Pa mpje - Study guides, Class notes & Summaries

PA MPJE Questions and Answers 100% Solved Codeine Limitation for Schedule III Not more than 18 mg/mL Not more than 90 mg per dosage unit Codeine Limitation for Schedule V Not more than 2 mg/mL and must have additional nonnarcotic API Emergency C2 prescription hard copy must be delivered in 72 hours (7 days for federal, PA more strict) May dispense partial fill C2 for LTCF patients for up to 60 days Partial Filling for C3-5 No dispensing beyond 6 months

PA MPJE 2024 QUESTIONS AND ANSWERS GRADED A+ Generic drug companies can submit what two abbreviated drug applications? ANDA or 505(b)(2) application What is the key difference between an ANDA and 505(b)(2) application? Drugs submitted under ANDA must be bioequivalent and have same route of administration, strength, and formulation Drugs submitted under 505(b)(2) can have different strength or formulation What Act approved in March of 2020 includes OTC monograph reform? The CARES Ac...

PA MPJE EXAM TESTBANK 2024/2025 Verified Exam Sets Actual Exam Questions Included

PA MPJE Questions and Answers (2022/2023) Already Passed Codeine Limitation for Schedule III Not more than 18 mg/mL Not more than 90 mg per dosage unit Codeine Limitation for Schedule V Not more than 2 mg/mL and must have additional non- narcotic API Emergency C2 prescription hard copy must be delivered in 72 hours (7 days for federal, PA more strict) May dispense partial fill C2 for LTCF patients for up to 60 days Partial Filling for C3-5 No dispensing beyond 6 months Where and how lo...

PA MPJE EXAM 2024 WITH 100% CORRECT ANSWERS Methaqualone schedule? - correct answer C1 Quaalude Heroin schedule? - correct answer C1 Mescaline schedule? - correct answer C1 GHB (gamma-hydroxybutyric acid) schedule? - correct answer C1 LSD schedule? - correct answer C1 Marijuana schedule? - correct answer C1 Peyote schedule? - correct answer C1 THC schedule? - correct answer C1 What ag

PA MPJE EXAM 2024 WITH 100% CORRECT ANSWERS Something that legislators pass by voting - correct answer Statue / Act / Law Administrative Agency - correct answer Group of experts who are APPOINTED and we hire them to write specifics of how we want law to be implemented and enforced Are federal regulations laws? - correct answer No the are promulgated by DEA but were not passed by legislators (we didn't vote in the DEA) What is common law? - correct answer Court decisions / Preceden...

PA MPJE EXAM 2024 WITH 100% CORRECT ANSWERS What agency is responsible for Food Drug & Cosmetic Act? What regulation is this under? - correct answer FDA; 21 CFR What agency is responsible for Controlled Substance Act? What regulation is this under? - correct answer DEA; 21 CFR, Chapter 1300 What agency is responsible for Controlled Substances Drug Device and Cosmetic Act? What regulation is this under? - correct answer PA Dept of Health; Title 28, Chapter 25 W

PA MPJE (PA LAW) EXAM 2024 WITH 100% CORRECT ANSWERS What is required on a pharmacy permit? - correct answer - name and address of pharmacy - name of current owner - name of current pharmacy manager When is a new permit required? - correct answer Change in... - name - ownership - controlling interest (file within 30 days of the change) When must a pharmacy file a change in permit? - correct answer Within 30 days of change How long is authorized for pharmacy breaks? - correct ...

PA MPJE EXAM 2024 WITH 100% CORRECT ANSWERS what packaging does not require NDC number - correct answer individual dosage units no law requiring NDC on rx labels SBOP members - correct answer commissioner of professional and occupational affairs director of bureau of consumer protection two public representatives two independent pharmacists two retail pharmacists one acute care pharmacist executive secretary (must be RPh) SBOP member appointment - correct answer appointed by gov...

PA MPJE-- Pennsylvania Pharmacy Regulations