Pharm 895 Safety & Prescriptive Authority Questions and Correct Answers | Latest Update | A+
Pure Food & Drug Act 1906 Ans: -Restricted manufacture & sale of drugs, outlawed misbranding and adulteration. Sherley Amendment 1912 Ans: -Barred fraudulent therapeutic claims, but required to show intent to defraud to prosecute. Federal Food, Drug, and Cosmetic Act (FFDCA) 1938 Ans: -Replaced Pure Food & Drug Act. -Removed requirement to demonstrate intent to defraud in drug misbranding cases. -Passed after a drug with antifreeze killed over 100 people. -Granted FDA authority to regulate food, drugs, & cosmetics. -Required proof of safety. -Labels must include adequate directions for use. Durham-Humphrey Amendment 1951 Ans: -Sale and use of prescription drugs must be under medical supervision. -Established written prescription system through pharmacists. Kefauver-Harris Amendments 1962 Ans: -Requires proof of safety AND efficacy for drugs released since 1938. -Established guidelines for reporting info about adverse reactions, clinical testing, and advertising of new drugs. Drug development timeline Ans: 1: In vitro studies. 2: Animal testing. 3: Clinical testing, three phases. 4: Marketing, can include phase 4 studies. In vitro studies Ans: -Takes 2 years on averag
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