Federal MPJE Practice Questions AND ANSWERS| 100 QUESTIONS

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: 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: Correct 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: Correct Answer: a medication that has an unapproved color additive What was the first law requiring drugs to be proven safe before being marketed? Correct Answer: Food, Drug, and Cosmetic Act What set of regulations specifies the required minimum manufacturing standards for pharmaceutical products in the US? Correct Answer: Good Manufacturing Practice (GMP) A drug has an NDC of . The 0350 represents: Correct Answer: the identity of the drug Which of the following is a Schedule II controlled substance? Correct Answer: pentobarbital A prescription for lorazepam can be refilled a maximum of how many times within a six-month period? Correct Answer: five Which of the following is NOT required on the manufacturer's drug container label for an oral drug product? Correct Answer: 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. Correct Answer: 14 days Which of the following is a mid-level practitioner? Correct Answer: Optometrist Durable Medical Equipment (DME) must meet which standards? Correct Answer: 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? Correct Answer: 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? Correct Answer: 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? Correct Answer: 0 refills In which situation would it be illegal for a pharmacy to compound drugs? Correct Answer: 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? Correct Answer: 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? Correct Answer: The prescription can be sent to the patient through mail Which of the following statements is/are true about narrow therapeutic index (NTI) drugs? Correct Answer: Small differences in the dose or blood concentration may lead to adverse reactions They require careful titration or patient monitoring for safe and effective use What Act set the requirements for child-resistant closures for prescription drugs, non-prescription drugs, and hazard household products? Correct Answer: Poison Prevention Packaging Act For which type of drug recall is there a possibility of temporary or medically reversible adverse effects, but the probability of serious adverse effects is remote? Correct Answer: Class II What types of patients are included in a Phase I clinical trial for drug development? Correct Answer: small group of healthy participants without the disease condition Re-importation of medications is only legal if performed by the: Correct Answer: original manufacturer What law requires drugs to be proven effective (as well as safe) before being marketed? Correct Answer: Kefauver-Harris Amendment Which DEA registration form is used for pharmacies to register with the DEA to possess and dispense controlled substances? Correct Answer: DEA Form 224 What information is required to be included in the transaction report transmitted from a manufacturer to a pharmacy when the pharmacy purchases bulk bottles of a medication? Correct Answer: transaction information transaction history transaction statement A pharmacist receives an urgent notification from a manufacturing company for a recall of a specific medication because it may cause serious adverse health issues or death. What type of drug recall is this? Correct Answer: Class I What Act requires health care facilities to report death or injuries caused by or suspected to have been caused by a medical device to the FDA or the manufacturer? Correct Answer: Safe Medical Device Act An example of a misbranded manufacturer's container of a drug would be: Correct Answer: there is no quantity of the contents listed on the container Which of the following is TRUE regarding the stocking and dispensing of methadone at retail pharmacies? Correct Answer: methadone may be stocked at a retail pharmacy, but may only be dispensed as an analgesic According to the FDA, a drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many