MPJE QUESTION AND ANSWERS PACKAGE DEAL A

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". • Au...

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...

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 sta...

how many compliance officers/inspectors does VA BOP have? 9 - 5 pharmacist inspectors assigned to inspect pharmacies, 4 non-pharmacist inspectors assigned to inspect other facilities licensed by the BOP how many pharmacist members are there on VA BOP? public members? -8 pharmacist -2 public do ...

What did the Federal Controlled Substances Act do? Why was it implemented? Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: ma...

In NJ what are the members of the BOP and how many are there? 11 members that are all citizens 2 public 1 State executive dept member 8 RpH What the the BOP RpH requirements? all must be registered as an RpH in NJ for 5 years or more all must be actively engaged in pharmacy and may continue i...

How many members make up GA Board? 8 Who commissions members of Board? Governor Who approves executive director of Board? Board of Community Health Who serves as Assistant Executive Director if there's no Executive Director of the Board? Director of GA Drugs & Narcotic Agency How many intern h...

How many members serve in the state board of pharmacy? 8 members (7 pharmacist and 1 consumer) How long does each member of the board of pharmacy serve? 5 years Who issues pharmacist licenses? The GA BOP Is the GA BOP a separate entity or under another department? Separate Entity How are board ...

Sherman Antitrust Act This act: Outlaws agreements that restrain trade. Prevent monopolies and mergers that lessen competition Federal Food Drug and Cosmetic Act This act states: No adulterated or misbranded drugs in interstate commerce Adulteration Gross - Think inside the capsule Misbranded I...

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 Amendme...