1) 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 Regulation [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]: (1 mark each)

(a) A tablet containing 300mg paracetamol, 5mg phenylephrine hydrochloride, 10mg noscapine, 4mg bromhexine hydrochloride and 15mg caffeine

(b) A capsule containing 100mg temozolomide

(c) A tablet containing 5 mg dihydrocodeine tartrate, 50mg guaifenesin, 17.5mg methylephedrine hydrochloride and 1.5mg chlorphenamine maleate

(d) An ophthalmic suspension containing 0.1% w/v dexamethasone, 3500iu/1ml neomycin sulfate and 6000iu/1ml polymyxin B sulfate

(e) A syrup containing 2.5mg/5ml promethazine hydrochloride, 4mg/5ml ephedrine hydrochloride and 4.75mg/5ml codeine phosphate

(f) A tablet containing 2mg diazepam

(g) A tablet containing 37.5mg tramadol hydrochloride and 325mg paracetamol

(h) A tablet containing 100mg levodopa, 25mg carbidopa and 200mg entacapone

(i) A capsule containing 120mg pseudoephedrine hydrochloride and 5mg cetirizine hydrochloride 

(j) An eye gel containing 0.3% w/w hypromellose and 0.22% w/w carbomer

(k) A cream containing 0.25% w/w triamcinolone acetonide, 0.5% w/w neomycin sulfate, 2% w/w mepyramine maleate and 3%w/w sulfadiazine

(l) A tablet containing 2mg chlorambucil Note: Structure of chlorambucil is 

(m) A topical spray containing 0.25% w/v fipronil

(n) A syrup containing 15mg/5ml dextromethorphan hydroboromide, 0.08ml/5ml cocillana liquid extract, 0.02ml/5ml Euphorbia liquid extract, 0.02ml/5ml senega liquid extract

(B) Describe the specific conditions under which the following Part I poisons NOT be considered as Schedule 3 poisons under the Pharmacy Poisons Regulations 

(a) Betahistine (4 marks)

(b) Pantoprazole (2 marks)

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 “medicine” under the Pharmacy and Poisons Ordinance. (3 marks)

(b) Describe the labeling requirements for a medicine to be supplied in Hong Kong as stipulated under the Pharmacy and Poisons Ordinance and its Regulations. If the medicine is for export purpose, what labeling requirements apply? (12 marks) 

(c) What additional labeling requirements apply if the medicine (i) is a lotion; (ii) is for the treatment of an animal; (iii) contains a Part 1 Poison (except Schedule Poison); and (iv) contains a Schedule 3 poison? (5 marks)

4. (a) Define “institution” under the Pharmacy Poisons Ordinance (2 marks)

(b) Describe the supply and recording requirements of medicines supplied to out-patients by institutions. (8 marks) 

(c) Describe “prescribed hospital” under the Dangerous Drugs Ordinance. (1 mark)

(d) 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. 

5. (a) Describe the definition of “sale by way of wholesale dealing” according to the Pharmacy and Poisons Ordinance. (1 mark)

(b) As given in the Pharmacy and Poisons Regulations, a licensed wholesale dealer must not sell or supply a poison to any person apart from certain types of person or recipient. Please list them out (11 marks) 

(c) As described in the Pharmacy and Poisons Regulations, what particulars are required to be recorded by a licensed wholesale dealer for each transaction by which any poison included in Part 1 of the Poisons List or any pharmaceutical product is acquired by him/her? What is the required time frame for making such record? (8 marks)