Florida MPJE: June 2023 Questions and Answers 100% correct Food, Drug, and Cosmetic Act of 1938 Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising ...

MA MPJE(2024 Latest Update)Accurate 100% Person Registration Requirements - ANSWER 1.) 18 years or older 2.) graduate from ACPE-accredited/board-certified school of pharmacy* 3.) at least 1500 hours of practical experience as intern 4.) Good moral character *Must pass MPJE with 75 *non-approved colleges must receive Foreign Pharmacy Graduate Examination Committee Certification (FPGEC) Personal Registration RENEWAL - ANSWER **ALL PERSONAL REGISTRATIONS EXPIRE ON DECEMBER 31 (12/31) O...

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

NJ MPJE Questions and Answers Already Passed Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. -misbranding Pure Food and Drug Act (1906) description -mandated accurate product labeling and r...

Pure Food and Drug Act - correct answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - correct answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properl...

Pharmacy Law Exam 1 (FDA & Product Classification/Regulation) *FDA* - ANSWER- What does the FDA enforce? - ANSWER-Federal Food, Drug and Cosmetic Act What is the FDA a component of? - ANSWER-Department of Health and Human Services (DHHS) What does the FDA regulate? - ANSWER-Human and veterinary drugs, biological pdts Medical devices Nation's food supply (except meat (USDA) and tap water (EPA)) Cosmetics Pdts that emit radiation *DRUG* - ANSWER- What is a drug according t...

Person Registration Requirements correct answers 1.) 18 years or older 2.) graduate from ACPE-accredited/board-certified school of pharmacy* 3.) at least 1500 hours of practical experience as intern 4.) Good moral character *Must pass MPJE with 75 *non-approved colleges must receive Foreign Pharmacy Graduate Examination Committee Certification (FPGEC) Personal Registration RENEWAL correct answers **ALL PERSONAL REGISTRATIONS EXPIRE ON DECEMBER 31 (12/31) OF EACH EVEN-NUMBERED YEARS** (...

Pure Food and Drug Act - correct answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - correct answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and prope...

MPJE Michigan, Questions and answers, 100% proven pass rate. 2022/2023. Document Content and Description Below MPJE Michigan, Questions and answers, 100% proven pass rate. 2022/2023. Which prescription type is good for 12 months - Noncontrolled and schedule 5 Which prescription type is good for 6 months - Schedule 3-4 Which prescription type is good for 90 days - Schedule 2 Max refills for non control - 11 Max refills for schedule 5 - 11 Max refills for schedule 3-4 - 5 Max refills for schedul...

Neither _____ nor _____ are required by an *ANDA*. - correct answer -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. - correct answer -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - correct answer -misbranding Pure Food and Drug Act (1906) description - correct answer -manda...