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South Africa SAHPRA’s Guidance: Destruction of Medicines and Scheduled Substances

The South African Health Products Regulatory Authority (SAHPRA) has issued an updated "Guideline for Destruction of Medicines and Scheduled Substances" outlining the safe and compliant destruction of medicines and scheduled substances across the country. This update aligns regulatory expectations with the Medicines and Related Substances Act (Act 101 of 1965) and the National Environmental Management: Waste Act (2008), reinforcing SAHPRA’s commitment to protecting public health and the environment.


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The guidance  provides clear expectations for how expired, substandard, falsified, unlawfully imported or otherwise undesirable medicines must be disposed of and destroyed.SAHPRA requires all health facilities — including pharmacies, manufacturers, wholesalers, distributors and licensed practitioners — to follow these requirements whenever medicines or scheduled substances leave the supply chain for destruction.

The guidelines ensure that these products are destroyed safely, irreversibly, and in compliance with national waste management legislation.


General Requirements for Disposal and Destruction

The guidance emphasises several core principles:

  • Disposal must prevent risks linked to incorrect destruction.

  • All waste must comply with Good Pharmacy Practice (GPP) rules.

  • Non-compliance must be reported to SAHPRA for investigation.

  • Destruction must follow environmental protection laws and use approved methods such as high-temperature incineration or chemical denaturing.


Special Witnessing and Documentation Requirements

The destruction of higher scheduled medicines (Schedules 5–8) requires SAHPRA authorization and the presence of witnesses:

  • Schedule 5 or 6: Requires an inspector, a pharmacist, or an authorized person to witness destruction.

  • Schedule 7 or 8: Must occur in the presence of an inspector and two pharmacists, or other persons authorized by the CEO of SAHPRA.

  • Destruction sites must issue certificates of destruction, maintaining records with product name/schedule, quantity, date, witnesses, and other details as required by SAHPRA[guidance:file:58].


Procedure for Applying for Destruction

Applicants (pharmacies, distributors, clinics, manufacturers) must:

  1. Submit a Permission Request: Applications for destruction must be sent to destruction@sahpra.org.za using the SAHPRA Destruction Form GLF-RC-INSP-03A.

  2. Complete Documentation: Include medicine names, quantities, batch numbers, dosage form, expiry dates, destruction company, responsible pharmacist, rationale, and details of witnesses.

  3. Prompt Processing: SAHPRA processes complete applications within 10 working days, providing written confirmation or requests for more information as needed


By strengthening regulatory oversight, SAHPRA ensures:

  • Controlled substances do not re-enter the illegal market.

  • Damaged, expired or falsified medicines never reach patients.

  • Waste treatment aligns with environmental legislation.

  • Nationwide consistency in how facilities handle medicine destruction.


For more details, please refer to the guidance provided: Guideline for Destruction of Medicines and Scheduled Substances

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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