CH. 1: CONSUMER SAFETY AND DRUG REGULATIONS
T/F
1)The pharmaceutical manufacturer has the authority to add additional active ingredients to a previously approved
pharmaceutical product.
CORRECT ANSWER 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.
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2)Drug strength may vary with each lot number of a medication.
CORRECT ANSWER 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.
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3)The Pure Food and Drug Act of 1906 established drug standards and official drug references.
CORRECT ANSWER 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).
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, Test Bank Questions
4)The 1906 Pure Food and Drug Act established consumer protections to prevent the inclusion of “dangerous ingredients”
without the knowledge of the consumer.
CORRECT ANSWER T
Morphine is one example of a dangerous ingredient that may have been included without the knowledge of the consumer.
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5)Medication labels need only include the trade name of the drug.
CORRECT ANSWER 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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6)The prescriber of the medication is the only health care professional who is responsible for being aware of new medications,
laws, and restrictions.
CORRECT ANSWER 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.
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7)A double-locked system is the recommended method for maintaining security of controlled substances.
CORRECT ANSWER T
A double-locked system may include two separate key entries or an electronic user identification and password access
system.
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8)Health care workers are responsible for maintaining records of all controlled substances received, dispensed, and destroyed.
CORRECT ANSWER T 1
9)Controlled substance records are to be kept for 10 years.
CORRECT ANSWER F
Records for the previous 2 years must be available at all times for inspection.
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MULTIPLE CHOICE QUESTIONS
1)Identify the drug standard in the following list.
a. Color c. Shape
b. Strength d. Taste
CORRECT ANSWER 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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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.
CORRECT ANSWER 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.
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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.
CORRECT ANSWER A
Drug standards state that all preparations of the same drug name must be of uniform strength, purity, and quality.
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