Federal MPJE Practice Questions with 100% Correct Answers

Federal MPJE Practice Questions with 100% Correct Answers what law prohibits the distribution of food and drugs that are misbranded or adulterated? - 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? - Answer- Controlled Substance Ordering System (CSOS) What agency is responsible for the federal Controlled Substances Act (CSA)? - 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? - 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? - Answer- the supplier Which DEA form must be completed and submitted to the DEA upon discovering a theft or significant loss of controlled substances? - 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? - Answer- Investigational New Drug Application (IND) Which phase of a clinical trial is first used to determine the efficacy of a drug? - Answer- Phase II What Act regulates the sale and recordkeeping requirements for prescription drug samples? - 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? - Answer- Prior Approval Supplement (PAS) Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need? - Answer- Fast track Schedule II controlled substances CANNOT be transferred in which of the following scenarios? - Answer- A researcher would like to transfer excess Schedule II controlled substances to a pharmacy to be dispensed to patients A patient wants to refill a prescription but was not satisfied with the pharmacy that filled and dispensed the prescription the first time. The patient demands the prescription be returned so they can take it to a different pharmacy to obtain refills. The pharmacist should: - Answer- offer to give a copy of the prescription to the patient, keep the original copy at the pharmacy, and recommend the patient request the prescription be transferred to another pharmacy if legal An example of an adulterated drug is: - Answer- a medication that has an unapproved color additive What was the first law requiring drugs to be proven safe before being mar