2025/2026 Exam Questions Marking
Scheme New Update | A+ Rated
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
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,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
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
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, 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)
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