WGU D398 OA EXAM / INTRODUCTION
TO PHARMACOLOGY OBJECTIVE
ASSESSMENT (OA) VERSION 1-5 (V1,
V2,V3,V4
SECTION 1: DRUG LEGISLATION, REGULATION & SAFETY
1. What was the primary purpose of the 1906 Pure Food and Drug Act?
A) To establish the FDA
B) To regulate controlled substances
C) To establish drug standards for strength, purity, and quality
D) To require prescription-only medications
Correct Answer: C
Rationale: The 1906 Pure Food and Drug Act established drug standards for
strength, purity, and quality. It was the first major federal legislation to regulate
drugs and food in the United States, prohibiting the sale and transport of
adulterated or mislabeled products .
2. Which federal agency was established by the 1938 Federal Food, Drug, and
Cosmetic Act?
A) Drug Enforcement Administration (DEA)
B) Food and Drug Administration (FDA)
C) Centers for Disease Control (CDC)
D) National Institutes of Health (NIH)
Correct Answer: B
,Rationale: The 1938 Federal Food, Drug, and Cosmetic Act established the Food
and Drug Administration (FDA). This act required that drugs be proven safe before
marketing .
3. What does the 1970 Controlled Substances Act regulate?
A) Food additives and preservatives
B) The abuse and distribution of controlled substances
C) Over-the-counter medication labeling
D) Drug manufacturing standards
Correct Answer: B
Rationale: The 1970 Controlled Substances Act regulates the abuse and
distribution of controlled substances. It established the five DEA schedules for
controlled substances and created the Drug Enforcement Administration (DEA) .
4. What is the primary role of the Drug Enforcement Administration (DEA)?
A) To approve new drugs for market
B) To regulate the manufacturing and distribution of controlled substances
C) To set drug pricing standards
D) To conduct clinical trials
Correct Answer: B
Rationale: The DEA's primary role is to regulate the manufacturing and
distribution of controlled substances. It enforces the Controlled Substances Act
and requires prescribers to register with the DEA .
5. Which of the following is classified as a Schedule I drug?
A) Morphine
B) Diazepam
C) Heroin
D) Albuterol
,Correct Answer: C
Rationale: Schedule I includes substances like heroin that have the highest risk of
abuse and are NOT approved for medical use in the United States. Morphine is
Schedule II, diazepam is Schedule IV, and albuterol is not a controlled substance .
6. Which drug schedule has the highest risk of abuse and is not approved for
medical use in the U.S.?
A) Schedule I
B) Schedule II
C) Schedule III
D) Schedule IV
Correct Answer: A
Rationale: Schedule I drugs have the highest risk of abuse and no accepted
medical use in the United States. Schedule II drugs have high abuse potential but
accepted medical uses. Schedules III-V have progressively lower abuse potential .
7. What does a Schedule II drug indicate about its potential for abuse?
A) Low risk of abuse and dependence
B) Moderate risk of abuse
C) High risk of abuse and dependence, but has accepted medical uses
D) No risk of abuse
Correct Answer: C
Rationale: Schedule II drugs have a high potential for abuse, some accepted
medical uses, and severe psychological or physical dependence. Examples include
morphine, amphetamines, and oxycodone .
8. The Durham-Humphrey Amendment of 1951 established what?
A) The DEA
B) The distinction between prescription and over-the-counter drugs
, C) The FDA
D) Generic drug regulations
Correct Answer: B
Rationale: The Durham-Humphrey Amendment of 1951 distinguished between
prescription and over-the-counter (OTC) drugs, requiring that certain drugs be
dispensed only with a prescription .
9. The Kefauver-Harris Amendment of 1962 required that drugs be proven:
A) Pure and potent
B) Safe and effective
C) Affordable and accessible
D) Generic and branded
Correct Answer: B
Rationale: The Kefauver-Harris Amendment required that drugs be proven both
safe AND effective before marketing, in response to the thalidomide tragedy that
caused severe birth defects .
10. What is the purpose of medication guides provided with prescription
medicines?
A) To advertise new medications
B) To educate patients on potential adverse effects and how to avoid them
C) To replace clinical judgment
D) To set medication prices
Correct Answer: B
Rationale: Medication guides are provided to educate patients on potential
adverse effects and how to avoid them. They must be given the first time a drug is
dispensed to the patient .
11. What is the primary function of the FDA in relation to drug safety?
TO PHARMACOLOGY OBJECTIVE
ASSESSMENT (OA) VERSION 1-5 (V1,
V2,V3,V4
SECTION 1: DRUG LEGISLATION, REGULATION & SAFETY
1. What was the primary purpose of the 1906 Pure Food and Drug Act?
A) To establish the FDA
B) To regulate controlled substances
C) To establish drug standards for strength, purity, and quality
D) To require prescription-only medications
Correct Answer: C
Rationale: The 1906 Pure Food and Drug Act established drug standards for
strength, purity, and quality. It was the first major federal legislation to regulate
drugs and food in the United States, prohibiting the sale and transport of
adulterated or mislabeled products .
2. Which federal agency was established by the 1938 Federal Food, Drug, and
Cosmetic Act?
A) Drug Enforcement Administration (DEA)
B) Food and Drug Administration (FDA)
C) Centers for Disease Control (CDC)
D) National Institutes of Health (NIH)
Correct Answer: B
,Rationale: The 1938 Federal Food, Drug, and Cosmetic Act established the Food
and Drug Administration (FDA). This act required that drugs be proven safe before
marketing .
3. What does the 1970 Controlled Substances Act regulate?
A) Food additives and preservatives
B) The abuse and distribution of controlled substances
C) Over-the-counter medication labeling
D) Drug manufacturing standards
Correct Answer: B
Rationale: The 1970 Controlled Substances Act regulates the abuse and
distribution of controlled substances. It established the five DEA schedules for
controlled substances and created the Drug Enforcement Administration (DEA) .
4. What is the primary role of the Drug Enforcement Administration (DEA)?
A) To approve new drugs for market
B) To regulate the manufacturing and distribution of controlled substances
C) To set drug pricing standards
D) To conduct clinical trials
Correct Answer: B
Rationale: The DEA's primary role is to regulate the manufacturing and
distribution of controlled substances. It enforces the Controlled Substances Act
and requires prescribers to register with the DEA .
5. Which of the following is classified as a Schedule I drug?
A) Morphine
B) Diazepam
C) Heroin
D) Albuterol
,Correct Answer: C
Rationale: Schedule I includes substances like heroin that have the highest risk of
abuse and are NOT approved for medical use in the United States. Morphine is
Schedule II, diazepam is Schedule IV, and albuterol is not a controlled substance .
6. Which drug schedule has the highest risk of abuse and is not approved for
medical use in the U.S.?
A) Schedule I
B) Schedule II
C) Schedule III
D) Schedule IV
Correct Answer: A
Rationale: Schedule I drugs have the highest risk of abuse and no accepted
medical use in the United States. Schedule II drugs have high abuse potential but
accepted medical uses. Schedules III-V have progressively lower abuse potential .
7. What does a Schedule II drug indicate about its potential for abuse?
A) Low risk of abuse and dependence
B) Moderate risk of abuse
C) High risk of abuse and dependence, but has accepted medical uses
D) No risk of abuse
Correct Answer: C
Rationale: Schedule II drugs have a high potential for abuse, some accepted
medical uses, and severe psychological or physical dependence. Examples include
morphine, amphetamines, and oxycodone .
8. The Durham-Humphrey Amendment of 1951 established what?
A) The DEA
B) The distinction between prescription and over-the-counter drugs
, C) The FDA
D) Generic drug regulations
Correct Answer: B
Rationale: The Durham-Humphrey Amendment of 1951 distinguished between
prescription and over-the-counter (OTC) drugs, requiring that certain drugs be
dispensed only with a prescription .
9. The Kefauver-Harris Amendment of 1962 required that drugs be proven:
A) Pure and potent
B) Safe and effective
C) Affordable and accessible
D) Generic and branded
Correct Answer: B
Rationale: The Kefauver-Harris Amendment required that drugs be proven both
safe AND effective before marketing, in response to the thalidomide tragedy that
caused severe birth defects .
10. What is the purpose of medication guides provided with prescription
medicines?
A) To advertise new medications
B) To educate patients on potential adverse effects and how to avoid them
C) To replace clinical judgment
D) To set medication prices
Correct Answer: B
Rationale: Medication guides are provided to educate patients on potential
adverse effects and how to avoid them. They must be given the first time a drug is
dispensed to the patient .
11. What is the primary function of the FDA in relation to drug safety?
