Compendia Study guides, Class notes & Summaries

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

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: -mandated accurate p...

EBM Exam 1 Questions & Answers 2023/2024 Name the useful tertiary source(s) for general product information? - ANSWER-Major Compendia (like Facts and Comparisions, Lexicomp, Micromedex, etc) Name the useful tertiary source(s) for self-care and OTC products - ANSWER-Handbook of Nonprescription Drugs Name the useful tertiary source(s) for adverse effects - ANSWER-Meyler's Side Effects of Drugs Side Effects of Drugs Annual Name the useful tertiary source(s) for availability of dos...

1906 Pure Food & Drug Act - Which act or amendment was the first to regulate the manufacture or sale of adulterated or misbranded drugs in interstate commerce? 1906 Pure Food & Drug Act - Which act or amendment was the first to recognize USP/NF as the official compendia? 1938 Food, Drug & Cosmetic Act - Which act or amendment required manufacturers to prove drug safety prior to marketing? 1938 Food, Drug & Cosmetic Act - Which act or amendment was the first to regulate medical devices and...

Florida MPJE Questions and Answers 100% Pass 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 Prescription Drug Marketing Act of 1987 Prevent...

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...

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** (...

Mpje Solved Questions and answers Actual test Latest DEAform 224 renew every? - new pharmacy registration to dispense controlled substances (application for new registration) - pharmacy registration is renewed every 3 years (renewal registration form DEA form 224a - chain=224b) - registration kept onsite - issued by attorney gen. 3 exceptions for registration for dispensing controlled substances - employees, contract carrier, ultimate user who has to obtain a registration as a chemical...

NJ MPJE 2022-2023; 521 Questions with 100% Correct Answers 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 Pu...

NJ MPJE 2022-2023; 521 Questions with 100% Correct Answers 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 Pu...