Chapter 1
1. Drug standards require that all preparations called by the same drug name must be of uniform ____.
a. effectiveness and reliability
b. cost, availability, and distribution method
c. dosage and route of administration
d. strength, quality, and purity
ANSWER: d
2. A friend of yours is complaining about the latest drug recall, which has affected her grandmother's heart
medication. She asks you whether there are any standards to ensure that a medication is consistent with the claims
of its label. How should you respond?
a. Sure, any reliable drug reference will do
b. Yes, the Controlled Substances Schedule
c. Possibly, but only if the physician signed a legal document
d. Yes, the United States Pharmacopeia and National Formulary
ANSWER: d
3. Which legislation requires that drug preparations containing dangerous ingredients have a labeled container indicating
the ingredient?
a. Pure Food and Drug Act
b. Controlled Substances Act
c. Drug Adulteration Prevention Act
d. Federal Food, Drug, and Cosmetic Act
ANSWER: a
4. What was the first law in the United States to require all drugs marketed in the United States to meet minimal
standards of strength, purity, and quality?
a. Federal Food, Drug, and Cosmetic Act
b. Pure Food and Drug Act
c. Controlled Substances Act
d. Drug Adulteration Prevention Act
ANSWER: b
5. What are legend drugs?
a. Drugs that are exceptionally safe and effective
b. Drugs that have the phrase “Caution—federal law prohibits dispensing without a prescription” on the label
c. Drugs that are manufactured before the Pure Food and Drug Act and therefore exempt from regulation
d. Drugs that have limited profitability because they are used to treat rare illnesses
ANSWER: b
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Chapter 1
6. Quinn hears on the news that the FDA has asked a company to withdraw a medication. Under what circumstances
can the FDA do this?
a. when more effective alternatives are available
b. never, because only the DEA can do this
c. when it is no longer profitable
d. when the benefits of a drug outweigh its risks
ANSWER: d
7. What legislation was created in response to a 1937 incident in which an inadequately tested drug caused the deaths
of 100 people?
a. Drug Adulteration Prevention Act
b. Pure Food and Drug Act
c. Controlled Substances Act
d. Federal Food, Drug, and Cosmetic Act
ANSWER: d
8. What legislation requires that new drugs be approved before they are released to the public?
a. The Drug Adulteration Prevention Act
b. The Federal Food, Drug, and Cosmetic Act
c. The Pure Food and Drug Act
d. The Controlled Substances Act
ANSWER: b
9. Your friend, Thomas, had a serious adverse reaction to an over-the-counter medication and found that a number of
other individuals had similar adverse reactions. Which agency is most likely to investigate this situation and take
action if a problem is found?
a. Food and Drug Administration
b. United States Pharmacopeia
c. National Formulary Enforcement
d. Drug Enforcement Agency
ANSWER: a
10. What agency was established by the Federal Food, Drug, and Cosmetic Act?
a. The Schedule of Controlled Substances Oversight Committee
b. The United States Pharmacopeia and National Formulary
c. The Drug Enforcement Administration
d. The Food and Drug Administration
ANSWER: d
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