Ref.: PPB/PLHK/JUN/25 

Pharmacy and Poisons Board of Hong Kong 

9 June 2025, Monday (3 hours) 

Pharmacy Legislation in Hong Kong 

Each question carries 20 marks. 

1. 

(A) Indicate by using the abbreviations respectively shown in square brackets, the legal classifications of the following drugs showing whether they are included in Part 1 of Schedule 10 to the Pharmacy and Poisons Regulations [P1], Part 2 of Schedule 10 to the Pharmacy and Poisons Regulations [P2], Schedule 1 to the Pharmacy and Poisons Regulations [S1], Schedule 3 to the Pharmacy and Poisons Regulations [S3], Part 1 of Schedule 1 to the Dangerous Drugs Ordinance [PIDD], Part II or Part III of Schedule 1 to the Dangerous Drugs Ordinance [P2DD], Schedule 1 to the Antibiotics Regulations [A], or none of the above [NP]: 

(1 mark each)

(a) A linctus containing 12.5mg/5ml diphenhydramine hydrochloride, 125mg/5ml ammonium chloride and 50mg/5ml sodium citrate 

(b) A suspension containing 100mg/5ml ibuprofen 

(c) An ear drops containing 5mg/g diethanolamine fusidate, 5mg/g framycetin sulfate, 100000iu/g nystatin and 2.5mg/g prednisolone 

(d) A topical solution containing 6900mg/100ml methyl salicylate, 4200mg/100ml menthol, 4500mg/100ml camphor, 300mg/100ml thymol, 100mg/100ml chlorphenamine maleate and 10mg/100ml nonivamide 

(e) A tablet containing 8mg bromhexine hydrochloride, 30mg caffeine, 15mg pentoxyverine citrate, 4mg chlorphenamine maleate, 20mg lysozyme hydrochloride, 500mg paracetamol and 10mg phenylephrine hydrochloride 

(f) A tablet containing 5mg empagliflozin and 850mg metformin hydrochloride 

(g) A tablet containing 10mg oxycodone hydrochloride and 5mg naloxone hydrochloride 

(h) A tablet containing 50mg praziquantel, 542mg oxantel embonate and 143mg pyrantel embonate 

(i) A solution containing 100mg/5ml ammonium bicarbonate, 0.15ml/5ml ipecacuanha tincture, 0.025ml/5ml concentrated anise water, 0.05ml/5ml concentrated camphor water and 0.25ml/5ml liquorice liquid extract 

(j) A cream containing 2% w/w fusidic acid and 1% w/w hydrocortisone 

(k) An injection vial containing 2.5mg thiamine nitrate, 3.6mg riboflavin, 40mg nicotinamide, 4mg pyridoxine hydrochloride, 100mg ascorbic acid, 60mcg biotin, 0.4mg folic acid, 5mcg cyanocobalamin and 15mg pantothenic acid 

(l) A cream containing 0.25% w/w desoximetasone Note: Structure of desoximetasone is 

(m) A syrup containing 15mg/5ml dextromethorphan hydrobromide, 30 mg/5 ml pseudoephedrine hydrochloride and 3.125mg/5ml promethazine hydrochloride 

(n) A syrup containing 4mg/5ml codeine phosphate, 4.9mg/5ml ephedrine hydrochloride, 2mg/5ml chlorphenamine maleate, 0.06ml/5ml cocillana liquid extract, 0.03ml/5ml senega liquid extract and 0.03ml/5ml squill liquid extract 

(o) An ointment containing 2% w/w mupirocin 

(p) A mouthwash containing 22.5mg/15ml benzydamine hydrochloride and 18mg/15ml chlorhexidine gluconate 

(B) Describe the specific conditions under which the following poisons would be exempted from the provisions of the Pharmacy and Poisons Ordinance as stipulated under regulation 8 of the Pharmacy and Poisons Regulations. (1 mark each) 

(a) Disulfiram 

(b) Clioquinol 

(C) Describe the specific conditions under which the following substances are NOT controlled as Schedule 3 poison under the Pharmacy and Poisons Regulations. (1 mark each) 

(a) Clobetasone butyrate 

(b) Hydrocortisone 

2. 

(a) Define "advertisement", "medicine" and "orally consumed product" under the Undesirable Medical Advertisements Ordinance on the advertising of medicines. (4 marks)
(b) Describe the regulation of advertisements relating to "orally consumed product" as stipulated by the Undesirable Medical Advertisements Ordinance. (16 marks) 

3. 

(a) Define "pharmaceutical product" and "poison" under the Pharmacy and Poisons Ordinance. (6 marks) 

(b) Describe how "Nicotine" is currently controlled under Schedule 1, Schedule 2 and Schedule 10 respectively under the Pharmacy and Poisons Regulations. (14 marks) 

4.

(a) Define "sale by way of wholesale dealing" and "manufacture" under the Pharmacy and Poisons Ordinance. (4 marks) 

(b) Describe the responsibility of an Authorized Person of a licensed manufacturer as stipulated under the Pharmacy and Poisons Regulations. (4 marks) 

(c) Describe the statutory duties regarding identity, purity, safety, etc. of a licensed manufacturer. (12 marks) 

5. 

(a) Define "dangerous drugs" under the Dangerous Drugs Ordinance. (2 marks) 

(b) Describe the statutory controls and requirements stipulated under the Dangerous Drugs Ordinance in relation to the storage, sales and supply and record keeping of dangerous drugs by a registered medical practitioner. (18 marks) 

END OF PAPER