Alabama MPJE | Questions and answers with 100% correct solutions | Graded A+
Pure Food and Drug Act (1906) aka Wiley Law ✔✔Prohibits adulteration and misbranding
Food, Drug and Cosmetic Act (1938) ✔✔-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) ✔✔-Established prescription and OTC drug categories
-Allowed for oral prescriptions
-Allowed for refills
Manufacturer label on Rx drugs after Durham-Humphrey Amendment ✔✔-Not required to have
directions for use
-"Caution: Federal law prohibits dispensing w/o a prescription"
Kefauver-Harris Amendment (1962) ✔✔-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? ✔✔FTC
Hatch-Waxman Amendment ✔✔-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 ✔✔Distributor registered with the DEA to destroy drugs