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Exam (elaborations)
TX MPJE EXAM QUESTIONS WITH CORRECT ANSWERS GRADED A+
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Food Drug and Cosmetic Act of 1938 - ANSWER Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 - ANSWER Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - ANSWER Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and established GMPs; gave FDA jurisdiction over Rx drug advertising Prescription Drug Marketing Act of 1987 (4 things) - ANSWER PDMA; bans reimportation of Rx drugs and insulin produced in US (except by manufacturer); bans sale, trade, or purchase of
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