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
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:
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.
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
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:
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.
