Pharmacy Law Practice Questions
1. Certain practitioners may prescribe medications. Which of the following practitioners would
least likely have the right to write a prescription?
A.
Doctors of Pharmacy (PharmDs)
B.
Medical Doctors (MDs)
C.
Physician Assistants (PAs)
D.
Nurse Practitioners (NPs)
2. Of the following laws and amendments regarding drugs in the United States, which was most
recently passed?
A.
Pure Food and Drug Act
B.
Food Drug and Cosmetic Act
C.
Durham-Humphrey Act
D.
Kefauver-Harris Amendment
3. Which of the following describes adulteration?
A.
"Prepared, packed, or held under unsanitary conditions"
B.
Labeling that is "false or misleading in any particular way"
C.
Failure to label "adequate directions for use"
D.
Failure to carry a label indicating "Warning–-May be habit forming" if the product is
habit forming
4. Which of the following describes misbranding?
A.
B.
"Prepared, packed, or held under unsanitary conditions"
Prepared in containers "composed, in whole or in part, of any poisonous or
deleterious substance"
C.
Failure to label "adequate directions for use"
D.
Containing unsafe color additives
5. You would expect to find all of the following except the ____ on a manufacturer's drug label.
A.
physician's name
B.
name and place of business of the manufacturer, packer, or distributor
C.
National Drug Code number
D.
statement of ingredients
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Pharmacy Law Practice Questions
6. You would expect to find all of the following except the ____ on an over-the-counter package label.
A.
patient's name
B.
active ingredients
C.
inactive ingredients
D.
National Drug Code number
7. All of the following describe provisions of the Durham-Humphrey Act except:
A.
separated drugs into legend and nonlegend.
B.
regulated the use of patient information.
C.
prescription medications required the supervision of a physician.
D.
refills could be phoned in from the physician's office.
8. The Kefauver-Harris Amendment of 1962 provided for all of the following except:
A.
requires all medications in the United States to be pure, safe, and effective.
B.
controlled substances are placed in one of five schedules.
C.
established procedures for both drug applications and investigational drugs.
D.
drug manufacturers are required to be responsible for good manufacturing processes.
9. Which of the following drugs would be classified as Schedule I under the DEA's guidelines?
A.
Oxycodone
B.
Hydrocodone
C.
Psilocybin
D.
Codeine
10. Last night a local pharmacy had their safe broken into, and Schedule II drugs were stolen. Which
form would need to be completed?
A.
DEA Form 106
B.
DEA Form 41
C.
DEA Form 222
D.
DEA Form 22
11. Which DEA form must be completed to verify the destruction of Schedule II narcotics?
A.
DEA Form 106
B.
DEA Form 41
C.
DEA Form 222
D.
DEA Form 22
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Pharmacy Law Practice Questions
12. The proper form used to order Schedule II medications for the pharmacy would be DEA form:
A.
106.
B.
41.
C.
222.
D.
22.
13. The first letter of a prescriber's DEA number would definitely not be:
A.
A.
B.
B.
C.
Q.
D.
M.
14. How many refills are available on a Schedule II medication?
A.
0
B.
1
C.
5
D.
PRN
15. A patient brings a prescription for Tylenol #3 (with codeine) #60 tablets with five refills. The patient
can only pay for 30 tablets this week. How many refills are available to be filled in the next 6 months
after this one to include the extra 30 tablets that have not been picked up?
A.
B.
5
330 tabs
C.
11
D.
PRN
16. The Poison Prevention Packaging Act of 1970 requires that most OTC and legend drugs be
packaged in a child-resistant container, which is one that cannot be opened by ____% of children
younger than 5 years but can be opened by ____% of adults.
A.
100; 90
B.
90; 100
C.
90; 80
D.
80; 90
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Pharmacy Law Practice Questions
17. All of the following describe the Orphan Drug Act except:
A.
medications that treat a condition for which there are fewer than 200,000 cases
worldwide.
B.
was passed in 1983.
C.
provides tax incentives and exclusive licensing of products.
D.
makes provisions for the use of drugs abandoned by a pharmaceutical company's
research and development team.
18. Which of the following is a provision of the Hatch-Waxman Act of 1984 (also known as the Drug
Price Competition and Patent Term Restoration)?
A.
Prohibits the reimportation of a drug into the United States by anyone except the
manufacturer
B.
Forbids the sale or distribution of samples to anyone other than those licensed to
prescribe them
C.
Encourages the creation of both generic and new medications by streamlining the
process for generic drug approval and by extending patent licenses
D.
Requires the following label to appear on all medications to be administered to
animals: "Caution: Federal law restricts this drug to use by or on an order of a licensed
veterinarian"
19. All of the following are provisions of OBRA 1987 except:
A.
resident's drug regimen must be free of unnecessary medications.
B.
retrospective drug use review.
C.
D.
behavioral modification and drug holidays are used to see if the medication may be
discontinued.
long-term care facilities must have the services of a consultant pharmacist.
20. "All medical devices are to be tracked and records be maintained for durable medical equipment"
describes a provision of which law or amendment?
A.
FDA Safe Medical Devices Act of 1990
B.
Dietary Supplement Health and Education Act (DSHEA) of 1994
C.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
D.
Combat Methamphetamine Epidemic Act of 2005
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Pharmacy Law Practice Questions
21. "The manufacturers of supplements are allowed to make claims with regard to general health
promotion, but not disease claims" describes a provision of which law or amendment?
A.
FDA Safe Medical Devices Act of 1990
B.
Dietary Supplement Health and Education Act (DSHEA) of 1994
C.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
D.
Combat Methamphetamine Epidemic Act of 2005
22. "Established conditions on the use and the disclosure of protected health information" describes a
provision of which law or amendment?
A.
FDA Safe Medical Devices Act of 1990
B.
Dietary Supplement Health and Education Act (DSHEA) of 1994
C.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
D.
Combat Methamphetamine Epidemic Act of 2005
23. "Placed ephedrine, pseudoephedrine, and phenylpropanolamine in the Controlled Substances Act
category 'scheduled listed chemical products'" describes a provision of which law or amendment?
A.
FDA Safe Medical Devices Act of 1990
B.
Dietary Supplement Health and Education Act (DSHEA) of 1994
C.
Health Insurance Portability and Accountability Act (HIPAA) of 1996
D.
Combat Methamphetamine Epidemic Act of 2005
24. Certain medications have severe side effects and are only approved for certain populations. Which
of the following describes stipulations for the use of clozapine (Clozaril)?
A.
Reporting of white blood cell (WBC) values and absolute neutrophil counts (ANCs)
B.
Indicated for multiple myeloma
C.
Blood should never be donated
D.
A woman can be excused from the requirements if she has not had a period 24
months in a row
25. Certain medications have severe side effects and are only approved for certain populations. Which
of the following describes stipulations for the use of thalidomide?
A.
CARE is designed to streamline the process.
B.
The system is used to detect agranulocytosis.
C.
The ANC is one of the measures that determine if a patient may take the medication
or not.
D.
A woman must have a negative pregnancy test result within the 24 hours before
beginning treatment.
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Pharmacy Law Practice Questions
26. All of the following have to do with the use of isotretinoin except:
A.
prescribed only for severe recalcitrant nodular acne unresponsive to other therapies.
B.
it might produce depression and psychosis.
C.
it might produce suicidal ideation and suicide.
D.
indicated for multiple myeloma.
27. Certain records must be maintained in the pharmacy. Which of the following would not have to be
maintained in the pharmacy?
A.
The biennial inventory of narcotics
B.
Change of pharmacist-in-charge inventory
C.
Over-the-counter medication orders
D.
Controlled substance invoices
28. Which chapter provides guidance on applying good compounding practices in the preparation of
nonsterile compounded formulations for dispensing or administration to humans or animals?
A.
USP 795
B.
USP 797
C.
USP 222
D.
USP 41
29. Which chapter contains many procedural training and quality assurance requirements for preparing
sterile products?
A.
USP 795
B.
USP 797
C.
USP 222
D.
USP 41
30. Which of the following publications would least likely have peer-reviewed material in it?
A.
American Journal of Pharmaceutical Education (AACP)
B.
Pharmaceutical Research (AAPS)
C.
American Journal of Health System Pharmacists (AJHP)
D.
Drug Topics
Resources
Mizner: Mosby's Review for the Pharmacy Technician Certification Examination, 3rd Edition
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Pharmacy Law Practice Questions
Answer Keys:
1. a
2. d
3. a
4. c
5. a
6. a
7. b
8. b
9. c
10. a
11. b
12. c
13. c
14. a
15. b
16. d
17. d
18. c
19. b
20. a
21. b
22. d
23. d
24. a
25. d
26. d
27. c
28. a
29. b
30. d
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