EXAM TEST QUESTIONS AND CORRECT ANSWERS (VERIFIED
ANSWERS) PLUS RATIONALES 2025/2026 Q&A
What does the Controlled Substances Act (1970) address? - CORRECT ANSWERS-It addresses
controlled substances and their categorization.
What does the Kefauver Harris Drug Amendment (1962) ensure? - CORRECT ANSWERS-It
ensures drug efficacy and greater drug safety, requiring manufacturers to prove effectiveness before
marketing.
Which schedule does meperidine (Demerol) fall under? - CORRECT ANSWERS-Schedule II,
indicating a high potential for abuse and possible severe psychological and physical dependence.
What characterizes Schedule I drugs? - CORRECT ANSWERS-They have a high potential for
abuse and no recognized medical use.
What type of information does the Natural Medicines Comprehensive Database provide? -
CORRECT ANSWERS-It contains evidence-based information on herbal medicines and herbal
combination products.
What does Drug Interaction Facts provide? - CORRECT ANSWERS-It contains comprehensive
information on drug interactions.
Which drug reference contains drug monographs for all drugs in a therapeutic class? - CORRECT
ANSWERS-Drug Facts and Comparisons contains drug monographs that describe all drugs in a
therapeutic class.
How are monographs formatted in Drug Facts and Comparisons? - CORRECT ANSWERS-
Monographs are formatted as tables to allow comparison of similar products, brand names,
manufacturers, cost indices, and available dosage forms.
,Which drug reference contains monographs about virtually every single-entity drug available in the US? -
CORRECT ANSWERS-AHFS Drug Information contains monographs about virtually every single-
entity drug available in the United States.
What therapeutic uses does AHFS Drug Information describe? - CORRECT ANSWERS-It
describes therapeutic uses of drugs, including both approved and unapproved uses.
Which online drug reference provides a comprehensive, up-to-date resource about medicines? -
CORRECT ANSWERS-DailyMed provides a standard, comprehensive, up-to-date look up and
downloadable resource about medicines.
What is the American Drug Index primarily used for? - CORRECT ANSWERS-The American
Drug Index is not appropriate for patient use.
What is the purpose of the American Hospital Formulary? - CORRECT ANSWERS-The
American Hospital Formulary is not appropriate for patient use.
What does the term 'drug reference' imply in this context? - CORRECT ANSWERS-The term
'drug reference' refers to resources that may not be appropriate for patient use.
Which legislation authorizes the FDA to determine the safety of a drug before marketing? -
CORRECT ANSWERS-The specific legislation is not provided in the notes, but it typically refers
to the Food, Drug, and Cosmetic Act.
What did the Federal Food, Drug, and Cosmetic Act of 1938 authorize the FDA to do? - CORRECT
ANSWERS-Determine the safety of all drugs before marketing.
What is the purpose of the Durham Humphrey Amendment (1952)? - CORRECT ANSWERS-
Defines drugs that cannot be used safely without medical supervision and restricts their sale to
prescription by a licensed practitioner.
,What is the potential for abuse associated with Schedule III drugs? - CORRECT ANSWERS-
They have some potential for abuse, leading to low to moderate physical dependence or high
psychological dependence.
What is the potential for abuse associated with Schedule IV drugs? - CORRECT ANSWERS-
They have low potential for abuse, leading to limited physical or psychological dependence.
What action would the FDA take to expedite drug development for a smallpox outbreak? -
CORRECT ANSWERS-Fast track the investigational drug.
What is meant by 'fast tracking' a drug by the FDA? - CORRECT ANSWERS-It means giving the
drug the highest priority within the agency after the Investigational New Drug Application is approved.
What is true about over-the-counter (OTC) drugs? - CORRECT ANSWERS-They are sold
without a prescription.
Are OTC drugs listed in the USP NF? - CORRECT ANSWERS-Yes, OTC drugs are listed in the USP
NF.
What is required for prescription drugs? - CORRECT ANSWERS-An order from a healthcare
provider who is licensed to prescribe.
Which is the most authoritative reference for medications that are injected? - CORRECT
ANSWERS-The Handbook on Injectable Drugs.
What does the Handbook on Injectable Drugs provide? - CORRECT ANSWERS-It is a
comprehensive reference on the compatibility of injectable drugs, with monographs for over 300
injectable drugs.
What is the role of the FDA in drug safety? - CORRECT ANSWERS-To ensure that drugs are
safe and effective before they are marketed.
, What does the term 'controlled substances' refer to? - CORRECT ANSWERS-Drugs that are
regulated by law due to their potential for abuse.
What is the significance of the term 'orphan disease' in drug research? - CORRECT ANSWERS-
Orphan diseases are not researched in a priority manner compared to more common diseases.
What is the consequence of omitting the preclinical research phase in drug development? -
CORRECT ANSWERS-It would compromise the safety and efficacy evaluation of the drug.
What is the difference between generic and trade names for drugs? - CORRECT ANSWERS-
Generic names are the official names of drugs, while trade names are the brand names under which they
are marketed.
What does the term 'monograph' refer to in the context of injectable drugs? - CORRECT
ANSWERS-A detailed written study or report on a specific injectable drug.
What is the importance of proving drug effectiveness to the FDA? - CORRECT ANSWERS-It
ensures that only safe and effective drugs are available to the public.
What does the term 'psychological dependence' mean? - CORRECT ANSWERS-A condition
where a person feels a compulsion to use a drug for its psychological effects.
What is the primary concern of the FDA during the clinical research phase? - CORRECT
ANSWERS-To ensure that all phases are completed safely.
What is the abuse potential of Lomotil? - CORRECT ANSWERS-Lomotil has a low abuse
potential and is classified as a Schedule V drug.
What is the classification of Lomotil? - CORRECT ANSWERS-Lomotil is classified as a Schedule
V controlled substance.