WGU D398: INTRODUCTION TO PHARMACOLOGY | 100% VERIFIED OBJECTIVE
ASSESSMENT QUESTIONS AND CORRECT ANSWERS | LATEST 2026/2027
VERSION (PASS GUARANTEE)
1. What is pharmacology? The study of drugs and their interactions with living
systems.
2. What is pharmacokinetics? The study of what the body does to a drug
(absorption, distribution, metabolism, excretion).
3. What is pharmacodynamics? The study of what the drug does to the body
(mechanism of action, effects).
4. What is the 1906 Pure Food and Drug Act? The first federal law regulating
drugs; required accurate labeling but did not require safety testing.
5. What did the 1938 Food, Drug, and Cosmetic Act establish? Required drugs
to be proven safe before marketing; established the FDA.
6. What did the 1962 Kefauver-Harris Amendment require? Proof of efficacy
(effectiveness) in addition to safety before drug approval.
7. What is the Controlled Substances Act of 1970? Established drug schedules
(I-V) based on abuse potential and medical use.
8. What are Schedule I drugs? High abuse potential, no accepted medical use
(e.g., heroin, LSD).
9. What are Schedule II drugs? High abuse potential, accepted medical use,
severe dependence risk (e.g., morphine, oxycodone, amphetamines).
10. What are Schedule III drugs? Moderate abuse potential, accepted medical
use (e.g., anabolic steroids, certain codeine combinations).
11. What are Schedule IV drugs? Low abuse potential (e.g., benzodiazepines,
tramadol).
12. What are Schedule V drugs? Lowest abuse potential (e.g., cough
suppressants with small amounts of codeine).
,13. What is the Orange Book? FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations; identifies generic equivalents.
14. What is a brand name drug? A drug sold under a proprietary, trademark-
protected name.
15. What is a generic drug? A drug marketed under its chemical name;
bioequivalent to the brand name.
16. What is bioequivalence? When two drug products have the same rate and
extent of absorption.
17. What is a chemical name? The exact molecular formula of a drug.
18. What is an official name? The nonproprietary (generic) name approved by
the FDA.
19. What is the USP-NF? United States Pharmacopeia-National Formulary;
official standards for drug strength, quality, and purity.
20. What is MedWatch? FDA's program for reporting adverse drug events and
product problems.
21. What is a black box warning? The FDA's strongest warning for drugs with
serious or life-threatening risks.
22. What is an IND (Investigational New Drug)? Application to begin clinical
trials on humans.
23. What are the phases of clinical trials? Phase I: Safety/dosage in healthy
volunteers; Phase II: Efficacy/side effects in small patient groups; Phase III:
Efficacy/monitoring in large, diverse populations; Phase IV: Post-marketing
surveillance.
24. What is a new drug application (NDA)? The formal proposal to the FDA to
approve a new drug for sale.
25. What is off-label use? Using an approved drug for an unapproved
indication, age group, dose, or form.
26. What is the Drug Enforcement Administration (DEA)? Agency responsible
for enforcing controlled substance regulations.
27. What is required to prescribe controlled substances? A DEA number.
,28. What is a drug monograph? A detailed description of a drug's properties,
uses, and effects.
29. What is PDR? Physicians' Desk Reference; a compilation of drug
information.
30. What is a package insert? The official FDA-approved labeling information
for a drug.
31. What is the Harrison Narcotic Act of 1914? First federal law to regulate
opiates and cocaine; required prescriptions.
32. What is the Durham-Humphrey Amendment of 1951? Distinguished
between prescription and over-the-counter (OTC) drugs.
33. What is the Dietary Supplement Health and Education Act (DSHEA) of
1994? Regulates dietary supplements differently from drugs; manufacturers
don't need to prove safety/efficacy before marketing.
34. What is DSHEA's role in supplement regulation? Supplements are
regulated as food, not drugs; FDA must prove a supplement is unsafe to
remove it.
35. What is GMP? Good Manufacturing Practice; regulations ensuring quality
control in drug production.
36. What is a drug recall? Removal of a drug from the market due to safety
concerns or defects.
37. What are the classes of drug recalls? Class I: Dangerous/defective, could
cause serious health problems; Class II: Might cause temporary/reversible
health problems; Class III: Unlikely to cause adverse health effects.
38. What is the FDA's role in drug approval? Evaluates safety, efficacy, and
manufacturing quality before approving drugs for sale.
39. What is a medication error? Any preventable event that may cause
inappropriate medication use or patient harm.
40. What is the Joint Commission's role in medication safety? Accredits
healthcare organizations and sets patient safety standards, including
medication management.
, SECTION 2: PHARMACOKINETICS (Questions 41–85)
41. What are the four processes of pharmacokinetics? Absorption,
Distribution, Metabolism, Excretion (ADME).
42. What is absorption? The movement of a drug from the site of
administration into the bloodstream.
43. What factors affect drug absorption? Route of administration, blood flow,
lipid solubility, pH, surface area, presence of food.
44. Which route of administration has the fastest absorption? Intravenous
(IV) — directly into bloodstream, 100% bioavailability.
45. What is bioavailability? The fraction of administered drug that reaches
systemic circulation.
46. What is the first-pass effect? The liver metabolizes a significant portion of
an orally administered drug before it reaches systemic circulation.
47. Which routes bypass the first-pass effect? IV, IM, sublingual, transdermal,
rectal (partially), inhalation.
48. What is distribution? The movement of a drug from the bloodstream to
tissues and sites of action.
49. What factors affect drug distribution? Blood flow, lipid solubility, protein
binding, pH, tissue permeability.
50. What is a drug's volume of distribution (Vd)? A theoretical volume that
would be needed to contain the total amount of drug at the same
concentration as in plasma.
51. What does a large Vd indicate? The drug distributes extensively into
tissues.
52. What does a small Vd indicate? The drug remains primarily in the
bloodstream.
53. What is protein binding? The binding of drugs to plasma proteins (mainly
albumin), making them temporarily inactive.
54. What is the significance of protein binding? Only unbound (free) drug is
active; drug interactions can occur when one drug displaces another.
ASSESSMENT QUESTIONS AND CORRECT ANSWERS | LATEST 2026/2027
VERSION (PASS GUARANTEE)
1. What is pharmacology? The study of drugs and their interactions with living
systems.
2. What is pharmacokinetics? The study of what the body does to a drug
(absorption, distribution, metabolism, excretion).
3. What is pharmacodynamics? The study of what the drug does to the body
(mechanism of action, effects).
4. What is the 1906 Pure Food and Drug Act? The first federal law regulating
drugs; required accurate labeling but did not require safety testing.
5. What did the 1938 Food, Drug, and Cosmetic Act establish? Required drugs
to be proven safe before marketing; established the FDA.
6. What did the 1962 Kefauver-Harris Amendment require? Proof of efficacy
(effectiveness) in addition to safety before drug approval.
7. What is the Controlled Substances Act of 1970? Established drug schedules
(I-V) based on abuse potential and medical use.
8. What are Schedule I drugs? High abuse potential, no accepted medical use
(e.g., heroin, LSD).
9. What are Schedule II drugs? High abuse potential, accepted medical use,
severe dependence risk (e.g., morphine, oxycodone, amphetamines).
10. What are Schedule III drugs? Moderate abuse potential, accepted medical
use (e.g., anabolic steroids, certain codeine combinations).
11. What are Schedule IV drugs? Low abuse potential (e.g., benzodiazepines,
tramadol).
12. What are Schedule V drugs? Lowest abuse potential (e.g., cough
suppressants with small amounts of codeine).
,13. What is the Orange Book? FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations; identifies generic equivalents.
14. What is a brand name drug? A drug sold under a proprietary, trademark-
protected name.
15. What is a generic drug? A drug marketed under its chemical name;
bioequivalent to the brand name.
16. What is bioequivalence? When two drug products have the same rate and
extent of absorption.
17. What is a chemical name? The exact molecular formula of a drug.
18. What is an official name? The nonproprietary (generic) name approved by
the FDA.
19. What is the USP-NF? United States Pharmacopeia-National Formulary;
official standards for drug strength, quality, and purity.
20. What is MedWatch? FDA's program for reporting adverse drug events and
product problems.
21. What is a black box warning? The FDA's strongest warning for drugs with
serious or life-threatening risks.
22. What is an IND (Investigational New Drug)? Application to begin clinical
trials on humans.
23. What are the phases of clinical trials? Phase I: Safety/dosage in healthy
volunteers; Phase II: Efficacy/side effects in small patient groups; Phase III:
Efficacy/monitoring in large, diverse populations; Phase IV: Post-marketing
surveillance.
24. What is a new drug application (NDA)? The formal proposal to the FDA to
approve a new drug for sale.
25. What is off-label use? Using an approved drug for an unapproved
indication, age group, dose, or form.
26. What is the Drug Enforcement Administration (DEA)? Agency responsible
for enforcing controlled substance regulations.
27. What is required to prescribe controlled substances? A DEA number.
,28. What is a drug monograph? A detailed description of a drug's properties,
uses, and effects.
29. What is PDR? Physicians' Desk Reference; a compilation of drug
information.
30. What is a package insert? The official FDA-approved labeling information
for a drug.
31. What is the Harrison Narcotic Act of 1914? First federal law to regulate
opiates and cocaine; required prescriptions.
32. What is the Durham-Humphrey Amendment of 1951? Distinguished
between prescription and over-the-counter (OTC) drugs.
33. What is the Dietary Supplement Health and Education Act (DSHEA) of
1994? Regulates dietary supplements differently from drugs; manufacturers
don't need to prove safety/efficacy before marketing.
34. What is DSHEA's role in supplement regulation? Supplements are
regulated as food, not drugs; FDA must prove a supplement is unsafe to
remove it.
35. What is GMP? Good Manufacturing Practice; regulations ensuring quality
control in drug production.
36. What is a drug recall? Removal of a drug from the market due to safety
concerns or defects.
37. What are the classes of drug recalls? Class I: Dangerous/defective, could
cause serious health problems; Class II: Might cause temporary/reversible
health problems; Class III: Unlikely to cause adverse health effects.
38. What is the FDA's role in drug approval? Evaluates safety, efficacy, and
manufacturing quality before approving drugs for sale.
39. What is a medication error? Any preventable event that may cause
inappropriate medication use or patient harm.
40. What is the Joint Commission's role in medication safety? Accredits
healthcare organizations and sets patient safety standards, including
medication management.
, SECTION 2: PHARMACOKINETICS (Questions 41–85)
41. What are the four processes of pharmacokinetics? Absorption,
Distribution, Metabolism, Excretion (ADME).
42. What is absorption? The movement of a drug from the site of
administration into the bloodstream.
43. What factors affect drug absorption? Route of administration, blood flow,
lipid solubility, pH, surface area, presence of food.
44. Which route of administration has the fastest absorption? Intravenous
(IV) — directly into bloodstream, 100% bioavailability.
45. What is bioavailability? The fraction of administered drug that reaches
systemic circulation.
46. What is the first-pass effect? The liver metabolizes a significant portion of
an orally administered drug before it reaches systemic circulation.
47. Which routes bypass the first-pass effect? IV, IM, sublingual, transdermal,
rectal (partially), inhalation.
48. What is distribution? The movement of a drug from the bloodstream to
tissues and sites of action.
49. What factors affect drug distribution? Blood flow, lipid solubility, protein
binding, pH, tissue permeability.
50. What is a drug's volume of distribution (Vd)? A theoretical volume that
would be needed to contain the total amount of drug at the same
concentration as in plasma.
51. What does a large Vd indicate? The drug distributes extensively into
tissues.
52. What does a small Vd indicate? The drug remains primarily in the
bloodstream.
53. What is protein binding? The binding of drugs to plasma proteins (mainly
albumin), making them temporarily inactive.
54. What is the significance of protein binding? Only unbound (free) drug is
active; drug interactions can occur when one drug displaces another.
