##  [What is the Classification of Drugs in Hong Kong?](/what-is-the-classification-of-drugs-in-hong-kong) 

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In Hong Kong, drugs are classified under the **Pharmacy and Poisons Ordinance (Cap. 138)**. This ordinance defines "pharmaceutical products" as substances or combinations of substances used for:

- Treating or preventing disease
- Restoring, correcting, or modifying physiological functions
- Making medical diagnoses

It also includes "advanced therapy products" such as gene therapy, somatic cell therapy, and tissue-engineered products.

Drug classification considers factors like pharmaceutical form, method of use, label indications, and registration status in Hong Kong.

## Control Over Registered Drugs 

Registered drugs are subject to various controls over their sale to protect public health. The **Poisons List** under the **Tenth Schedule of the Pharmacy and Poisons Regulations (Cap. 138A)** lists ingredients classified as poisons.

These poisons are further categorized under:

- Different **Parts** of the Poisons List
- Other **Schedules** under the Pharmacy and Poisons Regulations

The classification is based on potency, toxicity, and potential side effects.

## Drug Categories 

There are three main drug categories in Hong Kong:

1\. Over-The-Counter Medicines (OTC)

- Drugs that do not contain poisons
- Or contain **Part 2 poisons**
- The former can be sold in any retail shop
- The latter can be sold by **Authorized Sellers of Poisons (ASP)** (pharmacies or dispensaries) and **Listed Sellers of Poisons (LSP)** (medicine stores)

2\. Pharmacy-Only Medicines

- Drugs containing **Part 1 poisons**
- Can only be sold in **pharmacies (ASP)**
- Must be sold in the presence and under the supervision of a **registered pharmacist**

3\. Prescription-Only Medicines

- Drugs containing **Part 1 Third Schedule poisons**
- Sale must be authorized by a **prescription** from a:  
    
    - Registered medical practitioner
    - Registered dentist
    - Registered veterinary surgeon

## Additional Restrictions 

Some **Part 1 Poisons** are further classified into:

**First Schedule**

- Requires **sales records** including:  
    
    - Date of sale
    - Name, ID number, address, and signature of the purchaser
    - Name and quantity of the medicine
    - Purpose for which it is required

**Third Schedule**

- Requires **a valid prescription** for sale

**Other Ordinances**

- **Antibiotics** (under the **Antibiotics Ordinance - Cap. 137**)
- **Dangerous Drugs** (under the **Dangerous Drugs Ordinance - Cap. 134**)
- Both are also considered **prescription-only medicines**

**Regulatory Guidelines**

The **Pharmacy and Poisons Board** provides guidelines and lists of substances generally considered medicinal, such as antibiotics and paracetamol.

Possession or sale of **unregistered pharmaceutical products or prescription drugs** is **illegal** in Hong Kong. All pharmaceutical products must be **registered** with the Board.

**Freyr Solutions** is your trusted partner for navigating the Hong Kong pharmaceutical landscape.