What law prohibits the 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
the DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name
Coumadin tablets. Where can this information be found? - 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? - ANSWER the supplier
Which DEA form must be completed and submitted to the DEA upon discovering a theft or
significant loss of controlled substances? - 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? - ANSWER Investigational New Drug
Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug? - ANSWER
Phase II
1
, What Act regulates the sale and recordkeeping requirements for prescription drug samples?
- 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? - ANSWER Prior Approval Supplement (PAS)
Which FDA expedited review program is intended for drugs that treat serious conditions and
fill an unmet medical need? - ANSWER Fast track
Schedule II controlled substances CANNOT be transferred in which of the following
scenarios? - 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:
- 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: - ANSWER a medication that has an unapproved
color additive
What was the first law requiring drugs to be proven safe before being marketed? -
ANSWER Food, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing standards for
pharmaceutical products in the US? - ANSWER Good Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents: - ANSWER the identity of the
drug
2
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
the DEA
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name
Coumadin tablets. Where can this information be found? - 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? - ANSWER the supplier
Which DEA form must be completed and submitted to the DEA upon discovering a theft or
significant loss of controlled substances? - 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? - ANSWER Investigational New Drug
Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug? - ANSWER
Phase II
1
, What Act regulates the sale and recordkeeping requirements for prescription drug samples?
- 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? - ANSWER Prior Approval Supplement (PAS)
Which FDA expedited review program is intended for drugs that treat serious conditions and
fill an unmet medical need? - ANSWER Fast track
Schedule II controlled substances CANNOT be transferred in which of the following
scenarios? - 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:
- 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: - ANSWER a medication that has an unapproved
color additive
What was the first law requiring drugs to be proven safe before being marketed? -
ANSWER Food, Drug, and Cosmetic Act
What set of regulations specifies the required minimum manufacturing standards for
pharmaceutical products in the US? - ANSWER Good Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents: - ANSWER the identity of the
drug
2
