Federal MPJE UPDATED ACTUAL
Questions and CORRECT ANSWERS
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
Questions and CORRECT ANSWERS
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
