CT MPJE QUESTIONS AND ANSWERS 100% PASS

CT MPJE QUESTIONS AND ANSWERS 100% PASS How many CE hrs required to be completed upon second renewal 15 How many Live CE hrs 5 How many Law CE hrs 1 The Orange Book Food, Drug and Cosmetic Act 1938, Tamper-Evident Packaging, Medication Guides, Recalls, New drugs must show they are safe before marketing. Prohibits the movement in interstate commerce of adulterated and misbranded foods, drugs and devices. Established the FDA within the Health and Human Services Controlled Substances Act Schedules of Controlled Substances Combat Methamphetamines Epidemic Act Durham-Humphrey Amendements 1951, Defined Rx vs OTC Kefauver-Harris Amendements 1962, Manufacturers must prove drugs are both safe and effective (thalidomide) Drug quality and Security Act 503A and B compounding requirements Adulteration Effects the quality of the contents of the container. Filthy, putrid or decomposed, produced, packed of held in insanitary conditions, Does not conform to PET compounding standards. the container is poisonous or deleterious substance. Contains unapproved or unsafe color additive, does not confrom to strength, quality or purity. its AI is substituted or its stength or purity is decreased. OTC not packaged in a tamper resistant container Misbranded effects the literature on the container. needs place of manufacturers or packer/distributor, and accurate quanitity, cannot have fradulent or exaggerated claims, omission of pertinent info like RX only, Inconspicious printing, the drug would be dangerous if used as labeled, does not contain a product identifier Drug Approval Process (Pre-Clinical) Drug Developed --> Test on Animals --> IND Application --> (Clinical) Phase 1(Tests safety), 2(tests Effectiveness), 3 (More safety and effectiveness, different patient populations, dosages and in combination with other drugs ) New Drug Application Review Review Meeting (FDA and sponsor) --> NDA (Sponsor formally asks to market in the US includes all info gathered from phase 1-3) --> Application reviewed (60 days to decide) --> Drug labeling (FDA ensures correct info is communicated to HCP and Consumers) --> Facility inspection (FDA checks where the drug will be manufactured) --> FDA approves Drug Post Marketing Phase 4 (sponsor submits periodic safety updates to FDA) MedWatch is a voluntary system to report to FDA Department of Consumer Protection (DCP)