Compendia Study guides, Class notes & Summaries

Mpje Questions and Answers 2023 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 distributor? who...

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 ...

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...

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) OF EACH EVEN-NUMBERED YEARS** (11/1 notices s...

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...

Code of ethics - ANSWER-is a framework of shared vales of the profession that help guide the behaviors of a health education specialist. Consultation - ANSWER-is the process by which knowledge of one person is used to help another make decisions. Informal consulting - ANSWER-does not require a written agreement or formal contract. This type of consulting consists of acting as a resource person responsible for organizing health education materials and responding to requests for health educa...

MPJE NYS Pharmacy Law Exam With Complete Solution 2023 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 - SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... - Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? - 1) Seizure of dru...

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