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Alabama MPJE Questions and answers with solutions
Pure Food and Drug Act (1906) aka Wiley Law âœâ€Ã¢Å“â€Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) âœâ€Ã¢Å“â€-New drug could not be marketed unless safe
-Required manufacturer label to have directions for use and warnings about habit forming drugs
Durham-Humphrey Amendment (1951) âœâ€Ã¢Å“â€-Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey Amendment âœâ€Ã¢Å“â€-Not required to have
directions for use
-"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) âœâ€Ã¢Å“â€-New drug could not be marketed unless effective
-Informed consent
-FDA allowed to regulate prescription drug advertising
-Reporting of ADRs
-GMPs
Who regulates OTC drug advertising? âœâ€Ã¢Å“â€FTC
Hatch-Waxman Amendment âœâ€Ã¢Å“â€-Generics only have to submit abbreviated NDA (ANDA):
bioequivalence, not safety and efficacy
-Gives incentives to brand manufacturers by giving 5 more years of patent protection (up to 22 years)
Reverse distributor âœâ€Ã¢Å“â€Distributor registered with the DEA to destroy drugs
Alabama MPJE Questions and answers with solutions
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