1 for specific request mail
Federal MPJE Practice Questions and Correct
Answers | Latest Update
what law prohibits the distribution of food and drugs that are
misbranded or adulterated?
Ans: 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?
Ans: Controlled Substance Ordering System (CSOS)
Assignment Expert
What agency is responsible for the federal Controlled Substances Act
Guru01 - Stuvia
(CSA)?
Ans: the DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent
2026
to brand name Coumadin tablets. Where can this information be found?
Ans: 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?
Ans: the supplier
Which DEA form must be completed and submitted to the DEA upon
discovering a theft or significant loss of controlled substances?
Ans: 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?
Ans: Investigational New Drug Application (IND)
, 2 for specific request mail
Which phase of a clinical trial is first used to determine the efficacy of a
drug?
Ans: Phase II
What Act regulates the sale and recordkeeping requirements for
prescription drug samples?
Ans: 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
Assignment Expert
be submitted to the FDA in order to request approval for this change?
Ans: Prior Approval Supplement (PAS)
Guru01 - Stuvia
Which FDA expedited review program is intended for drugs that treat
serious conditions and fill an unmet medical need?
Ans: Fast track
2026
Schedule II controlled substances CANNOT be transferred in which of the
©
following scenarios?
Ans: 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:
Ans: 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:
, 3 for specific request mail
Ans: a medication that has an unapproved color additive
What was the first law requiring drugs to be proven safe before being
marketed?
Ans: Food, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing
standards for pharmaceutical products in the US?
Ans: Good Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents:
Assignment Expert
Ans: the identity of the drug
Guru01 - Stuvia
Which of the following is a Schedule II controlled substance?
Ans: pentobarbital
2026
A prescription for lorazepam can be refilled a maximum of how many
times within a six-month period?
©
Ans: five
Which of the following is NOT required on the manufacturer's drug
container label for an oral drug product?
Ans: 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.
Ans: 14 days
Which of the following is a mid-level practitioner?
Ans: Optometrist
Federal MPJE Practice Questions and Correct
Answers | Latest Update
what law prohibits the distribution of food and drugs that are
misbranded or adulterated?
Ans: 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?
Ans: Controlled Substance Ordering System (CSOS)
Assignment Expert
What agency is responsible for the federal Controlled Substances Act
Guru01 - Stuvia
(CSA)?
Ans: the DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent
2026
to brand name Coumadin tablets. Where can this information be found?
Ans: 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?
Ans: the supplier
Which DEA form must be completed and submitted to the DEA upon
discovering a theft or significant loss of controlled substances?
Ans: 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?
Ans: Investigational New Drug Application (IND)
, 2 for specific request mail
Which phase of a clinical trial is first used to determine the efficacy of a
drug?
Ans: Phase II
What Act regulates the sale and recordkeeping requirements for
prescription drug samples?
Ans: 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
Assignment Expert
be submitted to the FDA in order to request approval for this change?
Ans: Prior Approval Supplement (PAS)
Guru01 - Stuvia
Which FDA expedited review program is intended for drugs that treat
serious conditions and fill an unmet medical need?
Ans: Fast track
2026
Schedule II controlled substances CANNOT be transferred in which of the
©
following scenarios?
Ans: 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:
Ans: 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:
, 3 for specific request mail
Ans: a medication that has an unapproved color additive
What was the first law requiring drugs to be proven safe before being
marketed?
Ans: Food, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing
standards for pharmaceutical products in the US?
Ans: Good Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents:
Assignment Expert
Ans: the identity of the drug
Guru01 - Stuvia
Which of the following is a Schedule II controlled substance?
Ans: pentobarbital
2026
A prescription for lorazepam can be refilled a maximum of how many
times within a six-month period?
©
Ans: five
Which of the following is NOT required on the manufacturer's drug
container label for an oral drug product?
Ans: 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.
Ans: 14 days
Which of the following is a mid-level practitioner?
Ans: Optometrist
