Page 1 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
TRUE/FALSE
1. The pharmaceutical manufacturer has the authority to add additional active
ingredients to a previously approved pharmaceutical product.
ANS: F
According to the 1938 Federal Food, Drug, and Cosmetic Act and
Amendments of 1951 and 1962, all labels must be accurate and include a
listing of all active and inactive ingredients.
PTS: 1
2. Drug strength may vary with each lot number of a medication.
ANS: F
The 1906 Pure Food and Drug Act established that all drugs marketed in the
United States meet minimal standards of strength, purity, and quality.
PTS: 1
3. The Pure Food and Drug Act of 1906 established drug standards and official
drug references.
ANS: T
This act established that all drugs marketed in the United States meet
minimal standards of strength, purity, and quality. It also established two
official references that established the standards for making each drug: The
U.S. Pharmacopeia (USP) and the National Formulary (NF).
PTS: 1
4. The 1906 Pure Food and Drug Act established consumer protections to
prevent the inclusion of “dangerous ingredients” without the knowledge of
the consumer.
ANS: T
Morphine is one example of a dangerous ingredient that may have been
included without the knowledge of the consumer.
PTS: 1
5. Medication labels need only include the trade name of the drug.
ANS: F
Labels must include a listing of all active and inactive ingredients, warning
labels on certain preparations, and generic names for the medication
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,Page 2 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
PTS: 1
6. The prescriber of the medication is the only health care professional who is
responsible for being aware of new medications, laws, and restrictions.
ANS: F
The health care worker involved in administration of a medication also bears
the responsibility of being aware of the laws and restrictions pertinent to that
medication.
PTS: 1
7. A double-locked system is the recommended method for maintaining security
of controlled substances.
ANS: T
A double-locked system may include two separate key entries or an electronic
user identification and password access system.
PTS: 1
8. Health care workers are responsible for maintaining records of all controlled
substances received, dispensed, and destroyed.
ANS: T PTS: 1
9. Controlled substance records are to be kept for 10 years.
ANS: F
Records for the previous 2 years must be available at all times for inspection.
PTS: 1
MULTIPLE CHOICE
1. Identify the drug standard in the following list.
a. Color c. Shape
b. Strength d. Taste
ANS: B
Feedback
A Color is not a standard.
B Correct!
C Shape is not a standard.
D Taste is not a standard.
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,Page 3 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
PTS: 1
2. The risk of death from the use of street drugs versus prescription
medications is mostly due to:
a. a lack of control over quality, purity,
and strength makes street drugs
dangerous.
b. the risk is the same for both sources
of the same substance.
c. street drugs are approved for use.
d. the need for a prescription makes
drugs hard to obtain.
ANS: A
Feedback
A Correct!
B The lack of enforcement of drug
standards in illegal street drugs
poses a significant danger for the
consumer.
C The exact composition of a street
drug is unknown, and it may contain
dangerous contaminants or
undisclosed additional drugs.
D Street drugs are illegal.
PTS: 1
3. Drug standards regulate drug manufacture so that medications of the same
name will be of the same:
a. strength, purity, and quality.
b. shape, color, and taste.
c. purity, shape, and color.
d. quality, color, and shape.
ANS: A
Drug standards state that all preparations of the same drug name must be of
uniform strength, purity, and quality.
PTS: 1
4. The 1906 Pure Food and Drug Act includes which of the following provisions?
a. Regulation of drugs sold in the
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,Page 4 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
United States and Canada
b. Requires labeling to indicate if a
medication contained a “dangerous
ingredient”
c. Regulates illicit drugs
d. Requires information regarding
medications to be handed down
from one practitioner to the next
ANS: B
Feedback
A The Pure Food and Drug Act
regulates ALL drugs MARKETED in
the United States. If a drug is
manufactured in Canada, it must
meet USFDA requirements to be
marketed here.
B Correct!
C Illicit drugs are not regulated.
D The Pure Food and Drug Act
established two references of
officially approved drugs, the USP
and the NF.
PTS: 1
5. The Pure Food and Drug Act of 1906 was formulated:
a. to curb the use of street drugs.
b. as the first government attempt to
establish consumer protection in the
manufacture of drugs and foods.
c. in order to make drug
manufacturing profitable for the
drug companies.
d. as a means to identify addicting
drugs.
ANS: B
Feedback
A This applies to the Controlled
Substances Act of 1970.
B Correct!
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, Page 5 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
C The Pure Food and Drug Act was in
answer to a need for consumer
safety.
D The Pure Food and Drug Act was in
answer to a need for consumer
safety.
PTS: 1
6. Which act required that drug preparations containing morphine have a label
indicating the presence of morphine?
a. Federal Food, Drug, and Cosmetic
Act of 1938
b. Federal Food, Drug, and Cosmetic
Act Amendment of 1965
c. Controlled Substances Act of 1970
d. Pure Food and Drug Act of 1906
ANS: D PTS: 1
7. Identify a provision of the Federal Food, Drug, and Cosmetic Act and its
Amendments:
a. new products are required to be
approved by the Food and Drug
Administration.
b. the FD&C Act defined schedules for
substances that require specific
controls.
c. it set limitations on the use of
prescriptions.
d. the FD&C Act established USP.
ANS: A
Feedback
A Correct!
B This response applies to the 1970
Controlled Substances Act.
C Prescription limitations were defined
by the 1970 Controlled Substances
Act.
D USP was established by the 1906
Pure Food and Drug Act.
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CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS
TRUE/FALSE
1. The pharmaceutical manufacturer has the authority to add additional active
ingredients to a previously approved pharmaceutical product.
ANS: F
According to the 1938 Federal Food, Drug, and Cosmetic Act and
Amendments of 1951 and 1962, all labels must be accurate and include a
listing of all active and inactive ingredients.
PTS: 1
2. Drug strength may vary with each lot number of a medication.
ANS: F
The 1906 Pure Food and Drug Act established that all drugs marketed in the
United States meet minimal standards of strength, purity, and quality.
PTS: 1
3. The Pure Food and Drug Act of 1906 established drug standards and official
drug references.
ANS: T
This act established that all drugs marketed in the United States meet
minimal standards of strength, purity, and quality. It also established two
official references that established the standards for making each drug: The
U.S. Pharmacopeia (USP) and the National Formulary (NF).
PTS: 1
4. The 1906 Pure Food and Drug Act established consumer protections to
prevent the inclusion of “dangerous ingredients” without the knowledge of
the consumer.
ANS: T
Morphine is one example of a dangerous ingredient that may have been
included without the knowledge of the consumer.
PTS: 1
5. Medication labels need only include the trade name of the drug.
ANS: F
Labels must include a listing of all active and inactive ingredients, warning
labels on certain preparations, and generic names for the medication
Page 1 of 384 2/1/2026, 4:17:08 PM 2/1/2026, 4:16:56 PM
,Page 2 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
PTS: 1
6. The prescriber of the medication is the only health care professional who is
responsible for being aware of new medications, laws, and restrictions.
ANS: F
The health care worker involved in administration of a medication also bears
the responsibility of being aware of the laws and restrictions pertinent to that
medication.
PTS: 1
7. A double-locked system is the recommended method for maintaining security
of controlled substances.
ANS: T
A double-locked system may include two separate key entries or an electronic
user identification and password access system.
PTS: 1
8. Health care workers are responsible for maintaining records of all controlled
substances received, dispensed, and destroyed.
ANS: T PTS: 1
9. Controlled substance records are to be kept for 10 years.
ANS: F
Records for the previous 2 years must be available at all times for inspection.
PTS: 1
MULTIPLE CHOICE
1. Identify the drug standard in the following list.
a. Color c. Shape
b. Strength d. Taste
ANS: B
Feedback
A Color is not a standard.
B Correct!
C Shape is not a standard.
D Taste is not a standard.
Page 2 of 384 2/1/2026, 4:17:08 PM 2/1/2026, 4:16:56 PM
,Page 3 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
PTS: 1
2. The risk of death from the use of street drugs versus prescription
medications is mostly due to:
a. a lack of control over quality, purity,
and strength makes street drugs
dangerous.
b. the risk is the same for both sources
of the same substance.
c. street drugs are approved for use.
d. the need for a prescription makes
drugs hard to obtain.
ANS: A
Feedback
A Correct!
B The lack of enforcement of drug
standards in illegal street drugs
poses a significant danger for the
consumer.
C The exact composition of a street
drug is unknown, and it may contain
dangerous contaminants or
undisclosed additional drugs.
D Street drugs are illegal.
PTS: 1
3. Drug standards regulate drug manufacture so that medications of the same
name will be of the same:
a. strength, purity, and quality.
b. shape, color, and taste.
c. purity, shape, and color.
d. quality, color, and shape.
ANS: A
Drug standards state that all preparations of the same drug name must be of
uniform strength, purity, and quality.
PTS: 1
4. The 1906 Pure Food and Drug Act includes which of the following provisions?
a. Regulation of drugs sold in the
Page 3 of 384 2/1/2026, 4:17:08 PM 2/1/2026, 4:16:56 PM
,Page 4 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
United States and Canada
b. Requires labeling to indicate if a
medication contained a “dangerous
ingredient”
c. Regulates illicit drugs
d. Requires information regarding
medications to be handed down
from one practitioner to the next
ANS: B
Feedback
A The Pure Food and Drug Act
regulates ALL drugs MARKETED in
the United States. If a drug is
manufactured in Canada, it must
meet USFDA requirements to be
marketed here.
B Correct!
C Illicit drugs are not regulated.
D The Pure Food and Drug Act
established two references of
officially approved drugs, the USP
and the NF.
PTS: 1
5. The Pure Food and Drug Act of 1906 was formulated:
a. to curb the use of street drugs.
b. as the first government attempt to
establish consumer protection in the
manufacture of drugs and foods.
c. in order to make drug
manufacturing profitable for the
drug companies.
d. as a means to identify addicting
drugs.
ANS: B
Feedback
A This applies to the Controlled
Substances Act of 1970.
B Correct!
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, Page 5 Essentials of Pharmacology for Health Professions, 8th Edition by Bruce Colbert and Ruth Woodrow. 2/1/2026, 4:17:03 PM
C The Pure Food and Drug Act was in
answer to a need for consumer
safety.
D The Pure Food and Drug Act was in
answer to a need for consumer
safety.
PTS: 1
6. Which act required that drug preparations containing morphine have a label
indicating the presence of morphine?
a. Federal Food, Drug, and Cosmetic
Act of 1938
b. Federal Food, Drug, and Cosmetic
Act Amendment of 1965
c. Controlled Substances Act of 1970
d. Pure Food and Drug Act of 1906
ANS: D PTS: 1
7. Identify a provision of the Federal Food, Drug, and Cosmetic Act and its
Amendments:
a. new products are required to be
approved by the Food and Drug
Administration.
b. the FD&C Act defined schedules for
substances that require specific
controls.
c. it set limitations on the use of
prescriptions.
d. the FD&C Act established USP.
ANS: A
Feedback
A Correct!
B This response applies to the 1970
Controlled Substances Act.
C Prescription limitations were defined
by the 1970 Controlled Substances
Act.
D USP was established by the 1906
Pure Food and Drug Act.
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