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What additional security and record-keeping requirements apply when handling and storing controlled “dangerous drugs” (Dangerous Drugs)?

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

Q334 · Category G: Quality management and compliance systems (Q301–Q350)
In Hong Kong, medicines controlled under the Dangerous Drugs Ordinance (Cap. 134), such as certain potent painkillers and psychiatric medicines, are subject to stricter controls than ordinary prescription medicines. Security: these medicines must be stored in a sturdy, locked metal cabinet or safe, securely fixed to the building structure. Only authorised designated personnel (usually pharmacists) may hold the key or combination. Records: every transaction must be recorded by hand, in real time, in a dedicated, firmly bound Dangerous Drug Register. Each entry must include the date; the name and address of the person or organisation from whom the drugs are received or to whom they are supplied; details of the authorising document (such as a doctor’s prescription); and the quantity involved and balance remaining. Records must not be altered. Errors should be corrected by drawing a line through them and signing the correction.

📘 Regulatory basis

The Dangerous Drugs Ordinance (Cap. 134) and its regulations set out extremely detailed and stringent legal requirements for the possession, storage, supply and record-keeping of dangerous drugs. Any breach of the Ordinance may constitute a criminal offence.

📗 Drew Tang's recommendations

We recommend conducting independent stocktakes of all dangerous drugs at least quarterly, reconciling the physical quantities against the balances in the register. Any discrepancies must be investigated immediately. Provide specific training and conduct background checks for staff authorised to handle dangerous drugs. Keep all related prescription and order documents safely with the register. Strictly observe the principle of “dedicated personnel, dedicated cabinet and dedicated register”.

📕 Risk notice

Any discrepancy in records, security lapse or illegal supply involving dangerous drugs is an extremely serious offence and is highly likely to result in criminal prosecution and imprisonment. Regulators apply a zero-tolerance policy to the control of these medicines. Any minor clerical error, such as a missing signature or a late entry, could be used as evidence against you in court.

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