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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
i) An eye drop containing 10 mg/g fusidic acid
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