equipalazone) | Not stated | Kyron Animal Health (Pty) Ltd | 83/87 | S6 |
| Cyclizine a 39 01 morphine (Cyclimorph) | 10, 15 | Pharmacare limited û woodmead | 2 registrations | S6 |
| Methadone (Physeptone) | injection | Pharmacare limited û woodmead | B0771 | S6 |
| Codeine, morphine, papaverine (Omnopon-fresenius) | 1ml | Fresenius Medical Care South Africa (Pty) Ltd | B1006 | S6 |
| Fentanyl (Sublimaze) | 2ml/10 ml | Piramal Critical Care South Africa (Pty) Ltd | 2 registrations | S6 |
| Oxymorphone (Numorphan) | Not stated | Boots Pharmaceuticals (Pty) Ltd | B1560 | S6 |
| Methylphenidate (Ritalin) Cancelled | 10mg, 10mg. 20mg. 30mg. 40mg | Ciba-geigy (Pty) Ltd | B1611 | S6 |
| Phendimetrazine (Obex La) Cancelled | Not stated | Adcock ingram limited | C0714 | S6 |
| Phendimetrazine (Obesan X) | Not stated | Mdi Healthcare CC | C0877 | S6 |
| Diethylpropion (Tenuate Dospan) Cancelled | tablets | Adcock ingram limited | C0965 | S6 |
| Methadone (Physeptone) Cancelled | linctus | Acino Pharma (Pty) Ltd | G0523 | S6 |
| Codeine, morphine, papaverine (Omnopon-fresenius) | 1ml | Bodene (Pty) Ltd Trading As Intramed | K0304 | S6 |
| Buprenorphine (Temgesic) | 2 ml | Reckitt Benckinser Pharmaceuticals (Pty) Ltd | L0158 | S6 |
| Cathine (Thinz, Slenz) Cancelled | Not stated | Pharmacare limited û woodmead | 2 registrations | S6 |
| D-norpseudoephedrine (Eetless) Cancelled | capsules | Adcock ingram limited | M0169 | S6 |
| Cathine (Dietene, Appetrol Diet, Slim 'N Trim) | capsules | Adcock ingram limited | 3 registrations | S6 |
| Alfentanil (Rapifen) | 2 ml | Piramal Critical Care South Africa (Pty) Ltd | Q0327 | S6 |
| Alfentanil (Rapifen) | 10 ML | Janssen Pharmaceutica (Pty) Ltd | Q0328 | S6 |
| Sufentanil (Sufenta, Sufenta Forte) | 2 ml, 10 ml, 50 µg | Piramal Critical Care South Africa (Pty) Ltd | 3 registrations | S6 |
| Pentazocine (Sosenol) | 30 mg, 45 mg | Adcock ingram limited | 2 registrations | S6 |
| Pentazocine (Pentazocine Fresenius) | 30 mg/1 ml | Fresenius Kabi Manufacturing SA (Pty) Ltd | W0165 | S6 |