Pharmacy and Poisons Ordinance (Cap. 138) and Subsidiary Legislation
This domain tests how the Pharmacy and Poisons Ordinance (Cap. 138) controls poisons, pharmacists, pharmacy premises, and pharmaceutical products in Hong Kong. The exam expects you to know which registration or licence authorises each activity, how the subsidiary regulations fill in the procedural detail, and where the boundary lies between a registered pharmacy and a licensed seller of poisons.
Statutory architecture
Cap. 138 establishes the Pharmacy and Poisons Board and gives it functions that include registering pharmacists, registering retail pharmacies, licensing manufacturers and wholesale dealers, and registering pharmaceutical products. The Poisons List in Schedule 1 is divided into Part I and Part II. Part I poisons carry the tighter controls: sale is restricted to a registered pharmacist at a registered pharmacy, and many are prescription-only. Part II poisons are subject to lighter controls and may be sold by a licensed seller of poisons within the terms of its licence.
The subsidiary legislation supplies the operational rules. The Pharmacy and Poisons Regulations (Cap. 138A) deal with applications, fees, labelling, record-keeping, and conditions of registration. The product registration regulations separately require pharmaceutical products to be registered before sale, unless a specific exemption applies, such as a clinical trial or named-patient supply.
Who may sell what
- Registered pharmacy: must hold a valid retail pharmacy certificate and have a registered pharmacist in charge; the pharmacist must supervise dispensing and sale.
- Licensed seller of poisons (drugstore): may sell only the poisons permitted by its licence, typically Part II poisons, and cannot dispense prescriptions.
- Manufacturer and wholesale dealer licences: required for manufacturing and wholesale distribution of pharmaceutical products.
- Product registration: separate from premises registration; an unregistered product cannot be sold merely because the pharmacy is registered.
Worked example
A customer presents a prescription for amoxicillin. Amoxicillin is a Part I poison and prescription-only. The premises must be a registered retail pharmacy, and a registered pharmacist must check the prescription, dispense it, and supervise the transaction. The container must bear the prescribed particulars and the statutory poison warning. A drugstore holding only a poisons licence cannot dispense the prescription, even if it stocks amoxicillin.
Traps that cost marks
Confusing Cap. 138 with the Dangerous Drugs Ordinance (Cap. 134); treating "pharmacy" and "drugstore" as interchangeable; forgetting that product registration is distinct from pharmacy registration; and omitting the pharmacist's personal supervisory duty.