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Federal MPJE Practice Questions AND ANSWERS| 100 QUESTIONS

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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 Substanc...

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  • September 23, 2022
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  • 2022/2023
  • Exam (elaborations)
  • Questions & answers

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  • federal mpje practice
  • federal mpje
  • federal mpje practice questions and answers| 100 questions
  • federal mpje practice questions
  • what law prohibits the distribution of food and drugs that are misbranded

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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 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

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