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HONG KONG DRUG LICENSING

What specific rules apply to our pharmacy (Authorised Seller of Poisons) when storing and displaying different categories of “poisons”?

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

Q381 · Category H: Licensed operations and routine regulatory oversight (Q351–Q400)
As a pharmacy, you must comply with strict legal requirements for the storage and display of different categories of poisons, in order to protect public safety and prevent misuse or abuse. Part I poisons (prescription medicines) must never be accessible to the public and must be stored in a “non-public area”, such as a dispensing room or locked cabinet. Part II poisons (medicines sold by medicine shops) may be displayed in public areas, but must be kept separate from other non-medicinal goods, such as food and cosmetics. Certain Part I poisons listed in Schedule 1 are subject to stricter requirements: they must be kept in a locked container, with the key held by a registered pharmacist. All poison storage areas should also be kept clean and dry and protected from direct sunlight to maintain medicine quality.

📘 Regulatory basis

Sections 10 and 11 of the Pharmacy and Poisons Regulations (Cap. 138A) clearly prescribe the storage and custody requirements for Part I and Part II poisons, with the aim of physically segregating medicines with different levels of risk.

📗 Drew Tang's recommendations

We recommend that pharmacies take these requirements fully into account when designing their shop layout. Use clear labels and shelving partitions to distinguish clearly between different categories of products. Train all staff to ensure they know which medicines may be displayed openly and which must be kept under strict control. RGYS may assist with document preparation and project coordination within the written scope of services; personnel qualifications, statutory roles and professional judgements are to be verified and assumed by the respective responsible parties, while approval is determined independently by the competent authority. This can also demonstrate your professionalism to customers.

📕 Risk notice

Leaving prescription medicines where customers can easily reach them is an extremely serious breach. If discovered during a Department of Health inspection or if it leads to an incident, the pharmacy may face disciplinary action, including a fine or even revocation of its licence. The pharmacist in charge may also face allegations of professional misconduct.

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