Federal MPJE Practice Questions With Verified Solutions

Federal MPJE Practice Questions With Verified Solutions what law prohibits the distribution of food and drugs that are misbranded or adulterated? ️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? ️Controlled Substance Ordering System (CSOS) What agency is responsible for the federal Controlled Substances Act (CSA)? ️the DEA A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name Coumadin tablets. Where can this information be found? ️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? ️the supplier Which DEA form must be completed and submitted to the DEA upon discovering a theft or significant loss of controlled substances? ️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? ️Investigational New Drug Application (IND) Which phase of a clinical trial is first used to determine the efficacy of a drug? ️Phase II What Act regulates the sale and recordkeeping requirements for prescription drug samples? ️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? ️Prior Approval Supplement (PAS) Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need? ️Fast track Schedule II controlled substances CANNOT be transferred in which of the following scenarios? ️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: ️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: ️a medication that has an unapproved color additive What was the first law requiring drugs to be proven safe before being marketed? ️Food, Drug, and Cosmetic Act What set of regulations specifies the required minimum manufacturing standards for pharmaceutical products in the US? ️Good Manufacturing Practice (GMP) A drug has an NDC of . The 0350 represents: ️the identity of the drug Which of the following is a Schedule II controlled substance? ️pentobarbital A prescription for lorazepam can be refilled a maximum of how many times within a six-month period? ️five Which of the following is NOT required on the manufacturer's drug container label for an oral drug product? ️directions for administration A water-containing oral formulation that is compounded from commercially available drug products has a maximum beyond-use-date (BUD) of ___ when refrigerated. ️14 days Which of the following is a mid-level practitioner? ️Optometrist Durable Medical Equipment (DME) must meet which standards? ️It can withstand repeated use Appropriate for use in the home It is primarily for a medical purpose Federal investigations into thefts and robberies may take place per the Controlled Substances Registrant Protection Act (CSRPA) if the incident meets which of the following conditions? ️It will cost $500 or more to replace controlled substances An employee suffers from significant injuries or death What Act set the requirement that patients must be offered counseling on dispensed medications? ️OBRA 90 Under the iPledge Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, what is the maximum number of refills that may be authorized on a prescription? ️0 refills In which situation would it be illegal for a pharmacy to compound drugs? ️Dosage forms are sold only to other pharmacies and not physician offices What DEA form is necessary to purchase or transfer Schedule II controlled substances? ️DEA Form 222 What working at a retail pharmacy, a patient calls and says they just got home from the hospital after having broken their leg. The patient cannot make it to the pharmacy to pick up their prescription for a Schedule II controlled substance that is ready to pick up. The patient asks if the pharmacy can mail the prescription to the house (mail delivery). How should the pharmacist respond? ️The prescription can be sent to the patient through mail