,f Pharmacology for Health Professions, 8th Edition, Bruce Colbert, Ruth Woodrow
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
,https://www.stuvia.com/
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.
PTS: 1
2. The risk of death from the use of street drugs versus prescription
medications is mostly due to:
,https://www.stuvia.com/
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
United States and Canada
b. Requires labeling to indicate if a
medication contained a “dangerous
ingredient”
c. Regulates illicit drugs
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
,https://www.stuvia.com/
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.
PTS: 1
2. The risk of death from the use of street drugs versus prescription
medications is mostly due to:
,https://www.stuvia.com/
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
United States and Canada
b. Requires labeling to indicate if a
medication contained a “dangerous
ingredient”
c. Regulates illicit drugs
