Federal MPJE Practice Questions
what law prohibits the distribution of food and drugs that are misbranded or adulterated?
- answerPure 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? - answerControlled Substance Ordering
System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)? -
answerthe DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name
Coumadin tablets. Where can this information be found? - answerThe 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? - answerthe
supplier
Which DEA form must be completed and submitted to the DEA upon discovering a theft
or significant loss of controlled substances? - answerDEA 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? - answerInvestigational New Drug
Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug? -
answerPhase II
What Act regulates the sale and recordkeeping requirements for prescription drug
samples? - answerPrescription 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? - answerPrior Approval Supplement (PAS)
, Which FDA expedited review program is intended for drugs that treat serious conditions
and fill an unmet medical need? - answerFast track
Schedule II controlled substances CANNOT be transferred in which of the following
scenarios? - answerA 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: - answeroffer 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: - answera medication that has an unapproved
color additive
What was the first law requiring drugs to be proven safe before being marketed? -
answerFood, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing standards for
pharmaceutical products in the US? - answerGood Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents: - answerthe identity of the
drug
Which of the following is a Schedule II controlled substance? - answerpentobarbital
A prescription for lorazepam can be refilled a maximum of how many times within a six-
month period? - answerfive
Which of the following is NOT required on the manufacturer's drug container label for an
oral drug product? - answerdirections 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. -
answer14 days
Which of the following is a mid-level practitioner? - answerOptometrist
Durable Medical Equipment (DME) must meet which standards? - answerIt can
withstand repeated use
Appropriate for use in the home
It is primarily for a medical purpose
what law prohibits the distribution of food and drugs that are misbranded or adulterated?
- answerPure 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? - answerControlled Substance Ordering
System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)? -
answerthe DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name
Coumadin tablets. Where can this information be found? - answerThe 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? - answerthe
supplier
Which DEA form must be completed and submitted to the DEA upon discovering a theft
or significant loss of controlled substances? - answerDEA 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? - answerInvestigational New Drug
Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug? -
answerPhase II
What Act regulates the sale and recordkeeping requirements for prescription drug
samples? - answerPrescription 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? - answerPrior Approval Supplement (PAS)
, Which FDA expedited review program is intended for drugs that treat serious conditions
and fill an unmet medical need? - answerFast track
Schedule II controlled substances CANNOT be transferred in which of the following
scenarios? - answerA 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: - answeroffer 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: - answera medication that has an unapproved
color additive
What was the first law requiring drugs to be proven safe before being marketed? -
answerFood, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing standards for
pharmaceutical products in the US? - answerGood Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents: - answerthe identity of the
drug
Which of the following is a Schedule II controlled substance? - answerpentobarbital
A prescription for lorazepam can be refilled a maximum of how many times within a six-
month period? - answerfive
Which of the following is NOT required on the manufacturer's drug container label for an
oral drug product? - answerdirections 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. -
answer14 days
Which of the following is a mid-level practitioner? - answerOptometrist
Durable Medical Equipment (DME) must meet which standards? - answerIt can
withstand repeated use
Appropriate for use in the home
It is primarily for a medical purpose
