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Legislation June 2020
Introduction
Intro
Drug classification
Question
a) A tablet containing 200 mg lopinavir and 50 mg ritonavir
b) A sublingual spray containing 400 micrograms glyceryl trinitrate
c) A tablet containing 500 mg levofloxacin
d) A vial of powder for solution for infusion containing 1.5 mf epoprostenol
e) An ampoule of solution for injection/infusion containing 10 mg nicardipine
f) A syrup containing 1 mg/5ml ketotifen
g) A tablet containing 400 mg pentoxyfylline
h) Cough medicine containing codeine (updated Jan 2024)
i) An eye drop containing 10 mg/g fusidic acid
j) An oral suspension containing 100 mg/5ml ibuprofen
k) A cream containing 5% of povidone-iodine
l) A capsule containing 75 mg amfepramone
m) A tablet containing 100 mg erlotinib
Part 2 Poisons
Question 2 - Dangerous Drugs
Question
a) Definitions
b) Storage, supply, restrictions, record keeping
Question 3 - Labelling
Question
a) Definition of medicine
b) Labelling requirements
c) Additional labelling requirements
Question 4 - Manufacturing
Question
a) Definitions
b) Authorised person
c) Record keeping
ASPs and LSPs
Question
a) ASP and LSP
b) Conditions and limitations on sales
c) P1S1S3 Poisons
g) A tablet containing 400 mg pentoxyfylline
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