Federal MPJE Practice Questions with Guaranteed Accurate Answers

What law prohibits the distribution of food and drugs that are misbranded or adulterated? - correct answer Pure Food and Drug Act What is the system that can be used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances? - correct answer Controlled Substance Ordering System (CSOS) What agency is responsible for the federal Controlled Substances Act (CSA)? - correct answer the DEA A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name Coumadin tablets. Where can this information be found? - correct answer The Orange Book When a pharmacy submits a DEA Form 222 (single sheet) to purchase Schedule II controlled substances, who keeps the original copy of the DEA Form 222? - correct answer the supplier Which DEA form must be completed and submitted to the DEA upon discovering a theft or significant loss of controlled substances? - correct answer DEA Form 106 What is the first application that must be submitted to the FDA before a drug can be administered to humans in order to start testing? - correct answer Investigational New Drug Application (IND) Which phase of a clinical trial is first used to determine the efficacy of a drug? - correct answer Phase II What Act regulates the sale and recordkeeping requirements for prescription drug samples? - correct answer Prescription Drug Marketing Act A manufacturer has a drug that is currently on the market, but they want to change the way the drug is produced. What type of application must be submitted to the FDA in order to request approval for this change? - correct answer Prior Approval Supplement (PAS) Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need? - correct answer Fast track Schedule II controlled substances CANNOT be transferred in which of the following scenarios? - correct answer