Federal MPJE Practice Questions AND ANSWERS| 100 QUESTIONS
what law prohibits the distribution of food and drugs that are misbranded or adulterated?
... [Show More] 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 16103-0350-11. 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 people in the US? Correct Answer: 200,000
Which of the following ingredients has special labeling requirements if it is included in a product? Correct Answer: FD&C Yellow No. 5
In which case(s) is it appropriate to receive a faxed prescription for a Schedule II controlled substance? Correct Answer: Patient is a resident of a long-term care facility
Patient is enrolled in hospice program
Medication is intended for home infusion therapy
What is the acronym of the voluntary reporting system for medication adverse events? Correct Answer: FAERS
Within how many days must a prescriber deliver a written prescription for a Schedule II controlled substance that was called in orally to be dispensed in an emergency situation? Correct Answer: 7 days
A pharmacy intern wants to know where to find information on therapeutic equivalence between biologics. Which book contains this information? Correct Answer: The Purple Book
In which case(s) must an exact count be taken while performing a controlled substance inventory? Correct Answer: It is a Schedule II controlled substance
The bottle holds more than 1000 tabs/caps
Containers are sealed or unopened
The scheduling of controlled substances at the federal level is performed by the: Correct Answer: US Attorney General
A manufacturer of a prescription-only drug wants to reclassify the drug as an OTC drug. What is one of the forms that may be submitted to the FDA when requesting reclassification of a prescription-only drug to an OTC? Correct Answer: New Drug Application (NDA)
You are a pharmacist that suspects a fake controlled substance prescription was called into your pharmacy. You use the numbers in the provided DEA to verify if it is a true DEA number. It is indeed not a true DEA number because the last number is incorrect. The DEA number is BS5927683. What would be the correct last digit of the DEA number if it was accurate? Correct Answer: The number should be 1.
To check:
1) add together the first, third, and fifth numbers
2) add together the second, fourth, and sixth numbers. multiply this number by 2.
3) add the numbers together from steps 1 and 2.
the last digit of the number you get from step 3 is the last number of the DEA number. It should be a 1 in this case.
Which of the following prescriptions would likely be out of the scope of practice for a dentist? Correct Answer: Atorvastatin
Who is authorized to sign a DEA 222 Form at a community pharmacy? Correct Answer: The pharmacist who signed the most recent application for renewal of the pharmacy's DEA registration or someone authorized under a power of attorney
OTC drug advertising is regulated by the: Correct Answer: Federal Trade Commission (FTC)
A pharmacy may keep which of the following records at a central location other than the location registered with the DEA? Correct Answer: Controlled substance shipping and financial records
Acetaminophen with codeine (Tylenol #3) is classified under which controlled substance schedule? Correct Answer: Schedule III
A patient is admitted to a hospital and does not remember the names of the medication that she takes at home. The hospital pharmacist calls the patient's outpatient pharmacy to obtain a list of medications. Which of the following statements is true? Correct Answer: This is not a HIPAA violation because the information is being given to the hospital for treatment purposes
A warning stating "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" is required on the label on which of the following prescriptions? Correct Answer: Schedule II-IV
Registering with the FDA as an outsourcing facility allows a pharmacy to: Correct Answer: compound sterile products without receiving patient-specific prescriptions
Which of the following are appropriate ways to file paper prescription records at a pharmacy, based on federal law? Correct Answer: 3 buckets: Schedule II, Schedule III-IV, non-controlled
2 buckets: Schedule II-V and non-controlled
2 buckets: Schedule II filed separately, Schedule III-V and non-controlled filed together with a red "C" on controls
Standards and requirements for preparing sterile compounded drugs to ensure patient benefit and reduce risks such as contamination, infection, or incorrect dosing are outlined in which of the following? Correct Answer: USP Chapter <797>
Which of the following is/are required to register with the DEA? Correct Answer: a manufacturer that manufactures controlled substances
a pharmacy that dispenses controlled substances
a physician who prescribes controlled substances [Show Less]