South Africa classifies medicines into Schedules 0 to 8 under the Medicines and Related Substances Act, 1965. SAHPRA’s latest public “Consolidated Schedules” document states that the Minister of Health updates these schedules on SAHPRA’s recommendation. (SAHPRA) SAHPRA also has a dedicated “Names and Scheduling” unit that evaluates the scheduling status of medicines. (SAHPRA)
Quick schedule guide
| Schedule | Access level | Prescription needed? | Typical meaning |
|---|---|---|---|
| Schedule 0 | General sale | No | Low-risk medicines, often sold outside pharmacies. Schedule 0 includes substances registered under the Act that are not listed in other schedules. |
| Schedule 1 | Pharmacy-supervised OTC | Usually no | Sold with pharmacy involvement; some authorised health professionals may prescribe/supply within scope. |
| Schedule 2 | Pharmacy OTC / controlled | Sometimes | More controlled pharmacy medicines; repeat prescriptions may apply when prescribed. |
| Schedule 3 | Prescription medicine | Yes | Used for conditions needing professional diagnosis and management. |
| Schedule 4 | Prescription medicine | Yes | Similar controls to Schedule 3; includes many antibiotics and chronic-condition medicines. SAHPRA’s consolidated list includes many antimicrobials under Schedule 4, for example azithromycin and multiple cephalosporins. |
| Schedule 5 | Stricter prescription medicine | Yes | Higher-risk medicines, including many sedatives, psychiatric medicines, hormones, and controlled medicines; examples listed include lorazepam, midazolam, tramadol, sertraline, and testosterone. |
| Schedule 6 | Highly controlled prescription medicine | Yes | Stronger controlled substances, including opioids and other dependence-forming medicines; examples listed include fentanyl for therapeutic purposes, hydromorphone, and related substances. |
| Schedule 7 | Very restricted/prohibited except authorised use | Special authority/permit | Includes substances with high abuse potential or limited accepted medical use; access is tightly controlled. |
| Schedule 8 | Special controlled category | Special authority | The consolidated list includes substances such as amphetamine preparations and nabilone, with cross-references to Schedule 7. |
Prescription and repeat rules
For Schedule 3 and higher, medicines are generally prescription medicines and should be supplied only on a valid prescription from an authorised prescriber. A SAHPRA scheduling guideline states that Schedule 3 and 4 medicines are for diseases or conditions requiring professional medical, dental, or veterinary diagnosis and management. It also states that repeat prescriptions for Schedule 2, 3, or 4 substances are limited to a maximum period of six months’ supply in that guideline.
There was a South African government notice in 2020 excluding Schedule 2, 3 and 4 substances from the six-month limit in certain circumstances, allowing them not to be dispensed for longer than 12 months from the prescription date under the stated conditions. (Government of South Africa) Because this is a legal/regulatory point, pharmacies and prescribers should confirm the currently applicable rule for a specific prescription.
For Schedule 5, repeats are more restricted and usually must be specifically authorised by the prescriber, including the number of repeats and intervals. For Schedule 6, a South African Pharmacy Council notice states that a Schedule 6 substance may only be sold if the course of treatment does not exceed 30 consecutive days. (Pharmaceutical Council)
Prescription record requirements
Dispensing premises must keep prescription records for scheduled medicines. South African regulations require a prescription book or permanent record for Schedule 2, 3, 4, 5 and 6 medicines, including details such as the medicine name, dispensing date, dosage form, quantity, patient details, and prescriber details. (Government of South Africa)
Example medicine schedule table
| Medicine example | Possible schedule in South Africa | Notes |
|---|---|---|
| Low-dose paracetamol products | S0/S1 depending on product | Depends on strength, pack size and formulation. |
| Antihistamines such as chlorpheniramine | S2 in listed form | Listed in the consolidated schedules. (SAHPRA) |
| Amlodipine | S3 | Listed under Schedule 3. (SAHPRA) |
| Azithromycin | S4 | Listed under Schedule 4. (SAHPRA) |
| Lorazepam / Midazolam | S5 | Listed under Schedule 5. (SAHPRA) |
| Fentanyl for therapeutic purposes | S6 | Listed under Schedule 6, with Schedule 7 cross-reference. (SAHPRA) |
Important: The schedule can change depending on dose, route, indication, pack size, formulation, and exclusions. Always check the exact product label, package insert, pharmacy system, or SAHPRA schedule listing before dispensing or using a medicine. This page is for general information and is not medical or legal advice.