Federal mpje evaluation - Study guides, Class notes & Summaries

NEVADA MPJE QUESTIONS AND ANSWERS 100% PASS Laws vs. Regulations laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process 1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval --> begin Phase 1 study, Phase 2, then Phase 3 4) file a n...

NEVADA MPJE Question and answer 100% correct 2023Laws vs. Regulations laws - enacted through a federal or state legislative process regulations - (or rules) provide specific details to help implement the law, and are issued by state regulatory agencies (e.g. state board of pharmacy) FDA Drug Approval Process 1) pre-clinical testing (animals) 2) manufacturer files an investigational new drug (INDA) application with the FDA 3) INDA approval --> begin Phase 1 study, Phase 2, then Pha...

Multistate Pharmacy Jurisprudence Exam (MPJE) FEDERAL LAW Questions ans Answers | Latest Update Graded A+ (2023/2024). Isoproterenol inhaled products and thyroid hormones Correct Answer: Examples of prescription medications requiring special labeling True Correct Answer: True or false: The medication guide must be based on approved professional labeling Misbranding Correct Answer: Pharmacists who do not give out mandated medication guidelines are guilty of Drug name Manufacturer Indicate...

MA MPJE Exam with 1200+Questions and Answers RATED A+ 2023|2024 Why does the government regulate medical drugs? Correct answer: protect people from making risky choices and harming themselves Ma state law, how many hours may a pharmacist work? Correct answer: 12 hours per day Allowing people to care for themselves leads to what? Correct answer: market failures What are the 4 kinds of market failures? Correct answer: public goods Externalities Natural monopolies Information asymmet...

Indiana MPJE Final Exam Practice Questions With Correct Answers | Latest Upsdated 2023-2024. Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984 - Correct answer-Created abbreviated new drug application for generic drugs Allowed the marketing of a generic drug without conducting clinical studies but still required CGMPs and proof of bioequivalence Prescription Drug Marketing Act (PDMA) of 1987 - Correct answer-Established procedures, requirements, and minimum standar...

MPJE 2021 Federal Pharmacy Law Class notes 2023 Pure Food and Drug Act of 1906 - This law prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded Pitfalls: Did not require manufacturers to list the ingredients or directions on the label. Did not regulate cosmetics or medical devices. Food, Drug, and Cosmetic Act of 1938 - - Required that new drugs could not be marketed unless they had first been proven to be safe when used according t...

Indiana MPJE Exam Practice Questions and Answers | Latest Upsdated 2023-2024. Where to find Indiana laws and regulations (Rules in Indiana) - Correct answer-The Indiana Code (IC) Indiana Administrative Code (IAC) Pure Food and Drug Act of 1906 - Correct answer-Prevented the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors Food, Drug, and Cosmetic Act (FDCA) of 1938 - Correct answer-Required proof of safety o...

NABP -ANSWER National Association of Boards of Pharmacy ACPE -ANSWER Accreditation Council of Pharmacy Education MPJE -ANSWER Multistate Pharmacy Jurisprudence Examination NAPLEX -ANSWER North American Pharmacist Licensure Examination IPLA -ANSWER Indiana Professional Licensing Agency Indiana Code Citation Method: -ANSWER IC-Title-Article-Chapter-Section IC-TACS Indiana Administrative Code: -ANSWER Title IAC Article-Chapter-Section Chapter = Rule When does "practitioner...

NJ MPJE Questions and Answers 2023 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 produ...

MPJE Questions and Answers 2023 Sherman Anti-Trust Act 1890 1st federal act -outlawed monopolies. Designed to restore competition in the market and prevent companies from entering into agreements to control trade. Pure food and Drug Act 1906 -Prohibits misbranded and adulterated foods, drinks and drugs in interstate commerce What did the Pure food and Drug Act require? -Required that drugs meet the standards of strength and purity -Government was responsible for showing the l...