MPJE Questions Guide
What law prohibits distribution of food and drugs that are misbranded or adulterated? -
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? - answer Controlled Substance Ordering
System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)? – answer
DEA (US DOJ)
A pharmacist wants to know if generic warfarin tablets are bio-equivalent to brand
Coumadin tablets. Where can this information be found? - answer Orange Book
When a pharmacy submits a DEA Form 222 (single sheet) purchase Schedule II
controlled substances, who keeps the original copy of the DEA Form 222? - answer the
supplier
Which DEA form must be completed and submitted to the DEA upon discovering theft
or significant loss of controlled substances? - answer106
What is the first application that must be submitted to the FDA before a drug can be
administered in humans to start testing? - answerIND
Which phase of a clinical trial is first used to determine the efficacy of a drug? -
answerPhase II
What Act regulates the sale and record-keeping requirements for prescription drug
samples? - answerPrescription Drug Marketing Act (PDMA)
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
Which FDA expedited review program is intended for drugs that treat serious conditions
and fill an unmet medical need? - answerFast track
An example of an adulterated drug is - answera drug that contains an unapproved color
additive
What was the first law requiring drugs to be proven safe before being marketed? -
answerFood, Drug, and Cosmetic Act (FDCA)
, 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 - answeridentity of the drug
A prescription for lorazepam can be filled a maximum of how many times within a six-
month period? - answer5
A water-containing oral formulation that is compounded from commercially available
drug products has a maximum BUD of _______ when refrigerated - answer14 days
What Act sets the requirement that patients must be offered counseling on dispensed
medications? - answerOmnibus Budget Reconciliation Act of 1990 (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 refill? - answer0
In which situation would it be illegal for a pharmacy to compound drugs? -
answerDosage forms are sold only to pharmacies and not other physician's offices
What DEA form is necessary for the distribution, purchase, or transfer of Schedule II
controlled substances? - answer222
While working at a retail pharmacy, a patient calls and says they just got home from a
hospital after breaking their leg. The patient cannot make it to the pharmacy to pick up
their Schedule II 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? - answerControlled substances can be mailed with discreet outside packaging
What Act sets the requirement for child-resistant closures for prescription drugs, non-
prescription drugs, and hazard household products? - answerPoison Prevention
Packaging Act (PPPA)
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? - answerClass
II
What types of patients are included in a Phase I clinical trial for drug development? -
answerSmall group of healthy participants without disease
What law requires drugs to be proven effective (and safe) before being marketed? -
answerKefauver-Harris Amendment
Which DEA registration form is used for pharmacists to register with the DEA to process
and dispense controlled substances? - answer224
What law prohibits distribution of food and drugs that are misbranded or adulterated? -
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? - answer Controlled Substance Ordering
System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)? – answer
DEA (US DOJ)
A pharmacist wants to know if generic warfarin tablets are bio-equivalent to brand
Coumadin tablets. Where can this information be found? - answer Orange Book
When a pharmacy submits a DEA Form 222 (single sheet) purchase Schedule II
controlled substances, who keeps the original copy of the DEA Form 222? - answer the
supplier
Which DEA form must be completed and submitted to the DEA upon discovering theft
or significant loss of controlled substances? - answer106
What is the first application that must be submitted to the FDA before a drug can be
administered in humans to start testing? - answerIND
Which phase of a clinical trial is first used to determine the efficacy of a drug? -
answerPhase II
What Act regulates the sale and record-keeping requirements for prescription drug
samples? - answerPrescription Drug Marketing Act (PDMA)
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
Which FDA expedited review program is intended for drugs that treat serious conditions
and fill an unmet medical need? - answerFast track
An example of an adulterated drug is - answera drug that contains an unapproved color
additive
What was the first law requiring drugs to be proven safe before being marketed? -
answerFood, Drug, and Cosmetic Act (FDCA)
, 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 - answeridentity of the drug
A prescription for lorazepam can be filled a maximum of how many times within a six-
month period? - answer5
A water-containing oral formulation that is compounded from commercially available
drug products has a maximum BUD of _______ when refrigerated - answer14 days
What Act sets the requirement that patients must be offered counseling on dispensed
medications? - answerOmnibus Budget Reconciliation Act of 1990 (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 refill? - answer0
In which situation would it be illegal for a pharmacy to compound drugs? -
answerDosage forms are sold only to pharmacies and not other physician's offices
What DEA form is necessary for the distribution, purchase, or transfer of Schedule II
controlled substances? - answer222
While working at a retail pharmacy, a patient calls and says they just got home from a
hospital after breaking their leg. The patient cannot make it to the pharmacy to pick up
their Schedule II 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? - answerControlled substances can be mailed with discreet outside packaging
What Act sets the requirement for child-resistant closures for prescription drugs, non-
prescription drugs, and hazard household products? - answerPoison Prevention
Packaging Act (PPPA)
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? - answerClass
II
What types of patients are included in a Phase I clinical trial for drug development? -
answerSmall group of healthy participants without disease
What law requires drugs to be proven effective (and safe) before being marketed? -
answerKefauver-Harris Amendment
Which DEA registration form is used for pharmacists to register with the DEA to process
and dispense controlled substances? - answer224
