Pa mpje - Study guides, Class notes & Summaries

Indiana MPJE Exam Questions With Answers Latest Updated 2024 (GRADED A +) If an institutional pharmacy is closed and unattended by a pharmacist, how can a nurse obtain a needed medication while the pharmacy is closed? (All that apply) A. Remove from emergency kit B. Remove from floor stock of floor mechanical devices C. Ask authorized supervisory nurse to remove from pharmacy following proper procedures D. Ask a pharmacist to come in and get the medication for them. E. There is no way to g...

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 long inv...

PA MPJE (PA Law) Questions and Answers Already Passed What is required on a pharmacy permit? - name and address of pharmacy - name of current owner - name of current pharmacy manager When is a new permit required? Change in... - name - ownership - controlling interest (file within 30 days of the change) When must a pharmacy file a change in permit? Within 30 days of change How long is authorized for pharmacy breaks? 30 minutes What are the regulations for pharmacy breaks?...

PA MPJE Questions and Answers Latest Update Made Easy What agency is responsible for Food Drug & Cosmetic Act? What regulation is this under? FDA; 21 CFR What agency is responsible for Controlled Substance Act? What regulation is this under? DEA; 21 CFR, Chapter 1300 What agency is responsible for Controlled Substances Drug Device and Cosmetic Act? What regulation is this under? PA Dept of Health; Title 28, Chapter 25 What agency is responsible for Pharmacy Act? What regulation...

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 What agency is responsible for Pharmacy Act? What regulation is this und...

DEA Form 106 - correct answer Report Theft or Loss - Notify DEA and police of significant loss DEA 222 Order Forms Lost or Stolen in Transit - correct answer If a pharmacy determines that an unfilled 222 order form has been lost, the pharmacy executes another order form in addition to a statement containing the following information about the original order: The serial number The date of the lost form A statement stating that the goods covered by the first order form were not received thro...

Food, Drug, and Cosmetic Act - correct answer - Established FDA - New drugs must be SAFE prior to marketing Durham-Humphrey Amendment - correct answer - Established OTC + prescription drug classes - Authorized verbal Rxs and refill Rxs Kefauver-Harris Amendment - correct answer - New drugs must be safe AND effective - Established GMPs - Gave FDA jurisdiction over prescription drug advertising Prescription Drug Marketing Act - correct answer - Bands re-importation of prescrip...

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 / Precedents What is supremacy? - correct answer *Confli...

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 governor with approval of majority of senate how...

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 answer 30 minutes What are the regulations for pharmacy...

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...