1. 

(A) Indicate by using the abbreviations respectively shown in square brackets, the (1 mark each) 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 I of Schedule 1 to the Dangerous Drugs Ordinance [P1DD], 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]: 

(a) A tablet containing 200mg paracetamol, 45mg caffeine, 200mg salicylamide, 5mg phenylpropanolamine hydrochloride and 2mg chlorphenamine maleate 

(b) A tablet containing 100mg aspirin 

(c) A tablet containing 10mg solifenacin succinate 

(d) An ear drop containing 5mg/ml hydrocortisone, 2mg/ml chloramphenicol, 25mg/ml phenazone and 20mg/ml docusate sodium 

(e) A tablet containing 5mg oxethazaine, 126mg dried aluminium hydroxide and 84mg magnesium carbonate 

(f) A cream containing 20% w/w azelaic acid 

(g) A capsule containing 50 mg nitrofurantoin and 100 mg phenazopyridine hydrochloride 

(h) A tablet containing 250mg paracetamol, 150mg ethenzamide and 50mg caffeine 

(i) A capsule containing 300mg myrtol 

(j) A cream containing 0.64mg/g betamethasone dipropionate, 1.7mg/g gentamicin sulfate and 10mg/g clotrimazole 

(k) A syrup containing 1.67mg/5ml chlorphenamine maleate, 4.5mg/5ml codeine phosphate, 4mg/5ml ephedrine hydrochloride and 2.67mg/5ml bromhexine hydrochloride 

(l) A tablet containing 2.5mg indapamide 

Note: Structure of indapamide is 

(m) A tablet containing 2 mg hyoscine butylbromide, 2mg dicycloverine hydrochloride, 5mg chlordiazepoxide, 3mg chlorophyllin copper complex sodium, 350mg aluminium hydroxide magnesium co-dried gel and 40 mg magnesium oxide 

(n) A syrup containing 4mg/5ml ethylmorphine hydrochloride, 2mg/5ml chlorphenamine maleate, 2mg/5ml ephedrine hydrochloride, 75mg/5ml ammonium chloride and 0.1ml/5ml ipecacuanha 

(B) Describe the specific conditions under which the following substances would be considered as Part 1 poisons under the Pharmacy and Poisons Regulations. 

(a) Trientine (1 mark) 

(b) Icosapent ethyl (5 marks) 

2. 

(a) Define the differences between "authorized seller of poisons" and "listed seller of poisons" under the Pharmacy and Poisons Ordinance. (4 marks) 

(b) Describe the conditions and limitations on sale of Part 1 and Part 2 poisons by an "authorized seller of poisons" and a "listed seller of poisons" respectively. (8 marks) 

(c) What are the additional restrictions when an authorized seller of poisons sells a poison included in Schedule 3 to the Pharmacy and Poisons Regulations? (8 marks) 

3. (a) Define "prescribed hospital" and "diversion certificate" under the Dangerous Drugs Ordinance. (4 marks) 

(b) Describe the statutory requirements stipulated under the Dangerous Drugs Ordinance in relation to the storage, supply, restrictions and record keeping of dangerous drugs by a prescribed hospital. (16 marks)

4. 

(a) Define the substances to which the Antibiotics Ordinance applies. (4 marks) 

(b) Describe the control of sale and supply of antibiotics as stipulated under the Antibiotics Ordinance. (6 marks) 

(c) Describe the record-keeping requirements for an authorized seller of poisons in relation to the receipt and supply of antibiotics as stipulated under the Antibiotics Ordinance. (10 marks) 

5. 

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

(b) Describe the labelling requirements for an advanced therapy product, which is a Schedule 3 poison, to be supplied in Hong Kong as stipulated under the Pharmacy and Poisons Ordinance and its Regulations. (10 marks) 

(c) Describe the requirements for conducting clinical trial of an advanced therapy product stipulated under the Pharmacy and Poisons Regulations (4 marks) 

END OF PAPER