Chapter 01 10e - Colbert
Indicate the answer choice that best completes the statement or answers the question.
1. How should a healthcare professional properly dispose of expired controlled substances?
a. By flushing them down the drain.
b. By following the facilitys approved method.
c. By storing them until the physician decides what to do.
d. By returning them to the manufacturer.
ANSWER: b
2. How was drug information relayed to providers prior to the 1906 establishment of the U.S. Pharmacopeia?
a. The Internet
b. Encyclopedias
c. By passing it to the next generation
d. Schools of medicine and pharmacology
ANSWER: c
3. A pharmaceutical manufacturer wants to enhance an already approved medication by adding a new active
ingredient to improve its efficacy. What should the manufacturer do before making this change?
a. Proceed with the addition without any further approvals.
b. Conduct internal tests and then market the new formulation.
c. Submit an application to FDA for approval of the new active ingredient.
d. Add the ingredient and update the product label accordingly.
ANSWER: c
4. Which of the following requires both a prescription and a DEA number?
a. Standards
b. Controlled (schedule) drug
c. Legend drug
d. FDA
ANSWER: b
5. Which Act required that drug preparations containing morphine have a label indicating the presence of the
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
ANSWER: d
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,Name: Class: Date:
Chapter 01 10e - Colbert
6. How can healthcare professionals ensure they are aware of current drug scheduling changes?
a. By regularly consulting with pharmaceutical representatives.
b. By monitoring the activities of the DEA and FDA.
c. By waiting for changes to be posted at their facility.
d. By attending monthly seminars.
ANSWER: b
7. Which of these was/were established by the 1906 Pure Food and Drug Act?
a. Standards
b. Controlled (schedule) drugs
c. Legend drugs
d. National Drug Code Directory
ANSWER: a
8. The Controlled Substances Act sets tighter controls on which of the following?
a. Aspirin
b. Tylenol
c. Stimulants
d. Antibiotics
ANSWER: c
9. Which of the following is a directory listing of officially approved drugs?
a. DEA
b. Drug standards
c. NDC
d. USP/NF
ANSWER: d
10. Who among the following other than drug manufacturers must also be registered and identified with their own
DEA numbers?
a. The healthcare provider writing the prescription
b. The lab worker working on the prescription
c. All providers working in the physicians office or clinic
d. All providers working in the pharmacy
ANSWER: a
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,Name: Class: Date:
Chapter 01 10e - Colbert
11. Which of the following is a drug standard?
a. Color
b. Strength
c. Shape
d. Taste
ANSWER: b
12. The Pure Food and Drug Act of 1906 was formulated:
a. to control the use of drugs being abused by society.
b. as the first government attempt to establish consumer protection.
c. in order to make drug manufacturing profitable for drug companies.
d. as a means to identify addictive or abused drugs.
ANSWER: b
13. Once a drug or device has been approved for use in the United States, the:
a. DEA may withdraw approval if a safety concern exists.
b. only action that can be taken is requiring additional warnings be added to the labeling and recommending
voluntary withdrawal by the manufacturer.
c. FDA may reconsider its approval and withdraw it from the market to protect public safety.
d. DEA may demand its withdrawal from the market.
ANSWER: b
14. Drugs that treat diseases affecting a very small number of people are called what?
a. orphan drugs
b. OTC drugs
c. legend drugs
d. illicit drugs
ANSWER: a
15. A patient had a serious adverse reaction to an over-the-counter medication and it was 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. U.S. Pharmacopeia
c. National Formulary Enforcement
d. Drug Enforcement Agency
ANSWER: a
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, Name: Class: Date:
Chapter 01 10e - Colbert
16. Which of the following statements about schedules of controlled substances is correct?
a. Schedule 1 drugs can be prescribed or phoned in.
b. Schedule 2 drugs may only be called in during emergencies by a physician, followed by a written
prescription.
c. Schedule 3 drugs cannot be phoned in by a physician under any circumstances.
d. Schedule 1, 2, and 3 drugs can all be phoned in without restrictions.
ANSWER: b
17. Under what circumstances can the FDA request a company to withdraw a medication from the market?
a. When more effective alternatives are available
b. When it is no longer profitable for the company.
c. When the approval is pending with the DEA.
d. When the risks of a drug outweigh its benefits
ANSWER: d
18. A physician wants to prescribe a benzodiazepine for a patient experiencing severe anxiety. Given the regulations,
which of the following actions must the physician take for a Schedule IV drug?
a. Prescribe it electronically without verification.
b. Write a prescription that must be signed and submitted to the pharmacy.
c. Phone in the prescription to the patient.
d. Issue the prescription without any further steps.
ANSWER: b
19. Which of the following is the approval agency established by the 1938 Federal Food, Drug, and Cosmetic Act?
a. USP
b. DEA
c. NDC
d. FDA
ANSWER: d
20. What was the USP/NF established to do?
a. Provide a reference for all officially approved medications
b. Legalize the manufacture of medications
c. Give the public the information needed to safely make their own drugs
d. Help providers make clinical judgement
ANSWER: a
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Indicate the answer choice that best completes the statement or answers the question.
1. How should a healthcare professional properly dispose of expired controlled substances?
a. By flushing them down the drain.
b. By following the facilitys approved method.
c. By storing them until the physician decides what to do.
d. By returning them to the manufacturer.
ANSWER: b
2. How was drug information relayed to providers prior to the 1906 establishment of the U.S. Pharmacopeia?
a. The Internet
b. Encyclopedias
c. By passing it to the next generation
d. Schools of medicine and pharmacology
ANSWER: c
3. A pharmaceutical manufacturer wants to enhance an already approved medication by adding a new active
ingredient to improve its efficacy. What should the manufacturer do before making this change?
a. Proceed with the addition without any further approvals.
b. Conduct internal tests and then market the new formulation.
c. Submit an application to FDA for approval of the new active ingredient.
d. Add the ingredient and update the product label accordingly.
ANSWER: c
4. Which of the following requires both a prescription and a DEA number?
a. Standards
b. Controlled (schedule) drug
c. Legend drug
d. FDA
ANSWER: b
5. Which Act required that drug preparations containing morphine have a label indicating the presence of the
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
ANSWER: d
Page 1
,Name: Class: Date:
Chapter 01 10e - Colbert
6. How can healthcare professionals ensure they are aware of current drug scheduling changes?
a. By regularly consulting with pharmaceutical representatives.
b. By monitoring the activities of the DEA and FDA.
c. By waiting for changes to be posted at their facility.
d. By attending monthly seminars.
ANSWER: b
7. Which of these was/were established by the 1906 Pure Food and Drug Act?
a. Standards
b. Controlled (schedule) drugs
c. Legend drugs
d. National Drug Code Directory
ANSWER: a
8. The Controlled Substances Act sets tighter controls on which of the following?
a. Aspirin
b. Tylenol
c. Stimulants
d. Antibiotics
ANSWER: c
9. Which of the following is a directory listing of officially approved drugs?
a. DEA
b. Drug standards
c. NDC
d. USP/NF
ANSWER: d
10. Who among the following other than drug manufacturers must also be registered and identified with their own
DEA numbers?
a. The healthcare provider writing the prescription
b. The lab worker working on the prescription
c. All providers working in the physicians office or clinic
d. All providers working in the pharmacy
ANSWER: a
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,Name: Class: Date:
Chapter 01 10e - Colbert
11. Which of the following is a drug standard?
a. Color
b. Strength
c. Shape
d. Taste
ANSWER: b
12. The Pure Food and Drug Act of 1906 was formulated:
a. to control the use of drugs being abused by society.
b. as the first government attempt to establish consumer protection.
c. in order to make drug manufacturing profitable for drug companies.
d. as a means to identify addictive or abused drugs.
ANSWER: b
13. Once a drug or device has been approved for use in the United States, the:
a. DEA may withdraw approval if a safety concern exists.
b. only action that can be taken is requiring additional warnings be added to the labeling and recommending
voluntary withdrawal by the manufacturer.
c. FDA may reconsider its approval and withdraw it from the market to protect public safety.
d. DEA may demand its withdrawal from the market.
ANSWER: b
14. Drugs that treat diseases affecting a very small number of people are called what?
a. orphan drugs
b. OTC drugs
c. legend drugs
d. illicit drugs
ANSWER: a
15. A patient had a serious adverse reaction to an over-the-counter medication and it was 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. U.S. Pharmacopeia
c. National Formulary Enforcement
d. Drug Enforcement Agency
ANSWER: a
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, Name: Class: Date:
Chapter 01 10e - Colbert
16. Which of the following statements about schedules of controlled substances is correct?
a. Schedule 1 drugs can be prescribed or phoned in.
b. Schedule 2 drugs may only be called in during emergencies by a physician, followed by a written
prescription.
c. Schedule 3 drugs cannot be phoned in by a physician under any circumstances.
d. Schedule 1, 2, and 3 drugs can all be phoned in without restrictions.
ANSWER: b
17. Under what circumstances can the FDA request a company to withdraw a medication from the market?
a. When more effective alternatives are available
b. When it is no longer profitable for the company.
c. When the approval is pending with the DEA.
d. When the risks of a drug outweigh its benefits
ANSWER: d
18. A physician wants to prescribe a benzodiazepine for a patient experiencing severe anxiety. Given the regulations,
which of the following actions must the physician take for a Schedule IV drug?
a. Prescribe it electronically without verification.
b. Write a prescription that must be signed and submitted to the pharmacy.
c. Phone in the prescription to the patient.
d. Issue the prescription without any further steps.
ANSWER: b
19. Which of the following is the approval agency established by the 1938 Federal Food, Drug, and Cosmetic Act?
a. USP
b. DEA
c. NDC
d. FDA
ANSWER: d
20. What was the USP/NF established to do?
a. Provide a reference for all officially approved medications
b. Legalize the manufacture of medications
c. Give the public the information needed to safely make their own drugs
d. Help providers make clinical judgement
ANSWER: a
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