Pharmacy Law Final

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1. Which of the following is not required to be included on the label of a dispensed drug under the FDCA? c. The drug name

a. The dispenser name and address

b. The prescription serial number
c. The drug name
d. The prescriber name
2. A pharmacy repackages nonsterile solid dosage forms into PVC unit dose packaging. Which statement a. USP guidelines do
about USP beyond-use date guidelines is correct? not apply

a. USP guidelines do not apply

b. The earlier of one year form the date of repackaging or the expiration date on the bulk container
c. The earlier of six months from the date of repackaging or the expiration date on the bulk container
d. Not to exceed six months provided it does not exceed 25% of the remaining time between the date of
repackaging and the manufacturer's unopened bulk container
3. A patient visits the pharmacy and requests a particular OTC product, drug product A. Pharmacist Phil does d. Explain to the
not have Drug A in stock, but he does have drug product B from another manufacturer, which is identical patient that he is
to Drug A but is a prescription drug product. Since the two products are identical, what can Pharmacist unable to provide
Phil legally do? Drug A at this time

a. Sell the patient Drug B and charge the price of Drug A

b. Sell the patient Drug B after explaining that, although the products have different names, they are the
same
c. Sell the patient Drug B after verifying that the patient's condition requires the product
d. Explain to the patient that he is unable to provide Drug A at this time
4. Plan B can be sold: a. Without age or
point-of-sale
a. Without age or point-of-sale restriction restriction
b. Only from a licensed pharmacy, without age restriction
c. Only from a licensed pharmacy to females only
d. Only from a licensed pharmacy to purchasers over the age of 16
5. Which statement regarding patient package inserts (PPIs) is correct, assuming the drug is one for which a a. They must be
PPI is required? included for new
prescriptions and
a. They must be included for new prescriptions and refills refills
b. They must be given to an inpatient prior to administration of the first dose and for each subsequent
dose administered
c. A hospital physician can decide whether an inpatient should receive a PPI
d. A pharmacy may exercise professional judgment as to whether a PPI should be dispensed to a patient
6. Which statement regarding Medication Guides (MedGuides) is correct? D. All of these are
correct
A. The FDA can require manufacturers to publish MedGuides only for drugs that pose a serious and
significant concern
B. Since the enactment of the FDAAA, the FDA has considered every new MedGuide to be part of a
REMS
C. A MedGuide is required the first time a drug is dispensed to a healthcare professional for
administration to a patient in an outpatient setting.
D. All of these are correct
7. The FDA's attitude about the practice of the prescribing of approved drugs for off-label d. Accepts that the practice is
indications is that it: appropriate and rational

a. Regards the practice as illegal

b. Frowns on the practice but tolerates it
c. Encourages the practice
d. Accepts that the practice is appropriate and rational
8. What best describes the Drug Quality and Security Act of 2013, and its regulation of sterile c. The compounding entity
compounding of products? may register as an outsourcing
facility
a. The compounding entity must register as an outsourcing facility
b. The compounding entity must register as a manufacturer
c. The compounding entity may register as an outsourcing facility
d. Enforcement authority is vested with the state pharmacy board
9. Pursuant to the Prescription Drug Marketing Act, a prescriber can receive samples from a a. A written request on a
manufacturer by means of: proper form each time the
prescriber wants samples
a. A written request on a proper form each time the prescriber wants samples
b. A standing written request for samples
c. A verbal request from the manufacturer's representative
d. The manufacturer can supply the samples without request
10. The Drug Supply Chain Security Act: d. All of these are correct
a. Preempts state pedigree laws
b. Requires pharmacies to quarantine, investigate, and notify the FDA of suspect products
c. Requires pharmacies to receive a transaction history with the drug product
d. All of these are correct
11. Tax-free alcohol may be used by: a. Hospital pharmacies for
compounding medications for
a. Hospital pharmacies for compounding medications for inpatients inpatients
b. Hospital pharmacies for compounding medications for outpatients
c. Community pharmacies for compounding medications for patients
d. Outpatient charity clinics for compounding medications for patients, provided they charge
the patients for the compound
12. A pharmacy wishing to advertise prescription drug prices must meet which requirements, under b. The advertising must contain
federal law? the proprietary and established
name of the drug if it has both
a. There are no requirements, because this is reminder advertising
b. The advertising must contain the proprietary and established name of the drug if it has both
c. The advertising must contain the indications of the drug
d. The advertising must meet the fair balance requirements
13. Under the Durham-Humphrey Amendment, the law provides, in part that a prescription drug is c. Patients may take the drug
one that is unsafe for use except under the supervision of a practitioner because of " the for a condition that it will not
collateral measures necessary to use the drug." In this instance, "collateral measures" means cure, and postpone seeing a
that the: physician

a. Toxicity of the drug requires physician supervision

b. Pharmacological effects of the drug requires physician supervision
c. Patients may take the drug for a condition that it will not cure, and postpone seeing a
physician
d. Route of administration requires physician supervision
14. Which statement about the "beyond use date" on the label of a A. USP guidelines allow the earlier of the manufacturer's
dispensed multiple-unit drug container by a pharmacy is correct? expiration date, or one year from the date of dispensing

A. USP guidelines allow the earlier of the manufacturer's expiration

date, or one year from the date of dispensing
B. FDA guidelines allow the earlier of the manufacturer's expiration
date, or one year from the date of dispensing
C. All state laws mandate that the pharmacist must type the same date
that is on the manufacturer's label
D. Most state laws do ot mandate that an expiration or "beyond use"
date be typed on the label
15. Drug product A is identical to drug product B, each made by a b. Switched B from prescription to OTC, by means of an
different manufacturer. A is a prescription drug, and B is an OTC drug. SND
This is likely because the FDA:

a. Switched the active ingredients of the drugs to OTC by monograph

b. Switched B from prescription to OTC, by means of an SND
c. Switched A from OTC to prescription, by monograph
d. All of these are correct
16. Which statement about whether there should be a third class of drugs, d. All of these are correct
also known as "behind the counter" or "under conditions for safe use"
is correct?

a. Pharmacists have been in favor of the concept

b. The FDA has opposed the concept until recently
c. Medical organizations have opposed the concept
d. All of these are correct
17. A dentist issued a prescription to a patient for a statin drug for the c. Invalid, because the dentist has exceeded the scope of
purpose of reducing the patient's cholesterol level. This prescription is: practice under state law

a. Valid, because a dentist has prescriptive authority under state law

b. Valid, because a dentist has prescriptive authority under federal law
c. Invalid, because the dentist has exceeded the scope of practice
under state law
d. Invalid, because the dentist has exceeded the scope of practice
under federal law
18. Which statement about the historical evolution of Plan B is most d. The decision that Plan B be made available OTC
accurate? without point of sale or age restrictions was initially
made by a court, not the FDA
a. It was originally approved as an OTC drug but opposition caused it
to be switched to prescription
b. In the mid-2000s, the FDA denied an SNDA that Plan B could be
sold only from behind the counter of a pharmacy with proof of age 18
or older
c. A court decision agreed with the FDA's decision to reject the Citizen
Petition requesting the elimination of an age requirement
d. The decision that Plan B be made available OTC without point of sale
or age restrictions was initially made by a court, not the FDA
19. Physicians' authority to dispense medication: b. Is not covered by FDCA
dispensing standards under Durham-
a. Is prohibited under federal law Humphrey
b. Is not covered by FDCA dispensing standards under Durham-Humphrey
c. Can set more restrictive for physicians than for pharmacists when set by the state
d. All of these are correct
20. Which statement about consumer medication information (CMI) is correct? b. Approximately 71% of CMI was
deemed useful
a. Federal law mandates that CMI be dispensed to patients
b. Approximately 71% of CMI was deemed useful
c. About 50% of patients actually receive CMI
d. The FDA dose not favor the use of CMI
21. Medication Guides (MedGuides): a. Must be distributed when required,
to avoid an FDCA misbranding
a. Must be distributed when required, to avoid an FDCA misbranding charge charge
b. Replaced PPIs
c. May ne replaced by a pharmacy's CMI
d. Are mandatory the first time a patient receives a new drug
22. A plaintiff was injured by using a prescription drug that was prescribed for a use that the b. Allow the labeling as evidence of
drug's labeling warns against. The plaintiff wishes to introduce the labeling into evidence. the standard of care
What is the court likely to do?

a. Not allow the labeling into evidence

b. Allow the labeling as evidence of the standard of care
c. Allow the labeling as prima facie evidence of negligence
23. What did the Drug Quality and Security Act of 2013 accomplish regarding the traditional a. It reinstated the constitutional
compounding practice of community pharmacies pursuant to prescriptions? provisions of Section 503A enacted in
1997by the FDAMA
a. It reinstated the constitutional provisions of Section 503A enacted in 1997by the
FDAMA
b. It shifted enforcement authority from state pharmacy boards to the FDA
c. It established that pharmacy-compounded drugs are new drugs
d. It prohibits pharmacies from compounding in anticipation of prescriptions
24. Which statement is correct, pursuant to the Orange Book? c. Bioequivalent drugs are presumed
to be therapeutically equivalent
a. Drugs rated BX have been proved as not bioequivalent
b. Substitution of a B-rated product violates the FDCA
c. Bioequivalent drugs are presumed to be therapeutically equivalent
d. Pharmaceutically-equivalent drugs are presumed therapeutically equivalent
25. A hospital has excess inventory of drug products. Local community pharmacies would like b. Can sell inventory to the
to purchase the excess inventory since they can buy the products for less from the pharmacies for emergency reasons to
hospital than from the wholesaler. The hospital: alleviate a temporary shortage

a. Can sell inventory to the pharmacies, provided it charged the same amount as the
wholesaler
b. Can sell inventory to the pharmacies for emergency reasons to alleviate a temporary
shortage
c. Can sell inventory to the pharmacies without restriction
d. Cannot sell inventory to the pharmacies
26. What did the U.S. Supreme Court decide regarding the Virginia a. The First Amendment applies to recipients of speech
Advertising Case decision?

a. The First Amendment applies to recipients of speech

b. The First Amendment does not apply to commercial speech
c. The Virginia law served a valid interest in protecting its citizens
d. The First Amendment applies to recipients of speech, but does
not apply to commercial speech
27. The FDA is considering switching a product from OTC to prescription. c. Either the toxicity of the drug or the method of use
The manufacturer has challenged the FDA in court to prevent the requires the supervision of a prescriber
switch. In order to prevail, what must the FDA prove?

a. The toxicity of the drug requires the supervision of a prescriber

b. The mthod of use of the drug requires the supervision of a
prescriber
c. Either the toxicity of the drug or the method of use requires the
supervision of a prescriber
d. Both the toxicity of the drug and the method of use together
requires the supervision of a prescriber
28. A pharmacist dispensing a drug pursuant to prescription is exempt a. That the drug not be sold under the name of another
from the labeling requirements applicable to a manufacturer, except: drug

a. That the drug not be sold under the name of another drug
b. The quantity of the drug dispensed
c. The manufacturer's name
d. All of these are correct
29. Which statement about the beyond-use date for non-sterile or liquid c. Not to exceed six months, provided it does not exceed
drugs repackaged into unit containers, as established in the final 25% of the remaining time between the date of repackaging
1995 FDA CPG, is correct? and the manufacturer's unopened bulk container

a. One year from the date of repackaging, unless stability data or

manufacturer's labeling indicates otherwise
b. Not to exceed six months from the date of repackaging
c. Not to exceed six months, provided it does not exceed 25% of the
remaining time between the date of repackaging and the
manufacturer's unopened bulk container
d. Not to exceed six months, provided it does not exceed 50% of the
remaining time between the date of repackaging and the
manufacturer's unopened bulk container
30. What does the FDCA specify about prescribing prescription drugs? a. They may be prescribed by practitioners licensed by law

a. They may be prescribed by practitioners licensed by law

b. Which practitioners may be licensed by law to prescribe
(physicians, dentists, etc.)
c. The scope of prescriptive authority of a practitioner
d. All of these are correct
31. Which description of consumer medication information (CMI) is B. The FDA initially proposed that CMI be required for all new
most accurate? prescriptions; however, Congress established a voluntary
private-sector program
A. The FDA initially proposed that CMI be required for drugs
posing serious and significant concers; however, Congress
established a voluntary private-sector program
B. The FDA initially proposed that CMI be required for all new
prescriptions; however, Congress established a voluntary
private-sector program
C. The FDA has historically opposed distributing CMI to patients
D. Pharmacy organizations have historically supported
distributing CMI to patients
32. Pharmacists are required to dispense Medication Guides b. For prescription drugs the FDA has determined require
(MedGuides): MedGuides

a. For all prescription drugs

b. For prescription drugs the FDA has determined require
MedGuides
c. For prescription drugs that, in the pharmacist's professional
judgment, require MedGuides
d. For oral contraceptives
33. A pharmacist received a prescription for Zostat (fct ) with the c. Yes, it is legal under the FDCA. However, the pharmacist
direction to take t.i.d. for migraine headaches. Zostat is indicated should confirm the prescription accuracy with the prescriber
only for anxiety and labeled for once a day use. Is it legal to and, if confirmed, exercise professional judgment regarding the
use Zostat as prescribed? reasonableness of the risk in deciding whether to dispense the
prescription.
a. Yes, it is legal under the FDCA and the pharmacist should
dispense it
b. Yes, it is legal under the FDCA. However, the pharmacist
should confirm the prescription accuracy with the prescriber and,
if confirmed, dispense the drug without further consideration.
c. Yes, it is legal under the FDCA. However, the pharmacist
should confirm the prescription accuracy with the prescriber and,
if confirmed, exercise professional judgment regarding the
reasonableness of the risk in deciding whether to dispense the
prescription.
d. No, it's not legal to use Zostat in this manner and the
pharmacist should not dispense it.
34. Which statement accurately describes the history of the FDA's d. All of these are correct
position that pharmacy-compounded drugs are "new drugs?"

a. Prior to the FDAMA enacted in 1997, the FDA considered

pharmacy-compounded drugs "new drugs" by policy
b. A federal court of appeals ruled that pharmacy-compounded
drugs are not "new drugs," provided the pharmacy follows
FDAMA requirements.
c. The DQSA of 2013 established that pharmacy-compounded
drugs are not "new drugs"
d. All of these are correct
35. Under the Drug Quality and Security Act's regulations, an entity compounding and c. May register as an "outsourcing facility
dispensing sterile products: with the FDA

a. Must register as an "outsourcing facility" with the FDA

b. Must register as a manufacturer wit the FDA
c. May register as an "outsourcing facility with the FDA
d. May register either with the FDA or the state board as a "compounder"
36. What is the source of legal authority for pharmacists to engage in drug product b. State law
substitution?

a. The FDCA
b. State law
c. The orange book
d. Professional judgment
37. A patient, Mrs. Harvey, tells the pharmacist about a drug manufactured and sold in c. Mrs. Harvey could personally import
France, but not approved in the U.S. Mrs. Harvey wants to obtain that drug since no small amounts of the drug into the U.S.
drug approved in the U.S. is effective for her serious medical condition and this drug only if the drug does not present an
sounds promising. What is the pharmacist's best advice for Mrs. Harvey, pursuant to unreasonable risk to her and she provides
the FDA compassionate use policy? the name of her treating physician.

a. The pharmacy could order the drug for Mrs. Harvey.

b. Mrs. Harvey could personally import small amounts of the drug into the U.S.
c. Mrs. Harvey could personally import small amounts of the drug into the U.S. only
if the drug does not present an unreasonable risk to her and she provides the name
of her treating physician.
d. Mrs. Harvey's physician must order the drug for her.
38. A dietary supplement manufacturer contracted with a pharmacy to include the b. Both, the manufacturer and the
pharmacy's name on television ads for the product as a place where the product pharmacy are liable for false advertising
may be purchased. Unknown to the pharmacy, the ads contained false and
misleading statements. The FTC sued the manufacturer and the pharmacy. Is the
pharmacy liable?

a. The manufacturer is liable for false advertising, but not the pharmacy
b. Both, the manufacturer and the pharmacy are liable for false advertising
c. Neither the manufacturer nor the pharmacy is liable for false advertising
39. Drug product P is the original patented drug product. Drug products X, Y, and Z are c. P and X are therapeutically equivalent
generic drug products to P. The Orange Book classifies X as A rated to P. It classifies to one another
drugs Y and Z as B rated to P. Which statement is correct?

a. X, Y, and Z are therapeutically equivalent to P

b. Y and Z are therapeutically equivalent to one another
c. P and X are therapeutically equivalent to one another
d. Y and Z are therapeutically equivalent, and P and X are therapeutically equivalent
40. The FDA is considering combining the PPI, CMI, and Medication Guide into an easy- true
to-read document.

True or False
41. Pharmacist Phil receives a call from Dr. Young, a new pediatrician in town. Dr. Young informs d. Pharmacist Phil should
Pharmacist Phil that his mother is in town and is experiencing back pain from a recent surgery. Dr. tell Dr. Young that he can't
Young has tried to contact his mother's physician, but was unsuccessful. Dr. Young would like to fill the prescription
phone in a prescription for his mother for Tylenol #3 (schedule III pain medicine) until they can get because it is not in the
a hold of her physician. How should Pharmacist Phil respond? usual field of Dr. Young's
practice.
a. Pharmacist Phil should tell Dr. Young that he will fill the prescription as a professional courtesy,
but only for a 3 day supply
b. Pharmacist Phil should tell Dr. Young that he is allowed to perscribe that medication for his
mother, and will fill the prescription
c. Pharmacist Phil should tell Dr. Young that he can't fill the prescription because it is illegal for
physicians to prescribe for their family members
d. Pharmacist Phil should tell Dr. Young that he can't fill the prescription because it is not in the
usual field of Dr. Young's practice.
42. Harry Smith lives in a long-term care facility. The prescriber faxed to Pharmacist Phil a prescription a. yes, however, all the
for Oxycontin (schedule II) for 90 pills. Harry's insurance will only pay for 30 pills at a time. Can tablets must be filled
Pharmacist Phil fill the prescription for 30 pills at a time until all 90 are dispensed? within 60 days from the
date the prescription was
a. yes, however, all the tablets must be filled within 60 days from the date the prescription was issued
issued
b. yes, however, Mr. Smith must also be diagnosed as a terminally ill patient
c. yes, however, pharmacist Phil must obtain a new written prescription for his records each time he
fills another 30 pills
d. no, if Harry decides to get less than 90 tablet, he cannot obtain the remainder because schedule
II drugs cannot have refills
43. Which of the following does the CSA require to be on the pharmacy label of a dispensed d. all of the above
controlled substance in schedule II, III, and IV?

a. patient name
b. pharmacy address
c. the statement "Caution: federal law prohibits the transfer of this drug to any person other than
the person for whom it was prescribed"
d. all of the above
44. Who is allowed to prescribe controlled substances? d. all of the above

a. mid-level practitioners may prescribe controlled substances if authorized by state law

b. an agent or employee may communicate the prescription to a pharmacist
c. am agent or employee may prepare the prescription for the individual practitioner's signature
d. all of the above
45. Pharmacist Phil receives a call from a chain pharmacy located in a different state. Mrs. Neely is on d. yes, the CSA allows
vacation and would like to transfer her prescription for Ativan (schedule IV), for which she has three Mrs. Neely to transfer her
refills remaining. The state Pharmacist Phil is in and the state Mrs. Neely is visiting follow the same controlled prescription this
CSA restrictions regarding transferring controlled substances. Can Pharmacist Phil legally transfer one time only
the prescription?

a. no, the CSA prohibits controlled drug prescriptions from being transferred to a different state
b. no, the CSA prohibits transferring any controlled substances
c. yes, the CSA allows Mrs. Neely to transfer her controlled prescriptions prescriptions to another
state this time and then back to Phil's pharmacy for the next fill
d. yes, the CSA allows Mrs. Neely to transfer her controlled prescription this one time only
46. Bling Pharmacy called Zing Pharmacy requesting a transfer of a C-III Rx to Bling for a c. Bling must record on the
patient. The prescription has two refills remaining. Which statement is correct (assume that prescription it transfers from Zing
Bling and Zing do not share common electronic files)? the word "transfer" along with
several other points of information,
a. the Zing pharmacist can instruct the technician to verbally convey the required including Zing's prescription
prescription information to Bling. number
b. if the patient wants the last refill at Zing, Bling can transfer the prescription back.
c. Bling must record on the prescription it transfers from Zing the word "transfer" along
with several other points of information, including Zing's prescription number
d. Zing should Bling that the prescription legally can't be transferred.
47. Ringem Pharmacy is out of Oxycodone 5 mg and needs 100 tablets to fill an order. The c. Ringem must execute a 222 form,
Ringem pharmacist calls Marwall Pharmacy, which is next door; Marwall Pharmacy can keeping copy 3, sending copy 2 to
supply the tablets. What must occur for the transaction? the DEA and copy 1 to Marwall

a. Marwall must execute a 222 form, keeping copy 3, sending copy 2 to the DEA and copy
1 to Ringem
b. Marwall must execute a 222 form, keeping copy 2, sending copy 1 to the DEA and copy
3 to Ringem
c. Ringem must execute a 222 form, keeping copy 3, sending copy 2 to the DEA and copy 1
to Marwall
d. this transaction does not require the execution of a 222 form. Ringem and Marwall both
need to keep a record of the transaction.
48. In order to issue a controlled substance prescription, a prescriber must be: d. all of the above

a. an individual practitioner
b. authorized by state law to prescribe controlled substances
c. registered or exempt from registration under the CSA
d. all of the above
49. John Johnson is a physician's assistant authorized by the state he is licensed in to prescribe c. MJ
certain controlled substances. What is an acceptable DEA number for John?

a. JJ
b. AJ
c. MJ
d. BJ
50. Pharmacist Phil fills a new written prescription and two refills for Tylenol #3-a schedule III b. yes, but only if Phil knew that the
controlled substance. A couple months later, Phil learns from drug enforcement agents refills were not authorized
that the prescription was altered by the patient to receive refills that were never
authorized by the prescriber. Could Phil be held responsible under the CSA by allowing
the patient to receive the unauthorized refills?

a. yes, Phil violated the CSA when he filled the refills

b. yes, but only if Phil knew that the refills were not authorized
c. no, Phil does not have a duty to be alert for altered prescriptions
d. no, pharmacies are exempt from violating the CSA in circumstances such as this
51. During a controlled substances inventory, which medications require an exact count? a. a 100 count bottle of
hydrocodone with acetaminophen
a. a 100 count bottle of hydrocodone with acetaminophen
b. a 1000 count bottle of lorazepam
c. a 500 ml bottle of a schedule V cough syrup
d. a box of 20 diazepam suppositories
52. A patient brings a written prescription for Tylenol #3 (schedule III) to the pharmacy a. December 15, 2017
on July 1, 2017. The prescription was written and dated June 15, 2017 and has two
refills authorized under it. What is the last date the patient can obtain the refills for
this prescription?

a. December 15, 2017

b. December 31, 2017
c. January 15, 2018
d. never. Refills are not allowed with this prescription
53. A physician phones a pharmacy to call in a two-week supply of a C-II Rx a. we cannot dispense a 2 week supply,
(hydrocodone) for a patient. The pharmacist is familiar with the patient and the but only enough hydrocodone for the
physician, and knows the patient is terminally ill and has received hydrocodone emergency period. We must receive an
prescriptions before. The physician says the patient's wife will be in to pick up the original written prescription with the
medication in about an hour. What is the best response from the pharmacist to the notation 'Authorization for Emergency
physician, combining federal and state law? Dispensing' within seven days.

a. we cannot dispense a 2 week supply, but only enough hydrocodone for the
emergency period. We must receive an original written prescription with the notation
'Authorization for Emergency Dispensing' within seven days.
b. "We cannot dispense a two-week supply, but only enough hydrocodone for the
emergency period. The oral order will substitute for the original written file."
c. "We can dispense a two-week supply. We must recieve the original written
prescription with the notification 'Authorization for Emergency Dispensing' within
seven days."
d. This is most likely not an emergency situation, and we cannot dispense the
prescription.
54. Is the partial filling of a C-II drug permitted? d. it is permitted, provided the pharmacist
is unable to supply the full quantity, and
a. it is not permitted if the balance is dispensed it must be
b. it is permitted, provided the pharmacist is unable to provide the full quantity within 72 hours.
c. it is permitted however, the balance may not be dispensed
d. it is permitted, provided the pharmacist is unable to supply the full quantity, and if
the balance is dispensed it must be within 72 hours.
55. Which copy of the DEA 222 form does the supplier forward to the DEA? b. copy 2

a. copy 1
b. copy 2
c. copy 3
d. copy 4
56. What is not an appropriate first letter for a physician's DEA registration number? d. P

a. A
b. B
c. G
d. P
57. Which statement regarding PMPs is not correct? b. states are mandated by the DEA to
report all schedules of controlled
a. PMPs require pharmacist to report dispensed controlled substance prescriptions to substances
a database
b. states are mandated by the DEA to report all schedules of controlled substances
c. states may share reported information across state lines
d. states can determine which individuals have access to the database
58. Pharmacist Phil calls Dr. Smith's office to inform the office that Mrs. Jones is out of refills on her schedule c. no, nurse Nancy
IV drug prescription, and that she is requesting additional refills for it. Nurse Nancy tells Pharmacist Phil must verify with Dr.
that Dr. Smith is on vacation but that he authorized her to use her judgment on any refill authorizations, Smith prior to
and tells Pharmacist Phil to refill the prescription. Can Pharmacist Phil legally fill the prescription for Mrs. allowing the refill
Jones one more time?

a. yes, pharmacist Phil contacted the office and verified that Mrs. Jones is allowed to receive 1 additional
refill
b. yes, Dr. Smith properly delegated authority to nurse Nancy to add refills
c. no, nurse Nancy must verify with Dr. Smith prior to allowing the refill
d. no, refill requests and authorizations for controlled drugs cannot be made over the phone
59. For automated controlled substance records kept at a central location, within what business time frame b. 48 hours
must requested printouts be available at the pharmacy?

a. 24 hours
b. 48 hours
c. 72 hours
d. within a reasonable times
60. A pharmacy received a hand-written CII prescription for a one month supply of a pain medication without d. no, the
the prescriber's signature. Is this a valid prescription that the pharmacist can dispense? prescription is not
valid and cannot
a. yes, but only after the pharmacist contacts the prescriber and documents that the prescriber verified be dispensed
the prescription
b. yes, but only after the pharmacist verifies that the prescriber wrote the prescription, and the prints the
prescriber's name on the prescription
c. yes, but only after the pharmacist contacts the prescriber and converts the prescription to an
emergency verbal order.
d. no, the prescription is not valid and cannot be dispensed
61. A pharmacist received a prescription for 500 oxycodone tablets with the directions that the patient was to a. this prescription
significantly taper down the dosage over the next four weeks. The pharmacist called the prescriber, who is not for a
informed the pharmacist that the patient is an addict and that the prescriber is trying to detoxify the legitimate medical
patient. Which statement is correct? purpose and
should not be
a. this prescription is not for a legitimate medical purpose and should not be dispensed dispensed
b. this prescription is for a legitimate medical purpose and should be dispensed
c. this prescription is valid under DATA
d. this prescription of valid of the prescriber works at a registered narcotic treatment program
62. A faxed prescription for any CII from the prescriber to the pharmacy is acceptable in place of the original b. a resident of a
for which situation? skilled nursing
facility
a. any situation
b. a resident of a skilled nursing facility
c. an emergency situation
d. for terminally ill patients
63. A prescriber would like a patient to be able to obtain a three-month supply of a CII without d. all of the above
having to return to the office for new written prescriptions during that time frame. Which
are the legal options for the patient and the prescriber, assuming legitimacy is not an issue?

a. the prescriber can issue one CII prescription for a 3 month supply
b. the prescriber can issue 3 prescriptions, each for a 30-day supply. each prescription
except the first would specify the earliest date upon which the prescription can be filled
c. the prescriber can issue an electronic prescription for the CII medication at any required
time interval without the patient having to come to the office
d. all of the above
64. How may a prescription for a CIII drug be communicated to the pharmacy? d. all of the above

a. phone order
b. electronically
c. fax
d. all of the above
65. Which statement regarding a pharmacy reporting lost or stolen controlled substances is d. the pharmacy must report thefts
accurate? to the DEA and any losses that
were significant
a. the pharmacy must report the theft to the DEA, but not the loss.
b. the pharmacy must report all stolen and lost medications to the DEA.
c. the pharmacy must report any loss to the DEA, but may report to either the police or the
DEA
d. the pharmacy must report thefts to the DEA and any losses that were significant
66. Which statement correctly describes the written 222 form? b. the form contains 10 lines and
the purchaser must record on the
a. controlled substances may be ordered from schedules III - V form the number of the lines
b. the form contains 10 lines and the purchaser must record on the form the number of the completed
lines completed
c. only a pharmacist may complete and sign the form
d. all of the above
67. Which statement accurately describes pharmacy regulation? b. In the 20th century, pharmacists
organized themselves and
a. In the 19th century, pharmacists chose to self-regulate as retail merchants rather than developed clear systems of self-
healthcare professionals. governance.
b. In the 20th century, pharmacists organized themselves and developed clear systems of
self-governance.
c. States did not begin to regulate pharmacists by licensure until the 1960s.
d. All of these are correct
68. Most state pharmacy boards are composed of: c. pharmacists from different
practice settings
a. community pharmacists
b. hospital pharmacists
c. pharmacists from different practice settings
d. pharmacists elected by voters
69. What is the best advice for patients who ask you about getting their prescription a. Do business only with Internet
medications dispensed from an Internet pharmacy? pharmacies with the VIPPS seal.

a. Do business only with Internet pharmacies with the VIPPS seal.

b. All Internet pharmacies are in violation of federal law.
c. All Internet pharmacies are in violation of state law.
d. There is no problem doing business with an Internet pharmacy.
70. Which statement best describes continuous quality improvement laws? a. They are outcomes oriented.

a. They are outcomes oriented.

b. They typically do not protect records from discovery in negligence
actions.
c. They require that all dispensing errors be reported to the state board.
d. All of these are correct.
71. Mailem is a mail order pharmacy in Nevada that dispenses prescriptions c. The states can legally require Mailem to register
to patients in nearly every state. What regulatory authority do the states, with the state board and meet certain requirements
other than Nevada, have? that are not unduly burdensome.

a. The states have no authority to regulate Mailem.

b. The states can legally require that Mailem be licensed and conform to
the same requirements as pharmacies in that state.
c. The states can legally require Mailem to register with the state board
and meet certain requirements that are not unduly burdensome.
d. The states can impose stricter requirements on Mailem than it does on
in-state pharmacies.
72. A state pharmacy board revoked the license of a pharmacist in Arizona. b. The other state pharmacy board would likely
The pharmacist also held a license in another state and moved there to revoke the pharmacist's license; however, the
practice. Which statement is correct? pharmacist would be entitled to a hearing.

a. The other state pharmacy board would likely revoke the pharmacist's
license and the pharmacist would not be entitled to a hearing.
b. The other state pharmacy board would likely revoke the pharmacist's
license; however, the pharmacist would be entitled to a hearing.
c. The other state pharmacy board would not likely find out about the
revocation in Arizona.
d. The other state pharmacy board would not likely take any action
against the pharmacist's license even with knowledge of the revocation in
Arizona.
73. What best describes meals and other breaks for pharmacists? c. Many states require that employers allow
pharmacists a meal break, depending upon the
a. It has been established that providing work breaks does not reduce number of hours of the pharmacist's shift.
dispensing errors.
b. No state will allow a pharmacist to take a break away from the
pharmacy and leave the pharmacy open with only ancillary personnel in
the pharmacy.
c. Many states require that employers allow pharmacists a meal break,
depending upon the number of hours of the pharmacist's shift.
d. All of these are correct.
74. Why does society choose to license pharmacies and pharmacists? c. Protect the public.

a. Ensure the honesty and integrity of pharmacists.

b. Protect the profession.
c. Protect the public.
d. Increase healthcare costs.
75. A pharmacist is licensed and has been practicing in state A for three years. The pharmacist now b. The pharmacy may
wants to practice in state B. Which statement is correct? receive a license from state
A, through license transfer.
a. The pharmacist must take the NABLEX exam in state B.
b. The pharmacy may receive a license from state A, through license transfer.
c. The pharmacist may practice in state B using the license from state A.
d. The pharmacist must be licensed in state A for five years before practicing in another state.
76. A state board of pharmacy inspector found a pharmacy in violation of the law. The pharmacy was c. This violates the
sent a notice of violation within two weeks, with a fine. The notice provides that the pharmacy has pharmacy's due process
the option to pay the fine, or contest the violation, in which case the pharmacy could face license rights.
revocation or suspension. Which statement is correct?

a. This is legal, provided the board is following state law.

b. This is legal, even without a state law to the effect.
c. This violates the pharmacy's due process rights.
d. This is illegal, since boards cannot issue fines.
77. Which might a particular activity by a pharmacist be described as a standard of practice? d. It is an activity that most
pharmacists are expected to
a. It is prescribed by a law or regulation. perform.
b. It is not prescribed by a law or regulation.
c. It is prescribed by the code of ethics.
d. It is an activity that most pharmacists are expected to perform.
78. How do state laws and regulations apply to hospital pharmacy practice? b. Many state pharmacy
practice acts have not kept
a. Hospital pharmacy practice is so similar to community pharmacy practice that the laws and up to date with changes in
regulations are the same for each. hospital pharmacy practice.
b. Many state pharmacy practice acts have not kept up to date with changes in hospital pharmacy
practice.
c. Hospital pharmacies generally do not require licensure.
d. Hospital pharmacies are much more closely regulated than community pharmacies.
79. How has the Employee Income Security Act (ERISA) affected state efforts to regulate third party c. ERISA has hindered state
prescription insurance plans? efforts to regulate the plans.

a. ERISA has had little affect on state efforts to regulate the plans.
b. ERISA has enhanced state efforts to regulate the plans.
c. ERISA has hindered state efforts to regulate the plans.
d. ERISA does not impact state efforts to regulate the plans.
80. Which statement regarding state freedom of choice laws is correct? b. They allow any willing
pharmacy the right to
a. They are unconstitutional. participate in a third party
b. They allow any willing pharmacy the right to participate in a third party plan. plan.
c. They allow any willing patient the right to be a beneficiary in a health plan.
d. All of these are correct.
81. State pharmacy practice acts should focus on: d. All of these are correct.

a. structure requirements
b. process requirements
c. outcome requirements
d. All of these are correct.
82. What is the objective of licensure for pharmacists? a. To increase the quality of health care.

a. To increase the quality of health care.

b. To increase the cost of health care.
c. To promote self-governance of the profession.
d. To not distinguish between qualified and unqualified providers.
83. It is constitutional for a state to impose which restriction for d. All of these are correct.
pharmacy licensure?

a. The majority ownership of a pharmacy is by pharmacists.

b. Physicians may not own a pharmacy.
c. A pharmacy must designate a pharmacist-in-charge as
responsible for the pharmacy.
d. All of these are correct.
84. Which term is often used for state laws regulating the practice of c. Pharmacy Practice Act
pharmacy?

a. Licensing Act
b. Pharmacy Board Act
c. Pharmacy Practice Act
d. Pharmacy Licensing Act
85. What is a typical state requirement for pharmacist licensure? d. All of these are correct.

a. Graduate from pharmacy school

b. Attain a specific age
c. Demonstrate good moral character
d. All of these are correct.
86. Which statement about state pharmacy licensure exams is a. All states require licensure candidates to pass the NAPLEX
correct?

a. All states require licensure candidates to pass the NAPLEX.

b. All states require licensure candidates to pass the MPJE.
c. All states require licensure candidates to pass other exams,
such as a practical demonstration of ability.
d. All of these are correct.
87. What is a common justification for disciplinary action against a d. All of these are correct.
pharmacist at the state level?

a. Providing false information when applying for a license.

b. Being convicted of an act involving moral turpitude.
c. Engaging in unprofessional conduct.
d. All of these are correct.
88. Which statement about state-enacted continuous quality b. Pharmacies in states that have enacted CQI laws are
improvement (CQI) laws is correct? required to record, investigate, and act upon errors.

a. All states that have enacted CQI laws require error reporting to
the state board of pharmacy.
b. Pharmacies in states that have enacted CQI laws are required to
record, investigate, and act upon errors.
c. Pharmacies are provided no protection under state laws from
discovery in negligence actions for CQI reports.
d. States have ample resources to monitor CQI programs.
89. John is a pharmacist and an alcoholic who often drinks while in the pharmacy. In most states, the board of false
pharmacy has no alternative but to suspend or revoke John's license.

True or False
90. In addition to individual pharmacists being disciplined, license revocations, suspensions, and civil penalties true
may be assessed against the license of a pharmacy.

True or False
91. Pharmacist John did not advise the patient of a potential drug-drug interaction and the patient suffered c. negligence and
injury. If the patient sues, this is an example of: unintentional tort

a. negligence
b. intentional tort
c. negligence and unintentional tort
d. negligence and intentional tort
92. A pharmacist dispensed the wrong drug to a patient. However, the patient never took the drug but gave it a. Whether it was
to a family member who suffered harm. Had the right drug been dispensed, the family member would not foreseeable to the
have suffered this harm. The family member sued the pharmacist. What is the critical issue in this situation? pharmacist that
the patient would
a. Whether it was foreseeable to the pharmacist that the patient would have given the drug to the family have given the
member drug to the family
b. Whether the pharmacist breached a duty to the family member member
c. Whether the pharmacist has a duty to the patient
d. Whether the patient would have suffered harm had the patient taken the drug
93. A pharmacist left the pharmacy on a break and left the technician in charge with instructions not to fill any b. The pharmacist
prescriptions until he returned. Nonetheless, the technician filled and dispensed a new prescription to a might be found
patient. The drug was contraindicated for use in the condition that the patient suffered and the patient was liable even if he
injured. State law requires that the pharmacist be present in the pharmacy when a new prescription is had dispensed the
dispensed and requires direct supervision of a technician. What would happen if the court applied the drug.
doctrine of negligence per se in the lawsuit filed by the patient?

a. The technician would be liable, but not the pharmacist because he was not present.
b. The pharmacist might be found liable even if he had dispensed the drug.
c. The technician would be liable, but not the pharmacist because he told the technician not to dispense
any prescriptions.
d. The pharmacist would not likely be liable if he did not know the patient's condition
94. A pharmacist dispensed a drug refill to a patient without contacting the prescriber for authorization. The d. whether the
patient used the drug to commit suicide. The patient's estate sued the pharmacist. The central issue to be pharmacist was
decided in this case is: the proximate
cause of the
a. whether the prescriber would have authorized the drug had she been contacted suicide
b. whether the pharmacist owed the patient a duty of care
c. whether the patient would have committed suicide without the drug
d. whether the pharmacist was the proximate cause of the suicide
95. A pharmacist dispensed the wrong drug to a patient. The tablets looked different than the ones the b. The patient would not
patient had received before but the patient assumed a different generic was dispensed. After taking succeed because the act
a tablet the patient called the pharmacy to verify and was told the drug he received was the did not cause injury.
incorrect drug and to not take another. The patient suffered no injury but was so irate he sued the
pharmacist for negligence. What is the likely outcome of the lawsuit?

a. The patient would not succeed because he should have verified the drug before taking it.
b. The patient would not succeed because the act did not cause injury.
c. The patient would succeed because the pharmacist breached the duty she owed the patient.
d. The patient would succeed because this is negligence per se.
96. A pharmacy promoted its professional services, especially counseling and detecting potential drug c. The court would find
interactions. A patient received two prescription drugs at the pharmacy that together pose a very for the patient on the
high risk of a serious drug interaction. No one at the pharmacy detected the problem and the basis that the pharmacy's
interaction occurred, seriously injuring the patient and the patient sued. The state supreme court had promotional activities
ruled in an earlier case that pharmacists did not owe a general duty to warn patients. Based on the created a duty where
Baker case, what is the likely outcome of the lawsuit? one had not previously
existed.
a. The court would follow the state supreme court decision and find for the pharmacist.
b. The court would reverse the state supreme court decision and find for the patient.
c. The court would find for the patient on the basis that the pharmacy's promotional activities created
a duty where one had not previously existed.
d. The court would find for the patient on the basis that the interaction was foreseeable.
97. The learned intermediary doctrine states that manufacturers have a duty to warn _______ about B. Prescribers
warnings for adverse drug effects.

A. patients and prescribers

B. prescribers
C. pharmacists
D. patients
98. A patient was injured as the result of a prescription drug side effect. This side effect is listed in the c. the product is
package insert, but is not common. Assume the patient sued the pharmacist based on strict product defective and
liability and the court allowed the case to go to trial. The patient must prove that: unreasonably dangerous

a. the pharmacist breached the duty to the patient

b. the pharmacist-patient relationship is independent of the physician-patient relationship
c. the product is defective and unreasonably dangerous
d. the pharmacist failed to convey the manufacturer's warnings to the patient
99. The objectives of negligence law include: c. compensation

a. retribution
b. rehabilitation
c. compensation
d. All of these are correct
100. Harry sued pharmacist Mary for failing to advise him that the prescription drug he was prescribed d. The court decided that
and dispensed could cause tendon damage. Harry suffered extensive tendon damage and argued a pharmacist has no
that had he been aware of the potential for harm, he would have stopped taking the drug sooner and legal duty to advise
would not have suffered the harm. Why did the court award Mary summary judgment? patients of these types of
adverse risks
a. Harry could not prove that the drug actually caused the harm.
b. Harry could not prove that Mary did not advise him of the risks.
c. Mary proved that she did advise Harry of the risks.
d. The court decided that a pharmacist has no legal duty to advise patients of these types of adverse
risks
101. A pharmacist was very busy and typed the directions for the patient to take the drug four a. Yes, as a matter of law.
times a day instead of once per day. The patient followed the directions, was seriously injured
as a result, and sued. Is the pharmacist negligent?

a. Yes, as a matter of law.

b. The pharmacist may or may not be negligent, depending upon whether the pharmacist
acted reasonably and prudently.
c. No, on the basis of lack of foreseeability.
d. No, on the basis of lack of proximate cause.
102. Pharmacist Phil received an illegible prescription. Rather than calling the prescriber, Phil was c. Yes, because he did not call
pretty confident about which drug the prescriber intended, and dispensed the prescription. the prescriber.
Later, it turned out that Phil guessed incorrectly and the patient was injured. Did Phil breach
his duty to the patient?

a. No, it was the prescriber's fault.

b. No, not if it could be determined that a reasonable pharmacist would have guessed the
same way.
c. Yes, because he did not call the prescriber.
d. No, this is not the type of duty a pharmacist owes a patient.
103. What is the correct description of negligence per se? d. All of these are correct.

a. The statute establishes the standard of care.

b. The plaintiff must be in the class of persons the statute intended to protect.
c. The harm to the plaintiff must be the type that the statute intended to protect the plaintiff
from.
d. All of these are correct.
104. Pharmacist Polly dispensed the wrong drug to a patient. The drug prescribed was an analgesic, b. Yes, under the eggshell rule.
but the drug that Polly dispensed was a cardiac drug contraindicated in diabetes. The patient
was a diabetic and suffered injury. Had the patient not been diabetic, injury would not have
occurred. Is Polly liable in this situation?

a. No, because she did not owe the patient a duty.

b. Yes, under the eggshell rule.
c. No, because she did not breach her standard of care.
d. No, because a reasonable patient would not have been injured.
105. A jury determined that a pharmacist's negligent act caused the patient to be hospitalized and d. All of these are correct.
require home care for two years. The patient could not return to work for four years. Damages
likely owed by the pharmacist are:

a. medical expenses, including hospital and home care

b. lost wages for four years
c. for pain and suffering
d. All of these are correct.
106. Which statement about a jurisdiction that applies comparative negligence is correct? b. The percentage of fault by
the plaintiff would reduce the
a. Any negligence by the plaintiff would bar recovery of damages for the pharmacist's amount of damages to be
negligence. awarded by that percentage
b. The percentage of fault by the plaintiff would reduce the amount of damages to be
awarded by that percentage.
c. Any negligence by the plaintiff would not reduce the amount of damages to be awarded.
107. The package insert for a drug states that the risk of liver damage is extremely rare. A patient of d. No, based upon
Bill's Pharmacy nevertheless incurred liver damage from using the drug, and sued. Two years foreseeability.
earlier, the state supreme court held that pharmacists have a duty to warn. Did Bill have a duty
to warn the patient?

a. Yes, based upon his relationship with the patient.

b. Yes, based upon public policy.
c. No, based upon his relationship with the patient.
d. No, based upon foreseeability.
108. A pharmacist at DispensMor Pharmacy dispensed the wrong drug to a patient resulting in the d. All of these are correct.
patient's death. An investigation showed that the pharmacy had a history of errors, but did not
keep incident reports and made no effort to change its dispensing system to prevent errors
from occurring in the future. Which statement is correct?

a. DispensMor would likely be liable for the pharmacist's negligence under the doctrine of
respondeat superior.
b. DispensMor would likely be corporately negligent because of its dispensing system.
c. DispensMor would likely be liable for punitive damages.
d. All of these are correct.
109. A patient phoned the pharmacy saying she was just at her physician's office and the physician c. "I am sorry this happened
discovered she had been taking the wrong medication. She said her health had become so bad and I feel very badly for you.
that her physician was going to hospitalize her. How should the pharmacist respond? I will file an incident report.
Please keep us informed of
a. "I'm sorry, but I'm sure this is not our fault." your condition."
b. "I will investigate."
c. "I am sorry this happened and I feel very badly for you. I will file an incident report. Please
keep us informed of your condition."
d. "I cannot comment, but I wish you well."
110. A drug manufacturer marketed a drug for five years before studies discovered that the drug c. Neither those injured before
causes heart problems. As soon as the company discovered the adverse effect, it sent out or after the adverse effect was
warnings to all healthcare professionals and included the warning in its labeling. What would discovered would likely
happen if patients who used the drug and suffered heart problems sued the manufacturer under succeed.
strict liability?

a. Those who were injured before the adverse effect was discovered would likely succeed.
b. Those who were injured after the adverse effect was discovered would likely succeed.
c. Neither those injured before or after the adverse effect was discovered would likely
succeed.
d. Both those injured before and after the adverse effect was discovered would likely succeed.
111. If a patient sued a pharmacist under strict liability and the court applied the rationale of the c. Yes, on the basis that the
California Supreme Court, would the pharmacist win the case? pharmacist is an extension of
the physician and state law
a. Yes, on the basis that a pharmacy is not a retailer. provides that pharmacists are
b. Yes, on the basis that the prescription product is incidental to the provision of professional professionals.
services.
c. Yes, on the basis that the pharmacist is an extension of the physician and state law provides
that pharmacists are professionals.
d. Yes, on the basis that strict liability does not apply to professional services.
112. A pharmacist dispensed the wrong drug to a patient, which caused the patient a. Yes, as a matter of law.
serious harm. The drug dispensed and the drug prescribed have similar names. The
patient sued. Is the pharmacist liable?

a. Yes, as a matter of law.

b. No, because reasonable pharmacists make these types of errors.
c. No, if the pharmacist can prove that dispensing the wrong drug was not
foreseeable.
d. Yes, if the patient can prove the duty of a pharmacist is to dispense the right
drug.
113. The requirement under negligence law that a pharmacist must use the degree of c. duty
care that a reasonable and prudent person would use under similar circumstances
applies:

a. causation
b. damages
c. duty
d. statute of limitation
114. A pharmacist dispensed the wrong drug to a patient. The patient shared the drug d. All of these are correct.
with a friend, who was injured. Had the right drug been dispensed the friend
would not have been injured. What is the issue, if the friend sues?

a. Proximate causation
b. Foreseeability
c. Whether the pharmacist's negligent act has been severed by the act of the
patient
d. All of these are correct.
115. A jury determined that a pharmacist's negligent act caused the patient to be d. All of these are correct.
hospitalized and require home care for two years. The patient could not return to
work for four years. Damages likely owed by the pharmacist include:

a. medical expenses, including hospitalization and home care

b. lost wages
c. pain and suffering
d. All of these are correct.
116. For what reason would a court hold that pharmacists have a duty to warn patients b. Harm suffered by the patient should have
of a drug's dangers? been foreseeable by the pharmacist.

a. Patients rely primarily on the prescriber rather than the pharmacist for drug
information.
b. Harm suffered by the patient should have been foreseeable by the pharmacist.
c. Imposing the duty is in the best interests of pharmacists.
d. Prescribers do not have as much knowledge of drugs as pharmacists.
117. A court refused to apply a general duty to warn requirement on the defendant a. If the patient gave the pharmacy particular
pharmacy, but instead adopted a duty based upon special circumstances. information about a medical condition that, if
Applying this approach means that the pharmacy has a duty to warn the patient in used by the pharmacy, would have
which circumstance? prevented the harm

a. If the patient gave the pharmacy particular information about a medical

condition that, if used by the pharmacy, would have prevented the harm
b. If the patient was a regular patient of the pharmacy
c. If the pharmacy had a computer system that warned of drug-drug interactions
d. If the pharmacist regularly counseled patients
118. Under strict product liability, what is an accurate assumption about drugs? a. They are
unavoidably
a. They are unavoidably unsafe products. unsafe
b. If they cause harm they are defective. products.
c. They can always be made safer.
d. They are defective products even if properly manufactured and accompanied by proper warnings.
119. A court determined that an innovator drug manufacturer failed to change its labeling to warn of an adverse False
effect discovered post-market. The manufacturer argued that it complied with FDA labeling requirements and
could not change the label without FDA approval. An injured patient sued the manufacturer in state court under
strict product liability. The company's compliance with FDA labeling preempts the patient's product liability claim.

True or False
120. A court determined that a generic drug company failed to change its labeling to warn of an adverse effect True
discovered post-market. The manufacturer argued that it complied with FDA labeling requirements and could not
change the label without FDA approval. An injured patient sued the manufacturer in state court under strict
product liability. The company's compliance with FDA labeling would preempt the patient's product liability claim.
True or False