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What is the correct procedure for destroying a batch of expired or non-conforming medicines?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q369 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
The destruction of expired or non-conforming medicines must be strictly controlled and documented to prevent them from re-entering the market. The correct procedure is as follows: 1. Segregation and records: First, remove the medicines awaiting destruction from normal inventory and place them in a secure area clearly labelled ‘Non-conforming Goods’ or ‘Awaiting Destruction’. At the same time, prepare a detailed destruction list stating the name, batch number, quantity and reason for destruction of each medicine. 2. Select a destruction method: The method must ensure that the medicines cannot be reused. Common methods include incineration, chemical decomposition or solidification in cement. Medicines must never be disposed of directly in ordinary rubbish bins or drains. 3. Engage a qualified company: Destruction should be carried out by a specialist waste-treatment company holding the relevant licence. 4. On-site supervision: During destruction, the licence holder should send a staff member to supervise on site and ensure that all medicines are completely destroyed in accordance with the agreement. 5. Keep records: After destruction, obtain a Certificate of Destruction from the waste-treatment company and archive it together with all other documents, including internal destruction records and supervision records, for at least two years.

📘 Regulatory basis

Both the Code of Practice for Licensed Wholesale Dealers and GMP guidance require effective control of non-conforming goods and returned goods, including procedures for destruction. The disposal of medicines must also comply with the Environmental Protection Department’s requirements for chemical waste disposal.

📗 Drew Tang's recommendations

We recommend that clients prepare a detailed SOP for medicines destruction, defining every step and the responsible person from identification and segregation through to final destruction. Verify the qualifications of the waste disposal company. Destruction of controlled dangerous drugs may also require notification to the Department of Health and compliance with its specific guidelines. Maintaining a complete chain of destruction records is the only way to demonstrate to auditors or inspectors that non-conforming goods have been handled responsibly.

📕 Risk notice

Improper handling of medicines intended for destruction, such as reselling or casually discarding them, is a very serious violation. If these medicines ultimately harm public health or the environment, the company may face substantial legal liability and reputational damage. During a Department of Health inspection, failure to provide complete destruction records will also be regarded as a significant compliance deficiency.

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