Medicines & Related Substances Act (Act 101 of 1965)
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Medicines & Related Substances Act (Act 101 of 1965) — Key Facts for SAPC (South Africa) Core concept: The Medicines and Related Substances Act 101 of 1965 (as amended) is the primary legislation governing the registration, manufacture, importation, distribution, storage, and sale of medicines in South Africa. It establishes the regulatory framework administered by SAHPRA (the South African Health Products Regulatory Authority), which replaced the Medicines Control Council (MCC) in 2012. Every pharmacist must understand this Act — it determines which medicines may legally be dispensed, who may lawfully possess and supply them, how they must be stored and handled, and what records must be maintained. Unauthorised dealing in medicines is a criminal offence. High-yield point: Under the Act, no person may manufacture, import, or distribute a Schedule 1 or higher medicine unless they hold a licence issued by SAHPRA. No pharmacist may dispense a medicine that is not registered with SAHPRA (except in limited circumstances such as Schedule 1 medicines for individual patient needs). The Schedules under the Act classify medicines according to their potential for abuse and the level of control required, from Schedule 0 (safest, no prescription required) to Schedule 8 (most restricted, strictly controlled substances with high abuse potential). ⚡ Exam tip: In any scenario involving the handling, supply, or dispensing of medicines, the first question should always be: is this medicine lawfully in the supply chain? Was it manufactured/imported by a SAHPRA-licensed entity? Is it SAHPRA-registered? Is the pharmacist appropriately licensed to handle it at its Schedule level? The Act’s criminal provisions apply regardless of the pharmacist’s good intentions.
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Medicines & Related Substances Act (Act 101 of 1965) — SAPC (South Africa) Study Guide Overview: The Medicines and Related Substances Act 101 of 1965 (the “Medicines Act”) is the foundational statute for pharmaceutical regulation in South Africa. It establishes the framework for the registration of medicines, the licensing of manufacturers, importers, distributors, and wholesalers, the classification of medicines into Schedules based on their safety profile and abuse potential, the prescription requirements for higher-Schedule medicines, the control of Schedule 5 to 8 substances (including controlled substances such as narcotic analgesics and psychotropic substances), and the enforcement powers of the regulator (now SAHPRA). Every pharmacist interacts with this Act on a daily basis — from ensuring that the pharmacy only stocks SAHPRA-registered medicines, to applying the correct Schedule classification when dispensing, to maintaining the required records for Schedule 5 and above substances, to举报 suspect drug trafficking. Understanding this Act is fundamental to pharmacy practice and is the single most important piece of legislation for the SAPC examination. Core principles: The Medicines Act proceeds on the principle that medicines must be safe, effective, and of good quality before they may be supplied to the public. This is achieved through a mandatory pre-market registration system — no medicine may be sold, advertised, or supplied in South Africa unless it has been registered with SAHPRA (with limited exceptions). The Act classifies medicines into Schedules (Schedule 0 through Schedule 8) that determine the conditions under which they may be supplied. Higher Schedules require stricter controls, including prescription requirements, specialised record-keeping, secure storage, and additional licensing requirements. Key points:
- SAHPRA and its role: SAHPRA (the South African Health Products Regulatory Authority) is the statutory regulator responsible for the regulation of health products (including medicines, medical devices, and cosmetics) in South Africa. SAHPRA was established under the Medicines and Related Substances Act and replaced the Medicines Control Council in 2012. SAHPRA’s functions include: evaluating medicines for safety, quality, and efficacy before granting registration; licensing manufacturers, importers, and distributors of medicines; enforcing Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards; conducting post-marketing surveillance; and investigating and prosecuting non-compliant operators.
- Registration of medicines: Section 14 of the Medicines Act prohibits the sale, supply, or advertisement of an unregistered medicine in South Africa, subject to limited exceptions. Registration requires the applicant to submit a dossier of data demonstrating the medicine’s safety, quality, and efficacy to SAHPRA. SAHPRA evaluates the data and, if satisfied, enters the medicine on the Register of Medicines. A medicine on the register is assigned a registration number that must appear on the medicine’s labelling. Dispensing an unregistered medicine is a criminal offence, subject to a fine or imprisonment of up to 10 years, unless a specific exception applies (such as the Schedule 1 individual patient supply exception).
- Schedule classifications: The Schedules to the Medicines Act classify medicines according to their safety profile and potential for abuse. The primary Schedules are: Schedule 0 — medicines considered safe for general sale without prescription (e.g., certain analgesics, cough remedies); Schedule 1 — medicines requiring pharmacist supervision but not prescription (e.g., certain antibiotics, antifungals); Schedule 2 — medicines requiring a prescription and pharmacist supervision (e.g., most prescription medicines); Schedule 3 — medicines requiring a prescription and must be dispensed by a pharmacist (e.g., certain hormonal contraceptives); Schedule 4 — Prescription Only medicines (POM) — requiring a prescription from an authorised prescriber (e.g., most chronic disease medicines); Schedule 5 — potentially harmful substances requiring strict controls (e.g., certain sedatives, anabolic steroids); Schedule 6 — substances with severe abuse potential (e.g., opioids, certain stimulants); Schedule 7 — substances with very severe abuse potential (e.g., cocaine, morphine concentrates); Schedule 8 — narcotic drugs requiring maximum control (e.g., heroin, fentanyl analogues). Each Schedule imposes specific requirements regarding who may prescribe, dispense, possess, and store the substance.
- Prescription requirements: The Schedules determine the prescription requirements for each medicine. Schedule 2 through Schedule 4 medicines require a prescription from an authorised prescriber (a medical practitioner, dentist, vet, or in limited cases a pharmacist or nurse). Schedule 5 and above medicines require both a prescription and additional documentation. The prescription must be retained by the pharmacy for a minimum period (typically five years for Schedules 2-4, and indefinitely for Schedules 5-8). Prescriptions for Schedule 5 and above must be stamped, retained on the premises, and may not be repeated without a new prescription.
- Licensing of pharmacies and pharmacists: The Medicines Act requires that any person who wishes to manufacture, import, distribute, or wholesale medicines must hold a licence from SAHPRA. Retail pharmacies are not required to hold a separate SAHPRA wholesaler licence for their day-to-day dispensing activities, but they must source medicines from SAHPRA-licensed suppliers and maintain compliance with GDP standards for handling received medicines. The responsible pharmacist must ensure the pharmacy’s compliance with all applicable storage and record-keeping requirements.
- Record-keeping for Schedule 5-8 substances: The Medicines Act and its Regulations impose detailed record-keeping requirements for Schedule 5 and above substances. Records must show the date of receipt, the name and address of the supplier, the quantity received or dispensed, the name and address of the patient or prescriber, and the balance in stock. These records must be retained on the premises at all times, are subject to inspection by SAHPRA inspectors and police, and must be available for production on demand. Failure to maintain these records is a criminal offence and may result in the suspension or cancellation of the pharmacy’s licence to hold Schedule 5-8 substances.
- Penalties and enforcement: Contraventions of the Medicines Act may result in: criminal prosecution (fines and imprisonment for serious offences); confiscation of medicines; suspension or cancellation of SAHPRA-issued licences; and disciplinary proceedings before the SAPC for registered pharmacists. SAHPRA inspectors have broad powers of entry, inspection, and seizure. The police may be called to assist in cases involving suspected drug trafficking. Study strategy: Make the Schedules your core study focus — know which Schedule applies to each class of medicine, what the prescription and record-keeping requirements are for each Schedule, and what the criminal consequences are for Schedule violations. Use the Schedule classification as a framework for organising your knowledge of the Act’s requirements. Practise applying the correct Schedule to scenario medicines and identifying whether the pharmacist’s conduct in the scenario is compliant.
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Medicines & Related Substances Act (Act 101 of 1965) — Comprehensive SAPC (South Africa) Notes Full coverage: This topic provides comprehensive coverage of the Medicines and Related Substances Act 101 of 1965 (as amended) and its Regulations, with particular emphasis on the Schedules, the registration requirements, the licensing framework, the control of controlled substances, SAHPRA’s enforcement powers, and the interaction between the Medicines Act and other legislation relevant to pharmacy practice (including the Pharmacy Act, the CPA, and the Constitution). The Medicines Act is the central pillar of pharmaceutical regulatory law in South Africa and must be understood in its entirety before any pharmacy student can be considered competent to practise.
1. Historical Context and Development of the Medicines Act
The Medicines and Related Substances Act 101 of 1965 was enacted at a time when South Africa’s pharmaceutical regulation was underdeveloped and consumer protection in relation to medicines was inadequate. The Act established, for the first time, a comprehensive framework for the control of medicines in South Africa. It has been significantly amended several times since 1965, most notably by the Medicines and Related Substances Control Amendment Act 72 of 1969, which introduced the Schedule classification system; the Medicines and Related Substances Act 90 of 1997, which introduced additional controls; and the Medicines and Related Substances Amendment Act 14 of 2015, which amended the Act in preparation for and in connection with the establishment of SAHPRA. The Act is administered by SAHPRA under the direction of the Minister of Health.
2. The Register of Medicines and the Registration Requirement
Section 14 of the Medicines Act provides that no person may sell, expose for sale, advertise, or distribute any medicine unless it has been registered under the Act. This is the fundamental registration requirement. Registration involves the submission of a comprehensive technical dossier to SAHPRA demonstrating: the safety of the medicine (based on preclinical and clinical data); the quality of the medicine (based on pharmaceutical chemistry, manufacturing, and stability data); and the efficacy of the medicine (based on clinical trial data). SAHPRA evaluates the dossier through its evaluation committees and, if satisfied, enters the medicine on the Register of Medicines. Each registered medicine is assigned a unique registration number that must appear on all packaging, labelling, and advertising material.
The rationale for mandatory pre-market registration is consumer protection. Without a scientific evaluation of safety, quality, and efficacy before the medicine is allowed onto the market, patients would be exposed to the risk of harm from medicines that have not been adequately tested. The system also ensures that medicines are manufactured to consistent quality standards and that the information provided about the medicine’s properties and uses is accurate and not misleading.
The registration requirement applies to all medicines, including generic versions of original medicines. Generic medicines must demonstrate bioequivalence to the reference (original) medicine before they can be registered and dispensed. This is why the same active ingredient may be marketed under multiple brand names — each brand name represents a separate registered medicine that has been evaluated by SAHPRA for safety, quality, and efficacy.
Exemptions from registration: Limited exemptions from the registration requirement exist, including: Schedule 0 medicines (which are considered safe for general sale and are not subject to the registration requirement); medicines compounded for individual patient prescriptions by a pharmacist (where the formulation is prepared specifically for a specific patient’s needs and is not manufactured in advance or in bulk); and medicines dispensed under the provisions relating to Schedule 1 individual patient importation or supply (subject to specific conditions). These exemptions are narrow and must be carefully applied.
3. The Schedule Classification System
The Schedules to the Medicines Act represent one of the most practically significant features of the Act for practising pharmacists. The Schedules classify medicines according to their safety profile and potential for abuse, creating a graduated system of control that ranges from Schedule 0 (minimum control, medicines safe for general sale) to Schedule 8 (maximum control, substances subject to the strictest controls in South African law).
Schedule 0: Contains substances considered safe for general sale without prescription. These are medicines that can be sold in any retail outlet. Examples include certain mild analgesics (paracetamol at lower doses), certain antacids, and certain cough remedies. However, Schedule 0 medicines must still comply with labelling requirements and must not be advertised in a manner that is false, misleading, or promotes irresponsible use.
Schedule 1: Contains substances that are safe for use under pharmacist supervision but do not require a prescription. These may be sold only in pharmacies. The pharmacist must be involved in the sale — the patient must be attended to by the pharmacist, who must be satisfied that the medicine is appropriate for the patient’s condition. Schedule 1 medicines include certain antibiotics (topical antifungal agents, some oral antibiotics in specific formulations), certain sedatives, and certain slimming preparations.
Schedule 2: Requires a prescription and pharmacist supervision. These are prescription medicines that may be dispensed only on a valid prescription from an authorised prescriber. The pharmacist must verify the prescription, counsel the patient, and maintain dispensing records. Schedule 2 includes most prescription medicines for acute conditions.
Schedule 3: Requires a prescription and must be dispensed by a pharmacist (not a pharmacy assistant or pharmacist’s assistant). This Schedule was introduced to elevate certain medicines that require a pharmacist’s specific involvement in the dispensing process. Examples include certain hormonal contraceptives.
Schedule 4: Prescription Only Medicines (POM). These are the most common Schedule in pharmacy practice. They require a valid prescription and may be dispensed by a pharmacist or, under the pharmacist’s supervision, by a pharmacist’s assistant. Schedule 4 includes most chronic disease medicines such as antihypertensives, statins, and oral hypoglycaemic agents. prescriptions for Schedule 4 medicines may generally be repeated for the period specified by the prescriber, up to a maximum of six months (unless the prescriber specifically authorises a longer period for chronic conditions).
Schedule 5: Contains substances that have potential for abuse and dependence but are used therapeutically in controlled circumstances. Examples include benzodiazepines (with some exceptions), anabolic steroids, and certain barbiturates. Schedule 5 substances require a prescription and additional record-keeping requirements beyond those for Schedule 4. Records must be kept in a bound book with numbered pages, and entries must be made in ink with no cancellations or alterations.
Schedule 6: Substances with a recognized therapeutic need but with severe potential for abuse and dependence. Examples include opioid analgesics (codeine at higher doses), certain amphetamines (used in ADHD treatment), and some sedatives. Schedule 6 requires a prescription, a police declaration for possession (in certain cases), and more extensive record-keeping.
Schedule 7: Substances with very limited or no recognized therapeutic use in South Africa, with very high abuse potential. Examples include cocaine, cannabis in certain forms, and certain synthetic cathinones. These substances are rarely encountered in mainstream pharmacy practice and are subject to maximum control.
Schedule 8: Narcotic drugs. These are the most strictly controlled substances under South African law. Examples include morphine, pethidine, fentanyl, and heroin (which has no recognized therapeutic use in South Africa and is entirely prohibited). Schedule 8 substances require a prescription (in the case of those with therapeutic use), must be stored in a safe or strongroom with specific security requirements, must be recorded in a Schedule 8 register, and are subject to unannounced inspection by the South African Police Service and SAHPRA. Every Schedule 8 transaction (receipt, dispensing, and stock count) must be recorded contemporaneously.
4. Licensing of Manufacturers, Importers, and Distributors
The Medicines Act requires that any person who manufactures, imports, or distributes medicines must hold a licence issued by SAHPRA. This includes pharmaceutical manufacturers (who must comply with Good Manufacturing Practice or GMP standards), importers and exporters, wholesalers and distributors, and anyone who engages in the bulk importation of unregistered medicines (which requires a separate specific permit). Retail pharmacies sourcing medicines from unlicensed suppliers or holding unregistered medicines may be found to be in possession of illegally sourced medicines, which are subject to seizure and destruction.
Good Manufacturing Practice (GMP): Manufacturers must comply with SAHPRA’s GMP requirements, which set out the standards for pharmaceutical manufacturing facilities, including design and maintenance of premises, equipment, personnel qualifications and training, production and quality control procedures, documentation, self-inspection, and the handling of complaints and recalls. SAHPRA conducts inspections of manufacturing facilities and issues GMP certificates to compliant manufacturers. Medicines manufactured in non-compliant facilities may be seized and destroyed.
Good Distribution Practice (GDP): Distributors and wholesalers must comply with GDP requirements, which govern the storage, handling, transport, and delivery of medicines to ensure that their quality is maintained throughout the supply chain. Key GDP requirements include: appropriate storage conditions (including cold chain management for temperature-sensitive products); secure storage to prevent theft or tampering; procedures for handling product recalls and withdrawals; procedures for managing returned goods; and a system for ensuring that medicines are sourced only from licensed suppliers and supplied only to licensed customers. A pharmacy that sources medicines from a wholesaler must verify the wholesaler’s SAHPRA licence status and must maintain records of this verification.
5. Prescription Requirements and Responsible Prescribing
The Medicines Act and its Regulations set out the requirements for prescriptions for Schedule 2 through Schedule 8 medicines. A valid prescription must contain certain minimum information: the name, address, and qualification of the prescriber; the date of the prescription; the patient’s name and address; the medicine prescribed (generic name and dosage form, or trade name with generic name); the strength of the medicine; the dose and instructions for use; the quantity to be dispensed; the number of repeats authorised; and the prescriber’s signature. Prescriptions that do not contain this minimum information are technically invalid, and a pharmacist who dispenses against an invalid prescription may be in contravention of the Medicines Act and the SAPC’s Rules Relating to Pharmacy.
The Act also prohibits the dispensing of prescriptions that are more than a specified period old (typically six months from the date of the prescription, unless the prescriber has specified a longer period for a chronic condition). Pharmacists must check the date of the prescription before dispensing and must not dispense an expired prescription without contacting the prescriber to obtain a new prescription or an extension.
Controlled substances prescriptions: Prescriptions for Schedule 5 to Schedule 8 substances must meet additional requirements. They must be written in ink (or other indelible manner), must not contain cancellations or alterations, and must be retained on the premises for the required period. Schedule 5 and 6 prescriptions may be repeated only as specified by the prescriber. Schedule 7 and 8 prescriptions may not be repeated — each dispensing requires a new prescription.
6. Record-Keeping Requirements
The Medicines Act and its Regulations impose detailed record-keeping requirements that must be complied with by every pharmacy. The purpose of record-keeping is to create an audit trail that enables SAHPRA and law enforcement agencies to trace medicines from manufacturer to patient, identify any break in the chain of supply, and investigate suspected drug trafficking or fraud.
Schedule 2-4 dispensing records: The SAPC’s Rules Relating to Pharmacy require that pharmacies maintain patient medication records (PMRs) that include the patient’s details, the medicine dispensed, the date of dispensing, the prescriber’s details, and the quantity dispensed. These records must be retained for a minimum period (typically five years). Dispensing records for Schedule 2-4 medicines must be accessible for inspection by SAHPRA inspectors.
Schedule 5-8 records: These substances require more rigorous record-keeping. A bound register (a “Schedule 5-8 register” or “controlled substances register”) must be maintained for each Schedule 5 and above substance on the premises. Each entry must record: the date; the name and address of the supplier (for receipts) or the patient and prescriber (for dispensing); the quantity received or dispensed; and the balance remaining in stock. Entries must be made in indelible ink, without cancellations or alterations (errors must be struck through with a single line, corrected, and initialled). The register must be retained permanently on the premises. Stocktakes of Schedule 5-8 substances must be conducted at regular intervals (at least quarterly for Schedule 5 and 6; at least monthly for Schedule 7 and 8) and discrepancies must be reported to SAHPRA immediately.
Returns and recall records: Any medicines returned by patients, any stock returned to suppliers, and any medicines subject to a recall notice from the manufacturer or SAHPRA must be recorded. Returned medicines that are no longer in a condition fit for resale must be quarantined and disposed of in accordance with applicable waste management regulations — they cannot simply be discarded with ordinary refuse.
7. SAHPRA’s Enforcement Powers
SAHPRA is empowered by the Medicines Act to enforce compliance through a range of mechanisms: inspections of pharmacies, manufacturers, and distributors; sampling and testing of medicines; issuance of compliance notices requiring specific remedial action; suspension or cancellation of licences; seizure and destruction of non-compliant medicines; referral for criminal prosecution; and publication of compliance information to alert the public. SAHPRA inspectors have the power to enter any premises where medicines are manufactured, stored, sold, or dispensed, to inspect records, and to seize medicines and documents.
Criminal penalties for Medicines Act contraventions are severe. Section 34 of the Act provides for penalties of fine or imprisonment for up to 10 years for a first conviction for supply of unregistered medicines, and up to 15 years for subsequent convictions. Supplying Schedule 5-8 substances without a valid prescription or licence may attract additional criminal penalties under the Drugs and Drug Trafficking Act 140 of 1992, which operates concurrently with the Medicines Act and imposes its own drug trafficking penalties. The overlap between the Medicines Act and the Drugs and Drug Trafficking Act means that a pharmacist found in possession of or dealing in controlled substances outside the lawful supply chain may face prosecution under both statutes.
8. The Interaction Between the Medicines Act and Other Legislation
The Medicines Act does not operate in isolation — it interacts with several other pieces of legislation that affect pharmacy practice. The Pharmacy Act 53 of 1974 and the SAPC’s Rules Relating to Pharmacy set the professional standards for pharmacy practice, including the dispensing process, patient counselling, and record-keeping. These professional standards complement the Medicines Act’s regulatory requirements but are enforced by the SAPC rather than SAHPRA. A pharmacist who contravenes the Medicines Act may face both criminal prosecution (through SAHPRA and the courts) and disciplinary proceedings (before the SAPC), and a single act of misconduct may give rise to liability in both spheres.
The Consumer Protection Act 68 of 2008 applies to pharmacy service transactions, creating consumer rights in relation to the medicines supplied. The Medicines Act and the CPA overlap in the area of medicine safety — a medicine that is registered by SAHPRA is presumptively safe, and the CPA’s safety warranty is satisfied. However, a medicine that is found to be unsafe after registration (for example, due to a manufacturing defect discovered post-market) triggers both SAHPRA’s market surveillance powers under the Medicines Act and the CPA’s Section 61 liability provisions.
The Constitution also informs the interpretation and application of the Medicines Act. The right to access healthcare services (Section 27) may be relevant when patients are unable to access essential medicines due to regulatory barriers. The right to bodily integrity (Section 12) is engaged when medicines are administered to patients without informed consent. The right to administrative justice (Section 33) applies when SAHPRA makes decisions affecting the rights of pharmacists or pharmacy owners, requiring those decisions to be lawful, reasonable, and procedurally fair.
9. Problem-Solving Strategies and Common Mistakes
When approaching examination questions involving the Medicines Act, the key is to systematically address: (1) Is the medicine registered with SAHPRA? (2) What is its Schedule? (3) Who may lawfully prescribe it? (4) Who may lawfully dispense it? (5) What are the prescription and record-keeping requirements applicable to that Schedule? (6) Does the scenario describe compliance or a breach? (7) If a breach, what are the criminal and professional consequences? This systematic approach ensures no requirement is overlooked.
Common mistakes include: assuming that a medicine purchased from a SAHPRA-licensed wholesaler is automatically lawful at the dispensing point (the pharmacy must also comply with storage, record-keeping, and Schedule-specific requirements); conflating the SAPC’s Rules on generic substitution with the Medicines Act’s registration requirements (they are separate frameworks); failing to appreciate that a pharmacist who dispenses a Schedule 5-8 substance without the required documentation is not merely in breach of a professional rule but is committing a criminal offence; and overlooking the fact that SAHPRA and SAPC enforcement mechanisms operate concurrently — both may take action for the same conduct.
Practice: Work through past SAPC examination questions involving the Medicines Act, focusing on scenarios where medicines are dispensed outside the lawful supply chain, where Schedule requirements are not met, where record-keeping is deficient, and where a pharmacist discovers a potential controlled substance abuse situation. For each scenario, apply the Schedule classification, assess compliance with the Medicines Act’s requirements, and identify the criminal and professional consequences of any non-compliance.
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