Arizona MPJE Study guides, Class notes & Summaries

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

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 inventory records must be maintained 2 years at the inve...

What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 1) ...

Arizona state board of pharmacy consists of what type of members? Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members Qualifications to be on Arizona State Board of pharmacy for pharmacists Licensed pharmacist for 10 yrs Pharmacists/resident of Arizona 5 yrs prior to appointment Public Members must be state resident for 5 yrs prior to appointment Qualifications for Arizona State Board of Pharmacy for technicians Practice as tech f...

Arizona MPJE questions with correct answers

Arizona MPJE questions with correct answers

Arizona MPJE Well Researched Questions and Answers A+ Graded 100% out of 100% Arizona state board of pharmacy consists of what type of members? - CORRECT ANSWER-Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members Qualifications to be on Arizona State Board of pharmacy for pharmacists - CORRECT ANSWER-Licensed pharmacist for 10 yrs Pharmacists/resident of Arizona 5 yrs prior to appointment Public Members must be state resident for 5 ...

Arizona state board of pharmacy consists of what type of members? - Six pharmacists (at least one hospital pharmacist and retail pharmacist) One pharmacy tech Two public members Qualifications to be on Arizona State Board of pharmacy for pharmacists - Licensed pharmacist for 10 yrs Pharmacists/resident of Arizona 5 yrs prior to appointment Public Members must be state resident for 5 yrs prior to appointment Qualifications for Arizona State Board of Pharmacy for technicians - Practice...

Pure Food and Drug Act - Answer 1906 - Forbade the manufacture or sale of mislabeled or adulterated food or drugs, it gave the government broad powers to ensure the safety and efficacy of drugs in order to abolish the "patent" drug trade. Still in existence as the FDA. The Food Drug and Comestic Act of 1938 - Answer Established the Food and Drug Administration (FDA). Primarily regulates drug development, manufacturing, and marketing- focus on quality. Only safe and properly labeled dr...